cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease

Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease.

This is a 56-week (24-week randomized double-blind period, 24-week active treatment period, and 8-week safety follow-up period) multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of abiprubart in participants with Sjögren's Disease with moderate or high systemic disease activity according to the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI). The objectives of the study are to evaluate efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of abiprubart compared with placebo across the estimated therapeutic range using different dosing regimens of abiprubart.

Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of Sjögren's Disease according to 2016 American College or Rheumatology (ACR)-EULAR Classification Criteria.
* Has ESSDAI value ≥ 5, counting only the biological, hematological, articular, cutaneous, glandular, lymphadenopathy, and constitutional organ domains at Screening.
* Is seropositive at Screening for anti-Sjögren's-syndrome-related antigen A autoantibodies (SSA) antibodies tested at a central laboratory.
* Has stimulated whole salivary flow rate at Screening of ≥ 0.05 mL/min
* Weighs at least 40 kg and no more than 150 kg and has a body mass index (BMI) within the range of 18-40 kg/m2.

Exclusion Criteria:

* Prior exposure to any other anti-CD40/CD154 agent.
* Diagnosis of Sjögren's Disease overlap syndromes where another autoimmune rheumatic disease constitutes the principal illness, including fibromyalgia with currently active, inadequately controlled symptoms.
* Has received cataract surgery, Lasik, or other ophthalmologic surgery procedure (e.g., lachrymal plug) in the 6 months prior to Screening.
* Injectable corticosteroids (including intra-articular) within 8 weeks prior to randomization.
* Has started, stopped or adjusted dose/regimen of medications for treatment of, or known to cause dry mouth/eyes within the 30 days prior to screening or is anticipating change to these treatment regimens during the study.
* Has history of immunodeficiency (e.g., immune disorders or disorders that result in decreased immunity), including human immunodeficiency virus (HIV).
* History of thromboembolic event or a significant risk of future thromboembolic events.
* Has a known high risk of infection; Has a history of chronic or recurrent infectious disease; Has any known or suspected active infection, or has had a serious infection requiring hospitalization, or has been treated with IV/IM antibiotics for an infection within 8 weeks prior to first dose of study drug or treatment with oral antibiotics for an infection within 2 weeks prior to first dose of study drug.
Volumetric MRI Brain in Patients With Migraine

Assessment of the role of volumetric MRI in evaluation of different types of migraine .

Migraine is a common condition that many people experience during their lives. Evolving data reported that migraine patients have increased risk of developing silent brain lesions, such as white matter lesions and volumetric changes in both grey and white matter found on MRI .

These changes have been first investigated with CT scans which reported cerebral edema, atrophy and ischemia . With the advent of MRI and high-resolution devices, the most commonly reported structural changes were white matter lesions .

Volumetric brain MRI is the tool segments and measures volumes of the key brain structures-hippocampus, ventricles and other structures-and compares the volumes to standard normal values based on age, gender and cranial volume. This information helps assess neurological conditions and neurodegenerative diseases .

* In migraine patients ,Volumetric MRI techniques allow better assessment of WMLs and may provide a different comprehension of structural aspects related to the migraine pathophysiology. The identification of migraineurs' brain structural alterations through non-invasive neuroimaging methods and the use of accessible and easy to-use software brings new perspectives on the assessment of the impact of this condition in central nervous system macro-architecture .
* In previous studies, structural brain changes in migraineurs were assessed by an automated segmentation using (Free Surfer) method .

In our study, we aim to investigate these total and segmental structural changes of brain volume in migraine patients; as well as white matter lesions, in comparison to healthy controls, and in patients with episodic migraine in comparison to chronic type of migraine using another automated tissue segmentation (Vol brain) method.

Eligibility Criteria:
Inclusion Criteria:

* Patients with different types of migraine :

  * episodic migraine without aura (MoA)
  * episodic migraine with aura (MA)
  * chronic migraine (CM).

Exclusion Criteria:

* . History of acute myocardial infarction, ischemic or hemorrhagic stroke. . History of neurosurgery or brain trauma

  * Patients with contra-indications to MRI.
Early vs. Interval Postpartum IUD Insertion

Intrauterine devices (IUDs) are historically placed at a six-week postpartum visit for women who desire intrauterine contraception after delivery. A two-week postpartum visit could be a convenient time for women to receive contraception, including IUDs. Offering women IUDs at two-weeks postpartum may decrease the risk of undesired pregnancy and rapid repeat pregnancy. This study will compare IUD insertion at two different times after delivery: two-weeks and six-weeks postpartum. This will allow researchers to assess whether the timing of IUD placement affects whether an IUD is expelled, or pushed out of it's ideal location.

The purpose of this study is to determine the proportion of IUDs inserted in the Early Postpartum (EPP) period that are expelled at 6 months postpartum. This prospective, multi-site randomized trial will enroll approximately 404 women at three large academic hospitals in the United States.

Women will be recruited who are interested in receiving a levonorgestrel-IUD or a copper-IUD after delivery. Postpartum women who desire an IUD will be randomized to EPP IUD insertion (between 14-28 days PP) or interval postpartum IUD insertion (42-56 days PP) and the proportion of IUDs expelled will be compared between groups at 6 months postpartum. All women will be seen in clinic at 6-8 weeks and 6 months postpartum. Women randomized to EPP IUD placement will be seen at 2-3 weeks postpartum.

Provider perspectives of EPP IUD placement will also be evaluated, as will whether these attitudes change after 6 to 9 months of providing early postpartum IUDs.

Eligibility Criteria:
Inclusion Criteria:

* Gave birth less than or equal to 10 days ago
* Desires to use an IUD for Contraception (either copper or levonorgestrel)
* Willing and able to sign an informed consent
* Willing to comply with the study protocol
* Age greater than or equal to 18 years
* English or Spanish speaking

Exclusion Criteria:

* Uterine anomaly or leiomyomata which would not allow placement of an IUD
* Desire for repeat pregnancy in less than 6 months
* Evidence of intrauterine infection (chorioamnionitis or postpartum endometritis) treated with antibiotics
* Ruptured uterus at the time of delivery
* Received a postpartum tubal ligation or immediate postpartum IUD or implant at delivery
* Incarcerated women or women with significant cognitive impairment
* 4th degree perineal laceration sustained at delivery
* Any medical contraindication to IUD per the US Centers for Disease Control (CDC) Medical Eligibility Criteria
* Suspicion for new pregnancy
A Novel System to Detect Falls in Real-life Conditions

Medical alert devices with automatic fall detection functionality use accelerometry to detect a fall and can signal for help if the wearer forgets to, or is incapable of, pressing the alert button. This can save lives and prevent complications associated with long periods of time spent on the floor after a fall. In this project, the sensitivity and false alarm rate of a commercially available medical alert device will be tested in a population of 200 community-dwelling older adults.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the STRIDE Study at the Boston trial site (http://www.stride-study.org/).

Exclusion Criteria:

* Uses a medical alert device
Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations

In this study, participants will be imaged using two Optical Coherence Tomography (OCT) devices: device N, a standard conventional OCT device with an invention (comfortable chin and forehead rest that can be adjusted to fit each individual's size) attached to the device; and device C, the standard conventional OCT device with no invention attached. The investigators will assess whether the chin and forehead rest attachment (invention) provides a more comfortable experience for patients.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers; OR,
* AMD, diabetic retinopathy, central serous chorioretinopathy, and/or glaucoma or glaucoma suspects or any other suspected eye disease

Group-Specific Inclusion Criteria:

-- There are no group-specific inclusion criteria for patients with AMD, diabetic retinopathy, and central serous chorioretinopathy.

Healthy Volunteers

* A normal clinical ophthalmic examination.
* Reliable VF, reproducible glaucoma hemifield tests labeled within normal limits on at least one test.
* Good quality (adequate signal strength ≥ 6/10, without segmentation algorithm failure and motion artifacts \> 1 vessel diameter) RNFL and Ganglion Cell Inner Plexiform Layer (GCIPL) OCT, within normal limits.

Primary Open Angle Glaucoma (POAG)

* Clinical characteristics of glaucoma: optic nerve head (ONH) abnormalities: global rim thinning, rim notch, or disc hemorrhage; retinal nerve fiber layer (RNFL) defect.
* Typical glaucomatous field loss in reliable VF, reproducible glaucoma hemifield tests labeled outside normal limits on at least two consecutive tests.
* Good quality (adequate signal strength ≥ 6/10, without segmentation algorithm failure and motion artifacts \> 1 vessel diameter) RNFL and GCIPL OCT, labeled outside normal limits with typical glaucomatous RNFL and GCIL thinning.

Normal Tension Glaucoma (NTG)

* Identical to POAG criteria with IOP recorded at ≤ 21 mmHg at any time point.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

- Any medical treatment (e.g., chronic corticosteroid, hydroxychloroquine, chloroquine, thioridazine, canthaxanthine) or conditions that affect VF (e.g., stroke) and retinal thickness other than glaucoma.
Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health

Prescribing lifestyle changes to patients who are at risk of cardiovascular disease, may be an extremely cost effective mechanism of improving health for the individual themselves and the NHS. It is already proven that positive lifestyle changes such as improved diet, increased physical activity, quitting smoking and reducing alcohol consumption can lower the risk of cardiovascular disease, as well as reduce the risk of all-cause mortality.

P-PLAC2 (Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health) is a Phase II interventional study to determine the efficacy of a Lifestyle Prescription (LRx), from the viewpoint of patients and healthcare practitioners. The study uses a mixed methods design, and full study training and support will be provided to staff involved in the recruitment of patients, through to the behaviour change consultation, and end of study.

If the study proves successful, a lifestyle prescription (LRx) could then be made available to support NHS staff throughout all disciplines (specifically those working with patients who are at risk of cardiovascular disease (CVD).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over.
* Able and willing to provide written informed consent.
* Understands spoken and written English.

Exclusion Criteria:

* Participant is unwilling or unable to provide written informed consent.
* Participant is pregnant.
* Participant has a diagnosed psychological disorder.
* Participant has a drug dependency.
* Participant is housebound, or resides in a nursing home.
* Participant has behavioural issues or learning difficulties.
Single-blind RCT Comparing Smartphone vs. Paper-based HEP in Pelvic Floor PT

The goal of this randomized clinical trial is to investigate the impact of a smartphone-based application on patient-reported outcomes for patients with pelvic floor muscle weakness, and the relationship of patient adherence to outcomes in pelvic floor physical therapy compared to the paper-based standard of care.

An additional aim is the exploration and development of two patient-reported questionnaires to enhance understanding of exercise adherence in outpatient pelvic floor physical therapy and smartphone application self-efficacy. These goals will serve to improve practice recommendations for home exercise prescriptions in this patient population.

Participants will be asked to complete 6 patient-reported outcome measures after they complete four, 60-minute long physical therapy treatment sessions conducted one time per week according to the current standard of care for pelvic floor physical therapy.

The experimental group will be given a free pelvic floor muscle exercise application while the control group will be provided with the paper-based standard of care for their home exercise program.


Eligibility Criteria:
Inclusion Criteria:

* 18-85 years old

  * Referred to outpatient pelvic floor physical therapy for treatment of pelvic floor weakness
  * Generation 5 or later iPhone, Android, or Smart Device
  * Must be willing to receive Push Notification reminders from the application
  * Must have free space on device to download and install app
  * Must have access to the Google Play store or to iOS Apple App Store

Exclusion Criteria:

* ● Not Meeting Inclusion Criteria

  * Pelvic Organ Prolapse Surgery with complications
  * Neurodegenerative Disease
  * History of TBI or CVA with resulting impairment in long- or short-term memory
  * Denervation injury to the pelvic floor
  * Spinal cord injury
  * Pelvic Pain Condition
  * Incapable of Completing Outcomes Questionnaire without caregiver support
  * Unable to speak and read English
  * Current Pregnancy
  * Less than 6 weeks postpartum
  * Researcher judgement
Intact-cord Stabilisation and Physiology-based Cord Clamping in Caesarean Sections

This is a feasibility study with historical control designed to evaluate whether delivery of the placenta prior to umbilical cord clamping at caesarean sections is a feasible, safe and acceptable way of facilitating intact-cord stabilisation of preterm and term newborn infants.

Standard procedure when an infant is delivered by caesarean section is to wait to clamp the umbilical cord for approximately one minute, and then transfer the infant to a designated area for assessment and stabilisation. If the infant needs immediate resuscitation, the umbilical cord is cut earlier to expedite transfer to resuscitation equipment and qualified care (including stimulation, clearing airways and respiratory support).

It has been suggested in several pilot and clinical studies that keeping the umbilical cord intact during the infant's transition from intra- to extrauterine life may improve outcomes and survival, especially for preterm infants. Since length of the umbilical cord is limited, finding ways to avoid cutting the cord while initiating stabilisation and care is warranted. To date, most studies have reported on interventions that involve mobile resuscitation equipment; thus keeping the infant in close proximity to the mother. This may be extra challenging in caesareans sections, especially due to space constraints and maintenance of sterility.

The objective of this study to determine whether extra-uterine placental transfusion to facilitate intact-cord stabilisation and physiology-based cord clamping for infants delivered by caesarean section is feasible, safe and acceptable for infants and their mothers, as well as for involved personnel.

Eligibility Criteria:
Inclusion Criteria:

* live infants (singletons or dichorionic twins) born in gestational week 32+0 to 42+0
* delivered by CS in regional anaesthesia
* immediate care may be planned with involved personnel prior to delivery
* informed maternal consent is obtained (parental consent on behalf of the unborn child).

Exclusion Criteria:

* twins, triplets
* significant congenital malformations
* placenta complications with high risk of abnormal maternal blood loss
* severe fetal distress requiring cesarean section in general anaesthesia (crash CS)
* participation in any other clinical study within the last month
* not sufficient time for preparations or collection of maternal/parental consent
* mother does not comprehend Norwegian or English
Effect of Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius Stiffness and Ankle Range of Motion

This study will examine whether a technique called instrument-assisted soft tissue mobilization (IASTM) can reduce stiffness in the calf muscle (gastrocnemius) and improve ankle mobility. Muscle stiffness will be measured using a specialized ultrasound method called shear-wave elastography, while ankle range of motion will be assessed using the weight-bearing lunge test. Healthy volunteers will participate in this study, and measurements will be taken before and after a single IASTM treatment. The aim is to determine if this manual therapy technique can produce immediate changes in muscle properties and joint flexibility.

This interventional study aims to evaluate the acute effects of instrument-assisted soft tissue mobilization (IASTM) on the stiffness of the gastrocnemius muscle and ankle dorsiflexion range of motion. Muscle stiffness will be quantified using shear-wave elastography (SWE), a non-invasive ultrasound technique that measures tissue mechanical properties in real time. Ankle dorsiflexion range of motion will be assessed using the weight-bearing lunge test with the knee extended, a reliable functional measure of ankle mobility.

Participants will undergo baseline measurements followed by a standardized IASTM intervention targeting the gastrocnemius muscle. Post-treatment assessments will be conducted immediately afterward to capture acute changes. The study is designed to improve understanding of how IASTM influences muscle mechanical properties and functional joint mobility. Findings may have implications for the clinical use of IASTM in both rehabilitation and performance contexts.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45 years
* Healthy individuals without current lower limb injury
* No history of surgery to the ankle, knee, or calf
* Able to perform the weight-bearing lunge test without assistance
* Willing to refrain from intense lower-limb exercise 24 hours before testing

Exclusion Criteria:

* Current or recent (past 3 months) lower limb musculoskeletal pain or injury
* Known neuromuscular or vascular disorders affecting the lower extremity
* Use of medications affecting muscle tone or flexibility within 48 hours prior to testing
* Previous adverse reactions to manual therapy or IASTM
* Skin lesions, bruising, or conditions over the gastrocnemius that contraindicate IASTM
* Pregnancy
Surgical Research in Colombia Part 1

Global surgery has become the undisputed starting point for addressing a myriad of problems in surgery today. Therefore, it is necessary to constantly evaluate the scientific productivity in surgery, its behavior, validity and impact. In Latin America, specifically in Colombia, there are no studies that have analyzed this production. A retrospective cross-sectional bibliometric study was carried out, in which the Colombian Ministry of Science database was consulted with the validated results up to July 2021. In the search section for research groups, the keyword "Surgery" was used, and all associated Groups in Latin America and the Caribbean(platform where the information of the research groups can be found) and their registered products were reviewed


Eligibility Criteria:
Inclusion Criteria:

* Research groups with a main or secondary line of research in general or subspecialty surgery, registered in the base of the Colombian Ministry of Science

Exclusion Criteria:

* Research groups with other lines of research in the surgical sciences
Glucose Metabolism in the Immediate and Short Term Follow up After Bariatric Surgery

MIDAS involves an assessment of glucose levels obtained before and after bariatric surgery. There are two different procedural tests involved; an oral glucose tolerance test (mixed meal) and a hyperglycemic clamp test. Two tests are performed preoperatively and five more are performed postoperatively for a one year period. The associated labwork drawn with the mixed meal and clamp tests are demonstrating changes in glucose, insulin and gut hormone levels.

Tests performed are the Mixed Meal tolerance test, the Hyperglycemic Clamp test, c-peptide, free fatty acids, adipocyte hormone profile levels.

Eligibility Criteria:
Inclusion Criteria:

* Negative pregnancy test if female
* ADA criteria for diabetes type II
* Hematocrit \> 35 creatinine \< 1.9, AST \< 3X upper limit of normal, ALT \< 3X upper limit of normal, alkaline phos \<3X upper limit of normal
* Eligibility for bariatric surgery based on the NIH and clinical criteria
* Mentally and legally capable of providing consent

Exclusion Criteria:

* Lactating females
* Must not have type I diabetes
* Systemic steroids taken within 6 months
* Clinically significant heart disease
* Recent pulmonary embolism, untreated proliferative retinopathy, renal failure, uncontrolled hypertension, autonomic neuropathy, resting heart rate \> 100, neuromuscular or musculoskeletal disease.