cyrilzakka/clinical-trials huggingface dataset:
The Lighthouse Tenofovir Cohort Study

Lighthouse, in cooperation with the University Heidelberg Public Health Institute and the University Köln (Cologne) would like to set up a cohort to study baseline characteristics and long-term clinical outcomes of patients using Tenofovir based Antiretroviral Therapy at the Lighthouse. As of March 2014, patients above 18 years and giving informed consent coming to the Lighthouse to newly initiate ART will be approached to enroll in the cohort.

The results will be disseminated both nationally at the Ministry of Health Technical Working Group (TWG), at the annual Research Dissemination and Best Practices conferences of the College of Medicine and National AIDS Commission as well as internationally. The results will also be written up for publication in appropriate peer-reviewed journals.

The proposed observational cohort study will lead to improved identification of patients with virological failure and adverse drug effects, improved identification of relevant co-morbidities and result in better individual management. More importantly however, the results will allow estimates for the proportion of the described complications in the overall Malawian treatment cohort. This claim can be exemplified by the retrospective analysis of patients at the Lighthouse who were switched from the new 5A regimen to 6 A regimen as a result of adverse effects of Efavirenz.

The aim of this study is to describe baseline clinical characteristics and long-term outcomes of patients using Tenofovir based antiretroviral therapy at the Lighthouse Clinics. The specific objectives are outlined below:

Objective 1: To determine the prevalence of renal dysfunction at enrolment and during follow-up among adult HIV-infected individuals starting ART.

Objective 2: To determine the prevalence of Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infections among adult HIV-infected individuals starting ART and during treatment follow-up.

Objective 3: To determine the prevalence of non-communicable co-morbidities during treatment follow-up of HIV-infected individuals starting ARTand during treatment follow-up.

The study will take place at the Lighthouse, a tertiary referral ART centre, with over 25,000 patients, in Lilongwe, Malawi. Considering the study cost and power to detect a prevalence of 22% for renal impairment, we expect to have a convenience sample size of at least 850 patients at the end of three year follow-up period. The current retention at three years is almost 56%. Using this retention, we will therefore enrol almost 1,500 patients starting ART.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Able and willing to give informed consent
Dose-finding Study of MT-1303

The primary objectives of the study are:

* To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters
* To evaluate the safety and tolerability of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with RRMS.


Eligibility Criteria:
Inclusion Criteria:

* RRMS as defined by the revised McDonald criteria
* Evidence of recent MS activity defined as either:

  * at least one documented relapse in the previous 12 months, OR
  * a positive gadolinium (Gd)-enhanced MRI scan within 3 months prior to screening, OR
  * at least two documented relapses in the previous 24 months with a positive Gd-enhanced MRI scan within the previous 12 months
* Expanded Disability Status Score (EDSS) score ≥0.0 and ≤5.5 points.

Exclusion Criteria:

* Primary progressive, secondary progressive or progressive relapsing MS at screening
* Disease duration \>15 years combined with an EDSS score ≤2.0
* Relapse of MS during the Screening Period
* History or known presence of other neurological disorders likely to render the subject unsuitable for the study
* History of any of a list of pre-defined cardiovascular diseases
* History or known presence of any significant central nervous system, infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study
* Previous exposure to any sphingosine 1-phosphate receptor modulator
* Receipt of a live vaccine or systemic corticosteroid use within 28 days prior to randomisation
* Previous treatment with beta-interferons or glatiramer acetate within 14 days prior to randomisation
* Previous treatment with intravenous immunoglobulin, plasmapheresis, certain immunosuppressants, lymphocyte-depleting therapy, total body irradiation or bone marrow transplantation
* Need, or likely need for, treatment with Class I or III anti-arrhythmic drugs or with heart-rate-lowering beta-blockers or calcium-channel blockers, or with any other drugs which can reduce the heart rate
* Evidence of significant anaemia, thrombocytopenia, leucopoenia or lymphocytopenia, renal or hepatic impairment
* Clinically significant electrocardiogram (ECG) findings.
Impact of Anesthesia on the Dimension of the Ascending Aorta

The aim of this study is to evaluate the accuracy and reliability of intra-operative TEE after the induction of anesthesia when assessing proximal thoracic aorta diameters in a cohort of aortic aneurysm patients.

Dilatation of the ascending aorta often progresses silently in an asymptomatic patient, until an acute complication occurs (such as a dissection or rupture), which is directly related to the diameter of the aortic. To prevent these extremely harmful situations, aortic replacement surgery, as indicated by significant dilatation of the ascending aorta, could be the option of choice (1). The decision to perform elective surgery depends on the measurement of the thoracic aorta diameter, which would rely on the largest aortic dimension. Trans-thoracic echocardiography (TTE) is widely used to assess the aortic root (2), and results from computed tomography (CT) scans are used to evaluate the ascending aorta beyond the sinotubular junction (3, 4). Both these tests facilitate follow-up evaluation of patients with thoracic aortic aneurysm. Usually, patients are referred for surgery based on the findings of one or both of these examinations. Furthermore, when a patient is referred for surgery, intra-operative trans-esophageal echocardiography (TEE) is often performed after induction of the anesthesia in order to evaluate the aortic dimension and valve function.

In some cases, the diameter of the aorta is considered borderline for replacement, in which case the TEE measurement could reverse the decision-making, especially when the indication for surgery is due to valve pathology, with the aorta being a secondary consideration.

From the investigators experience, intra-operative TEE aortic measurements after the anesthesia are not entirely accurate, and could under-estimate the diameter of the aorta. Relying on intra-operative TEE measurements could result in under-treatment of the dilated aorta, especially when its replacement is secondary to other cardiac pathologies (e.g. AVR, CABG) that require surgery.

Influence of intra-operative anesthesia on TEE measurements of the aorta are not described in the current literature. If the investigators hypothesis is correct, adjustments will need to be made regarding the surgical management of patients with borderline aortic dimensions.

Eligibility Criteria:
Inclusion Criteria:

* Ascending aorta of 40 mm and above
* Patients who undergo cardiac surgery

Exclusion Criteria:

* Unstable patients
* Patients who underwent a previous cardiac surgery
* Patients who were diagnosed with aortic dissection
Carbon Dioxide Laser Treatment in Burn-related Scarring

This study evaluates the effect effect of ablative fractional CO2 laser (AFCO2L) on burns scar appearance and dermal architecture at 6 weeks and up to 3-years post-treatment. Half of the scar will receive AFCO2L and half the scar will receive standard care.

Ablative fractional CO2 laser (AFCO2L) is emerging as a promising scar treatment for burns patients. Fractionated delivery of CO2 laser treatment leaved columns of undamaged skin to quickly re-epithelialize and has reduced the previously higher risk profile of unfractionated ablative laser delivery in terms of permanent pigmentation changes, higher rates of infection and scarring. The exact mechanisms of CO2 laser action are still unclear, but likely involve a combination of macroscopic ablative fenestration, microscopic thermal collagen alteration and molecular profile alterations.

Use of AFCO2L for scar management is increasing amongst burn clinicians; consensus opinion and several large series have demonstrated safe and effective result, however robust randomised controlled evidence for the efficacy of CO2 laser on burns scarring is still lacking.

Eligibility Criteria:
Inclusion Criteria:

* Minimum burn injury scar area of 10x10cm
* Vancouver Scar Scale (VSS) score of \>5
* ≥6 months following injury
* Patient age 18+ years

Exclusion Criteria:

* Current pregnancy or lactation
* Patients unable to consent (dementia or another cognitive dysfunction)
* Non-English-speaking patients
* Scars on the face or hand (these anatomical areas were considered to be of significant aesthetic and functional importance and thus excluded from the trial )
Very Low Birth Weight Preterm Infant Bundled Care in the NICU

The purpose of this study is to explore the impact of bundling nursing care activities on the overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a Level IV Neonatal Intensive Care Unit (NICU). The study will evaluate differences in infant health when diaper changes occur at 3- versus 6-hours during 3-hour bundled care. Differences in infant skin health between 3- and 6-hour bundled care diapering at two sites (buttocks and chest) will also be evaluated.

Preterm infants' growth and developmental outcomes vary with illness severity and degree of neurological insult and unpredictable variations in outcomes exist even among healthy preterm infants. The variations in preterm infants' outcomes have led to the supposition that the neonatal intensive care unit (NICU) environment may negatively impact the health and development of these infants and significant research has been devoted to examination of light, noise, and caregiving interventions. Consequently, many NICUs have implemented neuroprotective strategies to reduce over simulation, promote sleep and facilitate brain development in high-risk infants including the grouping of care activities around a single caregiving event described as "clustering" or "bundling care". Yet, the number and type of caregiving activities that are included in bundled care and the timeframe between bundled care events has not been systematically studied. The inclusion and exclusion of certain care activities in any individual care event is often dictated by the infant's treatment plan or needs, but some activities like diapering may be optional. Understanding the impact of when to include optional, yet stress provoking interventions, will allow us to minimize overall environmental stress in hospitalized very low birthweight (VLBW) infants. Therefore, given the lack of data around bundled care, the investigators aim to explore through a randomized controlled design the impact of bundling diaper care activities on overall health of VLBW preterm infants. The investigators will include a focus on skin health because it is important to understand the benefits of decreased infant stress and any potential skin health trade-offs associated with longer versus shorter time between diapering care. Findings from this study will allow us to better understand the relationship between neonatal skin health while providing developmentally appropriate bundled care.

Eligibility Criteria:
Inclusion Criteria:

1. Must be participating in the Intensive Care Nursery standard 3-hour bundled care
2. Must wear a breathable diaper
3. Must be ≤ 32 weeks gestation at birth and weigh ≤ 1500g at birth.
4. Infants are expected to remain hospitalized for at least 4 weeks

Exclusion Criteria:

1. Neonatal Abstinence Syndrome
2. Humidified incubator
3. Diaper rash
4. Pre-existing or genetic skin conditions
5. Use of barrier creams
6. Severe illness requiring 1:1 nursing care: e.g. minimal stimulation protocol, high frequency ventilation, vasopressor drug support, or body cooling.
Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

A pterygium is a fibrovascular growth originating from the conjunctiva that grows onto the surface of the cornea. Frequently, these pterygia will recur even after surgical resection. Bevacizumab is an inhibitor of angiogenesis, which is needed for recurrent growth. The use of bevacizumab is poorly understood in inhibiting pterygium growth. The objective of this study is to compare the effects of wound healing and recurrence rates in postoperative bevacizumab versus pterygium excision alone.

This is a prospective trial. Thirty-one patients with a primary pterygium of at least 2 mm in size and without any previous ocular surgery will be included. Outcome measures will include best corrected visual acuity, intraocular pressure, recurrence, and any sight threatening complications at two weeks, two months, and six months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* any patient 18 years of age or older with a primary pterygium that extends at least 2 mm past the limbus

Exclusion Criteria:

* history of glaucoma
* previous ocular surgery
* steroid-response glaucoma
* previous myocardial infarct
* bleeding disorder
* pregnancy
* lack of patient cooperation
A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea

The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.


Eligibility Criteria:
Inclusion Criteria:

* 6 months to 12 years old
* Diagnosed with recurrent acute otitis media or chronic otitis media with effusion
* Must be first set of ear tubes.
* Patient may not have had any other previous otologic-related surgery.
* Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
* Patient may not have existing perforation of the eardrum.
* Patient must not require another surgical procedure other than myringotomy and tube insertion.
* Patient may not be a menarchal female
* Diabetic patients are not eligible
* Patient may not have any disease or condition that would negatively affect the conduct of the study
* Patient may not require any other systemic antimicrobial therapy during the study.
* Patient must meet certain medication washouts to be eligible
* Analgesic use (other than acetaminophen) is not allowed
* Patient may not be pre-disposed to neurosensory hearing loss
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Age
* Other protocol-defined exclusion criteria may apply
Familial Analysis of Keratoconus Risk

The principal objective of this study is to evaluate the frequency of KC inside family of patients with confirmed KC.

It's a familial, epidemiological, prospective, single-center study.

Keratoconus is a common bilateral progressive corneal ectatic disease causing visual impairment by inducing irregular astigmatism and corneal opacities. This disorder typically begins during teenage years, progresses until the age of 30 to 40 years and, in severe forms, may need a corneal transplantation.

Currently, keratoconus has not known etiopathogenesis, and it is difficult to detect subclinical forms.

Several risk factors seem to be implied, environmental and genetic : the risk of keratoconus in case of familial history of keratoconus isn't well known at that time, but seems to be important to consider to promote screening and follow up of patient with a familial history of keratoconus (KC).

Eligibility Criteria:
Inclusion Criteria:

Case :

* patient carrier of keratoconus
* more than 7 years
* patient who didn't expressed opposition as for computerization and use of data concerning him

Family of case

* to have a first degree family member (father, mother, brother, sister, child) carrier of keratoconus
* more than 7 years
* patient who didn't expressed opposition as for computerization and use of data concerning him

Exclusion Criteria:

* ocular pathology or antecedent of modification of cornea (surgery, traumatism, ocular hypertension, keratitis) which could interfere with topographical analysis
* wearing of rigid contact lens for 15 days before exams, or flexible lens for 5 days before exams
Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage

The DRAIN trial is an international multi-centre, 1:1 randomised, parallel-group, superiority clinical trial investigating gradual weaning vs. prompt closure of external ventricular drainage in patients with hydrocephalus following aSAH.

The primary objective is to investigate the beneficial and harmful effects of gradual weaning versus prompt closure of EVD treatment in patients with aSAH.


Eligibility Criteria:
Inclusion criteria

* \>= 18 years of age
* Diagnosis of aneurysmal subarachnoid haemorrhage (aSAH)
* External ventricular drain (EVD) for \>= 6 days
* Drain output of =\< 220 mL on day of randomisation
* Drain resistance of 10 or 15 cm H2O
* Stable or improving Glasgow Coma Scale (GCS) \>= 9 during the last 24 hours
* Signed informed consent (from patient or next-of-kin)

Exclusion criteria

* None-tolerability of an increase of resistance to 10 cm H2O due to clinical deterioration or an increase in ICP
* Severe pre-existing (physical or mental) disability or severe co-morbidity that would lead to poor outcome even if the patient made a full recovery from the aSAH
* Life expectancy shorter than 48 hours after admission
Atomoxetine and Huntington's Disease

The purpose of this research study is to evaluate the effect of atomoxetine (also known as Strattera) compared to placebo (inactive substance) on daily activities such as attention and focus, thinking ability and muscle movements in subjects with early Huntington Disease (HD) and attention deficit disorder (ADD).

No medications have been investigated to improve attention and executive functions in patients with Huntington's disease, despite the evidence that these cognitive domains can be abnormal even before motor symptom onset. Because cognitive symptoms are highly associated with functional disability, treatments aimed at improving cognitive functions would be of significant benefit to patients in the early stages of the disease. Atomoxetine is the ideal choice for such a trial. It has proven efficacy in adults with attention deficit hyperactivity disorder (ADHD) and it selectively targets norepinephrine and dopamine in the prefrontal cortex rather than in subcortical areas. This selectivity is an advantage for patients with HD, because motor side effects are less likely to be facilitated than with a psychostimulant. The present study is a feasibility study in which we propose to administer either 80 milligram (mg) atomoxetine for 4 weeks or placebo to 20 patients with early HD who also complain of mild cognitive symptoms. The groups will then crossover to the other condition (atomoxetine or placebo). Participants will be assessed on measures of ADHD symptoms and a sensitive battery of neuropsychological tests. Based on the shared neural circuitry in ADHD and HD, and the demonstrated effectiveness of atomoxetine on attention in adults with ADHD, improved performance on cognitive tests of attention and executive functions and on subjects' report of ADHD symptoms are expected in the atomoxetine treatment phase. No changes in motor status are predicted during the study.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed Huntington's disease (HD) diagnosis
* Age 18 to 65
* Must have mild HD
* Must have complaints of poor attention

Exclusion Criteria:

* Childhood history of attention deficit hyperactivity disorder (ADHD) symptoms
* Diagnosis of schizophrenia, bipolar affective disorder, dementia, delirium or severe anxiety
* Current use of a monoamine oxidase inhibitor (MAOI) medication
* Pregnancy
* Uncontrolled hypertension
* Tachycardia
* Cardiovascular or cerebrovascular disease
* History of a loss of consciousness for greater than (or equal to) 5 minutes
* Having any neurological disorder or insult other than Huntington disease
Cemented TrendHip® - Multicenter PMCF Study on Total Indications

This Post Market Clinical Follow-Up (PMCF) study to evaluate the performance and safety of the cemented TrendHip® stem in a prospective follow-up study with patients who underwent a hip arthroplasty with the investigational product (representative of usual clinical practice), at two follow-up examinations


Eligibility Criteria:
Inclusion: Inclusion criteria

* Patient older than 18 years.
* Patient who undergo / underwent a hip arthroplasty with cemented TrendHip® femoral stem according to the indications for implantation specified in the Instructions for Use.
* Patient not opposing participation in the study.

Exclusion: Exclusion criteria

* Patient with shortened life expectancy.
* The patient is unable to commit to the planned follow-up period.
Investigation of Stem Cells in Human Lipoaspirate

The overall purpose of this study is to enhance identification and isolation of ADSCs and adipocytes, to find the optimum culturing conditions to increase growth and volume of grafts, and to study the effects of cryopreservation on ADSCs and adipocytes. Fat injections are used in aesthetic surgery but tend to disassemble over time. If the investigators can enhance growth and volume of fat in culture, the investigators could use fat grafts in reconstruction of cancer and traumatic injury defects with the patients own cultured fat cells and grafts.


Eligibility Criteria:
Inclusion Criteria:

* All adults (18-70 yrs) who have scheduled surgical lipectomy of the hips, abdomen, or thighs are prospective subjects for this study.

Exclusion Criteria:

* Pregnant women will be excluded to protect the unborn child.
Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer

This study collects blood samples to determine if the DNA of HPV that causes cervical cancer can be detected in patients with cervical cancer that is new (primary), has come back (recurrent), or has spread to other places in the body (metastatic) and are undergoing treatment with surgery, radiotherapy, chemotherapy, and/or immunotherapy. Researchers may use this information to predict response (good or bad) of the cervical cancer to treatment and detect recurrent cancer sooner.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written consent
* Patient has given permission to give tumor/blood sample for research testing
* Histological confirmation of adenocarcinoma, adenosquamous, or small cell carcinoma of the cervix
* Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV
* Willingness to return to enrolling institution (Mayo Clinic Rochester or the University of Minnesota) for follow-up (during the Active Monitoring Phase of the study) or complete blood draws locally using study mail-in kits
* Consent to allow blood specimens to be shared with Mayo Clinic study personnel and potential external collaborators for sample analysis
* Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC)

  * FIGO 2019 Stage IB2-IIIC or not a surgical candidate
  * Plan to undergo definitive chemoradiotherapy including external beam radiotherapy, brachytherapy, and chemotherapy

Exclusion Criteria:

* Other active malignancy =\< 2 years prior to registration.

  * EXCEPTIONS: Non-melanotic skin cancer
  * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer
* Pregnancy or lactation
* Inability on the part of the patient to understand the informed consent to be compliant with the protocol