cyrilzakka/clinical-trials huggingface dataset:
HIV Provider Intervention to Address Intersectional Stigma and Medical Mistrust

Intersectional stigma and medical mistrust are prevalent among Black and Latina/Latino Americans living with HIV and are key contributors to racial/ethnic health disparities; yet, there are no evidence-based provider-level interventions available for HIV care providers to address intersectional stigma and medical mistrust with patients. The investigators propose to develop an online provider intervention, with community stakeholders' input, that provides psychoeducation and skills-building around addressing intersectional stigma and medical mistrust with patients. The investigators will conduct a pilot randomized controlled trial with 60 HIV care physicians (30/condition) to test the acceptability and feasibility of the online intervention and to determine preliminary effects (against a no-intervention control group) on providers' use of skills and HIV care delivery outcomes at baseline, immediate post, and 6-month follow-up.

The first aim will be an intervention development process that involves engaging community stakeholders to incorporate their input on the intervention manual and working with a provider training organization to develop an online platform for the initial pilot testing. The intervention will include psychoeducation and skills-building for providers to address intersectional stigma and mistrust, tailored to HIV care. This aim will include a usability test of the online intervention in 10 HIV clinical care providers. The second aim will be to conduct a pilot randomized controlled trial to compare two conditions (i.e., online provider intervention versus no-intervention control) on provider training outcomes (e.g., providers' use of skills learned in the intervention) and HIV care delivery outcomes (e.g., the estimated percentage of patients lost to care in the past year) measured at baseline, immediate post-intervention, and 6-month follow-up. Clinical providers (N = 60) providing care for patients living with HIV will be randomly assigned to the online provider intervention (n = 30) or control with no intervention (n = 30). The intervention will be delivered in groups (5-10 providers per group). A mixed-methods process evaluation at immediate post-intervention will determine the acceptability, feasibility, and appropriateness of the intervention, and will be used to refine the intervention.

Eligibility Criteria:
Inclusion Criteria:

* clinical providers (including physicians, physician assistants, nurse practitioners, registered nurses/case managers) caring for patients living with HIV,
* the majority of their patients are from racial/ethnic and sexual minority groups,
* can make the time commitment to participate in the study.

Exclusion Criteria:

* not HIV clinical providers
* cannot make the time commitment to participate
Local and Systemic Changes in Osteonecrosis of the Jawbone

Osteonecrosis of the Jawbone (ONJ) is a serious complication of antiresorptive therapies (ARTs), for example with bisphosphonates or Denosumab. Especially long term treatment with intravenous antiresorptive agents causing lesions and, less frequent, also oral administration. This study aims at elucidating local and systemic changes in patients with ONJ.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* with/without ART
* with/without MRONJ

Exclusion Criteria:

* smoker (\>10 cigarettes/day)
* pregnancy
New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)

Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a slow-growing tumour which despite low metastatic potential may cause significant local tissue destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week apart. This procedure is considered quite time- and resource-consuming. Introducing a single treatment session, with a new PDT session for treatment failures after 3 months, might represent an attractive simplification.

This randomised controlled single-blinded multi-centre study primarily aims to compare BCC lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard Metvix(R) PDT treatments 1 week apart.

Secondary objectives are to investigate the treatment response in relation to clinical and histological tumour characteristics such as tumour thickness, subtype and immunohistochemical markers.


Eligibility Criteria:
Inclusion Criteria:

* male/female above 18 years of age
* written informed consent
* 1 or more primary histologically verified BCC, clinically assessed as of either superficial of nodular type

Exclusion Criteria:

* pregnancy
* breastfeeding
* Gorlin's syndrome
* porphyria
* xeroderma pigmentosum
* history of arsenic exposure
* known allergy to MAL
* concomitant treatment with immunosuppressive medication
* physical or mental conditions that most likely will prevent patients attending follow-up sessions
Revision LR Femoral Stem for Hip Replacement

This is a post-market, monocentric Retrospective and prospective, observational, open-label and baseline clinical study in order to evaluate the performance and safety of Revision LR femoral stem


Eligibility Criteria:
Inclusion Criteria:

* Males and females of any race
* Age ≥ 18 years old
* A diagnosis or condition in the target hip of one or more of the following: Primary tumors or metastasis and relative outcomes; Advanced articular destruction generated by primary degenerative or post-traumatic arthrosis or rheumatoid arthritis;Fracture or avascular necrosis; Congenital or acquired deformity; Failures of previous operations, like osteosynthesis, articular reconstruction, arthrodesis, hemi-arthroplasty or total arthroplasty; Epiphyseal region general trauma, Willingness to comply with prescribed rehabilitation and study evaluation and ability to return for follow-up visits
* Signed study-specific Informed Consent Form

Exclusion Criteria:

* Acute or chronic infections, local or systemic infections,
* Septicaemia
* Persistent acute or chronic osteomyelitis
* Serious muscular, neurological or vascular diseases affecting the concerned limb
* Mass higher than 60 kg
Evaluation of Techniques for Tracheal Tube Exchange in Standard and Critical Care Patients

A randomized controlled study to evaluate different Techniques and Approachs for the Exchange of a tracheal tube or supraglottic airway device in a Simulator

Exchanging a tracheal tube (ETT) in the high-risk difficult airway patient carries the risk of hypoxemia and the potential of a lost airway. Maintaining continuous airway access during the exchange by incorporating an airway exchange catheter (AEC) or similar device may reliably lessen exchange risk, especially in the known or suspected difficult airway patient, by providing a conduit to facilitate ETT passage into the trachea. We evaluated some approven / etablished techniques in a Simulator based study design.

Eligibility Criteria:
Inclusion Criteria:

* residents and consultans of the Department of Anesthesiology

Exclusion Criteria:

* no
The Safety and Effectiveness of Megace in HIV-Infected Women

To further evaluate the safety of megestrol acetate (Megace) oral suspension in the treatment of anorexia and cachexia in HIV-positive women. To compare the effectiveness of 2 doses of Megace by measurement of weight gain, appetite grade, and other parameters at 12 and 24 weeks.

Patients are randomized to receive 1 of 2 doses of Megace oral suspension daily for 24 weeks; at 12 weeks, those receiving the lower dose who have not gained 5 pounds over baseline or had appetite improvement to good or excellent are escalated to the higher dose. Patients are evaluated at 4-week intervals. Dose may be adjusted to maintain a desired weight.

Eligibility Criteria:
Inclusion Criteria

Patient must have:

* HIV infection.
* Evidence of HIV wasting syndrome that includes anorexia (appetite fair or poor) and weight loss \>= 10 percent of pre-illness body weight.
* Perception of weight loss as a detriment.
* Life expectancy of at least 24 weeks.

Prior Medication:

Allowed:

* Megestrol acetate for weight gain at a dose \< 400 mg for \< 60 days, provided therapy was discontinued at least 3 months prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Poorly controlled hypertension.
* Heart failure.
* Deep vein thrombosis.
* Uncontrolled severe diarrhea.
* Treatable active current infection (excluding chronic low-grade opportunistic infections).
* Unable to intake food.
* Impaired digestive/absorptive function.

Concurrent Medication:

Excluded:

* Initiation during the study of any therapy to treat HIV or anorexia/cachexia (other than study drug).

Patients with the following prior conditions are excluded:

* Hospitalization for or exacerbation of illness associated with weight loss within the past 2 weeks.
* Participation in other investigational drug studies within the past month.
* Previous abnormal mammogram (if 35-40 years of age) or abnormal mammogram within the past year (if over 40 years of age).

Prior Medication:

Excluded:

* New antiviral therapy within the past 8 weeks.
* Medications to promote weight gain (e.g., corticosteroid, dronabinol) within the past 2 months.
* Megestrol acetate within the past 3 months. IV drug abuse not treated for at least 4 months.
Electronic Alert System for Improving Thromboprophylaxis in Hospitalized Medical Patients

The investigators aim to investigate whether a computer-based alert system in the electronic patient chart and order entry system using the Geneva Risk Score as clinical decision support tool to estimate the risk of venous thromboembolism improves the rate of appropriate thromboprophylaxis among hospitalized medical patients.

The use of thromboprophylaxis among acutely ill hospitalized medical patients remains inconsistent. The present study aims to improve the use of appropriate thromboprophylaxis by implementing a computer-based alert system combined with a Geneva Risk Score calculation tool in the electronic patient chart and order entry system. Consecutive acutely ill medical patients without indication for therapeutic anticoagulation or ongoing therapeutic anticoagulant treatment admitted to the medical wards of the University Hospital Bern, Switzerland, will be randomized in a 1:1 fashion to the alert group in which an alert and the Geneva Risk Score calculation tool will be issued in the electronic patient chart or to the control group in which no alert will be issued. The primary endpoint is the rate of appropriate thromboprophylaxis during hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Acutely ill medical patients admitted to medical wards

Exclusion Criteria:

* Indication for therapeutic anticoagulation or ongoing therapeutic anticoagulant treatment
Study of Growth Hormone and Bone in Obesity

Obesity is an important risk factor for osteoporosis and fractures. With the growing prevalence of obesity in the U.S., understanding the pathophysiology of bone loss in this population is of importance to public health. Growth hormone (GH) is a critical mediator of bone homeostasis and is markedly reduced in obesity. Our preliminary data suggest an important role for the GH/insulin-like growth factor 1 (IGF-1) system in the pathogenesis of bone loss in obesity. The development of novel imaging techniques provides an opportunity to investigate the effects of GH on skeletal structure and strength, which will provide insights into the pathogenesis of obesity related bone loss. Understanding the pathophysiology of bone loss in obesity may help identify new treatment targets for this important complication. The investigator hypothesizes that low-dose GH administration for 18 months will improve skeletal health.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65 and generally healthy
* BMI ≥ 25 kg/m2
* Bone mineral density (BMD) T score ≤ -1.0 and \> -2.5 (as measured by DXA)

Exclusion Criteria:

* For women: amenorrhea for 3 months, pregnancy or breastfeeding, polycystic ovary syndrome
* History of diabetes mellitus, cancer or other serious chronic disease
* Use of osteoporosis medications
* Anemia
Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in combination with irinotecan.

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design exploring weekly, bi-weekly, and tri-weekly dosing schedules. Successive MM-151 monotherapy cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified, and subsequently in combination with irinotecan. The study consists of three parts as follows: MM-151 monotherapy dose escalation (Part 1); MM-151 monotherapy expansion cohort in cetuximab-refractory colorectal cancer (Part 2); MM-151 + irinotecan dose escalation (Part 3). It is expected that approximately 4 study sites will participate.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed advanced malignant solid tumor that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy
* Patients must be \> 18 years of age
* Patients of their legal representatives must be able to understand and sign an informed consent form
* Patients must have evaluable or measurable tumor(s)
* Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy. Up to CTCAE Grade 1 is acceptable for patients with known peripheral neuropathy
* Women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-151 (an effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion Criteria:

* Patients for whom potentially curative antineoplastic therapy is available
* Patients who are pregnant or lactating
* Patients with an active infection or with an unexplained fever \> 38.5°C during screening visits or on the first scheduled day of dosing. (At the discretion of the investigator, patients with tumor fever may be enrolled.)
* Patients with untreated and/or symptomatic CNS malignancies (primary or metastatic); patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
Effects of Delayed Muscle Pain on Respiratory Muscle Function

The aim of the study was to determine whether delayed-onset muscle soreness (DOMS) in trunk muscles has an effect on respiratory function parameters, respiratory muscle strength, respiratory muscle endurance, and exercise capacity.

In 24 healthy university students was induced for the trunk muscles with a load equals to 80% of the maximum repetitive voluntary contraction. Pulmonary function parameters, respiratory muscle strength and endurance, exercise capacity, pain, fatigue, and dyspnea perception severity were recorded before DOMS and at the 24th and 48th hours after DOMS.

After DOMS, there is a decrease in respiratory performance values and exercise capacity of healthy individuals and athletes. Therefore, it should be taken into account that delayed muscle soreness before the competition may affect performance. It may be beneficial to take precautions for delayed muscle pain while creating training and exercise programs, and to create treatment programs in case of the emergence of DOMS.

Eligibility Criteria:
Inclusion Criteria:

* Being a healthy individual between the ages of 18-25
* Not having a regular exercise habit
* No infection until at least 3 weeks before the study

Exclusion Criteria:

* Lung disease
* Cardiovascular disease
* Neurological disease
* Orthopedic disease
The Effect of Pentoxifylline on Liver Function Tests in Fatty Liver Disease

This randomized double blind clinical trial was performed in patients with non-alcoholic fatty liver disease.They were randomly assigned to lifestyle modification alone or lifestyle modification plus Pentoxifylline groups. Liver function tests, metabolic profile and anthropometric measurements were checked at baseline and six months later.

This randomized double blind clinical trial was performed in patients with the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus Pentoxifylline groups. Fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein,homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.

Eligibility Criteria:
Inclusion Criteria:

Patients with persistent elevated aminotransferase levels and the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.

Exclusion Criteria:

* alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),
* heart disease (ischemic or congestive),
* hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion),
* renal disease (serum creatinine concentration of \> 1.5 mg/dl),
* any severe systemic co-morbidities, neoplasm,
* using any hepatotoxic medication during the past 3 months,
* pregnant or lactating women.
Electroacupuncture on Modifying Inflammatory Levels of Cytokines and Metabolites in Stroke Patients.

The study will make an association between the diagnosis of traditional Chinese medicine that establishes that the syndrome of blood stagnation generates alteration in blood flow, vascular dysfunction, and damage to the endothelium. This process is like what occurs in a stroke. It will use electroacupuncture to change this chronic inflammatory process, and to know the effects and efficacy of this technique in the regulation and modulation of to treat extensive inflammatory diseases. However, this inflammatory response must be associated with serum cholesterol levels, since they are associated with a stroke between the LDL-C/HDL-C ratio and the prognosis after a stroke.

An adequate early standardized diagnosis of ischemic stroke uses different treatment protocols for these patients, depending on their complexity. Therapeutic windows have been associated with better outcomes when reperfusion or recanalization occurs. Someone has shown strongly related clinical outcome in ischemic stroke to the timely revascularization benefit of acupuncture in stroke patients; electroacupuncture intervention on metabolism is associated with effects on the anti-inflammatory mechanism and metabolic modulation, effects of electroacupuncture stimulation at different spinal segmental levels in a rat model of diabetes mellitus, and another vascular effect of electroacupuncture generate the modulation of the elasticity of the blood vessels.

Electroacupuncture (EA) stimulation is commonly applied in the treatment of ischemic stroke in the clinic. The efficacy of EA is associated with the acupuncture points, intensity, intervals, and duration of the intervention of the treatment for stroke.

The inflammatory response might be associated with serum cholesterol levels since they are associated with a stroke between the LDL-c/HDL-c ratio and the prognosis after a stroke. This study evaluates the impact of electroacupuncture as a modifier of total cholesterol, HDL-c, and LDL-c blood levels and its anti-inflammatory effect in patients with cerebrovascular accidents. Measurement of the post-electroacupuncture serum level (total cholesterol, HDL-c, LDL-c, and triglycerides) will provide adequate information on the influence that these risk factors have on blood vessels and vascular endothelium.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of patients with acute ischemic stroke
2. Stroke diagnosed for the first time
3. Must be able to respond to simple commands and tolerate the electroacupuncture

Exclusion Criteria:

1. Malignant cancer diagnosis
2. Traumatic event
3. Immunosuppressive patients
4. Drug abuse
5. Pregnant or lactating women
6. Cardiac pacemaker patient
Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis

The goal of this clinical trial is to gain more information about how fibroblast activation protein inhibitor (FAPI) binds to a certain type of cells in fibrotic lung tissue and how this information can be used to better diagnose and track fibrotic lung disease activity.

Participants will undergo up to 4 PET/MRI scans using the FAPI radiotracer.

Researchers aim to develop a non-invasive PET/MRI imaging tool using FAPI as a PET radiotracer and MRI to assess the presence and extent of fibrogenesis (the process that leads to fibrosis and scarring) in the lungs.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Able and willing to provide informed consent
* Clinically evaluated for need for initiation of new treatment (in patients not on current treatment), initiation of change in current treatment, or addition of new treatment (to any current treatment) in the setting of fibrotic hypersensitivity pneumonitis (HSP) or idiopathic pulmonary fibrosis (IPF), per standard of clinical care at UW Health.
* Willing and able to undergo PET/MRI.
* Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:

  * The subject has their own prescription for the medication
  * Informed consent is obtained prior to the self-administration of this medication
  * They come to the research visit with a driver

Exclusion Criteria:

* Participant is unable or unwilling to provide informed consent
* Participant is pregnant
* Participant with contraindication(s) to or inability to undergo PET/MRI
* Participants with contraindications to GBCA will be asked to undergo research imaging without the use of contrast. Contraindications may be severe kidney disease or previously documented GFR \< 30 ml/min/1.73 m2