cyrilzakka/clinical-trials huggingface dataset:
ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML

This research study was planned to focus on a rare type of acute myeloid leukemia (with the subtype CBFA2T3::GLIS2 that overexpresses folate receptor alpha (FRα) (a protein on the surface of leukemia cells)) that has relapsed or is refractory. Relapse means the cancer has come back after treatment. Refractory means the cancer does not respond to treatment.

This study was planned as a Dose Escalation Safety Study to identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D). This study will also evaluate the tolerability of ELU001.

ELU001 is not a drug approved by the FDA (Food and Drug Administration) yet.

Eligibility Criteria:
Key Inclusion Criteria:

Patients must meet the following criteria to enroll in this study:

* Infants (\>1 month) and children (≤9 years) at time of enrollment.
* Relapsed or refractory CBFA2T3::GLIS2 positive AML
* CNS1 or CNS2 during screening
* Performance Status: Lansky ≥ 50
* Adequate Organ Function including liver, kidney, and heart

Key Exclusion Criteria:

Patients who meet any of the following are not eligible to enroll in this study:

* CNS3 Disease
* AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Kostmann syndrome or Diamond-Blackfan anemia, or bone marrow failure associated with inherited syndromes.
* Acute promyelocytic leukemia.
* Clinically significant active or chronic corneal disorder, particularly corneal epitheliopathy or any eye disorder that may predispose patient to this condition, or unable to comply with an age-appropriate ophthalmologic examination.
* Prior treatment with folate receptor-targeting anti-cancer agent(s) ≤ 21 days (or 2 half-lives must have elapsed before enrollment, whichever is longer), or received investigational anti-cancer treatment ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, prior to starting study drug, whichever is shorter.
Gait Pattern Comparison of Cruciate-retaining and Posterior-stabilized Arthroplasties

In total knee arthroplasty (TKA), the posterior-cruciate ligament-retaining (CR) and posterior-cruciate-ligament stabilized (PS) techniques are widely used depending on the individual preference of the surgeon. Comparative analysis of these two techniques is a major topic of investigation in arthroplasty research. The hypothesis of the present study is that compared with the CR technique, the PS technique is associated with a worse gait pattern. Smart-phone based gait analysis and patient-reported functional outcomes are evaluated in patients undergoing total knee arthroplasty with a CR and a PS technique, at 3, 6, and 12 months postoperatively.

Patients undergoing total knee arthroplasty are randomized to posterior-cruciate ligament-retaining (CR) and posterior-cruciate-ligament stabilized (PS) groups by generating random numbers with Microsoft Excel. The patients are/will be evaluated preoperatively and at 3, 6, and 12 months postoperatively, with knee scores (KSS and KOOS), life quality (SF-12), and smart-phone based gait analysis. All data will be calculated as mean and standard deviation values. The Student's t-test will be used for statistical analysis of the patient data. Statistical calculations will be performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of unilateral primary knee osteoarthritis
* Age 55 to 85 years
* Must be able to walk without support

Exclusion Criteria:

* Rheumatological joint diseases
* Previous knee surgery
* Neuromuscular diseases
* Bilateral knee osteoarthritis
* Insufficiency of knee collateral ligaments.
Effect of Enteral Formula (Commercial vs. Homemade) on Muscle Mass in Trauma Brain Injury

This randomized controlled clinical trial aims to determine whether there are differences in muscle mass (MM) in patients with traumatic brain injury who receive enteral nutrition based on polymeric formulas (homemade formula with blended natural foods versus commercial formulas).

Patients admitted to the intensive care unit (ICU) with traumatic brain injury (TBI) lose MM, especially during the first ten days because it's used for organic, immune and tissue repair functions; the patients with moderate or severe TBI are frequently unable to eat food by themselves, so they receive enteral nutrition support (NS) with polymeric formulas. This support has been shown to attenuate muscle loss. Polymeric formulas can be industrially formulated or made with natural food, but there is no information available on their effect on MM using indicators such as femoral muscle thickness (femoral thickness, rectus femoris and vastus intermedius) by ultrasound (US) and phase angle (PhA) obtained by bioimpedance (BIA), as well as gastrointestinal tolerance (GIT).

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 years - 65 years
* Sex: Both sexes
* Moderate/severe TBI (Glasgow \<13 points) admitted to the ICU
* Invasive mechanical ventilation \>48 hours
* Candidates for enteral nutrition via nasogastric/orogastric tube

Exclusion Criteria:

* Pregnant women
* Patients with pacemakers
* Food allergies: egg, chicken, fish, nuts, or lactose intolerance
* Brain death
* Limb amputation or presence of external limb fixators

Elimination criteria:

* Withdrawal of consent
* Transfer to another healthcare institution.
Smartphone Addiction and Isometric Strength of Rotator Cuff Muscles

To investigate the relationship between smartphone addiction and isometric rotator cuff muscles strength among adults

Smartphones play an important role in human life because they are used for communication, accessing the internet, and gaming. The rate of smartphone usage has increased over the last decade, as has the duration and frequency of use. according to one study, 79 percent of people aged 18 to 44 spent almost all of their time on their smartphones, with only two hours of the day spent without one.

No previous study has found a link between smartphone addiction and isometric Rotator Cuff muscular strength, to the authors' knowledge. Therefore, the primary purpose of this study will be to determine the relationship between smartphone addiction and isometric rotator cuff muscles strength.

Eligibility Criteria:
Inclusion Criteria:

- 1- This study will comprise healthy volunteers between the ages of 18 and 30 who needed to use a smart phone.

2- Subjects who put in more than 4 hours per day using smartphone.

Exclusion Criteria:

* Patients will rule out if

  1. They had any medical condition that could cause shoulder pain (such as impingement, subacromial bursitis, rotator cuff damage, or traumatic or degenerative supraspinatus tendonitis).
  2. Anyone with a positive Neer sign, a positive Hawkins sign, discomfort during shoulder elevation, pain at the location of the rotator cuff tendon, pain with resisted isometric shoulder abduction, or a history of pain in the C5 dermatome will be ruled out.
  3. Any individual who had previously suffered a musculoskeletal injury or surgery that could have influenced the measurement will be also eliminated.
Effect of Pre-medication in Pain Measures on Office Hysteroscopy

Will be perform a RCT to compare pain measure on office hysteroscopy after pre-medication with oral analgesic. Patients will be alocate to oral sodic diclofenac, scopolamin or placebo. We will compare visual analog score of pain after the procedure.

Patients: patients with indication of office hysteroscopy to evaluate uterine intracavitary abnormality.

Interventions Group 1 (control) The patients will receive about 2 h prior to the procedure 2 placebo tablets.

Group 2 (diclofenac + scopolamine) The patients will receive about 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of scopolamine 2 mg.

Group 3 (diclofenac only). Patients will receive approximately 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of placebo.

Pain during and 30 minutes after a hysteroscopy will be measured through the visual analog pain scale of 10 centimeters, considering 0 (no pain) and 10 (unbearable pain or the greatest pain ever experienced). Acceptance of the procedure and assessed through the Likert 5-point scale: 1) totally disagree; 2) disagree; 3) I do not agree or disagree; 4) I agree and 5) I totally agree.There will also be a need for analgesia after the procedure, the time spent in the observation room and the onset of vagal symptoms such as dizziness, malaise, nausea, vomiting or syncope

Eligibility Criteria:
Inclusion Criteria:

1. indication of intrauterine evaluation
2. Abnormal uterine bleeding
3. post-menopause uterine bleeding
4. infertility
5. recurrent miscarriage

Exclusion Criteria:

1. stenosis of the external cervical orifice,
2. pelvic inflammatory disease,
3. suspected gestation or pregnancy,
4. active bleeding at the time of examination
5. contraindication to the use of the study medication, diclofenac sodium and scopolamine,
A Study of the Effect of Mental Health Promotion on Mental Health Index

"Health" includes physical and mental aspects. The evaluation of "Mental Health" contains four domains: psychophysical health, perceived security of the living world, meaning and worth of life, satisfaction of family-social interaction.

We have established a Taiwan Mental Health Index scale based on literature review and experts' opinions in 2002. The reliability and validity were assessed to be satisfactory. This TMHI scale has been applied in nation-wide mental health surveys of 2002, 2003, and 2004.

In order to evaluate the effect of mental health promotion activities, this research project will adopt this TMHI scale as the assessment tool. 300 people will be recruited for study after signing the informed consent. The general population sample of 1076 subjects recruited in 2004, will be as the comparison sample. The difference in 4 dimensions of MHI will be analyzed between these two study groups. The 300 study subjects will be subcategorized into two groups of low and high attendance groups. The difference in MHI between groups will also be statistically examined using independent t-test. The statistical signification is set at α=0.05.

This study result will be as the reference for setting up effective mental health promotion program for general public.


Eligibility Criteria:
Inclusion Criteria:

* Normal people
* education years over 9 years
* with reading ability

Exclusion Criteria:

-
EFFECTS OF MUSIC THERAPY DURING ENDOSCOPY ON PAIN, ANXIETY AND VITAL SIGNS

This study was conducted to evaluate the effect of music therapy on the vital signs, anxiety and pain of the patients during endoscopy procedure

The aim of this study was to the effects of music during the endoscopy procedure on anxiety, pain and vital signs.This study was conducted as a randomized, controlled, double-blind trial. The study population consisted of patients in the endoscopy unit of a university hospital between June and December 2023. The patients were randomly divided into the experimental group, who listened to music during endoscopy, and the control group, which did not receive any intervention other than routine nursing care. This study, data were collected via a patient information form, the State-Trait Anxiety Inventory (STAI-State), the visual analogue scale (VAS), and a vital signs monitoring form.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have endoscopy procedure
* Being older than 18 years old
* Not having hearing problems
* ASA status between 1-3

Exclusion Criteria:

* Cognitive or psycological disorders
* Regular usage of analgesic/anxiolytic/sedaditive drugs
* Haemodynamic instability
Attention Training

The purpose of this study is to understand whether attention training is effective in moderating mind wandering.

Our subjective worlds are built from those things in our internal and external environments that capture our attention. Environments can be ambiguous with respect to which objects are most important for our attention, and the characteristics of stimuli that allow them to dominate attention are thus of great interest. Self-relevant objects, such as internally generated experience (e.g. thought), may receive substantial attention, but research on this dimension has been hampered by the difficulty of measuring such objects experimentally. The proposed study seeks to make headway in this area using several behavioral (accuracy, response time, response pattern) measures, with the hypothesis that internally generated experience will vie for attention in a way reflected by behavior. Such research will extend previous work the investigators' lab has done studying stimulus parameters that influence attention, and as a whole may present a more complete picture of how objects and attention interact to shape our worlds.

Eligibility Criteria:
Exclusion Criteria:

* Non-English speakers

Inclusion Criteria:

* Must be able to use a computer
Reliability and Validity of a New Ankle Dorsiflexion Lunge Test Using a Level Laser.

The study aims to find validity and intra-inter examiner reliability of the Lever Laser Lunge Test (LLLT). This is a new way to measure ankle range of motion during weight bearing, instead of classical dorsiflexion lunge test The study wants to assume that LLLT is comparable to the traditional test but more efficient because it could be used in different settings.

To reach this goal, these two non-invasive tests will be performed to measure the amount of movement of the ankle joint in healthy teenage basketball players.

Data will be statistically compared and studied.

The dorsiflexion lunge test or knee-to-wall test (DLT) measure the range of movement of weight bearing ankle dorsiflexion. This test is frequently used in sport setting, in order to identify ankle limitations which could lead to possible injuries or joint overloads.

DLT is a cheap and simple measurement method to assess the ankle dorsiflexion, however clinicians find possible bias that reduce the usability of this test.

In order to remove this bias, this study suggests a new measurement method carried out by a level laser to create a virtual wall (the vertical red line produced by the laser).

The study aims therefore to estimate the validity and intra-inter examiner reliability of this method, in comparison to the DLT.

The instruments used are a professional level laser and a rigid ruler. A group of male teenager basketball players from Bologna competitive sports clubs will be recruited.

In order to assess the validity of this new test the clinicians will compare statistically the outcome of both test In order to assess the intra and inter examiner reliability the clinicians will compare repeated measurements of the LLLT.

It is assumed that both measurement methods (traditional and laser method) have comparable validity but LLLT reliability intra and inter examiner should be higher than the DLT one.

Eligibility Criteria:
Inclusion Criteria:

* male teenagers basketball players enrolled in a competitive sports club;
* teenagers whose parents have signed the privacy and consent forms.

Exclusion Criteria:

* athletes who have suffered in the last 3 months of lower limb musculoskeletal disorders such as pain for more than 7 days (ankle distortion outcomes, leg/foot fractures, plantar heel pain, metatarsalgias, etc);
* athletes who have undergone surgery on their lower limb.
Identification of Novel Molecular Markers for Vasospasm

The purpose of the study is to identify novel genetic and protein markers for the process of cerebral vasospasm following aneurysmal subarachnoid hemorrhage.

Cerebral vasospasm is a recognized and poorly understood complication for many patients who have aneurysmal subarachnoid hemorrhage. Constriction of the cerebral arterial vasculature occurs as free subarachnoid blood under high pressure comes into contact with the surfaces of vessels, particularly in the basal cisterns. However, the exact pathophysiology of vasospasm is unknown. Morbidity and mortality rates for vasospasm are high despite improvements in management. Excluding the initial hemorrhage, cerebral vasospasm is recognized as the main cause of substantial disability and death. Cerebral vasospasm kills 7% of patients, and causes severe deficit in another 7%. Cerebral vasospasm almost never occurs before day 3, has maximal incidence at days 6-8, and rarely occurs after day 17. The disorder is clinically characterized by confusion or decreased consciousness with focal neurological deficit.

Experimental evidence suggests that red blood cell hemolysis and subsequent release of oxygen, hemoglobin, reactive oxygen species, and other as yet undescribed mediators are necessary for the development of vasospasm. The goal of this study is to use modern tools of genomics to identify novel molecular markers for the process of vasospasm by studying the release of micro ribonucleic acids (RNA) that are secreted into the cerebrospinal fluid following the initiation of vasospastic cascades. Micro RNA's have recently been identified as important regulators of many cellular processes including cell cycle progression, proliferation, tumor suppressors, oncogenes, and regulators of metabolic pathways. The researchers propose to study the levels of annotated micro RNA's in the cerebrospinal fluid (CSF) of patients who present with subarachnoid hemorrhage from presentation through the hospital stay. The researchers will correlate the level of these micro RNA's with patient clinical presentation, including transcranial Doppler measurements, Glasgow Coma Scale score, vital signs, and angiographic studies. It is well established that the process of vasospasm occurs over the course of many days. Long before vasospasm becomes clinically evident, cellular processes causing spasm are in action and the researchers hope to identify micro RNA mediators of these processes using high throughput screening methods.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with aneurysmal subarachnoid hemorrhage within 24-hours of bleed.
* Receive either open vascular clipping or endovascular coiling.

Exclusion Criteria:

* Patients under 18 years of age.
* Patients arriving at the hospital \>24-hours post-hemorrhage.
* Patients who are not candidates for further care.
Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)

This is a multi-site, open-label fixed-flexible dose long-term study of asenapine in participants with schizophrenia. Participants in this study consist of schizophrenia with residual subtype or receiving high dose/multiple antipsychotic drugs, treatment refractory, or elderly participants with schizophrenia. The treatment period is up to 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 20 years
* Participants who meet at least one of the following:

  * current diagnosis of schizophrenia of residual subtype
  * received treatment with 3 or more antipsychotic drugs
  * treatment-refractory participants with schizophrenia
  * 65 years old and over with positive schizophrenia symptoms with score of 3 (mild) or more in 1 or more items in the positive subscale of the Positive and Negative Syndrome Scale (PANSS) at the baseline
* Participants who have a Clinical Global Impressions-Severity (CGI-S) score of at least 4 (moderately ill) at the baseline

Exclusion Criteria:

* Uncontrolled, unstable clinically significant medical condition
* Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at Screening
* Positive pregnancy test at Screening, or the intention to become pregnant during the course of the study
* Seizure disorder beyond childhood (12 years old or younger)
* History of neuroleptic malignant syndrome
* Allergy or sensitivity to drugs such as psychotropics and antipsychotics
* Known history of or currently treated for narrow angle glaucoma
* Parkinson's disease
* Diagnosis of schizoaffective disorder; schizophreniform disorder
* Concurrent psychiatric disorder other than schizophrenia coded on Axis I; a primary diagnosis other than schizophrenia
* Diagnosis of borderline personality disorder
* Diagnosis of mental retardation or organic brain disorder
* Current (past 6 months) substance abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (excluding nicotine)
* Positive drug/alcohol tests at the Screening visit
* Imminent risk of self-harm or harm to others, in the Investigator's opinion
* Substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
* Currently under involuntary inpatient confinement
* Use of a non-approved drug in Japan within 12 weeks prior to informed consent
* Previously treated in an asenapine study
Optimal Margin Evaluation of Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

Online adaptive radiotherapy has demonstrated to be feasible to reduce inter-fractional radiotherapy errors as it re-optimizes treatment plan every fraction. To investigate the extent and value of margin reduction，we conduct a prospective clinical trial to determine the optimal margin and toxicity of smaller margin.

This is a prospective phase II clinical trial with an anticipated total of more than 380 radiotherapy fractions of 15 patients to evaluate optimal margin of iterative cone-beam computed tomography（iCBCT） guided online adaptive radiotherapy （oART） for postoperative treatment of endometrial and cervical cancer. Postoperative endometrial and cervical cancer patients with following characteristics are included in the present study:（a）underwent radical surgery （b）no residual tumor at the resection margin by postoperative pathology（c）pathological findings indicate risk factors but no metastasis (d) adjuvant radiotherapy are prescribe (e)without evidence of para-aortic metastatic lymph nodes. Five patients （almost 125 fractions）treated with oART have the target volume contoured on pre-treatment iCBCTs and end-treatment iCBCTs. Anterior-posterior, lateral, and superior-inferior shifts were calculated and the average shift in all directions was calculated. A clinical target volume (CTV) to planing tumor volume (PTV) expansion is determined and verifies on a validation cohort of 10 patients (almost 250 fractions) treated with oART. Record acute toxicity from the start of treatment to 3 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
2. Postoperative endometrial and cervical cancer patients with pathologically confirmed no residual tumor at the resection margin and no evidence of distant metastasis (FIGO stage IVB).
3. Pathological findings indicate risk factors and adjuvant radiotherapy are prescribe.
4. Karnofsky score ≥ 70.
5. Subjects aged ≥ 18 years and ≤ 70 years.
6. No evidence of para-aortic metastatic lymph nodes.
7. No contraindications to CT scanning.
8. Subjects must be able to cooperate in completing the entire study.
9. Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L.
10. Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN).

Exclusion Criteria:

1. Subjects who have received prior pelvic radiotherapy.
2. Subjects with other primary malignancies.
3. Subjects with contraindications to radiotherapy, as determined by the investigators.
4. Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.
5. Active infection with fever.
6. Active inflammatory bowel disease.