cyrilzakka/clinical-trials huggingface dataset:
Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome

This surveillance's objectives are

1. Unknown adverse reactions
2. Incidences of adverse drug reaction
3. Efficacy during long-term administration
4. Factors considered to have effect to safety and effectiveness
5. Incidences of status epileptics, skin disorders and hyper sensitivity reaction, and central nervous system-related adverse events(ataxia , somnolence and/or dizzy, etc.)


Eligibility Criteria:
All patients with Lennox-Gastaut syndrome and administrated Inovelon
Efficacy of Early Home-based Cardiac Rehabilitation Program for Patients After Acute Myocardial Infarction

The purpose of this study was to evaluate the effect of this CR program on the improvement of myocardial function using the three-dimensional speckle tracking echocardiography (3D-STE) in AMI patients.

The effect of early short-term home-based cardiac rehabilitation (CR) program on left ventricular function in acute myocardial infarction (AMI) patients is not clear yet.

Eligibility Criteria:
Inclusion Criteria:

* Being aged 18-65 years with a confirmed AMI diagnosis
* Being suitable for the CR program
* Undergoing PCI at the entry

Exclusion Criteria:

* Known ischemic heart disease, heart valvular lesions, intra-ventricular conduction disturbances, malignant arrhythmia, cardiac shock, and poor echocardiographic conditions to take STE examination
OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers

The purpose of this study is to evaluate OPTI-FREE® PureMoist® (OFPM) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.


Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent document;
* Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;
* Near spectacle add of +0.50 or greater;
* Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;
* Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
* Currently using a non-Alcon multi-purpose solution to care for lenses (at least 2 months);
* Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study;
* Other protocol-specific inclusion criteria may apply.

Exclusion Criteria:

* Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);
* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Known sensitivity to any ingredients in OFPM;
* Prior refractive surgery;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Pathological dry eye that precludes contact lens wear;
* Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
* Participation in any clinical study within 30 days of Visit 1;
* Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days;
* Other protocol-specific exclusion criteria may apply.
AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimisation study of AZD0486 to evaluate the safety, tolerability, and efficacy of AZD0486 monotherapy in participants with R/R B ALL who have received ≥ 2 prior lines of therapies. The study will consist of 3 parts. Part A monotherapy dose escalation. Part B dose optimisation. Part C Dose expansion at the recommended phase 2 dose (RP2D)

This dose escalation and optimization study is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy in r/r B-ALL.

Eligibility Criteria:
Inclusion Criteria:

* Age: 16 years and older (Part A), 12 years and older (Parts B and C).
* Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with:

  1. Bone marrow infiltration with \>/= 5% blasts
  2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option.
  3. Philadelphia positive participants are allowed in Part A if intolerant or refractory to TKIs.
* For participants older than 16 years, Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. For Participants 16 years or younger, Lansky score more or equal to 50%.

The above is a summary, other inclusion criteria details may apply.

Exclusion Criteria:

* Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria).
* Isolated extramedullary disease relapse.
* Testicular leukemia
* History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; or prior Grade 4 neurotoxicity with CAR-T or TCE therapy.
* History of other malignancy (with certain exceptions).
* Unresolved AEs \>/= Grade 2, from prior therapies
* Prior therapy with TCEs within 4 weeks, CAR T-cell therapy or autologous HSCT within 8 weeks or prior alloSCT within 12 weeks of start of therapy.
* GVHD requiring immunosuppressive therapy within 3 weeks prior to AZD0486 treatment.

The above is a summary, other exclusion criteria details may apply.
Weight Variation During Chemotherapy in Breast Cancer Patients

Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied.

Thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.


Eligibility Criteria:
Inclusion Criteria:

* menopausal women
* breast cancer
* patients requiring chemotherapy treatment
* WHO performance status 0-2

Exclusion Criteria:

* diabetics
* patients with metastases
* other cancer
Rhabdomyolysis - a Study of Patients and Laboratory Values to Guide Treatment

Rhabdomyolysis is a potentially life-threatening syndrome characterized by breakdown of skeletal muscle, and leakage of intracellular substances such as myoglobin and creatine kinase (CK) into the circulation. The aetiological spectrum of rhabdomyolysis is extensive, and the clinical spectrum varies from a transient subclinical increase in CK activity to acute kidney injury (AKI) as a serious complication. There are no large prospective studies and only a few retrospective studies on rhabdomyolysis.

Rhabdomyolysis is a potentially life-threatening syndrome characterized by breakdown of skeletal muscle, and leakage of intracellular substances such as myoglobin and creatine kinase (CK) into the circulation. The aetiological spectrum of rhabdomyolysis is extensive, and the clinical spectrum varies from a transient subclinical increase in CK activity to acute kidney injury (AKI) as a serious complication. There are no large prospective studies and only a few retrospective studies on rhabdomyolysis.

The project will give much needed information about incidence, aetiologies and the clinical course of rhabdomyolysis. The main objective will be to study rhabdomyolysis with focus on the development of AKI and how laboratory values can guide treatment, and thus act as basis for guidelines. More knowledge is needed about rhabdomyolysis and long-term kidney injury, and the study will aim to identify a risk population for later kidney injury, thus being able to refer this group to follow-up and prevent further injury. On the other hand, exercise-induced rhabdomyolysis patients are probably hospitalized more than necessary these days, and over-treatment could be prevented if better guidelines were obtained. The possible cardiotoxicity of myoglobin needs further study, and would benefit the patient group but also fill a knowledge gap for the clinicians. Therefore, this project will ideally obtain new knowledge for the health services, potentially improve existing practice and fill important knowledge gaps.

Eligibility Criteria:
1. Main study:

   * Inclusion Criteria: Patients age 18 years and older, with a muscle injury developed before hospitalization and serum CK activity ≥5000 U/L and/or serum myoglobin concentrations ≥1000 ng/ml within 72 hours after admission will be included.
   * Exclusion Criteria: Patients with unknown identity will be excluded.
2. Sub-study on rhabdomyolysis and cardiac enzymes:

   * Inclusion Criteria: All patients with troponins over 14 ng/L and who otherwise fulfills the inclusion criteria can be included.
   * Exclusion Criteria: Acute coronary syndrome, heart failure, arrythmia, previous myocarditis, circulatory shock, acute pulmonary embolism, thoracic trauma/heart trauma or CKD before hospitalization.
Analyzing Acoustic Properties of the Vowel "a" Collected Via Mobile Phone From Individuals Diagnosed With Chronic Obstructive Pulmonary Disease and Health Control Groups

The Study aims to identify the changes in voice caused by Chronic Obstructive Pulmonary Disease (COPD) statistically for identifying the potential digital voice biomarkers.

1058 voice recordings collected via mobile phones over time in form of the Swedish utterance of vowel "a" will be analysed using vowel quadrilateral space and the Mann-Whitney U test.

The significance threshold p-value will be set to 0.05, and vocal features consisting of 101 base line acoustic features and MFCC features will be analysed between the COPD and HC groups. The most significant features that remain under the significance threshold will be reported.

Eligibility Criteria:
Inclusion Criteria:

* being 18 years old and older.

Exclusion Criteria:

* being under 18 years old and older.
Incidence of Early Pregnancy Loss in Patients With Unexplained Infertility

Unexplained fertility could be partly caused by a higher incidence of early pregnancy loss in this group. 65 women with unexplained infertility and 65 healthy controls will collect daily urine samples form the luteal phase. hCG and creatinine levels are measured in order to detect pregnancies and early pregnancy loss.


Eligibility Criteria:
Inclusion Criteria:

* Unexplained infertility

Exclusion Criteria:

* IVF treatment
Rapamycin - Effects on Alzheimer's and Cognitive Health

This study will evaluate the safety, tolerability, and feasibility of 12 month oral rapamycin treatment in older adults with amnestic mild cognitive impairment (aMCI) and early stage Alzheimer's disease (AD).

The study will consist of a screening/baseline period of up to 90 days pre-study drug, with a 12-month (+3 day) treatment period with rapamycin, followed by a post-treatment assessment completed within 14 days of the final study drug dose, and a final assessment conducted 6-months (+14 days) after the final study drug dose. The study duration is not expected to exceed 90 weeks for participants.

Eligibility Criteria:
Inclusion Criteria:

1. Both genders and all ethnic groups
2. Ages 55 to 89 years
3. Diagnosis of MCI or AD (Mini Mental Status Examination (MMSE): 18-30; Clinical Dementia Rating Scale (CDR) = 0.5 - 1; California Verbal Learning Test III (CVLT-III) Delayed Recall ≤16% based on age-adjusted norms, clinician approval)
4. Amyloid positivity based on Amyloid PET Imaging
5. Labs: Normal blood cell counts without clinically significant excursions; normal liver and renal function; and glucose control (HbA1c \< 6.5%). Fasting lipid panel and prothrombin time/prothrombin time test/international normalized ration (PT/PTT/INR) within normal limits
6. A legally authorized representative (LAR) designated to sign informed consent (if necessary) must attend the Screening visit and accompany the participant to all remaining visits to provide reported outcomes
7. Stable dose of AD medications (Donepezil, rivastigmine, Memantine, galantamine) for at least three months is allowed

Exclusion Criteria:

1. Diabetes (HBA1c≥6.5% or antidiabetic medications)
2. History of skin ulcers or poor wound healing
3. Current tobacco or illicit drug use or alcohol abuse
4. Use of anti-platelet or anti-coagulant medications other than aspirin
5. Current medications that affect cytochrome 450 3A4 (CYP3A4)
6. Immunosuppressant therapy within the last year
7. Chemotherapy or radiation treatment within the last year
8. Current or chronic history of liver or kidney disease or known hepatic or biliary abnormalities
9. Untreated hypertriglyceridemia (fasting triglycerides \< 250 mg/dl)
10. Current or chronic history of pulmonary disease or abnormal pulse oximetry (\<90%)
11. Chronic heart failure
12. Pregnancy or lactation
13. Recent history (past six months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack
14. Significant neurological conditions other than AD or MCI
15. Poorly controlled blood pressure (systolic BP\>160, diastolic BP\>90 mmHg - based on two readings)
16. Active inflammatory, COVID-19, autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or severe mental illness
17. History of, or MRI, or CT positive for, any space occupying lesion, including mass effect or abnormal intracranial pressure, which would indicate contraindications to lumbar puncture
18. Organ transplant recipients
Acustocerebrography (ACG) in Severe Brain Injury

The study will enable the clinical applicability of the multiple-spectral-sonography for detection of severe brain injury in ICU patients. For this, the ACG diagnostic system (Sonovum AG, Leipzig, Germany) should be used as additional diagnostic tool in prospective single-center study.

A multiple-step procedure, including repetition of the clinical examinations after a waiting period and use of additional technical diagnostic tools e.g. magnetic resonance tomography and Transcranial Doppler sonography (TCD) are needed for determining of severe brain injury and irreversible brain function failure.

This study will enable the clinical applicability of the multiple-spectral-sonography for detection of severe brain injury in ICU patients. For this, the ACG diagnostic system (Sonovum AG, Leipzig, Germany) should be used as additional diagnostic tool in prospective single-center study.

The ACG-method is a bedside non-invasive sonography that has been shown to be useful in previous studies analyzing circulatory changes in rat cerebral blood vessels, for example, to distinguish between brain-ischemia and -hemorrhage. Additionally, in the case of brain death, the spontaneous electrical activity, which can be measured by means of ACG as global elasticity, was not longer detectable.

In the study should include 30 adult ICU-patients in patients suspect to severe brain injury. The inclusion of patients will be started if written informed consent was obtained from participants or their representatives. After the inclusion, the ACG is measured three times a day. In addition, the routinely practice (treatment and diagnostic) for patients with severe brain injury (neurological clinical examinations, use of additional technical diagnostic tools e.g. magnetic resonance tomography and Transcranial Doppler sonography (TCD); Standard Medical Care) should be made and documented. From all patients basic demographic data, pre-morbidity, vital parameters, blood parameters, Illness severity scores (APACHE-II, SOFA, GCS), drug levels, microbiological results and cranial MRI/CT results will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* suspected severe brain injury

Exclusion Criteria:

* open skull brain trauma
* skull fractures in the temporal area
* decompression-craniotomy
Cleanser for Acute Wounds

The proposed study will be a prospective trial of management of acute traumatic wounds (less than 24 hours from injury and without previous intervention aside from a dressing for coverage). The study design involves a prospective single arm, 35 subject study that analyzes the effect of the subsequent application of a novel wound cleanser and wound gel on subjects' acute traumatic wounds and the respective microbial loads over a 28 day study duration.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 89 years old.
* Patients receiving care in the ED/trauma bay or admitted to Brooke Army Medical Center (BAMC) from the ED or trauma bay.
* At least one wound area must measure equal to or greater than 2cm\^2 to include partial or full thickness tears.
* Wound sustained less than 48-hours from time of enrollment.
* The wound must be untreated/open beyond bedside stabilization such as irrigation and debridement (i.e., no stitches, steristrips, dermabond, OR washouts, etc).
* Capable of providing informed written consent by self or through Legally Authorized Representative (LAR).
* Ability to read/speak English (participant and/ or LAR).

Exclusion Criteria:

* Ages less than 18 or greater than 89 years old.
* Patients not receiving care in the ED/trauma bay or admitted to BAMC through the ED or trauma bay.
* Wound area less than 2 cm2.
* Wound sustained greater than 48-hours from the time of enrollment.
* Wounds that have been closed/repaired at the time of screening (i.e. stitches, steristrips, dermabond, washouts in the OR, etc.) or anytime during the study duration.
* Not capable of providing informed written consent by self or through LAR.
* Non-English reading and speaking (participant and/or LAR).
* Have received more than one dose of antibiotics prior to enrollment or during the study duration.
* Suspected or confirmed signs/symptoms of active wound infection or gangrene.
* Patients with osteomyelitis.
* Wounds with exposed tendons, ligaments, or bone.
* Patients undergoing active renal dialysis.
* Patients receiving (within 30 days of enrollment) or scheduled to receive a medication or treatment which is known to negatively affect wound healing such as systemic steroids (i.e. continuous prednisone), immunosuppressive therapy, chemotherapy, autoimmune disease therapy, cytostatic therapy, vascular surgery, angioplasty, or thrombolysis.
* Pregnant, breastfeeding, or women of childbearing potential who do not agree to use an effective form of contraception during their participation in the study.
* Participation in another investigational device, drug, or biological trial that may interfere with results within 30 days of screening.
* Anyone deemed by the PI to be unlikely to comply with all study procedures.
Identify microRNAs in Cachexia in Pancreatic Carcinoma

The purpose of this study is to determine the proportion of pancreatic patients who experience weight loss and cachexia, and to identify any differences in the genes between patient groups.

This research study will retrospectively examine 1395 patients from the University of Alabama and the University of Oklahoma Stephenson Cancer Center (OU-SCC) pancreatic cancer cohorts. The prospective arm, will enroll a total of 100 eligible volunteers at the OU-SCC. The demographic and medical data from the retrospective and prospective arms will be combined (1495 patients) to ascertain any racial disparities in pancreatic cancer patients with cachexia. Perspective volunteers at the OU-SCC will undergo routine tests to determine if their cancer is operable. Pancreatic tumors will be removed from the eligible patients, as part of their normal standard of care and will be examined for genes that may be related to unexplained muscle loss and compared to tumor tissue from other patients with pancreatic cancer. An optional hand strength exam, and standing on a scale that measures weight, muscle, and body fat will be available to OU-SCC patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient, who is ≥ 18 years old at the time of informed consent.
2. Patients with operable pancreatic tumors diagnosed in the last 12 months prior to consent with clinical discretion or pathology confirmed as adenocarcinoma.
3. Patient has stage I or higher disease who is considered a candidate for surgical resection of pancreatic cancer, with or without neoadjuvant chemotherapy.
4. Ability to provide written informed consent and HIPAA authorization.

Exclusion Criteria:

1. Patients with pancreatic adenocarcinoma who do not meet the criteria for surgical resection.
2. Patient has cancer diagnosis other than primary pancreatic adenocarcinoma.
Diabetic Shoulder Mobility

The primary goal of this project is to determine how advanced glycation end-product (AGEs) accumulation and shoulder movement (humeral thoracic range of motion and "activity count") interact to contribute to shoulder limited joint mobility (LJM), pain and disability, and if an intervention consisting of a tailored dose of stretching and active shoulder movement can reduce these problems in people with diabetes mellitus (DM). The investigators will focus on the following measures that span health domains; Skin intrinsic fluorescence to measure AGEs; Ultrasound to measure supraspinatus tendon thickness; 3 dimensional joint range of motion and "activity counts" to measure shoulder movements; and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire to measure patient reported pain and disability. The investigators will test the innovative hypothesis that metabolic and movement factors interact to cause severe shoulder problems in people with DM and that an optimized shoulder movement intervention can have an important impact on reducing the development of limited joint mobility, pain and disability in this population.


Eligibility Criteria:
Inclusion Criteria:

* individuals with type 2 DM and duration of diagnosed diabetes more than 10 years OR type 2 DM and presence of a 'positive prayer sign' OR shoulder flexion \< 150 degrees; disability of arm, shoulder and hand (DASH) scores in the range of \<70%; between the age of 40-70 will be recruited.

Exclusion Criteria:

* currently diagnosed adhesive capsulitis
* diagnosed rotator cuff tear
* recent (6 months) upper extremity injury and/or fractures
* surgery in the upper extremity or thorax
* cervical radiculopathy
* thoracic outlet syndrome
* stroke with residual upper extremity involvement
* severe skin allergies in area to be tested
* rheumatic conditions
* known connective tissue diseases
* carpal tunnel syndrome
* use of a cane
* individuals who engage in heavy upper extremity/ overhead use (ie, painters, tennis players) because they likely have a different mechanism of injury than those with low shoulder activity.