cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate to severe active systemic lupus erythematosus (SLE), antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.


Eligibility Criteria:
Key Inclusion Criteria:

* Age: 12 to 70 years old.
* Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.
* Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.
* Health Status: Adequate organ function to tolerate treatment.
* Consent: Able to provide informed consent or assent/obtain parental consent and comply with study procedures.

Key Exclusion Criteria:

* Pregnancy/Breastfeeding: Women must not be pregnant or nursing.
* Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.
* Active Infections: No recent or ongoing serious infections.
* Recent Cancer or Prior Cell Therapy: No active/recent malignancies, prior CAR T-cell therapy, or organ transplant.
* Allergies: No known allergies to study treatments.
* Weight Restriction: Must weigh at least 50 kg (110 lbs).
Xperience Pro PMCF Study

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Xperience Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Xperience Pro .

The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Xperience Pro in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated with Xperience pro according to routine hospital practice and following instructions for use
* Informed consent signed

Exclusion Criteria:

* Not meet inclusion criteria
Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis: Double Blinded, Randomized Clinical Trial

The aim of the study is to evaluate the efficacy of a wearable device using pulse electromagnetic fields on pain intensity reduction, measured by visual analogue score (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in patients affected by osteoarthritis Secondary aim is the evaluate the effect on knee effusion reduction, when present and to evaluate pain intensity changes corrected by pain threshold measured by pressure algometry.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of primary OA of the knee according to the ACR criteria, including radiologic evidence of OA
* age \>40 years
* symptomatic disease for at least 6 months prior to enrollment
* persistent pain despite receiving the maximum tolerated doses of conventional medical therapy, including acetaminophen (4 gm/day) and/or a nonsteroidal antiinflammatory drug (NSAID), with persistent pain defined as a minimum mean score of 25 mm on the visual analog scales (VAS) for global pain (0-100-mm range for each) daily pain during the month prior to study enrollment
* ability to attend followup appointments

Exclusion Criteria:

* secondary causes of OA
* local or systemic infection
* diabetes mellitus
* systemic arthritis
* allergy to anesthetic agent or contrast material
* coagulopathy
* anticoagulant therapy
* had previous IA steroid injection
* avascular necrosis of bone
* patients who are on specific OA pharmacological therapy (NSAIDS, opioids) for more than 2 weeks prior enrollment
Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2

The routine treatment of children with antimalarials will be monitored. Children with a positive malaria film and/or a positive rapid diagnostic test (RDT) will have a capillary blood sample taken to verify the diagnosis and to monitor the pattern of resistance.

Children from Bissau seeking medical advice and who are recommended treatment for malaria in accordance with the current routines will be included as follows:

All children getting the clinical diagnosis of malaria will be registered and basic information collected.

All children with a positive malaria film and/or a positive RDT will be asked for a capillary blood sample (app. 50 - 100 microliters on a filterpaper). Using PCR the parasitological diagnosis will be verified and if parasites are identified the resistance patterns will be examined. Both the capillary blood samples and the RDTs (if taken by the health staff) will be used in order to examine whether the RDTs can be used for routine monitoring of resistance in an area.

The study does not interfere in the routine treatment of the health staff. None of the children will be followed.

Eligibility Criteria:
Inclusion Criteria:

* Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.

Exclusion Criteria:

* Children where the parents do not accept to participate in the study.
Epidural Pulsed Radiofrequency Treatment in Failed Back Surgery Syndrome

Low back pain can persist in some patients with history of back surgery. In some cases, an increase in pain may even occur, and chronic pain may make treatment more difficult. A component of chronic pain is neuropathic pain, and its specific evaluation and treatment is important. Low back pain and radicular pain in the lower extremities are the main symptoms of failed back surgery syndrome (also called persistent spinal pain syndrome in new terminology).

There are many methods for treatment of failed back surgery syndrome, such as analgesic medications, physical therapy, interventional pain treatment applications, and re-surgery options. Epidural pulsed radiofrequency therapy has recently become popular among interventional pain management procedures, and studies on its effectiveness are increasing. However, studies with a multifaceted approach that also evaluate neuropathic pain are lacking in the literature. In this study, it was planned to investigate the effect of epidural pulsed radiofrequency therapy on pain palliation, including neuropathic pain, in patients diagnosed with failed back surgery syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-80
* History of at least one operation due to lumbar disc herniation
* Having radicular pain radiating to the lower extremities

Exclusion Criteria:

* Having undergone surgery for an etiology other than lumbar disc herniation
* Accompanying spinal stenosis and spondylolisthesis
* Presence of fracture, infection, coagulopathy and pregnancy
* Mental disorders that may negatively affect cooperation during assessments.
Peanut Protein Supplementation to Prevent Muscle Atrophy and Improve Recovery Following Total Knee Arthroplasty

This randomized controlled trial will study the effects of peanut protein supplementation on changes in muscle size and quality in patients undergoing total knee arthroplasty.

Total knee arthroplasty (TKA) is an effective treatment for patients with knee osteoarthritis (OA) accompanied by severe pain and functional limitations. With the success of this treatment and increasing incidence of OA, it has been projected that \~3.5 million older adults will undergo TKA annually by the year 2030. While TKA is effective for reducing pain and improving health-related quality of life, TKA patients experience significant skeletal muscle atrophy and weakness in the surgical leg following surgery which, long-term, can compromise balance, functional mobility and increase fall risk. Thus, interventions to mitigate muscle atrophy and weakness post-surgery are essential to improving long-term outcomes in patients undergoing TKA.

This randomized controlled trial will study the effects of peanut protein supplementation on changes in muscle size and quality in patients undergoing total knee arthroplasty. Patients (n=30) between the ages of 60-75 years scheduled to undergo total knee arthroplasty at the Jack Hughston clinic/hospital will be recruited to participate. Participants will be stratified by gender and randomized to a peanut protein (PP) supplementation (72g daily, n=15) or waitlist control (standard care with no PP, n=15) group who will be provided with PP following the intervention. Participants in the PP group will consume PP daily starting 7 days prior to surgery and for 6 weeks post-surgery. Participants will be monitored for changes in muscle size and quality (peripheral quantitative computed tomography), upper-leg strength (isokinetic dynamometry), knee range of motion (ROM; goniometry), pain (questionnaire and pressure algometry), and functional mobility outcomes (questionnaire, timed up and go, 2-min walk test) prior to surgery and at 6 and 12-weeks post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* total knee arthroplasty scheduled within two weeks under the care of surgeons at the Jack Hughston Clinic

Exclusion Criteria:

* history of invasive lower extremity surgery within the last 5 years
* allergy to peanuts or peanut products
* Body Mass Index \<20 or \>35 kg/m2
* currently adhering to a restrictive weight loss diet
* current or recent (within the last 2 months) steroid use
* any physical condition that interferes with performing post-surgery rehabilitation
* known peripheral vascular disease, kidney disease, liver disease, or uncontrolled endocrine disorder
* known overt cardiovascular or metabolic such as heart disease/failure or diabetes
* Radiation exposure within the last 6 months other than dental x-rays or associated with current knee treatment/diagnosis
Very Low Calories Ketogenic Diet in Migraine.

Ketogenesis is a physiologic phenomenon due to starvation or ketogenic diet (KD), a drastic restricted carbohydrate dietary regimen that induces lipid metabolism and ketone body (KB) synthesis. We followed, in a dietician clinical setting, a group of migraineurs who randomly received a one-month prescription of experimental diet, followed by a one-month of carbohydrate progressive reintroduction, then another one-month of experimental diet, followed by a one-month of carbohydrate progressive reintroduction. Experimental diets are a very-low calorie KD, or an isocaloric non-ketogenic diet.

Aim of our study is verify if during ketogenesis migraine improves.

The ketogenic diet (KD) is a high-fat, low-carbohydrate diet for long used to treat refractory epilepsy. Ketogenesis, ketone-body formation, is a physiologic phenomenon also observed in patients following low-carbohydrate low-calorie diets for rapid weight loss. Different Authors evidenced a protective effect of ketone bodies also on migraine; however, KD effectiveness in this disorder is under scrutiny yet again. In fact, some concerns makes the matter a still open question: available studies were anecdotal, or conducted on small numbers; not all patients were diagnosed as migraineurs according to current headache classification; during ketogenesis there could be an avoidance of potentially trigger foods. Moreover, to comply with ketogenic diet, great motivation is needed and often migraineurs did not have it.

Aim of this study is verify in a double blind parallel group cross over design if ketogenesis is really able to prevent/avoid headache attacks in episodic migraineurs.

Methods: Thirty-five consecutive episodic migraineurs, with an attack frequency higher than 2 attacks per months, will be enrolled. Two different kind of diet, a KD and a standard weight-loss diet (SD), will be consecutively administered in each patient recruited in the study for one month. Randomly patients will start with KD or SD. At the end of the second month differences between diets will be detected.

KD will consist of 4 daily pharmaceutical meal substitutes composed by low-carbohydrate, low-fat, rich in protein serving of food, already commercially available. SD will consist in a similar eating program, with serving of food with addition of carbohydrate to avoid ketogenesis.

Eligibility Criteria:
Inclusion Criteria:

* kept a headache diary for at least 1 month
* migraine disease onset before the age of 50
* at least one migraine attack per month in the last 3 months
* \<15 days/month with headaches.

Exclusion Criteria:

* prophylactic treatment in the previous 3 months
* over consumption of acute anti-migraine medication (triptan, analgesic, or ergotamine)
* pregnancy or lactation
* type I diabetes
* serious organic or psychiatric disorders that the investigators judged as having the potential to influence the trial evaluation.
AI-Augmented Motivational Interviewing Training for Primary Care

This study will examine the impact of training primary care providers (PCPs) in motivational interviewing (MI) using artificial intelligence (AI) to augment the training process. MI is a patient-centered approach to engaging patients in their own care. There will be a control group and two intervention groups, with the intervention groups receiving a different amount of MI training. The hypothesis is that the AI-augmented MI training will result in improved patient outcomes, improved clinician wellbeing, and reduced behavioral manifestation of clinician biases. This mixed-methods project will also collect qualitative data from structured interviews and focus groups with participating PCPs to examine perceived facilitators and barriers to the use of the MI approach in primary care.

Motivational interviewing (MI) is an evidence-based patient-centered approach that has been demonstrated to be effective in increasing patient engagement in their own care. Using MI, a clinician is compassionate curious to understand patients\&#39; perspective on their behavior, and conversationally guides them to discover a need for behavior change. However, MI is not widely utilized in primary care practices and challenging to teach, in part because many primary care providers (PCPs) take a direct approach with their patients by educating and advising them regarding steps to improve their health. However, simply telling patient what to do tends to be ineffective, leading to frustration on the part of both patients and PCPs.

To help implement the MI approach more widely, our team has developed an artificial intelligence (AI) augmented tool for MI skill development, ReadMI™ (Real-time Assessment of Dialogue in Motivational Interviewing). The goal of this project is to: 1) examine the association of AI-measured proficiency in MI to patient outcomes, PCP wellbeing, and PCP manifestations of bias, and 2) to determine the extent to which AI-augmented MI skills training can impact the same outcome, wellbeing, and bias manifestation variables in a randomized controlled trial (RCT). This mixed-methods project will also employ structured interviews and focus groups of participating PCPs to collect qualitative data for better understanding both facilitators and barriers to the implementation of MI in primary care.

The overall hypothesis is that PCPs with the strongest MI proficiencies will have patients with better outcomes, and that those PCPs will also demonstrate less burnout and less manifestation of bias. Additionally, it is hypothesized that making use of AI in MI training will be seen by PCPs as a facilitator to the use of MI in their practices.

Eligibility Criteria:
Inclusion Criteria:

* Primary care providers (physicians, physician assistants, and nurse practitioners) employed in primary care practices of the Premier Physician Network of Premier Health (southwest Ohio) are eligible to participate.

Exclusion Criteria:

* Eligible PCPs who opt to not provide informed consent for participation will be excluded from the study.
AWAITS: A Web-based E-health Application for Active Illicit Opioid Users

The purpose of this research study is to:

1. assess how participants like the AWAITS e-health application as measured by their feedback on the intervention
2. test the impact of AWAITS on knowledge about opioid overdose and risk-reduction strategies.
3. assess the proportion of participants who accept a list of local treatment providers
4. test the impact of AWAITS on interest in being tested for HCV/HIV.

The pre-post study of AWAITS will: 1) assess the acceptability of AWAITS as measured by participant feedback about the intervention; 2) test the impact of AWAITS on knowledge about opioid overdose, as measured by the OOTAS; 3) assess the proportion of participants who accept a list of local MAT treatment providers; and 4) test the impact of AWAITS on interest in being tested for HCV/HIV.

The acceptability of AWAITS will be assessed with a feedback form which includes questions about how helpful the intervention was (scale of 1-4), what the patient liked most and least about the intervention, and any suggestions for improving it. The average (and standard deviation) for the rated helpfulness of the intervention will be derived and the qualitative data about what they liked most and least about the intervention and suggestions for improvement will be tabulated. Pre-/post-changes in the percent of correct knowledge assessment items (i.e., about overdose and MAT) and interest in HCV/HIV testing will be analyzed using a Wilcoxon signed-rank test. The proportion of participants accepting a list of local MAT treatment providers will be calculated.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Not enrolled in MAT per self-report
3. Self-reports illicit opioid use

Exclusion Criteria:

3. Does not acknowledge reviewing "Information Sheet for Research" within REDCap
Understanding Acute Sarcopenia

This study aims to characterise acute changes in muscle mass, strength, physical performance in hospitalised older adults. We will assess the impact of these changes upon physical function at three month follow-up, and assess for the impact of clinical and immune-endocrine factors upon these changes.

Study Design

Time-limited cohort study involving serial measurements of Bilateral Anterior Thigh Thickness (BATT) using ultrasound, handgrip strength, physical performance, and physical function measured using the Patient Reported Outcome Measures Information System (PROMIS®). We aim to fully characterise changes in these patients, and will perform a comprehensive evaluation of clinical factors including nutrition and physical activity, and measure immune-endocrine markers of inflammation.

Study Participants

Elective colorectal surgery, emergency abdominal surgery, and medical patients aged 70 years and older

Planned Size of recruitment target

56 elective colorectal patients, 56 emergency abdominal surgery patients, and 56 medical patients with acute infections

Follow up duration

3 months

Primary research question

Does acute change in quadriceps muscle thickness, handgrip strength and/or physical performance within one week of hospitalisation predict change in patient reported physical function at three months?

Eligibility Criteria:
Inclusion Criteria:

ELECTIVE COHORT

* Aged 70 years or older at time of recruitment
* Expected to undergo an elective major colorectal surgery procedure

EMERGENCY SURGERY COHORT

* Aged 70 years or older at time of recruitment
* Emergency admission
* Expected to undergo emergency abdominal procedure during admission, or emergency abdominal procedure performed within previous 48 hours

MEDICAL COHORT

* Aged 70 years or older at time of recruitment
* Emergency admission for acute bacterial infection or presumed acute bacterial infection

Exclusion Criteria:

ELECTIVE COHORT

* Unable to provide written informed consent at time of recruitment
* Unable to understand verbal English
* Life expectancy less than 30 days

EMERGENCY SURGERY COHORT

* Unable to provide written informed consent at time of recruitment and no consultee available
* Unable to understand verbal English
* Life expectancy less than 30 days

MEDICAL COHORT

* Unable to provide written informed consent at time of recruitment and no consultee available
* Unable to understand verbal English
* Life expectancy less than 30 days
Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors

This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects
* 18 years and older
* Must have histologic documentation of advanced solid tumors
* Must have received and have progressed, are refractory or, intolerant to standard therapy and must not have a curative therapy option

Exclusion Criteria:

* Concurrent enrollment in another clinical study
* Prior participation in clinical studies that include durvalumab alone or in combination
* Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
A Study to Evaluate the Efficacy and Safety of AD-223

The purpose of this study is to evaluate the efficacy and safety of AD-223

Condition or disease : hypertension

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Other inclusions applied

Exclusion Criteria:

* Orthostatic hypotension with symptom
* Other exclusions applied
Assesment of Lactulose vs Lactobacillus Acidophilus Effect in CKD Patients

Assessment for usage of laxatives and probiotics ,and its role in improving uremic parameters of CKD as GFR, UREA ,CREATININE, CLINICAL and UREMIC assessment (lower limb edema ,UOP,base of chest ,vomiting ,dyspnea,blood pressure measurement)

with advanced CKD stages ,also have been linked to the high prevalence of constipation in CKD,Lactulose is a synthetic disaccharide.Lactulose is poorly absorbed from the gastrointestinal tract remains virtually unchanged and is then fermented by gut microbiota that increase osmotic effects and intraluminal gas formation . lactulose reduces the nitrogen products and urea, creatinine, uric acid, and b2- microglobulin levels. Lactulose also suppress tubulointerstitial fibrosis in a rat model of a kidney disease study . Lactulose modifies the gut microbiota, increasing the abundance of Bifidobacteria and Lactobacilli after 8 weeks of 30 ml lactulose syrup thrice daily, and ameliorates CKD progression by suppressing uremic toxin production .probiotics include vast array of products with living organisms whose purpose is to improve intestinal microbial balance and produce beneficial effect on ones health .probiotics is an alternative therapy for patients with CKD

Eligibility Criteria:
Inclusion Criteria:

* CKD stages 3,4,5 with non-dialysis receiving a diagnosis of constipation
* DM nephropathy

Exclusion Criteria:

* IBS (ulcerative colitis -crohns)
* HCV ,HBV ,
* autoimmune patients,
* malignancy pt
* cirrhotic patients
* haemodialysis patients
* cardiovascular patients
* abdominal surgery,
* gut obstruction,
* pregnancy,
* patients with ESRD on dialysis,
* history of lactulose allergy.