cyrilzakka/clinical-trials huggingface dataset:
An Open-Label Evaluation of the Independent Effects of Coadministration of a High-Fat Meal and Naltrexone Blockade on the Pharmacokinetic Profile of Dilaudid OROS (Hydromorphone HCI) 16mg

The purpose of this study was to compare the pharmacokinetic (the way a drug enters and leaves the blood and tissues over time) profile of Dilaudid OROS 16mg (Dilaudid Slow Release; hydromorphone HCL) administered under fasting conditions, following a high-fat breakfast meal. The study also examined the effect of naltrexone blockade on the pharmacokinetic profile of Dilaudid SR.

This was a randomized (patients are assigned different treatments based on chance), open-label, three-way crossover study, performed in normal, healthy adults. Each patient received orally administered treatments (a different treatment during each dosing phase): Treatment A: single dose of Dilaudid SR 16 mg administered under fasting conditions without the naltrexone block;Treatment B: single dose of Dilaudid SR 16 mg administered under fed conditions without the naltrexone block, Treatment C: single dose of Dilaudid SR 16 mg administered under fasting conditions with naltrexone HCL 50mg block (3 oral doses of 50mg each administered 12 hours prior to , at the time of, and 12 hours after Dilaudid SR 16mg administration). There was a 7-day washout period between dosing phases.

Venous blood sampling times were 0 (prior to dosing),2,4,6,8,10,12,16,20,24,30,36,42,and 48 hours after each Dilaudid SR administration. LC/MS/MS (Liquid Chromatography/Mass Spectroscopy/Mass Spectroscopy)techniques were employed for the analysis of plasma for hydromorphone concentration. Each patient randomly received orally-administered treatments of single dose of Dilaudid SR 16mg; under fasting conditions without the naltrexone block; under fed conditions without naltrexone block; under fasting conditions with naltrexone 50mg block (3 oral doses of 50mg naltrexone HCL each administered 12 hours prior to, at the time of, and 12 hours after hydromorphone administration); 7-day washout period between dosing phases.

Eligibility Criteria:
Inclusion Criteria:

* Patients were non-smoking, healthy volunteers with body weights between 135 and 220 pounds and within + - 10% of their recommended weight range for their height and body frame according to the 1984 Metropolitan Height and Weight Tables
* A negative baseline urine drug screen for cannabinoids, opiates, cocaine, ethanol and barbiturates.

Exclusion Criteria:

* Patients intolerant of or hypersensitive to hydromorphone or naltrexone
* Patients with any gastrointestinal disorder that may affect the absorption of orally administered drugs
* Patient with depressed respiratory function
* Patient with impaired renal or hepatic function
* Patients with dependence to opiates
* Pregnant or breast feeding
* Female Patients of childbearing potential must have a negative pregnancy test each week prior to administration of study drug and required to be following a medically recognized contraceptive program prior to and during the study.
Evaluation of T1rho Magnetic Resonance Imaging for Diagnosis of Cartilage Lesions in Hips With Developmental Dysplasia

One of the leading causes of hip arthritis is developmental dysplasia of the hip (DDH). DDH can lead to major damage in the hip joint and may result in hip arthritis later in life. Patients recruited into this study will be undergoing corrective hip surgery within the next 6 months with a goal of preventing further hip problems down the road. This study is being done to see how well a newer type of Magnetic Resonance Imaging (MRI) detects hip cartilage damage compared to an older but well validated MRI method.

The start of arthritis can first be detected in certain molecules in the joint. Proteoglycan is a molecule that is important to cartilage structure, and is lost as arthritis develops. Magnetic resonance imaging (MRI) is one of the best ways to image cartilage, and an investigational MRI technique that has shown great promise in detecting proteoglycan amounts is called T1-rho.

In this study, patients with hip dysplasia will undergo this investigational MRI in addition to a well validated MRI method (called dGEMRIC) to see if T1-rho is as good as dGEMRIC at detecting cartilage damage. The dGEMRIC MRI requires an injection of a contrast agent, while the T1-rho MRI does not. If the T1-rho is shown to be as useful as the dGEMRIC method it can then be used to look at cartilage damage in the hip without having to have an injection.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of developmental dysplasia of the hip (DDH)

Exclusion Criteria:

* patients under the age of 18
* pregnancy and/or lactation
* non-MRI compatible implants (stents, electronic devices, cardiac pacers or wires)
* severe claustrophobia
* prior contrast allergic reaction
* kidney impairment
* previous hip surgery
* osteoarthritis on conventional radiographs (Tönnis Grade\>0)
* additional underlying hip diseases such as posttraumatic arthritis, Legg-Calvé-Perthes-Disease (LCPD), or slipped capital femoral epiphysis (SCFE)
Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants

Feeding intolerance is a common problem in preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with birth weight equal or less than 1500 g

Exclusion Criteria:

* Significant congenital malformations
* Severity of illness such that death is likely in the first few days after birth
The Healthy Options Feasibility Study

The investigators hypothesize that having health care providers other than physicians within a "Groupe de Médecine de Famille" conduct cardiovascular risk assessments and teach lifestyle interventions to primary prevention patients will increase the likelihood that patients will adopt and maintain healthy lifestyles. These objectives will be supported by providing subjects with a cardiovascular risk profile estimating the subject's risk of cardiovascular disease and teaching them how to use the resources related to lifestyle changes available on the www.myhealthcheckup.com Web site.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 30-79 years of age without known cardiovascular disease but with one or more risk factors such as obesity, a sedentary lifestyle, dyslipidemia, hypertension, cigarette smoking, or diabetes
* Have provided informed consent
* Recent (past 6 months) fasting lipid profile results in the medical charts

Exclusion Criteria:

* Unable or unlikely to follow and/or complete study or evidence of uncooperative attitude
* Subject is not literate in either French or English
* Subject does not have easy and regular access to the Internet
* Exercise or weight loss are contra-indicated for medical reasons
Assessing Fall Risk Using Transcranial Magnetic Stimulation and Quantitative Sensory Testing

The elderly are at high risk of falls due to neurophysiological changes, such as motor and sensory impairment, that occur with aging. The incidence of falls in older adults is high, with approximately 30% of adults over the age of 65 falling at least once per year. Falls can lead to serious consequences such as fractures, hospitalization, and loss of independence. The changes in neurophysiology have also been found to decrease balance control in aging people, leading to postural instability. It is well-known that postural balance is influenced by sensory inputs, including touch, proprioception, vision, and vestibular, as well as motor output such as motor controls. Impairments in these systems contribute to postural instability and an increased risk of falling in the elderly.

The data collection will be arranged in the same order. Practice trials will be provided before the start of the data collection. The entire data collection session will take approximately 90 minutes. Data collection will be conducted for both the baseline and the 3-month follow-up.

The data collection will include:

1. Demographic information such as age, sex, body height, body weight, body mass index, medical history, medical diagnosis, body composition, and the MoCA (Montreal Cognitive Assessment).
2. Neurophysiological assessments such as electromyography and Quantitative Sensory Testing (QST).
3. Functional tests such as the Timed up and go test and Chait stand test.

Eligibility Criteria:
Inclusion Criteria:

1) Male and female individuals aged 65-80 years.

Exclusion Criteria:

1. History of previous lower limb surgery, such as total knee replacement or ankle surgery.
2. History of a neurological disorder, such as stroke or Parkinson's disease.
3. History of vestibular disease, such as Meniere's disease.
4. History of seizures or epilepsy.
5. The presence of metal implanted devices in or around the head area
6. MoCA score \< 26
The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia

Evaluation of a one session VR - enhanced Video exposure therapy for dental phobia. Diagnosed dental phobics will be randomly assigned to one of two conditions: (1) Psychoeducation + VR exposure (2) Psychoeducation + Video Control treatment. Prior to getting the therapy, participants will be evaluated with a questionnaire battery, diagnosed with a structured clinical interview and will participate in a psychophysiological symptom assessment. Then, after a 2-week waiting period, participants again fill in questionnaires, and the Intervention will take place. Within 2-weeks after the second questionnaire assessment participants will be screened with the structured interview again and will fill in questionnaires.


Eligibility Criteria:
Inclusion Criteria:

- diagnosed Specific Dental Phobia

Exclusion Criteria:

* Schizophrenia or other Psychotic Illnesses
* Bipolar Disorder
* Chronic Headache
* other neurological disorders such as epilepsy
* Hearing problems
Validation of a Mobile Phone Based on EPRO Tool in Subjects With Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) may involve a variety of organ systems expressed differently from patient to patient, and so can be difficult to characterize clinically. Patient reported outcomes (PROs), which consist of feedback directly from patients regarding their symptoms without interpretation by a clinician, are typically used in SLE to supplement other clinical measures. Standard PROs typically used in SLE include the 36-item short form health survey (SF-36), the functional assessment of chronic illness therapy - fatigue (FACIT-F), and the patient global assessment (PtGA), administered by paper or electronic tablet during the clinic visits. The recent development of electronic mobile device technology, such as the smartphone, has made it possible to collect PRO information away from the clinical site in the subject's environment. This study will assess by measurement equivalence testing whether data collected via a smartphone are comparable to that collected in standard fashion and whether PROs obtained in the subject's environment may be more informative than that collected in the physician's office on paper.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent
2. Males or females, aged 18 years or older
3. Classification of SLE by either the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics Classification (SLICC) criteria
4. On a stable SLE treatment regimen consisting of any of the following medications for a period of at least 30 days prior to Screening

   * Corticosteroids (\<30 mg prednisone or equivalent per day)
   * Hydroxychloroquine or equivalent anti-malarial
   * Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil or sodium), cyclophosphasmide, belimumab, calcineurin inhibitors (e.g. tacrolimus, cyclosporine)
5. Willing to perform and comply with all study procedures, including attending clinic visits at Baseline, Month 1, and Month 2 as scheduled

Exclusion Criteria:

1. Rapidly progressive neurologic disease
2. Cognitive dysfunction that might interfere with the capacity to use the ePRO device
3. Any condition that might in the investigator's opinion might preclude completion of the study
4. Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 1 year prior to Screening
5. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not caused by SLE (e.g., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the Investigator, could confound the results of the study or put the subject at undue risk.
Onstep Versus Lichtenstein, the Onli Trial.

The objective of this study is to evaluate chronic pain and sexual dysfunction after inguinal hernia repair involving mesh fixation with sutures (Lichtenstein) compared with no mesh fixation (Onstep). The study hypothesis is that a smaller proportions of patients operated without mesh fixation (Onstep) will have chronic pain that impairs daily function.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnose of a primary groin hernia that requires surgical intervention.
* Eligible for procedure performed under general anesthesia

Exclusion Criteria:

* Not able to understand Danish, written and spoken.
* Emergency procedures
* Previous inguinal hernia on ipsilateral side.
* ASA score more than 3.
* Incarcerated or irreducible hernia.
* Local (site of surgery) or systemic infection.
* Contralateral hernia being operated at the same time or planned operated during follow-up.
* Other abdominal hernias being operated at the same time or planned operated during follow-up.
* Previous surgery that has impaired the sensation in the groin area.
* BMI \> 40 or \< 20.
* Daily intake of alcohol \>5 units, 1 unit = 12g pure alcohol.
* Known disease that impairs central or peripheral nerve function.
* Concurrent malignant disease.
* Impairment of cognitive function (e.g. dementia).
* Chronic pain that requires daily medication.
* Mental disorder that requires medication.
Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting

Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe hemophilia A in patients who have not yet received treatment for their hemophilia. Study subjects will be males less than 6 years old who have not taken any clotting factor or other blood products before the study. The safety and effectiveness of ReFacto AF will be determined in this study by tests and procedures done at the doctor's office.

Regulatory Commitment

Eligibility Criteria:
Inclusion Criteria:

* Male subjects \<6 years of age with severe hemophilia A (FVIII:C \<1%) based on clinical records, including newborns.
* No prior exposure to factor products or any blood products.

Exclusion Criteria:

* Presence of any bleeding disorder in addition to hemophilia A.
* Treatment with any investigational agent or device within the past 30 days.
* Any condition(s) that compromises the ability to collect study-related observations, or that poses a contraindication to study participation (these conditions include, but are not limited to, inadequate medical history to assure study eligibility; and expectation of poor adherence to study requirements).
Oral Care With 3% Hydrogen Peroxide (Oroxid®) in ICU - Effects on the Lower Airway Microbial Colonisation

HyPerMICROBE is a single-centre, controlled, randomised, prospective, superiority clinical trial to compare the efficacy of daily oral care with 3% hydrogen peroxide (Oroxid®) versus standard of care (0.2% chlorhexidine digluconate) on the cumulative incidence of lower respiratory tract microbial colonisation in mechanically ventilated adult critically ill patients.

Rationale: Ventilator-associated pneumonia (VAP) is the most common hospital-acquired infection (HAI) in the intensive care unit (ICU), and its impact is very high in terms of morbidity, length of hospital stay and overall costs. Chlorhexidine for oral care in critically ill has no clear impact on VAP rates and may cause harm. 3% hydrogen peroxide (Oroxid) could be a promising substitute.

Aim: To test effectivity and safety of 3% hydrogen peroxide solution on ventilator-associated complications

Design: Prospective, single center, parallel group randomised controlled trial. Subjects: ICU patients (general ICU)

Treatment in the intervention group: daily oral care with 3% hydrogen peroxide

Control group: Standard-of-care protocolised daily oral care with 0,2% chlorhexidine

Primary outcome: Cumulative incidence of lower respiratory tract microbial colonisation analysed by Kaplan-Maier method, censored in the case of ICU discharge or extubation \> 24h.

Secondary and exploratory outcomes: Differences in the relative risk of infection related ventilator-associated complications, antibiotic (ATB) consumption analysis, intraoral complications, reported using the Bedside oral exam (BOE) score, validated and adopted for ICU, length of ICU stay in days (time frame: at 3 months), number of ventilator-free days (time frame: at 28 days); that is, number of days, out of 28 days after admission, that patient has not been supported by mechanical ventilation

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. In-patient of ICU and expected to stay \> 5 days
3. Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation (MV) ≥ 72h
4. Clinical Pulmonary Infection score (CPIS) less than 6 at the baseline
5. No history and symptoms of aspiration at the baseline

Exclusion Criteria:

1. ATB therapy of respiratory infection on admission
2. Suspected pulmonary infection on admission and in the first 48h of mechanical ventilation
3. Pregnancy
4. Oral ulcers or injuries
5. Patient with a history of hydrogen peroxide allergy
IBER Salvage Treatment Followed by Ibrutinib Maintenance for Relapsed or Refractory PCNSL

This is a multicenter, single-arm, prospective phase II study to evaluate the efficacy and safety of a novel combination regimen for relapsed/refractory PCNSL. Specifically, ibrutinib will be administered in combination with ifosfamide, etoposide and rituximab (IBER) as a salvage chemotherapy, which is followed by maintenance ibrutinib monotherapy of fixed duration.

Given the limited activity of salvage therapy with high-dose methotrexate re-treatment and/or alkylator-based treatment in patients with relapse or refractory PCNSL, the development of novel salvage chemotherapy regimen remains an area of clinical unmet need.

Ibrutinib, an oral inhibitor of bruton tyrosine kinase (BTK), is known to induce death of diffuse large B-cell lymphoma (DLBCL) cells with dysregulated B-cell receptor (BCR) signaling and has shown promising activity in patients with a variety of B-cell malignancies. Recently, several studies reported that ibrutinib may have an excellent single-agent clinical activity against relapsed or refractory PCNSL. Furthermore, proven pharmacokinetic data suggested that ibrutinib successfully penetrated the BBB and reached the achievable concentration in cerebrospinal fluid. When ibrutinib is administered in combination with BBB-destructing chemotherapeutic agents (such as, temozolomide or etoposide) for salvage treatment of PCNSL, therefore, anti-lymphoma activity of ibrutinib could be maximized.

In this context, this phase II study is designed to evaluate the efficacy and safety of IBER salvage chemotherapy followed by ibrutinib maintenance for transplant ineligible patients with relapsed or refractory PCNSL.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed PCNSL of CD20+ diffuse large B cell lymphoma (DLBCL)
* PCNSL relapsed or refractory after frontline methotrexate-based chemotherapy (with or without radiation therapy)
* At least one measurable lesion, which is defined as longest diameter of lesion \> 0.5 cm, by contrast-enhanced MRI
* ECOG performance status 0-2
* Normal function of major organs

Exclusion Criteria:

* PCNSL other than DLBCL
* Primary ocular lymphoma
* PCNSL accompanied by systemic involvement
* Active infection with hepatitis B or C virus
* Known history of human immunodeficiency virus (HIV) infection
* Therapy with myelosuppressive chemotherapy or biologic therapy \< 21 days prior to registration
Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina

In this study the investigators will use careful scientific blinding of patient and their subsequent healthcare staff so that the investigators can determine exactly how much difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6 weeks blinded phase, all patients will be unblinded and the patients who had undergone sham procedure will be offered the active therapy.

The investigators will perform a multi-centre prospective randomised double-blinded comparison of the treatment of stable angina with percutaneous coronary intervention (PCI) and optimal medical therapy (OMT) versus a sham procedure and OMT. Two hundred patients with stable angina and one or more angiographically significant coronary stenosis of 70% or more in a single vessel that is suitable for angioplasty will be recruited. Baseline investigation of functional capacity and myocardial ischaemic burden will be performed. This will be followed by a coronary angiogram and invasive physiological investigation followed by randomisation to PCI or a sham procedure. Follow-up investigation of functional capacity and myocardial ischaemic burden at 6 weeks will then be performed.

Eligibility Criteria:
Inclusion Criteria:

* Stable angina and at least 1 lesion with angiographic stenosis ≥70% in a single vessel suitable for stent implantation

Exclusion Criteria:

* Acute coronary syndrome
* Previous coronary artery bypass graft surgery
* Left main stem disease
* Contraindications to PCI or drug-eluting stent (DES) implantation
* Heavily calcified or tortuous vessels
* Chronic total occlusion in target vessel
* Life expectancy \<2yr
* Pregnancy
* Age \<18yr or \>85yr
* Angiographic stenosis ≥ 50% in non-target vessel
* Inability to consent
Evaluating the Impact of Training for IHSS Workers

This trial investigates whether high-quality training for consumer-directed home health workers impacts health outcomes for care consumers and employment outcomes for care workers. The investigators are conducting this study in the context of the In-Home Supportive Services (IHSS) program, a consumer-directed, Medicaid-funded home care program in California serving elderly and disabled Medicaid recipients. The investigators will partner with the Center for Caregiver Advancement (CCA), a training provider based in California, to conduct a randomized evaluation of the impact of training for IHSS workers on labor and health care outcomes. The evaluation will enroll IHSS workers in San Bernardino County, where CCA will be expanding its program.

Participants will be randomized to either a group that receives CCA's training or a control group that does not receive training.

Participants randomized to the training group will complete a 30 hour online course that teaches fundamental caregiving skills. Training includes personal care, infection control, nutrition and body mechanics, medication adherence, and home safety.

Researchers will compare outcomes between IHSS providers in the two groups and between IHSS consumers who receive care from the IHSS providers in the two groups to see if training impacts health, health care, and labor market outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Current IHSS provider
* Live in San Bernardino County
* IHSS consumer lives in San Bernardino County