cyrilzakka/clinical-trials huggingface dataset:
To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).

This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis (OA) of the Knee


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of OA of the knee according to the American College of Rheumatology (ACR) criteria.
2. OA Symptoms for at least 6 months prior to screening.
3. Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of \> 9 on a 20 point scale for the target knee immediately prior to randomization.

Exclusion Criteria:

1. History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
2. History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.
3. History of gastrointestinal bleeding or peptic ulcer disease.
4. Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).
5. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening.
6. Concomitant use of systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.
Efgartigimod for Stiff Person Syndrome (ESPS)

The goal of this clinical trial is to examine the proportion of patients with stiff person syndrome with no worsening in stiffness and/or spasms while on efgartigimod-hyaluronidase (EFD) when compared to their current treatment. The main questions it aims to answer are:

* proportion of patients with stiff person syndrome with no worsening in DSI and HSS scores
* whether there are changes in laboratory values, vital signs, electrocardiogram, or depression, and suicide risk during the trial, as well as the incidence of any adverse events.

Participants will come to the clinic up to 18 times and have up to 5 phone call visits during the course of the trial. During these visits a variety of measures will be collected, including blood samples, neurological and physical exams, patient reported outcomes on stiffness, spasms, depression, and suicide risk.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80, men and women, capable of giving informed consent.
2. Must have unexplained stiffness of limb and axial (trunk) muscles and involuntary striated muscle spasms.
3. DSI and HHS must be \>=2 (to allow for detection of improvement).
4. Presence of serum (or CSF) anti-GAD antibodies regardless of titers.
5. Stable dosage for at least two months before screening visit with antispasmodics (muscle relaxants, benzodiazepines, baclofen).
6. Women with children bearing potential must be willing to use highly effective contraception method during and for a minimum of 90 days after the last dose of IP.

Exclusion Criteria:

1. Exclusionary conditions:

1a. type 1 DM

1b. Cancer, except basal cell skin cancer

1c. Infections: HIV, Hepatitis B or C, clinically significant active infection not sufficiently resolved in the investigator's opinion

1d. Serum IgG (\<6 g/L) at screening

1e. pregnancy/breast feeding. 2. Exclusionary medications: rituximab within 6 months of screening. 3. IVIG or PLEX treatment 4 weeks prior to screening. 4. History of any type of solid organ or bone marrow transplant.
A Completed-cycle Local Audit of Patient Load in the SHO-led ENT Casualty Clinic

ENT UK guidelines recommend booking no more than 6 patients during each 4-hour clinic session. Retrospectively, the investigators counted patients booked for each clinic on ourbooking system. The second cycle showed improved compliance with guidelines.

Background The investigators' centre runs a regular ENT casualty clinic, run by an SHO, for rapid assessment and treatment of simple, acute ENT cases. ENT UK guidelines from 2017 recommend that no more than 6 patients be booked for an SHO to see during a 4-hour clinic session. This study aims to assess whether this centre meets those guidelines.

Method Data was retrospectively collected from MedWay, the centre's networked booking system. The number of patients booked for each ENT casualty clinic was counted over a period of two months. This was repeated two months after intervention to close the loop.

Result In the first cycle, 2 out of 22 clinics (9%) were found to be compliant with guidelines. Our intervention was to inform clinic booking staff of the guidelines. In the second cycle, 20 of 24 clinics were compliant (83%).

Discussion Anecdotally, prior to intervention, SHOs would often struggle to keep up with the casualty clinic caseload, and clinics would overrun. Clinic booking staff were not previously aware of ENT UK guidelines, and the number of clinic slots was set arbitrarily. This was easily and effectively resolved by educating staff. It can be learned that de facto management practice is not always based on guidelines or evidence; and highlights the importance of auditing all aspects of how organisations are run. Further quality improvement studies should focus on what happens to patients who can no longer be fit into existing casualty clinics.

Eligibility Criteria:
Inclusion Criteria:

* All ENT casualty clinics with patients booked within the study time period

Exclusion Criteria:

* All clinics that were not staffed by an SHO
Ultrasound Guidance Versus Electrical Stimulation for Continuous Popliteal-Sciatic Nerve Blocks

Research study to determine if pain relief following foot and/or ankle surgery is influenced by the technique used to place perineural catheter. The catheters are placed using ultrasound-guidance or nerve stimulation and the method is selected at random using a computer program. This may help to determine if one of these methods is associated with an increased success rate and incidence of foot numbness during the infusion.

Specific Aim 1: To determine the relationship between perineural catheter placement technique (ultrasound-guidance and electrical stimulation) and quality of postoperative analgesia during continuous popliteal-sciatic nerve blocks following moderate-to-severely painful orthopedic surgery.

Hypothesis 1: When inserting a perineural catheter for a continuous peripheral nerve block, the use of electrical stimulation, as compared with ultrasound-guidance, is associated with decreased pain the morning following moderate-to-severely painful orthopedic surgery as measured with a numeric rating scale.

Specific Aim 2: To determine the relationship between perineural catheter placement technique (ultrasound-guidance and electrical stimulation) and degree of sensory deficit during continuous popliteal-sciatic nerve blocks following moderate-to-severely painful orthopedic surgery.

Hypothesis 2: When inserting a perineural catheter for a continuous peripheral nerve block, the use of electrical stimulation, as compared with ultrasound-guidance, is associated with increased sensory deficit the day following moderate-to-severely painful orthopedic surgery as measured with a simple 0-10 scale (0=no numbness; 10=completely insensate) of the part of the foot with the greatest sensory deficit at the time of the data-collection phone call.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgery with a planned popliteal-sciatic perineural catheter for postoperative analgesia
* Expected postoperative pain to be at least moderate in severity the day following surgery (often not adequately treatable with oral analgesics alone)
* Age 18 years or older

Exclusion Criteria:

* Pregnancy
* Inability to communicate wiht the investigators and hospital staff
* Incarceration
* Current chronic opioid use (daily opioid equivalent of \>10mg oxycodone for more than the previous four weeks)
* History of alcohol or opioid abuse
* Neuropathy in the surgical extremity
* Any physical, mental or medical conditions which may confound quantifying postoperative pain resulting from surgery
Equivalence Study Comparing a Cost-Effective PC-Based Ultrasound Training Tool to Traditional Simulators in Third-Year Medical Students

Brief Summary:

The goal of this clinical trial is to determine if a cost-effective, PC-based ultrasound training tool is as effective as a traditional, medium-cost ultrasound simulator for teaching third-year medical students thoracic and abdominal ultrasound skills. This study focuses on improving access to high-quality ultrasound training in educational settings with limited resources. The main questions it aims to answer are:

1. Does the PC-based tool help participants improve their ability to optimize ultrasound images in a way comparable to the traditional simulator?
2. Can participants using the PC-based tool identify and interpret pathological conditions with the same accuracy as those using the traditional simulator?

Participants are third-year medical students enrolled in a structured internship. They will:

1. Watch educational videos covering key concepts in thoracic and abdominal ultrasound imaging.
2. Rotate through training stations where they will practice using either the PC-based tool or the traditional simulator.
3. Perform hands-on exercises with healthy volunteers to practice image acquisition and recognition of anatomical structures.
4. Complete pre- and post-training assessments to measure their progress in skills such as image optimization and identifying pathological conditions.

This study aims to explore whether a low-cost digital solution can provide equal educational value, offering a practical alternative to traditional simulators in resource-limited settings.


Eligibility Criteria:
Inclusion Criteria:

* Third-year medical students enrolled in the "Approach to Ultrasound" internship.
* Participants who have completed the preliminary blended learning videos on thoracic and abdominal ultrasound techniques.
* Participants with or without prior minimal experience in using an ultrasound probe, provided they have not undergone formal specialized ultrasound training.

Exclusion Criteria:

* Inability to attend all training sessions and assessments as per the study schedule.
* Physical or medical conditions that limit the ability to perform hands-on ultrasound practice (e.g., musculoskeletal injuries).
* Refusal to provide informed consent.
Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma

In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival.


Eligibility Criteria:
Inclusion Criteria:

* Stage II or III multiple myeloma according to Durie and Salmon criteria, patients older than 75 years, previously untreated patients.

Exclusion Criteria:

* Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
* Primary or associated amyloïdosis
* World Health organisation performance index of at least 3
* Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more
* Cardiac or hepatic dysfunction
* Cerebral circulatory insufficiency
* Absolute contraindication to corticosteroids
* Peripheral neuropathy clinically significant
* History of venous thrombosis during the last 6 months
* HIV or hepatitis B or C positivity
* Patients who had geography, social, or psychological conditions which might prevent adequate follow-up.
Surveying Parents About Genome Screening of Newborns

A 10 minute baseline survey will be administered to parents of healthy newborn infants while in the hospital after delivery at Brigham and Women's Hospital, to be followed by a 25 minute survey 3-24 months later. We will measure parents' attitudes and preferences related to genome screening of newborns. The specific aims of this study are:

1. To investigate whether parents' opinions regarding genome screening of newborns change between the first 48 hours post-partum and 3-24 months post-partum.

   a. We hypothesize that there will not be significant differences between interest in genome screening results in the 48 hours post-partum compared to 3-24 months post-partum.
2. To determine whether seeing hypothetical genome screening results affects parents' decisions regarding whether they would want genome screening for their newborn.

   1. We expect many parents to state initially (in the 48 hours post-partum) that they would elect to have genome screening for their newborn if it were available. In the follow-up survey, half of study participants will receive hypothetical scenarios in which they will need to struggle with the probabilistic and ambiguous nature of the information that could be derived from genome sequencing. We will examine whether this alters their preferences. We will also explore whether parents who receive hypothetical genome screening results scenarios are more likely to alter their preferences than parents who do not receive hypothetical scenarios.


Eligibility Criteria:
Inclusion Criteria:

* Parent of a healthy newborn in the BWH Department of Obstetrics
* English-speaking

Exclusion Criteria:

* Impaired decision-making capacity
* Newborn with life-threatening health concerns in the 48 hours post-partum
Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)

The objective of this clinical trial is to evaluate the FIM optimal configuration and confirm the safety and performance/efficacy of the FIM when exposed to a larger and more varied population of users.

70 Eligible subjects will be enrolled to the study and examined with the FIM to determine the degree of pupil dilation/Contraction resistance.

The study will be conducted in two main stages: 1) pupil dilation measuring and 2) functional examination. The tests' sequence will be randomized, at least 30 minutes between each test.

Eligibility Criteria:
Inclusion Criteria:

* Healthy and not diagnosed with any chronic disease that might influence the eye and pupilary muscle.
* Age 18-45 years old.
* Willing and able to sign the informed consent, after reading the study information form

Exclusion Criteria:

* Any known or diagnosed neurological disorders.
* A known medical history of ophthalmic surgery or any other disease that might influence the iris control muscle.
* Volunteers with a narrow or closed angle of the anterior chamber
* Presence of a corneal pathology which precludes measurement of the pupil dilatation
* Using of psychiatric medications
* Pregnancy
* Recent use (last 48hr) of pupil dilator eye drops.
* The volunteer is participating in other trials using drugs or devices
* Drug or alcohol abuse
Improved Use of Antibiotic Guidelines in Hospital Environment

The purpose of this study is to determine if the use of antibiotic guidelines and thus antibiotics can be improved through a description of possible barriers leading to tailored interventions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed community-acquired pneumonia (CAP)
* Diagnosed community-acquired pyelonephritis

Exclusion Criteria:

* CAP: hospital-acquired pneumonia; patients transferred from other hospital; death within 24h, aspiration pneumonia, immunocompromised status, palliative status, admission due to social reasons
* Pyelonephritis: urinary tract with functional or physical abnormalities, urinary catheterisation, pregnancy, (immunocompromised status, palliative status, admission due to social reasons and history of renal transplant.
the Effects of Individualized Tai Chi Training on Balance Control in Elderly

Traditional Tai Chi is too complex for most elderly individuals. There have been few reports regarding the development of simplified Tai Chi programs to suit the physical needs of elderly adults. However, these programs were not individualized according to the participants' balance control abilities.The investigators already developed an individualized Tai Chi program. This objective of the study was to investigate the effect of individualized Tai Chi training.

Background: Balance control is an important skill for human to maintain a myriad of postures and activities. The elderly suffering from balance impairment by aging have high rate to increase fall-related injuries, restricted activities, declined physical functions, and decrease quality of life. Tai Chi (TC) has been demonstrated as an innovative way to promote balance function, which is a suitable exercise for older people because of its slow movement, changeable base of supports, multi-directions weight shifting and less impact on lower extremities. Recent systematic reviews have shown that TC exercises have significant benefits in improving balance control, but most of them are only connected with healthy elderlies. Actually, the long standing time and training duration, challenged recollection by its sequence forms, and complex coordination for upper and lower extremities of TC usually make it difficult to practice for some elderlies with poor physical functions. Therefore, the method of individualized TC exercise program, integrated with biomechanical analyses, is developed in this research. It can afford an easier and more applicable training for elderly to improve the balance abilities.

Purposes:To evaluate the effects of individualized Tai Chi training on balance control in elderly.

Methods: This research is a quasi-experimental design and prospective study. Participants were recruited and assigned into individualized TC, entire TC group and home-based education group

Eligibility Criteria:
Inclusion Criteria:

Participants in the study were community-dwelling volunteers aged over 65 years. Participants were ambulatory and did not

Exclusion Criteria:

have any history of

1. diagnosed central nervous system
2. vestibular pathology
3. cognitive impairment
4. visual deficit
5. fracture of lower limb in recent 6 months
6. with Tai Chi practice experience for more than 2 months.
7. severe hearing impairment to follow instruction
CLE and OCT in Acute Respiratory Insufficiency

Acute respiratory distress syndrome is a severe complication of critical illness. The diagnosis of ARDS is difficult, and it could be important to differentiate ARDS from other causes of acute respiratory failure. Innovative probe-based imaging techniques such as 'Confocal Laser Endomicroscopy' (CLE) and Optical Coherence Tomography (OCT) are high resolution optical techniques that, combined with conventional bronchoscopy, have been found to provide non-invasive, real-time near-histology information about the alveolar compartment in non ventilated non-critically ill patients.

It is important to identify the underlying cause of respiratory failure, in order to determine the appropriate treatment. Histopathology would help treatment decisions, however is in the fast majority of this critically ill patient-group not available. CLE is enables near histology/microscopic analysis during bronchoscopy, by tissue illumination with a low-power laser. Optical Coherence Tomography is the optical equivalent of B-mode ultrasonography, that consists of a small rotating optical fibre. Both the CLE and OCT techniques are minimally invasive and little time consuming. Therefore different areas of the lung can be sequentially imaged. With this pilot study the investigators aim to describe normal alveolar areas and areas with abnormalities in critically ill patients with non resolving acute respiratory failure mandating a standard bronchoscopy or laryngoscopy with or without bronchoalveolar lavage.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to intensive care unit of academic medical center in Amsterdam
* Indication for a procedure to investigate the airways that can be combined with pCLE/OCT

Exclusion Criteria:

* Inability and willingness to provide informed consent by family-members
* Inability to comply with the study protocol
PK and Food Effect of Pregabalin Study After Dosing in Healthy Male Volunteers

This study is to assess the pharmacokinetics of Pregabalin controlled release formulation after multiple dosing as compared to Pregabalin immediate release formulation and the food effect of high fat diet after single dosing in healthy male volunteers.

Cohort 1 study is to assess the PK of Pregabalin controlled release formulation as compared to Pregabalin immediate release formulation. Cohort 1 subjects will be admitted to the clinic at Day 1. All subjects will receive multiple dosing for three days of YHD1119 or Pregabalin IR and will remain in the clinic until completion of all assessment on Day 19 including collection of PK sample. The treatment periods were separated by a washout period (10-17 days).

Cohort 2 study is to assess the food effect of high fat diet after single dosing. Cohort 2 subjects will be admitted to the clinic at Day -1. All subjects will receive a single dose of YHD1119 and will remain in the clinic until completion of all assessment on Day 9 including collection of PK sample. The treatment periods were separated by a washout period (7-14 days).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male with body mass index (BMI) between 18.5 and 28 kg/m2
* Who has not suffered from clinically significant disease
* Provision of signed written informed consent

Exclusion Criteria:

* History of and clinically significant disease
* A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
* Administration of other investigational products within 3 months prior to the first dosing
Psychobiology in Inflammatory Bowel Disease(IBD)

Patients with ulcerous colitis and Crohn's disease, age 18-60, with a relapse within the last 18 months and an activity index ≥4, with a long time stress level ≥60 on the perceived stress questionnaire (PSQ) were randomized to a stress management intervention program or treatment as usual and followed up for 18 months.

The study includes distressed patients with ulcerous colitis and Crohn's disease with relapse or enduring activity last 18 months and an simple activity index ≥4, on stable medication last 4 weeks. All patients were followed by a gastroenterologist at baseline, 3, 6, 12 and 18 months follow up and a psychiatrist or clinical psychologist at 18 months. Half of the patients received additional psychosocial intervention (education, relaxation, supportive psychotherapy with stress management). Assessments include gastrointestinal assessments; blood tests; psychiatric evaluations and psychometric evaluations.

Eligibility Criteria:
Ulcerous colitis and Crohn's disease verified by histology and endoscope Relapse last 18 months or enduring activity Activity index≥4 PSQ≥60