cyrilzakka/clinical-trials huggingface dataset:
Long-term Efficacy and Safety of Lamazym for the Treatment of Patients With Alpha-Mannosidosis

The overall objective is to evaluate the long-term efficacy, safety and tolerability of repeated Lamazym i.v. treatment in patients 5-21 years of age with alpha-Mannosidosis


Eligibility Criteria:
Inclusion Criteria:

* The subject must have participated in the phase 1 trial (EudraCT number: 2010-022084-36) and phase 2a trial (EudraCT number: 2010-022085-26)
* Subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject)
* The subject and his/her guardian(s) must have the ability to comply with the protocol

Exclusion Criteria:

* The subject cannot walk without support
* Presence of known chromosomal abnormality and syndromes affecting psychomotor development, other than alpha-Mannosidosis
* History of bone marrow transplantation
* Presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical conditions that, in the opinion of the Investigator, would preclude participation in the trial
* Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the trial.
* Pregnancy: Before the start of the treatment the investigators will decide whether or not there is a need for contraception. This assessment will be done through interviews with the patient and parents. The evaluation will be done continuously during the study
* Psychosis within the last 3 months
* Planned major surgery that, in the opinion of the investigator, would preclude participation in the trial
* Participation in other interventional trials testing IMP except for studies with Lamazym
The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly

Perioperative Neurocognitive Disorders(PND) is a common perioperative complication among the elderly, especially in the plastic surgery. Different anesthesia methods have different incidences of PND, but it's still unknow which is better between spinal anesthesia and nerve block combined with general anesthesia. We will apply a psychometric battery test which contain different cognitive domains to estimate the incidence of PND at a week a month and a year after surgery with different anesthesia methods. Study has showed that functional magnetic resonance imaging (fMRI) could detect a cognitive decline through spontaneous neuronal activity in the cortex and hippocampus. In our study, multi-mode imaging technology is used to conduct in-depth research on MRI and make correlation analysis with cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* aged 60-85years
* ASA I-III
* Received elective surgery of unilateral lower extremity orthopedics
* The anesthesia lasted more than 2 hours

Exclusion Criteria:

-
The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux

Recent studies have demonstrated that patients with throat-related reflux often require twice daily proton pump inhibitor therapy to attain significant symptomatic improvement, with once daily therapy offering little relief. As dexlansoprazole is a twice-daily release proton pump inhibitor requiring only once-daily dosing, it may provide laryngopharyngeal reflux (LPR) symptomatic relief comparable to that of twice daily dosing, yet be more readily approved by third party payers because of its once daily dosing requirements. It is hypothesized that, in patients with pharyngeal-probe proven throat reflux, there will be significantly greater improvement in symptoms and pharyngeal probe findings in those patients receiving dexlansoprazole than those receiving placebo alone.

The aim of the study is to compare outcomes, based on RSI-based symptomatic improvement and pharyngeal probe results, after LPR patients are treated for two months with once-daily (QAM) Kapidex versus placebo.Forty patients with pharyngeal pH probe-documented LPR and an elevated reflux symptom index (RSI) (≥14) will be enrolled into a double-blinded placebo controlled study. Twenty patients will receive Kapidex once daily, while twenty receive placebo. Patients will return at two months for evaluation with repeat RSI documentation and repeat pharyngeal pH probe testing. Student t-test will be used to determine if the change in RSI and pH-probe results differs between the study and placebo group.

Eligibility Criteria:
Inclusion Criteria:patients with an abnormal Restech pH probe study and also have an RSI of 14 or greater will be invited to participate in the study

Exclusion Criteria:known intolerance or allergy to proton pump inhibitors, hypersecretory conditions (Zollinger-Ellison), self-reported anxiety/depression (shown to affect RSI),16 history of laryngeal irradiation, or have been on twice daily Proton pump inhibitors (PPI) therapy for greater than 2 months without symptomatic relief (with an RSI ≥14)
Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia

This trial is going to evaluate the safety and effectiveness of intranasal DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia,and to investigate the optimal dose of intranasal DEX in breast lumpectomy.

Breast lumpectomy associated with a high level of anxiety, fear and pain requires fast and effective anaesthesia techniques. Presently, this procedure is usually performed under general or local anaesthesia. General anaesthesia provides an effective sedation; however, for minor procedures, general anaesthesia is resource-intensive and postoperative complications, such as nausea, vomiting or extended time to ambulation, are more likely. Local anaesthesia alone may be uncomfortable or uncooperative for patients. Therefore, an efficient drug regimen is required that reduces analgesic consumption, minimises opioid-related side effects and shortens post-anaesthesia care unit (PACU) stay following surgery.

Dexmedetomidine (DEX) is a highly selective α2 adrenoreceptor agonist that provides sedation without respiratory depression. Its sedative, anxiolytic, analgesic and haemodynamic effects have made it a useful adjunct to anaesthesia and sedation. DEX may provide a conscious sedation under monitored anaesthesia care (MAC) that is a logical middle ground between general anaesthesia and local anaesthesia. Intranasal DEX was recently shown to provide satisfactory anaesthesia and premedication sedation in healthy volunteers and paediatric patients. The intranasal route is not only effective, but also well-tolerated and convenient This trial is going to evaluate the safety and effectiveness of intranasal DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia, and to investigate the optimal dose of intranasal DEX in breast lumpectomy.

Eligibility Criteria:
Inclusion Criteria:

* with ASA(American Society of Anesthesiologists) physical status I and II
* scheduled for breast lumpectomy

Exclusion Criteria:

* a history of heart block
* upper respiratory tract infection
* asthma
* allergy to DEX or local anaesthetics
* memory or cognitive dysfunction
* pregnancy
* lack of understanding the consent process
* impaired liver or renal function
* a history of drug or alcohol abuse
Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa

Viral hepatitis kills nearly one million people each year, even though effective treatment exists. The aim of this study is to establish a treatment protocol for hepatitis B, which is simple and cheap enough to be implemented in resource-limited settings.

Chronic viral hepatitis is a major health problem globally. Each year nearly one million deaths are attributable to either hepatitis B or C. In Ethiopia 5-10% of the general population are infected with hepatitis B. Oral antiviral treatment of hepatitis B exists, but high costs and advanced laboratory requirements have been barriers to offer such treatment in resource-limited settings, resembling the situation in treatment of HIV/AIDS a decade ago.

The present study will investigate a simplified approach to hepatitis B treatment in resource-limited settings, inspired by the recent success of HIV treatment in such settings. The critical research question is how to identify patients with expected benefit of treatment in the absence of advanced laboratory support. A WHO expert panel recently suggested treatment criteria for use in settings without advanced laboratory facilities, but these criteria have not yet been tested out in real life. The present study will build on and develop the WHO approach to treatment of hepatitis B, aiming to develop a treatment protocol that can be feasible in other resource-limited countries. The potential public health benefit for poor people in low- and middle-income countries is substantial.

Eligibility Criteria:
Inclusion Criteria:

* Consenting adults (≥18 years) residing in Ethiopia who are HBsAg positive

Exclusion Criteria:

* Children \<18 years, other terminal disease (cancer etc.)
Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2011).

Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD) and may affect all segments of the digestive tract.

Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD) and may affect all segments of the digestive tract. These are diseases of multifactorial origin in which environmental and genetic factors are predominant.The EPIMAD registry, the world's largest epidemiological register for IBD, identifying all incident cases in the four departments of the North West of France showed between 1988 and 2007, an increase in the annual incidence of MC 71 % (6.5 / 105 (1988-1990) 11.1 / 105 (2006-2007) p \<0.0001) in the age group 10-19 years. At the same time, the annual incidence of UC decreased 4.3 / 3.5 105 inhabitants / 105 inhabitants (20%), with phenotypic presentation remained stable. The increase in the incidence of CD will contribute to increase its weight in the health system, particularly in the pediatric CD frequently associated with an aggressive phenotype causing specific complications such as malnutrition, pubertal delay or thrive. These complications have a important impact on the quality of life with a long-term risk of functional disability. They may be associated with increased mortality. Immunosuppressants (azathioprine, methotrexate) have been used in pediatric forms only from the 90s and anti-TNF antibodies (infliximab and adalimumab), until the 2000s. These new therapeutic classes have profoundly changed the management of pediatric IBD. Although there is little data on the impact of these new treatments, early introduction of immunosuppressive and anti-TNFs seems to influence the natural history of IBD diagnosed in pediatric age. Anti-TNFs appear to be associated with more frequent and deeper remission. With the advent of these new treatment, new therapeutic targets such as endoscopic mucosal healing and more recently the deep remission combining clinical remission, biological and endoscopic, appears. However there is no data in the general population assessing the impact of new treatments and new therapeutic strategies in the pediatric population. Potential risks associated with the increasing use and early use of biological treatments in this particular population remain to be determined in the general population.

The main hypothesis of this study is that changes in therapeutic strategies in IBD diagnosed before 17 yeras old could influence the cumulative incidence of surgical resection and complications specific to this population as failure to thrive and delayed puberty, insertion socio-professional, the extension of the disease, hospitalization rates, and the rate of cancer.

Eligibility Criteria:
Inclusion Criteria:

Patients in the pediatric cohort EPIMAD registry with a diagnosis of CD or UC or probable between 1988 and 2011.

Exclusion Criteria:

* None
Real-World Data Study of Troriluzole-Treated Patients With Spinocerebellar Ataxia (SCA) Compared to a Matched Natural History Control

The purpose of this study is to leverage two sources of real-world data (RWD) to assess the effectiveness of troriluzole after three years of treatment in patients with SCA by comparison to an external control of untreated patients who were followed in a natural history cohort.

Real world evidence of effectiveness will be assessed from the RWD sources to examine the treatment effects of toriluzole in SCA out to 3 years. Progression rates of SCA differ by genotype and long-term follow-up is needed to assess for potential efficacy in this rare disease.

This study comprises multiple sources of RWD including: 1) the Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA/US SCA Natural History cohort; 2) the European Integrated Project on Spinocerebellar Ataxias (EUROSCA/European SCA Natural History Cohort); and 3) the 3 year OLE data from troriluzole treated subjects in Study BHV4157-206 (NCT03701399). Each participant of the study will have their efficacy and/or safety data collected as pre-specified in the original protocols from the RWD sources.

The effectiveness of troriluzole in SCA after 3 years of treatment from the long-term, open-label extension from Study BHV4157-206 will be compared to external control subjects collected from CRC-SCA (US SCA Natural History cohort) and EUROSCA (European SCA Natural History Cohort). A propensity score matching (PSM) analysis will be utilized to create equipoise across groups being examined in the analysis.

The primary outcome will be change from baseline in the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA). Another endpoint examined will be a newly developed and validated composite endpoint for SCA, the Spinocerebellar Ataxia Composite Score (SCACOMS).

Eligibility Criteria:
Key Inclusion Criteria for troriluzole-treated participants (BHV4157-206):

* Between the ages of 18-75
* Genetic confirmation of the following specific hereditary ataxias: SCA1, SCA2, SCA3, SCA6, SCA7, SCA8, and SCA10
* Screening f-SARA total score of ≥3 and score of ≥1 on gait item of the f-SARA.
* Ability to ambulate 8 meters without human assistance (canes and other devices were allowed)
* Subjects initially randomized to troriluzole

Key Inclusion Criteria for participants selected from the natural history studies:

* Between ages of 18-75
* CRC-SCA: either a genetic confirmation or a diagnosis of SCA 1, 2, 3, 6, 7, 8, and 10 in themselves or a family member; EUROSCA: genetic confirmation of SCA genotypes 1, 2, 3 and 6.

Key Exclusion Criteria for troriluzole-treated participants (BHV4157-206 study):

* Screening f-SARA score of 4 on any item of the f-SARA
* Any other medical condition that could predominantly explain or contribute significantly to the subjects' symptoms of ataxia or that could confound assessment of ataxia symptoms

Key Exclusion Criteria for participants selected from the natural history studies:

• Treatment with troriluzole
Analysis of Changes in Blood Glucose Spinal Epidural Nerve Block with Steroids in Patients with Low Back Pain

This study aims to investigate the effect of different doses of dexamethasone used in epidural nerve block procedures on blood sugar levels. Patients with spinal conditions such as stenosis or disc herniation will be enrolled. Blood glucose and HbA1c levels will be measured before the procedure, and participants will use continuous glucose monitoring devices for 2-3 days before the procedure. They will be randomly assigned to one of three groups: no dexamethasone, 5mg dexamethasone, or 7.5mg dexamethasone. Blood glucose will be monitored for one week after the procedure, and follow-up will be done two weeks later to assess pain and blood sugar data. This study will help determine how steroid doses affect blood sugar, especially in elderly patients, and provide more accurate information than previous studies.


Eligibility Criteria:
Inclusion Criteria:

* patients need to epidural steroid injection for treating back pain
* patients diagnosed with diabetes or prediabetes.

Exclusion Criteria:

* Patients with poorly controlled blood sugar.(HbA1c\>8.5)
Intraocular Lens Power Calculation for Combined Phaco-vitrectomy Procedures

The aim of the study is to evaluate the degree of refractive error postoperatively in combined procedures and to calculate a new constant in order to improve current state of the art biometry calculations.

The IOL power calculation in combined phaco-vitrectomy has been performed similar to that in cataract surgery alone. In patients who undergo combined phaco-vitrectomy, deviations in refractive outcomes may be observed because of possible errors in measurement of axial length, changes in the properties of the vitreous cavity after removal of the vitreous, or intraocular tamponade. Most of the previous studies have reported variable degrees of myopic shift after phaco-vitrectomy for diabetic retinopathy, epiretinal membrane, and macular hole. Furthermore, use of intraoperative gas may increase further the risk of anterior displacement of the intraocular lens which may induce a higher myopic shift. However, these publications did not provide any quantification of the spherical deviations nor calculate any specific constant in order to improve currents state of art biometry calculations.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo a combined procedure with phacoemulsification and pars plana vitrectomy

Exclusion Criteria:

* Sulcus fixation of the IOL, sulcus suture of the IOL, or intra-scleral IOL fixation because of intraoperative posterior capsule rupture
* corneal disease, such as keratoconus, that interfered with refractive results
* IOL implantation with a toric IOL or multifocal IOL
* History of previous vitrectomy or corneal transplantation
* Other coexisting ocular disease such as proliferative diabetic retinopathy, advanced age-related macular degeneration, uveitis, acute retinal necrosis, Coat's disease, proliferative vitreous retinopathy, or trauma
* Intraocular tamponade using silicon oil
A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting

The purpose of this study is to prospectively compare a standard of care manual toileting protocol (e.g., "check and change" strategy) to toileting patterns recorded by the TENA Identifi system in identifying incontinence patterns and events, and, whether such data differentially improve a care planning strategy, nursing effort, product use, and wet-time for urinary incontinence.

Urinary incontinence in nursing homes influences resident dignity and quality of life. It also drives significant use of healthcare resources, including time and caregiver assistance, and costs of care. Various toileting programs are used to address urinary incontinence, including habit training, bladder training, prompted voiding, and check and change procedures. Clinical trials have found that 33% to 60% of residents either became continent or reduced the frequency of incontinence episodes to less than one per day with the introduction of a prompted voiding program.

There are several drawbacks to current programs. Manually recorded wet checks do not identify when incontinence occurs, only when wetness is detected, reducing the precision of time of incontinence to the window of time between checks. Nursing home staff create individualized care plans for each resident, based on standard check and change procedures, but poor precision in ascertaining timing and quantity of incontinence episodes can contribute to less frequent resident toileting or changing.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females 55 years of age or older with stable clinical status
2. Long-stay status (more than 90 days)
3. Ambulatory and able to use a toilet either independently or with assistance
4. Minimum Data Set (MDS) Level 1 (occasionally), 2 (frequently) or 3 (always) rating of incontinence
5. Currently wearing disposable briefs for urinary incontinence

Exclusion Criteria:

1. Chronically bed-bound (MDS G0110A rating 8)
2. MDS self-performance rating of 4 (total dependence) for toilet use
3. Fecal incontinence (MDS H0400 rating 0)
4. Use of urinary appliance such as catheters or ostomies (MDS H0100 Z)
5. Private duty nurse care
6. Residents who tear at clothing or disposable undergarments
7. Current urinary tract infection receiving treatment
8. Current diarrhea receiving treatment
9. Residents who are not likely to benefit from a toileting plan based on assessment of nursing staff
Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects

This Phase I, open-label, randomized, 3-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be determined. Participants will be randomized to one of six treatment sequences to receive three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females, between 18 and 55 years of age, inclusive
* Body mass index between 18.5 and 29.9 kg/m\^2, inclusive

Exclusion Criteria:

- Clinically significant findings from medical history or screening evaluations.