cyrilzakka/clinical-trials huggingface dataset:
The Effect of Illness Management Skill Training Applied to Patients with Schizophrenia

This study was aimed to examine the effectiveness (illness management and recovery, engulfment, quality of life) of a 12-week the Illness Management Skills Training applied to patients with schizophrenia. The main questions it aims to answer are:

Hypothesis (H1-1): Illness Management Skills Training applied intervention group has lower engulfment than the control group.

Hypothesis (H1-2): Illness Management Skills Training applied intervention group has higher quality of life than the control group.

Hypothesis (H1-3): Illness Management Skills Training applied intervention group has higher illness management and recovery level than the control group.

Researchers were compared the Illness Management Skills Training to a control group (no intervention) to see if the Illness Management Skills Training works on engulfment, quality of life, illness management and recovery in patients with schizophrenia.

Participants were:

- attended the Illness Management Skills Training, one session per week for 12 weeks, 60 minutes per session, in addition to routine outpatient clinic check-ups.

The study examined 110 individuals aged 18-65 who were diagnosed with schizophrenia and applied to the S.U. Faculty of Medicine Mental Health and Diseases Polyclinic in the last year, according to the inclusion-exclusion criteria. A total of 50 individuals diagnosed schizophrenia were included in the study. These individuals were randomly assigned to two groups: intervention and control. Pre-test data were collected using the "Personal Information Form", "Modified Engulfment Scale", "SF 36 Quality of Life Scale" and "Illness Management and Recovery Scale-Patient Form" from the intervention and control groups by researchers between August 2024 and February 2025 in the Group Therapy Room of the Mental Health and Diseases Polyclinic, based on self-reporting. The "Illness Management Skills Training" was applied to the intervention group in 4 groups, one session per week, for a total of 12 weeks. At the end of the Illness Management Skills Training, both the intervention and control groups were administered the "Modified Engulfment Scale", "SF 36 Quality of Life Scale" and "Illness Management and Recovery Scale-Patient Form". No intervention was applied to the control group throughout the 12-week program; the patients continued with their routine outpatient clinic check-ups.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65,
* Having been diagnosed with Schizophrenia for at least 6 months according to ICD-10,
* Being registered with the Selcuk University Faculty of Medical Hospital Mental Health and Diseases Polyclinic,
* Coming to the polyclinic for regular check-ups,
* Getting a mild/moderate score from the Positive and Negative Syndrome Scale (PANSS),
* Taking medication regularly,
* Being at least literate.

Exclusion Criteria:

* Having an organic mental disorder or mental retardation,
* Having a visual or hearing impairment,
* Participating in a program similar to the intervention to be implemented.
Effect of Randomization to Neuromuscular Blockade on Physical Functional Impairment and Recovery in ARDS

The proposed work will determine the effect of neuromuscular blockade on physical function and recovery in patients with ARDS. The investigators will conduct a prospective ancillary study at five PETAL clinical centers that will evaluate the neuromuscular structure and function of ROSE (Reevaluation of Systemic Early Neuromuscular Blockade) patients during and after critical illness, including in-person assessments at 6 months after hospital discharge. The investigators hypothesize that patients randomized to NMB will have an increase in ICU-acquired neuromuscular dysfunction during and after critical illness.

The investigators will assess this dysfunction in different ways, appropriate for patients' stage of critical illness and anticipated recovery. During critical illness, the investigators will use nerve conduction studies (NCS) to assess nerve and muscle function, identifying presence of early neuromyopathy (primary outcome, Aim 1). Additional early assessments will include bedside ultrasound to determine muscle mass and echogenicity, indices of atrophy and loss of muscle architecture. Later in acute hospitalization as patients are able to participate in testing, the investigators will use hand grip dynamometry to assess muscle strength (primary outcome, Aim 2). Additional assessments at this time will be hand held dynamometry to determine proximal muscle strength, dual energy x-ray absorptiometry (DEXA) and repeat ultrasound to evaluate muscle mass, and short physical performance battery (SPPB) to assess activity. After hospital discharge-at 6 months after ARDS-the investigators will assess activity in-person using the SPPB (primary outcome, Aim 3). Additional post-hospital assessments include detailed evaluation of healthcare utilization, six minute walk testing (6MWT) to determine endurance, and repetition of previous assessments of muscle structure, function and strength to provide novel, detailed information of recovery process.

Each aim tests a distinct hypothesis of the effect of randomization to NMB on ICU-acquired neuromuscular dysfunction, investigating different time points and aspects of physical function, so aims are not interdependent. For example, it is plausible that the direct toxicity of NMB on muscle will lead to early evidence of neuromyopathy, manifest as reduced muscle depolarization amplitudes with nerve stimulation. But if NMB attenuates lung injury, strength may be improved by hospital discharge, despite early injury to muscle.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be enrolled in the PETAL Network's ROSE study
* Patients must have at least one complete leg

Exclusion Criteria:

* Complete spinal cord injury with deficits at level T1 or above
* Severe peripheral neuromuscular disease (specifically motor neuron disease (ALS) or acute Guillain-Barre Syndrome)
* Inability to obtain informed consent
Project SHARE (motherS Have All the Right microbEs)

This is an exploratory study designed to collect microbial samples from several body locations from 6 pairs of mothers and their newborn infants at various time points.


Eligibility Criteria:
Inclusion Criteria:

* Mother- pregnant female, singleton infant
* Infant- vaginal birth, breastfeeding as primary source of nutrition

Exclusion Criteria:

* Mother- antibiotic, steroid or antimicrobial use
* Infant- antibiotic, steroid or antimicrobial use
Mobile CBT for Negative Symptoms

This randomized controlled clinical trial will test a combined group contact plus mobile CBT-informed skills training intervention targeting defeatist attitudes in consumers with schizophrenia in comparison to a supportive contact control group in order to change motivational negative symptoms linked to defeatist attitudes.

The primary purpose of this project is to determine if mCBTn at the optimal dose from the R61 produces greater reduction in severity of defeatist attitudes than a supportive contact control group in consumers with schizophrenia spectrum disorders with persistent moderate-to-severe experiential negative symptoms. A second aim is to determine whether reduction in defeatist attitudes mediates improvement in experiential negative symptoms and psychosocial functioning in mCBTn. The third aim is to determine whether mCBTn increases pupil dilation and whether changes in pupil dilation (an objective psychophysiological biomarker of effort) are associated with changes in defeatist attitudes and negative symptoms. The final aim is to explore predictors of response to mCBTn, including device use and group session adherence, demographics, neurocognitive impairment, and negative and other symptom severity at baseline.

Eligibility Criteria:
Inclusion Criteria:

* DSM-5 diagnosis of schizophrenia or schizoaffective disorder.
* Meets prospective criteria for persistent moderate-to-severe experiential negative symptoms in at least two of the three CAINS Motivation and Pleasure domains (mean of 2 -moderate- or greater for items averaged within the Social, Work or Recreational domains) at the beginning and end of a 2-week evaluation phase.
* Moderate-to-severe defeatist attitudes (DPAS \> 50).
* ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed for reading treatment manual consumer workbook).
* Clinically stable and stable on current medications (no changes within 3 months prior to enrollment and meeting all inclusion/exclusion criteria during longitudinal baseline evaluation at both week -2 and 0).

Exclusion Criteria:

* Prior CBT in the past 2 years.
* Greater than moderate PANSS positive symptoms (P1-Delusions, P2- Disorganization, P3-Hallucinations, or P6-Suspiciousness - any item \>5).
* Severe depression on the Calgary Depression Scale for Schizophrenia (CDS \>8).
* Extrapyramidal symptoms.
* Ocular damage, disease, surgery or medications that affect pupil dilation.
* DSM-5 alcohol or substance use disorder in past 3 months.
* Level of care required interferes with outpatient skills training (e.g., hospitalized; severe medical illness).
* Unable to adequately see or manually manipulate the mobile device.
Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

use of lanadelumab in patients with acquired angioedema


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of AAE with recurrent attacks without urticaria (decreased C1INH functional, quantitative levels, decreased C4 and decreased C1q levels, no family history of angioedema), presence of anti-C1INH antibody and/or paraproteinemia (e.g. monoclonal gammopathy of unknown significance)
* historical attack rate of \>= on attack per month prior to starting tranexamic acid (TAA)

Exclusion Criteria:

* History of anaphylaxis or hypersensitivity to biologics
* History of major systemic disease not well controlled in opinion of the PI
* Women who are pregnant or breast feeding
* Concurrent participation in other clinical trials
* HAE Type 1 or 2 and normal complement HAE
Nasopharyngeal Airway Guide Nasogastric Tube Placement

Nasogastric tube placement is essential for various surgery and critically ill patients. However, NG tube insertion in anesthetized, paralyzed, and intubated or unconscious patients may be difficult, with reported success rate less 50% on the first attempt without any auxiliary devices. Endotracheal tube intubation narrow the space of oropharynx and hypopharynx. Loss ability to swallow and tongue drop also made the NG tube coil in the mouth easily. Investigators assume nasopharyngeal airway can facilitate NG tube insertion by opening a channel from nostril to epiglottis and reduce complications by protecting nasal cavity while inserting NG.


Eligibility Criteria:
Inclusion Criteria:

* Patient should be \> 20 years old, ASA 1\~3 under going schedule general anesthesia with endotracheal tube intubation
* Patient who required NG tube placement for perioperative care

Exclusion Criteria:

* Coagulation abnormality (PLT≤100000, INR\>1.2 \& PT≥13)
* Hemodynamic unstable (with inotropic agent use)
* Arrythmia
* Esophageal varices or stricture, Esophageal cancer, trauma or previous esophageal surgery
* Gastric cancer involve cardiac orifice
* Corrosive chemical (strong acid or alkali) ingestion
* Skull base fracture
* Recent nasal surgery, nasal fracture or severe nasal obstruction
* Loose teeth that make endotracheal tube can not fix right side
Improving Primary Care Access to Urinary Incontinence Treatment for Women Veterans

The PURSUIT project aims to improve access to evidence-based nonsurgical UI treatment for women Veterans in the Southeast region of the United States using the most effective remote delivery modality. Using cluster randomization, the study will compare two models at the practice level: (1) the use of a practice facilitation toolkit with a mHealth UI modality alone and (2) the practice facilitation toolkit with a mHealth UI model combined with education on clinical pathways for consultation. Patient level outcomes related to UI symptom improvement will be compared. Patient and provider perceptions of factors that could influence future remote UI treatment scalability will also be assessed. All primary care practices will receive practice facilitation with a PURSUIT toolkit that includes (1) 1-2 visits with a practice facilitator; (2) mobile-health or mHealth application training (MAT); 3) online resource hub; and (4) health information technology (HIT) assistance. PURSUIT's future goal is to disseminate the most effective modality for delivering nonsurgical UI treatment for women Veterans nationally within the VHA.

PURSUIT aims to recruit 62 practices to participate in the trial implementation at 50 practices. Specifically, Community-Based Outpatient Clinics (CBOCs) from VA Integrated Service Network (VISN) 7 will be targeted, spanning the states of Alabama, Georgia, and South Carolina. The project will focus on VISN 7 CBOCs, serving at least 50 women Veterans with primary care services, will be recruited through connections with local women's health providers. The team estimates outreach to approximately 50,000 women Veterans and estimates that 30 percent (n=15,000) of these women will have UI symptoms, and, among those, 15 percent (n=2,500) will participate.

Eligibility Criteria:
Inclusion Criteria:

* Veteran
* English-speaking, community-dwelling women Veterans
* Diagnosis of UI (all types)
* Access to the internet via a mobile device or computer

Exclusion Criteria:

* Women Veterans who are currently pregnant or less than 12 weeks postpartum
Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer

This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed adenocarcinoma of the breast
* Tumor shows 3+ overexpression of the human epidermal growth factor receptor 2 (HER-2)/proto-oncogene by immunohistochemistry assay, or is fluorescence in situ hybridization (FISH)+
* Stage IV disease
* Measurable disease
* At least 3 weeks since prior cytotoxic chemotherapy
* At least 4 weeks since radiotherapy with full recovery
* At least 4 weeks since major surgery with full recovery
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* At least 18 years old
* Absolute neutrophil count (ANC) at least 1.5 x 10\^9 cells/L
* Platelets at least 100 x 10\^9 cells/L
* Hemoglobin at least 9 g/dL
* Aspartame aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5X upper limit normal
* Alkaline Phosphatase less than 1.5X upper limit normal
* Creatinine less than 1.5 gm/dL
* Normal left ventricular ejection fraction
* Negative pregnancy test
* Agree to use method to avoid pregnancy
* Informed Consent is obtained

Exclusion Criteria:

* Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One year since Taxane and Herceptin treatment.
* Cumulative life-time dose of doxorubicin is greater than 360 mg/m\^2
* Concurrent immunotherapy or hormonal therapy
* Parenchymal brain metastases, if present, must be documented to be clinically and radiographically stable for at least 6 months after treatment
* Serious intercurrent medical or psychiatric illness, including serious active infection
* History of congestive heart failure
* History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer
* Patients who have received an investigational drug within the previous 3 weeks
* Patient is currently enrolled in another clinical study receiving investigational therapies
* Pregnant or nursing women
Intraoperative Sonographically Guided Resection of Non-enhancing Gliomas

The purpose of the study is to determine whether intraoperative ultrasound guided resection of glioma without contrast enhancement in magnetic resonance imaging can achieve higher extent of resection than surgery without intraoperative sonography

Gliomas, not enhancing contrast agent in magnetic resonance imaging (MRI), are usually low-grade gliomas. They rarely show intraoperative fluorescence using 5-aminolevulinic acid or fluorescein. Intraoperative high-field MRI, sonography and navigation are the only ways to assess extent of their resection during surgery. MRI is the gold standard, but interrupts surgical workflow and only few hospitals are equipped with device like that. Navigation eventually looses it's precision due to brainshift. Ultrasound allows assess tumor remnants in real time but has worse imaging quality. Currently no randomized trials published their results about efficiency of intraoperative sonography in removing low-grade gliomas.

Objective of the study is to determine whether intraoperative ultrasound guided resection of non-enhancing gliomas can achieve higher extent of resection than surgery without intraoperative sonography.

Participants of the study will be randomly operated with and without intraoperative ultrasound. Extent of resection will be assessed in postoperative MRI by blinded radiologists.

Eligibility Criteria:
Inclusion Criteria:

* single supratentorial gliomas without contrast enhancement in preoperative magnetic resonance imaging (presumed low-grade gliomas)
* newly diagnosed
* previously untreated
* Karnofsky Performance Status 60-100%
* age 18-79 years
* performed magnetic resonance imaging with contrast enhancement

Exclusion Criteria:

* glioma spreading to brainstem
* previously performed radiotherapy, chemotherapy or immunotherapy
* planned supratotal tumor resection until neurophysiologically revealed eloquent areas
BLOOD BIOMARKERS in PAEDIATRIC MTBI

The goal of this observational study is to identify blood biomarkers that could help in the management of paediatric patients with mild TBI. The main questions it aims to answer are:

1. How can blood biomarkers reduce unnecessary CT scan and reduce the length of stay at the emergency department?
2. How can blood biomarker predict post-concussion symptoms?

Participants will have a blood sample taken when they are admitted at emergency department and will receive a questionnaire describing their symptoms 14 days and 3 months after their trauma.

Mild Traumatic Brain Injury (mTBI) in children is a very frequent reason for presentation at the paediatric emergency department. In most cases, the trauma will not lead to intracranial lesions. The first objective for clinicians is therefore to detect all children in need of neurosurgical intervention after mTBI. Although computerized tomography (CT) is currently the modality of choice for acute intracranial haemorrhage identification, care should be taken to avoid unnecessary exposure to ionizing radiation in the developing brain. Monitoring the occurrence of bleeding usually involves an observation period which generally extends from six to twenty-four hours. This time is stressful for the child and parents as well as time and cost consuming for the hospital. In addition to the acute conditions, it has been described that post-concussion symptoms can occur in the weeks or months following the trauma, and neuropsychological follow-up of these children could help prevent or reduce the symptoms. The aim of our study is to find biomarkers that can identify children with clinically important intracranial injury and/or children that will eventually suffer from a post-concussion syndrome.

Eligibility Criteria:
Inclusion Criteria:

* mTBI within 24 hours

Exclusion Criteria:

* refusal of child or parents
* evidence of intoxication with alcohol or other substances
* history of TBI ( less than one month)
* epilepsy, encephalitis, meningitis, melanoma
Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction

Despite the use of guideline directed optimal medical therapy, 12% of patients with stable coronary heart disease and 18% of patients with recent acute coronary syndrome experience recurrent major adverse cardiovascular events 1. The risk of recurrent cardiovascular events may be related to persistent elevation of thrombin beyond the index event 2,3

which leads to progression of cardiovascular disease by inducing inflammation, endothelial dysfunction and thrombosis 4. In patients with coronary heart disease, vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) have been explored as secondary prevention strategies and have shown cardiovascular benefits at the cost of higher bleeding events 5,6,7,8.

howeverLeft ventricular thrombus (LVT) usually appearswithin 1 month after ST-segment elevation myocardial infarction (STEMI) and mostlyforms after anterior STEMI.9,11Although the prevalenceof LVT after acute myocardial infarction hasdecreased dramatically in modern times due to the progress of reperfusion therapy, LVT incidence in patients with anterior STEMI remains at 4% to 26%.10,12 It complicates acute myocardial infarction and is associated with a higher incidence of poor outcomes.9


Eligibility Criteria:
Inclusion Criteria:

* patients with anterior ST-segment myocardial infarction on acetylsalicylic acid and clopidogrel

Exclusion Criteria:

1. Patients with liver cirrhosis.
2. Patients with severe mitral stenosis .
3. Patients with bleeding tendency (HASBLED score ≥ 3)
4. Severe renal impairment ( creatinine clearance \< 30 ml/min ).
5. patients with prosthetic valve .
6. patients on ticagrelor treatment
7. patients with Atrial Fibrillation
Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss

To compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60 mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings

Exclusion Criteria:

* Presence of metabolic bone disease, fractures, blood clots, or recent cancer.
* Any use of selective estrogen receptor modulators, investigational drugs, or recent use of osteoporosis treatments, certain hormones, or medication for blood clots or seizures.