cyrilzakka/clinical-trials huggingface dataset:
Automatic PredICtion of Edema After Stroke

To use machine learning for early detection of malignant brain edema in patients with MCA ischemia

Malignant cerebral edema following large ischemic strokes account for up to 10% of all ischemic strokes. Mortality rates are high and most of the survivors are left severely disabled. Although decompressive craniectomy has been shown to significantly decrease mortality, high morbidity rates among survivors are reported. The optimal timepoint when neurosurgical decompression should be performed in the individual patient varies and is a subject of debate.

Early prediction of malignant brain edema to identify those patients who benefit from surgical treatment is a clinical challenge. The aim of this study is to use machine learning for comprehensive analysis of CT images as well as clinical data from 1500 patients with large ischemic MCA strokes in oder to develop a model for early prediction of malignant brain edema. In a first step algorithms automatically identify characteristic imaging features and clinical data of 1400 retrospective data sets to create a multistage model (learning phase). This is followed by a validation phase where the model is tested with 100 other retrospective data sets.

Eligibility Criteria:
Inclusion Criteria:

* Acute ≥ subtotal MCA infarct (M1-M2 occlusion)
* with or without malignant brain swelling
* with or without reperfusion therapy
* with or without neurosurgical decompression
* with or without death following malignant brain edema

Exclusion Criteria:

* Non-acute MCA infarct
* \< subtotal MCA infarct
Self-Monitoring Shopping Intervention

The purpose of this study is to examine the effectiveness of a self-monitoring intervention to improve shopping performance in adults with intellectual disability (ID) secondary to Down syndrome (DS). The research question asks, can an 8-week self-monitoring intervention, provided in a community-based setting, increase observable shopping skills in adults with ID secondary to DS?

Adults with intellectual disability secondary to Down syndrome often have difficulty performing complex activities of daily living, such as shopping. These difficulties may, in part, be influenced by deficits in metacognitive abilities, which include self-monitoring of one's performance. There is evidence that interventions which target self-monitoring skills can improve functional performance in adults and adolescents with traumatic brain injury.

Functional magnetic resonance imaging (fMRI) studies on adults with Down syndrome have demonstrated impairments in metacognitive abilities, resulting from significant volume reduction in the frontal lobes and anterior cingulate cortex. These deficits likely contribute to the difficulties experienced by this population when performing instrumental activities of daily living (IADL), such as shopping. Although metacognitive-focused interventions that address self-monitoring skills have been used to improve functional performance in adults and adolescents with traumatic brain injury, these techniques have not yet been used to improve IADL performance in adults with intellectual disability secondary to Down syndrome.

This 16-week study is a single-subject ABA design across ten participants to determine the effectiveness of a self-monitoring intervention on shopping performance in adults with intellectual disability secondary to Down syndrome. The intervention will span 8 weeks and will include weekly sessions that are delivered in an alternating group-individual format. Sessions will provide participants the opportunity to practice and apply self-monitoring techniques across a variety of shopping tasks and settings to promote generalization and transfer of learning. This study has the potential to provide preliminary information on the effectiveness of a self-monitoring intervention, provided in community-based settings, to increase observable shopping skills in adults with intellectual disability secondary to Down syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Adults with intellectual disability secondary to Down Syndrome
* Members of a community center called GiGi's Playhouse Hillsborough

Exclusion Criteria:

* Severe behavioral disorder that would prevent cooperation with study protocol
REnAL denervatIon by ultraSound Transcatheter Emission

The REALISE trial is a single-arm, open-label, prospective, post market evaluation to be conducted on twenty (20) eligible patients with a twelve month follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Resistant hypertension, as defined in the 2007 ESH-ESC guidelines
* 18 years of age or older
* Negative pregnancy test for female patients of childbearing potential
* Willing and able to comply with follow-up requirements
* Signed informed consent

Exclusion Criteria:

* Secondary hypertension
* Main renal arteries length \< 20 mm
* Main renal arteries diameter \< 4 mm
* Renal artery stenosis
* Iliac/femoral artery stenosis precluding insertion of the catheter
* Allergy to contrast media
* Currently participating in the study of an investigational drug or device
* Hemodynamics abnormality
* Moderate to severe renal insufficiency
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A

Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.

The intradetrusor injection of onabotulinumtoxin A for treatment of idiopathic overactive bladder and urgency urinary incontinence refractory to anticholinergic or β-agonist treatment was approved by the United States Food and Drug Administration (FDA) in 2013. Since then, multiple randomized placebo-controlled trials have demonstrated the effectiveness of the treatment. Currently, Allergan, Inc. and the FDA recommend the intravesical administration of onabotulinumtoxin A with dilution to 100 units/10 mL with preservative-free 0.9% Sodium Chloride Injection, as 20 injections of 0.5 mL each. Currently, in clinical practice there has been no standardization in the number of intravesical injections, with a single dose of onabotulinumtoxin A being administered in as few as 1 injection to as many as 40 injections into the detrusor muscle. Given the increasing use of this treatment modality, the investigators aim to compare patient outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to the recommended 20 injections for the treatment of idiopathic overactive bladder or urgency urinary incontinence refractory to medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Women \>=18 years of age with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, overactive bladder.
* Procedure scheduled in either the outpatient clinic or the operating room to be performed without use of sedation, general, or neuraxial anesthesia.

Exclusion Criteria:

* Male gender.
* Women \<18 years of age.
* Non-English speaking.
* Pregnancy (patient will self-report pregnancy).
* Participant has symptoms of overactive bladder due to any known neurological reason (e.g. spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.)
* Participant uses clean intermittent catheterization or indwelling catheter to manage urinary incontinence.
* Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy.
* Participant has a known allergy or sensitivity to any botulinum toxin preparation.
* Participant has any medical condition that may put her at increased risk with exposure to onabotulinumtoxin A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.
* Participant is scheduled for administration of onabotulinumtoxin A with use of sedation, general, or neuraxial anesthesia.
Immediate Implant vs.Socket Shield Technique in Esthetic Zone

immediate implant placement versus socket shield approach

This study was a randomized controlled clinical trial; patients were randomly allocated to two groups: the study group: ten dental implants were placed in the maxillary esthetic zone, implants were placed using the socket shield technique with immediate loading; and the control group: ten implants were placed immediately with immediate loading. Preoperative and 6 months postoperative CBCT were performed for both groups to assess the dimensional changes in the labial bone plates. Implant stability quotients (ISQs), pink esthetic scores and attachment loss were measured at the time of implant placement and 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

Patients of 20-45 years of both sexes. Good oral hygiene Demonstrating non-restorable maxillary anterior single rooted teeth in the esthetic zone with as far diagnosable.

Fairly intact buccal periodontal tissues. Patients' acceptance to sign the informed consent. Labial bone plates less than 1.5 mm in thickness or cases with labial root curvatures.

Intact root with no mobility in the tooth and no sub-gingival caries.

Exclusion Criteria:

Patients with systemic diseases that would interfere with the normal healing such as uncontrolled diabetes mellitus.

History of radiation therapy to the head and neck. No history of bruxism/ para-functional habits. (119) Teeth with periodontal disease, vertical root fracture, horizontal fracture at or below the bone level, and teeth with local pathologic incidents that affect the labial part of the root as external or internal root resorption were also excluded.

Maxillary 1st and 2nd premolars. Pregnant and lactating females.
Foot Spine Syndrome "RAFFET Syndrome"

case series aimed to describe a new clinical condition for the first time in the medical literature called Foot Spine Syndrome or "RAFFET Syndrome". This syndrome was reported in 11 patients (6 males and 5 females) out of 4000 patients with a history of chronic low back pain (CLBP) throughout 2 to 6 years in an outpatient clinic in Egypt from 2016 to 2022.

Foot pain is usually derived from systemic disorder or local physical issues, such as tendonitis, arthritis, or bursitis. However, in some cases, pain in your foot may be linked to problems in your spine. This case series aimed to describe a new clinical condition for the first time in the medical literature called Foot Spine Syndrome or "RAFFET Syndrome". This syndrome was reported in 11 patients (6 males and 5 females) out of 4000 patients with a history of chronic low back pain (CLBP) throughout 2 to 6 years in an outpatient clinic in Egypt from 2016 to 2022. The patients suffered from CLBP that did not respond to physical therapy or any medication for long. They all had clinical spinal instability, hallux rigidus, foot abnormalities and tightness of hip flexors and adductors accompanied with weakness of hip extensors and abductors on the affected side. Manual therapy for the big toe including; Maitland mobilization (Grade 3,4), Mulligan mobilization with movement techniques, muscle energy techniques, manual therapy for plantar fascia, strengthening exercises and self-stretching exercises was performed.

Eligibility Criteria:
Inclusion Criteria:

* patients with a history of chronic low back pain (CLBP) did not respond to physical therapy or any medication for long. They all had clinical spinal instability, hallux rigidus, foot abnormalities and tightness of hip flexors and adductors accompanied with weakness of hip extensors and abductors on the affected side

Exclusion Criteria:

* any structural deformity (wedge fracture) or previous spinal surgeries. Spinal tumors or fracture or presence of active infection in the lumbar spine. Systematic disorder (Rheumatoid) Cauda equine lesion, the presence of any comorbidities such as hypertension, DM, hyperlipidemia, obesity, and any autoimmune disease, history of patients who suffered from cancer, unexplained weight loss, immunosuppression, prolonged use of steroids, intravenous drug use, urinary tract infection, pain that is increased or unrelieved by rest, fever, significant trauma related to age, bladder or bowel incontinence, urinary retention (with overflow incontinence), saddle anesthesia, loss of anal sphincter tone, major motor weakness in lower extremities, fever, and vertebral tenderness.
Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis

This is a randomized, double-blind study of excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily for plaque psoriasis.

The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD.

The hypothesis of this study is that excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily will lead to improved efficacy of these treatments alone.

The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD. The primary endpoint will be the comparison between the change in NPF score of plaques treated with excimer laser and those treated with sham treatment.

The secondary objectives are to compare the number of excimer light treatments and time necessary to achieve an average lesion assessment score of 0 to 1 in subjects treated with acitretin 25 mg PO or tazarotene gel 0.1% QD, and to evaluate adverse events related to combinations of the study treatments.

Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent
* Must be at least 18 years old
* Must have been diagnosed with stable plaque type psoriasis covering between 1 and 5% BSA
* NPF-PS ≥8 (based additive scores averaged over all lesions for erythema, scale, and thickness range of score = 0-5)
* No systemic or phototherapy in the 4 wks prior to entering the study
* No topical therapy other than emollients (no corticosteroids, vitamin D analogs, vitamin A analogs) in the 2 wks prior to entering the study
* Women on tazarotene gel must not be pregnant nor planning to become pregnant during the study and must be on two forms of birth control
* Subjects known to not tolerate oral acitretin at 25 mg/day and women of child-bearing potential may be enrolled and treated with topical tazarotene gel 0.1%

Exclusion Criteria:

Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:

* Unstable disease
* Only treatable sites are in intertriginous areas or on face
* Subjects unable to tolerate frequency of visits
* NPF-PS severity score \<8 additive score of erythema, scale, and thickness, averaged over all lesions
* History of inability to tolerate topical tazarotene 0.1% gel and or acitretin 25 mg/day
* Women of childbearing potential are excluded from the actretin arm of the study.
Using Device Delivering Ophthalmic Solution in a Spray Form Instead of Eye Drops

The purpose of the study is to confirm that Vigamox reaches similar aqueous concentration when administered as the commercially available eye drops or as a spray delivered from a proprietary device.

Patients scheduled for elective cataract surgery, will be randomly allocated to receive Vigamox 4 times , 1 hour prior to surgery, either via the experimental device in a spray form, or via the regular, commercially available bottle.

Aqueous sample will be collected and submitted to a masked laboratory for measuring Vigamox concentration.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective cataract surgery

Exclusion Criteria:

* Known allergy to quinolone compounds
A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer

The goal of this clinical trial is to evaluate CLBR001 and ABBV-461 as a treatment for patients with locally advanced or metastatic breast cancer. The goals are to establish the safety and efficacy of the combination therapy while establishing the optimal biologic doses.

Patients will be administered a single infusion of CLBR001 cells followed by cycles of ABBV-461 with regular assessments of safety and disease response to treatment.

CLBR001 + ABBV-461 is novel switchable CAR-T cell combination therapy comprised of an autologous CAR-T product (CLBR001, the switchable CAR-T cell \[sCAR-T\]) and ABBV-461 (the "switch" biologic molecule). ABBV-461 acts as an adapter molecule that controls the activity of the CLBR001 CAR-T cell product.

Eligibility Criteria:
Inclusion Criteria:

* Refractory or relapsed locally advanced or metastatic breast cancer
* Exhaused all standard of care therapy options
* Measurable disease at time of screening in accordance with RECIST v1.1 criteria
* Women or men age ≥18 years of age at time of consent
* ECOG performance status 0 or 1
* Must provide a biopsy sample obtained during the screening period, following the end of the most recent prior line of therapy
* Adequate hematological, renal, and liver function

Exclusion Criteria:

* History of a clinically significant infection within 4 weeks prior to consent
* Active bacterial, viral, and/or fungal infection
* Prior allogeneic stem cell transplant
* Prior lentiviral- or retroviral-based therapy including CAR-T cell therapy
* Prior lymphodepleting or T-cell cytotoxic therapy within 3 months of enrollment
* Subjects receiving attenuated vaccines within 4 weeks of consent or need for live vaccine within 12 months of starting study therapy
* History of significant cardiovascular conditions within the past 6 months
* Subjects with a prior history of or concurrent malignancy whose natural history or treatment has the potential to interfere with either the safety or efficacy assessment of the investigational regimen
A Pilot and Feasibility Study of a Dietary Intervention with Low-protein Meals in Cancer Patients Receiving Immunotherapies

The main idea of this study is that a low protein diet may alter the environment surrounding the tumor, enhancing the body's immune response leading to greater anticancer effects of treatment. This study intends to use a low-protein diet as a tool to enhance the immune response generated by immune check point inhibitor treatments.

This is a single center, randomized, open label study to assess the feasibility of a low-protein diet intervention in cancer patients who are receiving immunotherapies. Subjects will be randomized in a 1:1 ratio to either immunotherapy plus control diet arm (\~20% protein content) or immunotherapy plus intervention low-protein diet arm (10% protein content).

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented solid tumor malignancies which is amenable for immunotherapy treatment with immune checkpoint inhibitors (i.e. PD1, PD-L1, CTLA inhibitors) as single agents or in combination.
* Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan of the chest, abdomen, and pelvis
* Life expectancy of at least 6 months
* Adults ≥ 18 years of age
* Adequate hematologic, renal, and liver function as evidenced by the following:

  * White blood cell (WBC) ≥ 2,500 cells/μL
  * Absolute neutrophil count (ANC) ≥ 1,000 cells/μL
  * Platelet Count ≥ 100,000 cells/μL
  * Hemoglobin (HgB) ≥ 9.0 g/dL
  * Creatinine ≤ 2.0 mg/dL
  * Total bilirubin ≤ 2 x upper limit of normal (ULN)
  * Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN
  * Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN

Exclusion Criteria:

* • Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher

  * Treatment with any of the following medications or interventions within 28 days of registration:

    * Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.
    * High dose calcitriol \[1,25(OH)2VitD\] (i.e., \> 7.0 μg/week)
  * A requirement for systemic immunosuppressive therapy for any reason
  * Any infection requiring parenteral antibiotic therapy or causing fever (temperature \> 100.5°F or 38.1°C) within 1 week prior to registration
  * A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT imaging
  * Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives
Validation of the Adenomyosis Calculator

Adenomyosis is a disease where ectopic endometrial glands affect the muscular wall of the uterus. Women that suffer from dysmenorrhea or infertility caused by adenomyosis need to confirm or rule out adenomyosis, and therefore tools for non-histologic confirmation of adenomyosis are indubitably required. Transvaginal ultrasound has been shown to be useful in diagnosing adenomyosis, but the interpretation of findings requires significant expertise in ultrasound and experience with diagnosing adenomyosis. This is because adenomyosis shows a very heterogeneous appearance in ultrasound. There are many different diagnostic signs that have to be considered and weighed.

In a previous study, the investigators have developed a diagnostic algorithm that helps clinicians diagnose adenomyosis with transvaginal ultrasound and a clinical examination. It showed good diagnostic accuracy and seemed to be very robust with regards to artifacts and experience of the examiner. It is now necessary to validate this prediction model in a new, prospective study so it can be used in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal (defined by having had menstruation the last six month)
* If amenorrhea with levonorgestrel intrauterine device, the woman should be \< 45 years old
* Hysterectomy planned due to a benign condition
* Hysterectomy does not require morcellation it is allowed to divide the uterus into 2-3 pieces, given that the orientation of the specimen is still possible for the pathologist)
* Written consent is given
* Can communicate in Norwegian or English at the Norwegian study sites, and Finnish, Swedish or English at the Finnish study site.

Exclusion Criteria:

* Gynecological cancer present at the time of inclusion
* Use of gonadotropin-releasing hormone agonist or antagonist within the last 3 months prior to the ultrasound evaluation
* Prior endometrial ablation or resection
* Postmenopausal status or no menstrual bleeding for the last 6 months, or amenorrhea with levonorgestrel-intrauterine device and age \>45 years.
* Need for morcellation of the uterus