cyrilzakka/clinical-trials huggingface dataset:
FDA: Lowering Orthopedic Opioid Dosing (FLOOD)

This randomized trial evaluates an intervention to minimize use of opioids following total hip and total knee replacement. Half the participants will receive an intervention (mailed educational materials, followed by a pharmacist call), and half will receive usual care.

Surgeons and anesthesiologists prescribe opioids and other analgesic medications for acute, post-surgical pain. Recent studies have reported that some patients persist in taking opioids for months beyond the surgery. While opioids are commonly used for pain management following surgery, patients and their providers often don't have a planned method to optimize opioid exposure. This can lead to patients entering a cycle of opioid use that is difficult to manage, because, as opioid exposure is continued, pain relief is reduced and side effects increase. The investigators' study is aimed at reducing opioid exposure following total hip and total knee replacement.

Eligibility Criteria:
Inclusion Criteria:

* total hip replacement or total knee replacement
* 1 year membership with KPNW prior to enrollment

Exclusion Criteria:

* managed by pain clinic, in other pain management trial
* patients at low risk of persistent opioid use
Identify the State of Laminae Milling by Sound

After verifying the signals collected in the laboratory, the investigators performed a preliminary verification in the surgery, in which the sound pressure signals of lamina milling were collected during the surgery to identify milling status.

The sound of milling cortical bone and cancellous bone were recorded during posterior spinal decompression.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with myelopathy caused by spinal stenosis who had undergone posterior decompression.

Exclusion Criteria:

1. Receipt of surgery using an anterior approach or circumferential spinal cord decompression through a posterior approach;
2. Experience of trauma;
3. History of spinal tumor;
4. Previous spinal surgery;
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.

The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy postmenopausal women

Exclusion Criteria:

* History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies.
* History or presence of malignancy or estrogen-dependent neoplasia. Subjects with a documented history of any malignancy, except for basal or squamous cell carcinoma of skin, which has been treated and fully resolved for a minimal 5 years.
* History or presence of benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products.
Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis/Fibrosis Database

The primary goal of this study is to establish a database of people with varying levels of hepatic fibrosis and various etiologies of liver disease for use in future research protocols.

The Fibroscan device will determine liver stiffness as well as the amount of fat through another application on the machine called controlled attenuation parameter or Controlled Attenuation Parameters (CAP). The liver stiffness measurements are then translated into a score that tells how much liver fibrosis or fat is present. Patients identified with potential for fatty liver or specific liver-related diseases causing fibrosis would be approached for a voluntary FibroScan measurement. From these patients, the investigators will collect information related to demographics, disease history, medical comorbidities, social history, laboratory and radiologic parameters. This information, along with clinical data associated with the patient will be placed in a database for use in identifying potential subjects for future trials.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with known, or suspected risk factors for steatosis (fat) or hepatic fibrosis
* Subjects who have been previously diagnosed with Non-Alcoholic Steatohepatitis (NASH) but who do not have current steatosis (fat) or fibrosis scoring
* Subjects who have other known liver diseases ie: HCV

Exclusion Criteria:

* Patients less than 18 years of age
* Pregnancy
* Patients that do not want to be contacted for consideration in future research studies.
* Patients diagnosed with ascites or peritoneal dialysis
* Body mass index (BMI) ≥40
Drug-drug Interaction Study With MDV3100 and a Cocktail of Substrates

A drug-drug interaction study to investigate the potential pharmacokinetic interaction between MDV3100 and a cocktail of substrates for pioglitazone (CYP2C8 substrate), S-warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and midazolam (CYP3A4 substrate).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
* Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration);
* Progressive disease by prostate specific antigen (PSA) or imaging whether or not after chemotherapy in the setting of medical or surgical castration. Disease progression for study entry is defined as one or more of the following 3 criteria:

  * PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥1 week between each determination. The PSA value during the pre investigational period should be ≥2 μg/L (2 ng/mL);
  * Soft tissue disease progression defined by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) for soft tissue disease (see Appendix A);
  * Bone disease progression defined by two or more new lesions on bone scan.

Exclusion Criteria:

* Confirmed CYP2C8, CYP2C9, or CYP2C19 poor metabolizer status based on genotyping analysis;
* Absolute neutrophil count \< 1,500/μL, platelet count \< 100,000/μL, and hemoglobin \< 5.6 mmol/L (9 g/dL) during the screening period (NOTE: patients may not have received any growth factors or blood transfusions within 7 days prior to the hematologic laboratory values obtained during the screening period);
* Total bilirubin \> 1.5 times, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the upper limit of normal during the screening period;
* Creatinine \> 177 μmol/L (2 mg/dL) during the screening period;
* Albumin \< 30 g/L (3.0 g/dL) during the screening period;
* Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide), 5 α reductase inhibitors (finasteride, dutasteride), estrogens, or chemotherapy within 4 weeks prior to enrollment (Day 1 visit) or plans to initiate treatment with any of these treatments during the study;
* Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to enrollment (Day 1 visit) or plans to initiate treatment with any of these treatments during the study;
* Structurally unstable bone lesions suggesting impending fracture;
* History of seizure, including any febrile seizure, loss of consciousness, or transient ischemia attack within 12 months prior to enrollment (Day 1 visit), or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization)
Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy

The expertise in the characterization of transcriptomics profile in lesional psoriatic skin and on the availability of innovative therapy for these patients.The investigators propose to follow the modification of the skin transcriptomics profile in psoriatic patients during successful Adalimumab biotherapy. Skin transcriptomics profiles of normal skin, psoriatic non lesional skin, and psoriatic lesional skin before and after biotherapy will be compared. The investigators will focus on the modification of the cytokine "signature" in these skin lesions and of some markers of keratinocyte inflammation. The modification of the transcriptomics profile induced by the biotherapy will be correlated to the clinical response Psoriasis Area and Severity Index.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic plaque psoriasis involving at least 10% of body surface area with no previous biotherapy.
* Adalimumab prescribed in usual practice

Exclusion Criteria:

* Patients presenting a contraindication to the use of Adalimumab:

hypersensibility in Adalimumab or in one of the excipients.

* Patients presenting an evolutionary tuberculosis or the other severe infections such as sepsis and opportunist infections
* presenting patients one cardiac insufficiencies moderated in severe
* Patients under anakinra or abatacept
* current participation in another study of clinical research
A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation

Numerous studies describing surgical treatments to preserve hip replacements has several controversies and none of these procedures are universally accepted nor have compelling evidence for osteonecrosis of the femoral head (ONFH). With developing a newly approach osteonecrotic device surgical procedure to support the regeneration of necrotic bone and articular cartilage in vivo, this will be the first randomized-controlled feasibility study to determine its safety in ONFH patients.

Total of 20 patients were enrolled and randomized in this study. There are two groups, 10 patients in osteonecrotic device group; 10 incore decompression group. After their baseline data has been collected and their surgical procedure has been completed, the following postoperative data collection are then continued to 6 weeks, 12 weeks, 6 months, one year, and two years' prior from the start of their surgery, in order to understand the new approach of the osteonecrotic device's safety in comparison to the core decompression surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally matured between age 20 to 70 (epiphyses of the femoral head are confirmed to be closed on the radiography, CT, or MRI scan
* Patients without any allergies or major systemic or organ diseases
* Patient's affected hip diagnossied as the 3rd stage of ONFH by MRI

Exclusion Criteria:

* Other lower lib fractures
* Pregnancy
* Extensive degenerative arthritis in hip
* Severe osteoporosis in the head and/or neck of the femoral bone
* Rheumatoid immunity or metabolic arthritis that appears to have severe cartilage damage in the hip
* Stiffness in the hip due to other reasons or medical history with its range of motion clinically measures less than 20 degrees in the abduction and less than 90 degrees flexion
* Diagnosed with either Stage 4, 5, or 6, of ONFH classification by either radiography, MR, CT scan.
Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation

In this randomized multicentric phase II study it will be investigated whether an accelerated postoperative radiotherapy with photons or protons (7 fractions per week, 2 Gy single dose) may improve locoregional tumour control in non-small cell lung cancer (NSCLC) in comparison to conventional fractionation (5 fractions per week, 2 Gy single dose).

This study is a randomized multicentric trial. Within this study an accelerated irradiation schedule (7 fractions per week, 2 Gy single dose) will be compared with the currently used conventional fractionation schedule (5 fractions per week, 2 Gy single dose) for postoperative radiotherapy with photons or protons in patients with NSCLC. The primary endpoint is locoregional tumour control after 36 months. Secondary endpoints are overall survival of patients, local recurrence-free and distant metastases-free survival after 36 months, acute and late toxicity as well as quality of life for both treatment methods.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed non-small cell lung cancer
* previous tumor resection with curative intention
* postoperative indication for irradiation (\> pN1 and/ or R1)
* R2-resection or recurrence postoperative/after adjuvant chemotherapy diagnosed by the restaging-imaging
* exclusion of distant metastases (M0)
* age \> 18 years
* good general condition (ECOG performance status 0 or 1)
* written informed consent
* appropriate compliance to ensure close follow-up
* women of childbearing age: adequate contraception

Exclusion Criteria:

* histologically confirmed small cell lung cancer
* distant metastases
* no written informed consent or lack of cooperation relating to therapy or follow-up
* previous (\< 5 years) or concomitant other malignant disease (exception: malignant disease, which is very likely healed and not influenced therapy or follow up of the non-small cell lung cancer, e.g. carcinoma in-situ, basaliomas, very early skin cancers)
* for proton therapy: heart pacemaker
* previous radiotherapy of the thorax or lower neck region
* pregnancy or lactation
* participation in another intervention study or not completed follow-up of a intervention study. Exceptions are psychological studies, supportive or observation studies, the previous therapy of non-small cell lung cancer is in accordance with the guideline and the participation in radiotherapy studies is not excluded in the trial protocol of the previous study
Psychological Assessment in Patients Treated with Spinal Cord Stimulation

This is a prospective observational study to investigate the impact of spinal cord stimulation (SCS) procedure in chronic pain perception and management. Patients' psychological status at different time points and its correlation with pain outcomes and satisfaction with the SCS intervention will be also evaluated.

The primary aim is to study the associations between psychological variables and intervention outcomes (pain reduction, satisfaction, removal of SCS). Our hypothesis is that people with higher scores in anxiety and depression symptoms would report lower satisfaction with SCS procedure and higher levels of perceived pain after the implantation of the device

More than 30% of people worldwide suffer from chronic pain (CP), defined as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage".

Patients suffering from CP in charge of the Palliative Care and Pain Therapy Division at the European Institute of Oncology IRCCS (Milan, Italy) will be proposed to undergo SCS surgical implantation to mitigate pain symptoms.

The SCS surgical implantation is a two-step procedure; after the hospital admission, a temporary SCS device will be firstly implanted. In this way patients have the possibility to experiment the device impact on their CP conditions, to familiarize with the external device and adjust to its presence, and to eventually grow their motivation toward the implantation of the permanent device. Only after one month, if the patients are convinced of the intervention utility, the temporary device will be changed with a permanent one.

After the medical consultation, patients accepting the surgical procedure and meeting the inclusion criteria will be invited to participate to the study.

Patients signing the Informed Consent will receive a link to complete a set of questionnaires investigating psychological well-being, the impact of chronic pain in daily activities and the decision-making process to undergo to a surgical procedure. Participants who will not be able to complete the online form, will fill it on paper. Patients will complete different questionnaires at different time-points before and after the two-step SCS implantation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients suffering from chronic pain (VAS\>4) from at least 6 months
2. Patient eligible for SCS implantation
3. Age \>18 years old
4. Willingness and ability to comply with scheduled visits and other trial procedures
5. Understanding and speaking Italian language
6. Written informed consent

Exclusion Criteria:

1. Psychiatric disorders or conditions that might impair the ability to give informed consent
2. Comorbidity that may impact on compliance to study procedures
Increased Focus on Protein Intake Among Geriatric Patients

Up to approximately 38 (unknown drop-out rate) geriatric patients (at least 65 years old) are recruited from a Geriatric ward at Slagelse Sygehus. After inclusion and baseline measurements, each individual will be randomized into either an intervention or control group arranged in blocks of 8 The intervention group (n≤19) will receive protein enriched snacks/dishes in the morning and late evening, before bedtime. Moreover, upon discharge the intervention group will receive individual dietary counseling focusing on choosing protein-rich foods and on protein rich meals. The control group (n≤19) will receive normal hospital food without enrichment and no dietary counseling at discharge. In both groups the following data will be obtained: recorded protein intake, anthropometric measurements (weight, height, body composition estimated with bioimpedance), functional ability (De Morton Mobility Index (DEMMI) and Barthels ADL-index), hand grip strength, sarkopenic status (SARC-F), quality of life (EQ-5D-3L), length of stay (LOS) and readmissions (within 30 days after discharge). During hospitalization food intake will be registered, as well as 24 hour recall interviews and food frequency questionnaires will be done at follow-up visits.

Assessments will be performed at baseline, on the day of discharge and 4 weeks after discharge (follow up).

The primary outcome is change in protein intake from Baseline to 4 weeks after discharge.

The hypothesis is that serving of individually selected protein enriched snack/dish in the morning and before bedtime during hospitalization results in higher protein intake during hospitalization and that this experience combined with dietary counseling at discharge, results in a higher protein intake at 28 days after discharge. Further, we hypothesize that the increased protein intake will affect functional level, hand grip strength, sarcopenic status and quality of life in geriatric patients and will lead to shorter LOS and fewer readmission frequency.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥65 år and admitted to the geriatric ward at Slagelse Hospital.
* Expected length-of-stay, LOS: more than 3 days
* Normal kidney function. (As long as the kidney values remain stable during the intervention it is deemed safe to take part, as the amount of protein given will not exceed the amount recommended by the Danish authorities.

Exclusion Criteria:

* Dysphagia
* Patients exclusively fed by tube/probe or parenteral nutrition.
* Gastrointestinal problems, that makes normal food intake impossible.
* People suffering from dementia, deliriousness or severe memory loss
* Patients abusing alcohol
* Patients in isolation
* Terminal patients
* Patients that do not speak Danish or English
* Patients suffering from food allergies/intolerances that makes it impossible to accommodate to the protein enriched foods.
Lofexidine Pharmacokinetics in the Presence of Paroxetine in Healthy Volunteers

The purpose of this study is to determine the pharmacokinetics, safety and tolerability of lofexidine HCl in the presence of paroxetine in healthy adults.

This is a Phase 1, open-label, single-sequence study to determine the pharmacokinetics, safety and tolerability of lofexidine HCl in the presence of paroxetine in healthy adults. Lofexidine HCl is an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids. Paroxetine HCl is an orally administered psychotropic drug indicated in the treatment of major depressive, obsessive compulsive, panic, social anxiety, and generalized anxiety disorders. Paroxetine is a strong CYP2D6 inhibitor.

Eligibility Criteria:
Inclusion Criteria:

* Subject is between ages of 18 to 60 years at enrollment with a body mass index (BMI) between 18 and 35 kg/m2.
* Female subjects must not be lactating, and must either a) be postmenopausal or b) agree to use an acceptable form of birth control from screening until 14 days after completion of the study.
* Subject is in good health based on medical history, physical exam, laboratory profile, and electrocardiogram (ECG) as judged by the Investigator.
* If subject smokes, subject agrees to limit smoking while in the study to not more than 10 cigarettes per day.

Exclusion Criteria:

* History of suicidal ideations or depression requiring professional intervention including counseling or antidepressant medication over the past 12 months.
* History or presence of allergic or adverse response to lofexidine, paroxetine, or related drugs.
* Received any drugs capable of inhibiting CYP enzymes CYP1A2, CYP2C19, or CYP2D6 within 14 days or 5 half-lives (whichever is more) before Day 1.
* Consumes more than 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) or has a significant history of alcohol abuse or drug/chemical abuse within the last 1 year.
* Has a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Assess Measurements of Wireless Cardiac Output Device

Heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality. The management of heart failure patients is complex and has become a priority world over. Effective methods to keep heart failure patients out of the hospital are essential, both in the interests of the patient's health, as well as to reduce the burden on the health care system

Heart failure patients should be in a position to provide readings of their weight, blood pressure, fluid intake, thoracic fluid, heart rate, heart rate variability, respiration rate, stroke volume, cardiac output, medications and other important parameters and communicate this data to care providers using wireless technology. This data should be made available to medical personnel regularly and on a periodic basis. In this manner the health care providers can detect and respond to warning signs or alerts before the patient's condition worsens to warrant a visit to the doctor or a hospital admission with features of heart failure decompensation. Programs for chronic heart failure that include remote monitoring have been shown to have a positive effect on clinical outcomes in community dwelling patients with chronic heart failure.

In preparation for a study evaluating the effectiveness of mobile monitoring, the value of Stroke Volume and Cardiac Output need to be validated against FDA approved devices that are available in a hospital or clinic setting. This study covers the validation of the measurements taken with the proposed home monitoring device, Perminova's CoVaTM Sensor (Sensor) against clinic devices such as bio-impedance devices, echocardiogram, Doppler and/or MRI

Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender above the age of 18 years
* The subject is able and willing to provide written informed consent prior to enrollment in the study
* One or more of the following diagnosis
* New York Heart Association (NYHA) classification class of I-IV or Stages A-D
* Symptoms of dyspnea
* Chronic renal failure on renal replacement therapy

Exclusion Criteria:

* Patients who may not come for follow up or likely to drop out of the study
* Any illness which may preclude regular follow up
* Patient is unable or not willing to wear electrode patches as required
* Patient has skin sensitivity to adhesive or hydrogel materials used in electrode patches
* Patient is considered by the PI to be medically unsuitable for study participation