cyrilzakka/clinical-trials huggingface dataset:
Dynamic MRI of the Behaviour of Female Pelvic Floor

The purpose of this study was to test the suitability of dynamic magnetic resonance imaging for the pelvic floor floor, bladder neck and urethra in healthy volunteers, in stress incontinent patient and in women with genital prolapse.

Traditional methods for evaluation of urinary incontinence in women include urodynamics, cystourethroscopy, cystourethrography and ultrasonography.Magnetic resonance imaging (MRI) offers a new tool for evaluation of morphology and function of the urogenital compartment of the female pelvis. Moreover, MRI gives opportunity to study function of the pelvic floor organs in terms of mobility and reactions during different physiological and provocative activities.

The aim of the present study was by means of dynamic MRI to evaluate the behaviour of the mid-urethra, bladder neck, cervix and rectum in different maneuvers in three different study groups. Sixteen healthy volunteers with no complaints of urinary symptoms or urogenital prolapses, 42 stress urinary incontinence patients and 16 women with third degree genital prolapse were examined respectively.

Eligibility Criteria:
Inclusion Criteria:

* healthy women without any urogenital symptoms
* stress urinary incontinence ( group II )
* genital prolapse of third degree ( group III)

Exclusion Criteria:

* previous incontinence or prolapse surgery
* lower urinary tract anomaly
* current UTI or \> 3 UTI episodes within the past year
* previous radiation therapy of the pelvis
* active malignancy
* neurogenic disease which can be associated with bladder disorders
* patient unable to understand the purpose of the study
* patient immobile
Clinical Study on Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed Glioblastoma

This is a prospective, single-center, open-label, 3+3 dose escalation Phase 1 safety study. Adults with newly diagnosed GBM or gliosarcoma will receive macitentan in addition to the standard of care treatment for GBM. The study consists of a screening period, a treatment period, and a 30-day safety follow up period. The treatment period includes 6 weeks of concurrent therapy (macitentan+RT+TMZ), 4 weeks of monotherapy (macitentan) and 12 cycles of maintenance therapy (macitentan+TMZ). The study will end when the last treated subject has completed study treatment and the 30-day safety follow-up period.

The planned duration of the study is approximately 34-38 months depending on the number of dose levels and cohorts of subjects enrolled. Subject participation in the study will be for approximately 16 months.


Eligibility Criteria:
Inclusion Criteria:

* Subjects at least 18 years of age
* Histologically proven supratentorial GBM or gliosarcoma
* Use of effective contraception by women of childbearing potental.
* Use of effective contraception by fertile males with a female partner of childbearing potential.
* Interval of at least 3 weeks after biopsy or open surgery and able to begin study treatment.
* Result from a post-operative contrast-enhanced brain MRI within 72 hours after surgery or biopsy.
* Adequate bone marrow function
* Karnofsky Performance Score of at least 70.

Exclusion Criteria:

* Prior treatment for glioblastoma or gliosarcoma.
* Evidence of leptomeningeal spread of glibolastoma or gliosarcoma.
* Tumor foci below the tentorium or beyond the cranial vault.
* Evidence of recent hemorrhage on post-operative contrast enhanced brain MRI (except hemosiderin, resolving hemorrhage changes related to surgery, presence of punctuate hemorrhage in tumor).
* Aspartate aminotransferase or alanine aminotransferase \> 3 times the upper limit of normal.
* Supine systolic blood pressure \< 100 mmHg or diastolic blood pressure \< 50 mmHg.
* Medical history of orthostatic hypotension.
* International normalized ratio \> 1.5 on anticoagulant therapy, active bleeding on low molecular weight heparin, or chronic condition with a high risk of bleeding.
* Severe renal impairment.
* Severe hepatic impairment.
* Severe, active co-morbidity: (e.g. cardiac disease; respiratory disease; chronic hepatitis; hemtological and bone marrow diseases; severe malabsoprtion; human immunodeficiency virus).
* No concurrent strong CYP3A4 inducers or inhibitors.
* No investigational drug within 4 weeks of starting study treatment.
* Any life-threatening condition that could affect protocol compliance.
Evaluation of EndoRefix Endovascular Delivery System and Staple

This study is intended to provide data to verify safe delivery of a staple previously intended for use in open surgical procedures. A newly modified delivery system will provide endovascular access for implantation of a staple during endovascular graft procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female \>21 years of age
2. Undergoing endovascular stent grafting for AAA repair
3. Post endovascular stent grafting where stent stabilization is necessary due to stent fixation failure and/or persistent endoleak.

Exclusion Criteria:

1. Pregnant
2. Religious, cultural or other objection to the receipt of blood, or blood products.
3. Unwilling to comply with follow-up schedule
4. Unwillingness, or inability to provide informed consent to both trila and procedure
5. Ruptured Aneurysm
6. Area where staple is to be placed has significant loose thrombus associated with it
7. Acute or chronic aortic dissection or mycotoc aneurysm
8. Allergy to device materials
9. Allergy to or intolerance to use of contrast media or cannot be exposed to suitable remedial treatment such as steroids and/or diphenhydramine.
10. Clinically and morbidly obese such that imaging would be severely adversely affected.
11. Uncorrectable bleeding abnormality
12. Inflammatory aneurysm
13. Connective tissue disease (e.g., Marfans syndrome, Ehlers Danlos syndrome)
14. Patients with PTFE grafts
15. Patients with investigational grafts (i.e., those grafts that are not FDA approved)
Fixed-schedule Benzodiazepine Dosing vs Based on a CIWA-Ar Alcohol Protocol in Alcohol Detoxification.

Does the use of a symptom-triggered therapy (with assessment making use of a CIWA-Ar scale) decrease the total amount of benzodiazepines given to patients with alcohol dependence and are less patients still dependent on benzodiazepines on their departure in comparison with the use of a fixed-schedule dose of benzodiazepines?

Methodology This study will be a retrospective study using administrative and clinical patient data of patients presenting for alcohol detoxification at the Psychiatry department of the Universitair Ziekenhuis Brussel. Two periods in the data will be compared. One period will be consisting of patient data before 2013 when the hospital still used the fixed-schedule dosing of benzodiazepines. The other period will be consisting of patient data after 2013 when the hospital switched to the symptom-triggered prescription of benzodiazepines.

Inclusion \& Exclusion criteria Inclusion criteria are patients with the age of 18 years or older who were treated for alcohol .dependence at the UZ Brussel in one of the periods stated above. The criteria for exclusion were found in the literature and include pregnancy, use of central nervous system (CNS) depressant agents, history of dementia, acute psychosis, and severe hepatic dysfunction (15-18). Comorbid benzodiazepine dependence. A history of severe epilepsy on withdrawal,... Outcomes The main outcome measures will be the total amount of benzodiazepines given during the hospital stay, whether the patient is still dependent on benzodiazepines when leaving the hospital, the length of the hospital stay, and some baseline patient characteristics. These patient characteristics will include age, sex, race/ethnic group, primary reason for hospitalization, body mass index (BMI), blood alcohol level (BAL) on admission, international normalized ratio (INR), diagnosis of co-morbid psychiatric disorder, history of other substance abuse, indicators of withdrawal severity (e.g. CIWA-Ar, tremor, seizures), discharge medications, benzodiazepine dose administered (15-18).

Eligibility Criteria:
Inclusion Criteria

* patients who were treated for alcohol dependence at the UZ Brussel in one of the periods stated above.

Exclusion Criteria:

pregnancy, use of central nervous system (CNS) depressant agents, history of dementia, acute psychosis, and severe hepatic dysfunction. Comorbid benzodiazepine dependence. A history of severe epilepsy on withdrawal,...

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Influence of Glidescope Assisted Endotracheal Intubation on Intraocular Presure

Tracheal intubation with traditional Macintosh laryngoscope is associated with increase in intraocular pressure along with tachycardia and hypertension. These effects are not desirable in ophthalmic patients especially in patients with glaucoma. GlideScope video laryngoscope system is a new approach for laryngoscopy and tracheal intubation. It does not require a direct line of sight to the glottis when intubating with the Glidescope and as a result intubation is much less stimulating to the patient. Therefore GlideScope video laryngoscope assisted intubation could be a preferable technique for intraocular surgery offering advantages in terms of intraocular pressure and cardiovascular stability.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1 or 2 with normal intra-ocular pressure.

Exclusion Criteria:

* history or occurrence of difficult intubation.
* presence of previous anterior segment pathology.
* previous intraocular surgery.
* patients with history of glaucoma.
* brain pathology and other neurological disorder which might affect to their intraocular pressure.
Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families

The purpose of this study was to explore the potential for directly targeting smoking cessation, regardless of motivation level, in a subsample of neonatal intensive care unit (NICU) parents with the ultimate goal of reducing secondhand smoke (SHS) in their homes.


Eligibility Criteria:
Inclusion Criteria:

* Eligible mothers of any age or ethnic background must have an infant that is at least 1 week prior to the estimated date of hospital discharge in the NICU (ensuring time for the intervention)
* report that a household resident smokes at least 5 cigarettes per day, on average, within the 2 months preceding the screening visit
* agree to attend intervention sessions
* live within 50 miles of our center
* and have access to a telephone

Exclusion Criteria:

* Mothers were ineligible if they met criteria for severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol
* were unable to read, write, and speak English
* were unable or unwilling to provide signed consent for participation
* and were unable or unwilling to meet study requirements for data collection and intervention purposes.
* Within the month immediately preceding the screening visit, use of any form of tobacco or nicotine products other than cigarettes (e.g., e-cigarettes, chewing tobacco, etc.) on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study
* Current use of NRT or enrollment (or plans to enroll) in another smoking cessation program in the next 3 months
* Uncontrolled hypertension (systolic blood pressure \[SBP\] greater than 180 or diastolic blood pressure \[DBP\] greater than 110)
* History of severe cardiovascular (stroke, heart attack), kidney (e.g. chronic or acute kidney failure) or liver disease, or other unstable disease in the last 3 months
* History of hypersensitivity or allergic reaction to NRT or similar chemical classes or any component of these formulations (including allergy to latex)
Effects of Home Based Exercise Therapy in Early Cirrhosis

Individuals with Cirrhosis have been shown to have a low aerobic capacity. While supervised exercise training has been shown to be an effective intervention to remedy this, there is currently no data on home based exercise interventions in this population. This study will evaluate the effects of a home based exercise program on the aerobic capacity of enrolled early stage liver cirrhosis patients, as well as changes in quality of life, thigh muscle thickness, and thigh muscle oxygen consumption.


Eligibility Criteria:
Inclusion Criteria:

- Age \>18 and less than or equal to 70 years Liver Cirrhosis Child Pugh Class A or B If required, primary or secondary Variceal prophylaxis in place

Exclusion Criteria:

- Post-liver transplantation Hepatocellular carcinoma beyond transplant criteria Active non-hepatocellular carcinoma malignancy Significant cardiac disease Hemoglobin (\<80 g/L) Oxygen saturation at rest \<95% Known myopathy Chronic renal failure on dialysis Physical impairment making it impossible to ride an exercise bike or treadmill Orthopedic abnormality preventing exercise training HIV infection Patient unwilling to consent to study Child Pugh class C
Parent Education for Young Teen Females

The study has the potential to improve understanding of the link between early alcohol and sexual initiation and to provide a proven, selective, female-focused intervention for addressing these risks. The goal is to set young women on a course that protects their health and reduces the burden that problem drinking and HIV disease is taking on African American and Latino communities.

The aims of this study are to to characterize and address the combined risks of early alcohol use and early sexual initiation within a population of urban African American and Latina adolescent females who are at high risk for HIV, AIDS, and other STI. Past research by the investigative team has documented that nearly 10% of females in our target population have initiated sex by fall of 7th grade and more than half have done so by spring of 10thgrade. Although alcohol use is more comparable with national figures, the combination of early alcohol and early sexual initiation is troubling, yet under-addressed by existing interventions. We will develop and test an intervention that builds upon a promising strategy for influencing adolescents: parent education. Three parenting mechanisms shown to influence adolescent risk behavior are targeted: parental monitoring, household rule setting, and communication. Informed by a community advisory board and a series of focus groups, a set of three audio-cds for parents of young adolescents will be developed. Through dramatic role-model stories, these CDs will help parents address alcohol prevention and the link between early alcohol use and sexual initiation and risk taking. Families and middle school daughters will then be enrolled into a randomized pilot test of the intervention's efficacy. Parent and student surveys will be conducted at baseline and 3-month post-intervention follow up to assess whether the intervention is beneficial in terms of promoting positive parenting practices, positive attitudes toward healthy behaviors, and reducing girls' risks.

Eligibility Criteria:
Inclusion Criteria:

* 8th grade girls and parents at participating schools

Exclusion Criteria:

* Non-English speaking
Does Subacromial Injection With Glutamate Receptor Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?

The hypothesis of the present study is that in patients with rotator cuff tendinopathy a specific pharmacological blocking of peripheral glutamate-receptor N-methyl-d-aspartate receptor type1 (NMDAR) glutamate receptors will result in pain alleviation. Activated NMDAR1 has been demonstrated to be crucial for pain regulation in various pain disorders, and in biopsies from patients with tendinopathy, NMDAR1 was found to be activated.

To test this hypothesis a specific NMDA receptor antagonist, ketalar (ketamine), will be injected guided by ultrasound into the subacromial space in patients with rotator cuff tendinopathy, and subsequently the pain response will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of rotator cuff tendinopathy by exercise-related shoulder pain with positive impingement tests as described by Hawkins and Neers, and MRI findings consistent with tendinopathy.
* Symptom duration at least 1 year to ensure neuronal ingrowth and NMDAR expression

Exclusion Criteria:

* previous surgery in any shoulder.
* previous cortisone use, either as injections or orally
* symptoms or signs of cervicobrachialgia or polyneuropathy
* full thickness rotator cuff ruptures verified by MRI
* primary inflammatory mediated pain, hence, patients with glenohumeral arthrosis, glenohumeral arthritis or systemic disorders predisposing for arthritis
* a central component of pain perception manifested by radiating pain in the involved limb; implying worse outcome after subacromial decompression.
* pregnancy
* breastfeeding
* reduced liver function (Increased serum bilirubin, ASAT or ALAT), decompensated heart failure (NYHA class 3-4)
* increased intracranial pressure or disease of the central nervous system (CNS)
* chronic alcoholism
* epilepsy
* psychiatric disease, increased intraocular pressure
* acute intermittent porphyria
* hyperthyroidism
* use of thyroid hormones
* upper respiratory tract infections
* pneumonia
* intracranial lesions
* acute head injuries
* ocular injuries
* hydrocephalus
* risk factors predisposing for intra-articular bleeding
* increased risk of infection
Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste Keratoconus

Primary objective of this study was evaluate the diagnostic capacity of fourier analysis of keratometric data in differentiating moderate KC and FFK from healthy corneas.

Study participants were recruited from the Cornea Outpatient service in a consecutive if eligible basis. Two study groups were formed: a)KC group included patients those were diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system, b) FFK group (FFKG) that included patients diagnosed with FFK, and c) Control group (CG) was formed by refractive surgery candidates. Pentacam (Pentacam HR, Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were performed by the same experienced operator in a consistent way.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of keratoconus KC in the fellow eye according to the Amsler-Krumleich criteria (FFKG)
* KISA index between 60 and 100% in the FFK eye (FFKG)
* lack of any KC-related findings / signs in the slit-lamp biomicroscopy (FFKG)
* uneventful ophthalmologic history (CG)
* no indications of corneal pathology in slit-lamp biomicroscopy and Placido \*disk-based videokeratography (CG)
* KISA index value less than 60% (CG)
* diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system (KCG)

Exclusion Criteria:

* for all study groups:

  * previous incisional eye surgery
  * corneal scars and opacities
  * history of herpetic keratitis, severe eye dryness
  * pregnancy or nursing
  * current corneal infection
  * glaucoma
  * suspicion for glaucoma
  * IOP lowering treatment
  * underlying autoimmune disease
Feasibility of an Immersive Virtual Reality Based Biofeedback Intervention for Outpatients in Rheumatology

The purpose is to study the use of virtual reality (VR) and biofeedback in rheumatology clinics to help manage chronic pain in patients with rheumatologic diseases. The objective is to know the usefulness of VR/biofeedback-based therapy in the clinic.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with Rheumatoid arthritis, Systemic Lupus Erythematosus, Seronegative Spondyloarthropathy, Myositis, Psoriatic Arthritis, vasculitis or other autoimmune conditions.
* Patients must be on a stable regimen of medications.
* Patients should have pain, measured at the time of entry using a Visual Analog scale, of \>5/10 at least 4 days in the last 30 days

Exclusion Criteria:

* Patients who are deemed by the study team to be unable to use the VR headset and follow instructions for any reason.
* Patients who have a history of vertigo and/or dizziness
* Patients with a history of seizure disorder
Nutritional Status and Its Modifications After Hip Replacement

Data literature lacks of evidence concerning the variation of the nutritional status in patients undergoing hip surgery, thus preventing an effective application a nutritional support program. It is therefore necessary to start identifying the clinical steps (pre-operative and post-operative) that may be defined as critical control points for malnutrition. The observation should foresee the identification of nutritional status indicators, such as weight, hemoglobin, albumin, food intake, and others that might affect a proper recovery. This study aims to investigate the prognostic nutritional factors that might influence clinical outcomes, and their variation in relation to hospitalization and rehabilitation periods.

Data literature lacks of evidence concerning the variation of the nutritional status in patients undergoing hip surgery, thus preventing an effective application a nutritional support program. It is therefore necessary to start identifying the clinical steps (pre-operative and post-operative) that may be defined as critical control points for malnutrition. Patients undergoing hip surgery would be enrolled before the surgical operation and would be evaluated three times: preoperative, postoperative, and after discharge. The observation should foresee the identification of nutritional status indicators, such as weight, hemoglobin, albumin, food intake, and others that might affect a proper recovery. This study aims to investigate the prognostic nutritional factors that might influence clinical outcomes, and their variation in relation to hospitalization and rehabilitation periods.

Eligibility Criteria:
Inclusion Criteria:

* caucasian
* arthroplasty intervention program with hip prosthesis placement
* signature and acceptance of informed consent to collaborate in all the procedures necessary for the study

Exclusion Criteria:

* heart failure stage III-IV
* renal failure stage III-IV
* actual cancer
* past neurological disorders (including, but not limited to cerebral ischemia, cerebral haemorrhages, brain tumors, endocranial aneurysms)
* neurodegenerative disorders (including, but not limited to Alzheimer's dementia, fronto-temporal dementia)
* actual major psychopharmacological therapies
* pregnancy certified by self-declaration
* inability to adhere to the rehabilitation protocol or to carry out the controls
* non-acceptance of informed consent
* revision interventions
* previously established and documented sleep disorders
* shift or part-time worker