cyrilzakka/clinical-trials huggingface dataset:
Role for Biochemical Assays and Kayser-Fleischer Rings in Diagnosis of Wilson Disease

The investigators aimed to identify factors associated with symptoms and features of Wilson disease from a large cohort during long-term follow-up

Wilson disease is an autosomal recessive disorder that impairs copper homeostasis and is caused by homozygous or compound heterozygous mutations in ATP7B, which encodes a copper-transporting P-type ATPase. Patients have variable clinical manifestations and laboratory test results, resulting in diagnostic dilemmas. Therefore, the investigators aimed to identify factors associated with symptoms and features of Wilson disease, thereby give timely diagnosis for patients.

Eligibility Criteria:
Inclusion Criteria:

* genetically diagnosed patients with wilson disease

Exclusion Criteria:

* Deny follow-up
Acute Effects of Whole Body Vibration in Chronic Stroke

Whole body vibration has been found to be useful in promoting bone health, balance, and muscle performance in older adults. The overall aim of the proposed study is to determine whether whole body vibration (WBV) has immediate beneficial effect in neuromotor performance in patients with stroke. It is hypothesized that a single session of WBV will induce significant improvement in leg muscle strength in people with chronic stroke.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of stroke
* stroke onset \>6 months
* \>18 years of age
* \>able to walk for short distance independently with or without walking aid
* able to understand simple verbal commands

Exclusion Criteria:

* other neurological conditions
* peripheral vascular disease
* vestibular disorders
* significant musculoskeletal disorders (e.g. rheumatoid arthritis)
* pregnancy
Comparison of Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients

In trauma patients with high shock index, the investigators compare the effects on hemodynamics between ketamine and etomidate.

In trauma patients, rapid sequence intubation is recommended. The drug of choice, however, has been debated. One cohort comparative study showed ketamine had benefit in hemodynamics compared to etomidate in trauma patients. One observational study showed in high shock index patients, ketamine showed maintain systolic blood pressure. And other retrospective showed less clinical hypotension was less in ketamine. However there is no randomized controlled study comparing ketamine and etomidate in trauma patients. The purpose of this study is comparing the effects of hemodynamics between ketamine and etomidate in high shock index trauma patients.

Eligibility Criteria:
Inclusion Criteria:

* age 19\~70
* Shock index ≥ 0.9
* Patients who need intubation regarding to Ajou trauma center protocol

Exclusion Criteria:

* during CPR
* CPR before hospital arrival
* Severe head trauma
* Steroid intake history
Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant

The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant


Eligibility Criteria:
Inclusion Criteria:

Patients with DLBCL

* and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation
* and relapse after complete remission or disease progression after partial remission following autologous stem cell transplantation.
Reliability and Validity of a New Device Measuring Spinal Rotation on the Transverse Plane

The purpose of this research is to investigate the reliability and validity of a new device similar to a scoliometer. The intended name of the device will be Scolioscope

Οne cohort of participants will be used and the reliability of the equipment will be used to test/retest the repeatability of the measurements

The validity will be measured against a gold standard for measuring angles

Eligibility Criteria:
Inclusion Criteria: lumbar and thoracic scoliosis -

Exclusion Criteria: recent spinal surgery, cancer, spinal fixation

-
Efficacy Study of NuCel® in Patients Undergoing Fusion of the Lumbar Spine

The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.

The study is a prospective, single center clinical trial to establish the efficacy of NuCel, a minimally manipulated allograft tissue, for use in lumbar interbody and intertransverse fusion procedures. Subjects will undergo standard interbody fusion surgery as per the signed informed consent with NuCel and autograft bone. Patients will be evaluated postoperatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years (if required).

Eligibility Criteria:
Inclusion Criteria:

* Must be diagnosed with degenerative disease of lumbar spine

Exclusion Criteria:

* Back pain due to injury
* Back pain that is caused by infection, cancer, lesions(growths) or bone disease such as osteoporosis
* Any terminal (will not recover from the disease) or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis
* Any other medical condition that might affect normal healing
* Less than 21 years of age
* More than three levels of fusion needed
* Recent history (within past 6 months) of any chemical or alcohol dependence
* Morbid obesity (Body Mass Index of more than 40)
* Currently a prisoner
* Currently experiencing a major mental illness
* Pregnancy at the time of enrollment
* Previously diagnosed with diseases of the bone such as osteoporosis, osteopenia or osteomalacia (softening of the bones). Patients with any of the risk factors for osteoporosis may have DEXA scans performed prior to study entry.
The Effect of Sevoflurane on Airway Hyperreactivity During the Perioperative Period.

To investigate the effects of sevoflurane on respiratory parameters and respiratory inflammation in healthy and RSV-infected under general anesthesia and to propose suitable perioperative airway protection measures for children with respiratory virus infection undergoing general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily joined this study and signed an informed consent form；
2. Age: 2-5 years old；
3. The patient should have a good general condition and no serious internal medicine comorbidities (ASA classification of the American Anesthesiology Association is Grade I); BMI ≤ 20;
4. Plan to undergo elective adenoidectomy or adenotonsillectomy with tracheal intubation.

Exclusion Criteria:

1. Children with a history of allergic asthma;
2. Children with space-occupying lesions of the chest and lungs, or acute bronchiolitis or pneumonia;
3. Children with cardiovascular diseases that may cause cough, wheezing, and other symptoms;
4. Children who used leukotriene modulators, β2 receptor agonists, anticholinergics, theophyllines, or hormonal treatment drugs within two weeks;
5. Children allergic to propofol, sevoflurane, or other anesthetic agents;
6. Children with a family history of malignant hyperthermia;
7. Children with liver and kidney dysfunction;
8. The result of rapid antigen detection and nucleic acid test for RSV was inconsistent, or children combined with pathogen infections other than RSV;
9. Children with fever.
Optimal Measurement of Spleen Stiffness Among Veterans With Metabolic Dysfunction-Associated Steatotic Liver Disease

A growing number of people are being diagnosed with fatty liver disease, also known as metabolic-dysfunction associated liver disease (MASLD). Fatty liver disease can unknowingly progress to serious liver disease and even permanent scarring (cirrhosis).The purpose of this research is to learn the best way to detect serious liver disease as early as possible in patients with fatty liver disease by measuring the stiffness of the spleen. Secondarily, the study hopes to understand how the stiffness of the spleen relates to the severity of liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Able to consent for participation in a clinical study
* Able to read and comprehend English
* Evidence of fatty liver disease on previous liver biopsy, imaging or clinical documentation

Exclusion Criteria:

* Pregnant
* Known decompensated cirrhosis or hepatocellular carcinoma
* Absence of spleen
* Documentation of alcohol use disorder or alcohol use greater than 20g/day for women or greater than 30 g/day for men
* Unable to provide informed consent
A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed.

Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide.

Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of \> 6 months.
* Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation.
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
* Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol.
* Creatinine clearance (CrCl) \>= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion.

Exclusion Criteria:

- Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.
Eye-tracking-based Artificial Intelligence Detects Abnormalities of the Oculomotor System in Type 1 Diabetes

Abnormalities of the oculomotor system may represent an early sign of diabetic neuropathy and are currently poorly studied. The investigators designed an eye-tracking-based test to evaluate the oculomotor function in patients with type 1 diabetes.

The investigators used the SRLab -Tobii TX300 Eye tracker®, an eye-tracking device, coupled with a software that we developed to test abnormalities of the oculomotor system. The software consists in a series of screens divided in 5 classes of parameters (Resistance, Wideness, Pursuit, Velocity and Optokinetic Nystagmus \[OKN\]) to evaluate both smooth and saccadic movement in different directions. 40 healthy volunteers and 40 patients with long-standing type 1 diabetes will be enrolled to analyze the alterations in the oculomotor system and function.

The study will enroll 40 healthy volunteers and 40 patients with long-standing type 1 diabetes. The aim of the study is to analyze alterations in the oculomotor system function as an early sign of diabetic neuropathy. A novel eye-tracking-based test will be employed and 5 parameters will be analyzed through the use of a computer-based test which will record timeframes of eye movements towards an object, type of eye movements, time between the first eye movement, number of visualization required to recognize the object across the screen. Each of these parameter will be employed to assess whether Resistance, Wideness, Pursuit, Velocity of eye movements and movements related to the Optokinetic Nystagmus are altered in type 1 diabetes as compared to non diabetic subjects.

Eligibility Criteria:
Patients:

Inclusion Criteria:

* Type 1 diabetes
* willing to give consent

Exclusion Criteria:

* Diabetic retinopathy and other ocular diseases
* other endocrine disease
* malignancy

Healthy volunteers:

Inclusion Criteria:

* willing to give consent

Exclusion Criteria:

* Other ocular diseases
* Any endocrine disease
* Malignancy
TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer

The purpose of this research study is to determine if TLK286 given in combination with carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is refractory or resistant to platinum chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Are a woman 18 years of age or older
* Have histologically or cytologically confirmed epithelial cancer of the ovary or fallopian tube, or primary peritoneal cancer
* Have platinum refractory or resistant cancer
* Measurable disease according to radiographic RECIST criteria with documented tumor progression

Exclusion Criteria:

* Had treatment with first-line chemotherapy other than platinum-based regimens (carboplatin or cisplatin)
* Have clinically significant cardiac disease
* Have any sign of intestinal obstruction interfering with nutrition at the time of study entry
* Are pregnant or lactating
* Had prior treatment with liposomal doxorubicin for ovarian cancer
* Had prior treatment with TLK286
Studying Tumor Samples From Women Who Have Undergone Chemotherapy for Breast Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor samples from women who have undergone chemotherapy for breast cancer.

OBJECTIVES:

Primary

* To identify gene sets for risk of recurrence using molecular profiling in samples from women with lymph node-positive or high-risk lymph node-negative breast cancer on clinical trial ECOG-E2197.

Secondary

* To define a set of significant genes as prognostic markers of recurrence.
* To compare the prognostic value of the Oncotype DX™ (ODX) 21 gene assay of clinical trial with gene sets determined in this study.
* To compare the DASL™ assay of the ODX 21 genes with ODX assay results of clinical trial.
* To compare the prognostic value of selected genes with gene sets determined in this study.

OUTLINE: This is a multicenter study.

Samples are used in molecular profiling by applying a custom panel of breast cancer-related genes to a cDNA-mediated Annealing, Selection, Extension, and Ligation (DASL™) assay, immunohistochemistry, and other studies.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer tumor samples collected on clinical trial ECOG-E2197
* Histologically lymph node-positive (N1-3) OR high-risk lymph node-negative disease
* Hormone receptor-positive or negative disease (status known)
* HER2 status known

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Intensive Nutrition in Acute Respiratory Distress Syndrome (ARDS): A Clinical Trial (INTACT)

The investigators propose a prospective randomized clinical trail to evaluate the impact of intensive medical nutrition therapy (IMNT) in patients with acute respiratory distress syndrome (ARDS) or acute lung injury (ALI) on short and long-term outcomes. Participant's (N = 200) will be randomized to receive either standard care (SC e.g. ad lib feeding of standard food) or IMNT provided early as enteral nutrition (EN) and continued as intensive diet therapy tailored to maximize oral intake until hospital discharge. Primary outcomes evaluated include infections while hospitalized, immune parameters (CD4 and CD8 cells, serum IL-10 and leptin levels, numbers of T regulatory cells and markers for T cell anergy), days on mechanical ventilation, in the ICU and hospital , and changes in fat free mass(measured by dual energy x-ray absorptiometry), weight, muscular weakness (measured as hand grip strength), fatigue (measured as distanced traveled in 6-minute walk) and pulmonary function.

This study was terminated early due to greater deaths occurring in the intervention group vs the control group. There were a total of 22 deaths, 16 in the intervention and 6 in the control.

Eligibility Criteria:
Inclusion Criteria: Adult patients (\> 18 years) with a diagnosis of acute lung injury, with viable GI function for enteral feeding

-

Exclusion Criteria: Patients who are (1) transferred from another ICU, (2) previously admitted to the ICU during the same hospitalization, (3) do not resuscitate status or \< 12 month perceived survival due to underlying disease state (4) severely immunosuppressed, (5) immobility prior to ICU admission, (6) documented neurological disease prior to admission. -
N-PhenoGENICS: Neurocognitive-Phenome, Genome, Epigenome and Nutriome In Childhood Leukemia Survivors

To find possible therapeutic targets to help prevent long-term brain and behavioural side effects in survivors of childhood leukemia that may have been caused by chemotherapy (Treatment-Related late Adverse Neuro-Cognitive Effects: TRANCE). The study hypothesis is that genetic variations of the elements in the folate-related cycles and methotrexate disposition networks are associated with the deficit phenotype (TRANCE) of childhood leukemia survivors.

Hypothesis Genetic variants of the elements in the folate-related cycles and methotrexate disposition networks are associated with the TRANCE phenotype of childhood leukemia survivors.

Objectives

1. To identify TRANCE phenotypes of the childhood leukemia survivors.
2. To characterize the folate and vitamin B12 levels of these children
3. To identify DNA methylation patterns associated with TRANCE trait in the leukemia survivors
4. To identify SNPs associated with the TRANCE trait in the leukemia survivors.
5. To identify the "deficit genotype" associated only with the TRANCE leukemia survivors, but not with general population children who show developmental phenotypes similar to TRANCE: TRANCE-unique deficit variant
6. To replicate the association between the TRANCE-unique deficit variants and the TRANCE trait in a population of childhood leukemia survivors.
7. To evaluate the importance of rare genetic variants in the TRANCE trait in the leukemia survivors.

Study design: A case-control study of leukemia survivors

Analyses

1. Leukemia survivors will be characterized by their status of neurocognitive function, and categorized into the Deficit case and the non-deficit Control case.
2. They will be also characterized by the following attributes

   1. Pathway-based genetic variant status (folate and PK-related genes)
   2. Folate and vitamin B12 status
   3. Epigenetic markers
3. Comparative analyses between neuro-cognitiive deficit phenotype (TRANCE) and Control on those parameters

Eligibility Criteria:
Inclusion Criteria:

* Past diagnosis of acute lymphoblastic leukemia
* 8 years : 0 months - 20 years : 11 months old at the time of their study visit
* At least 2 years : 0 months from the last treatment for acute lymphoblastic leukemia at the time of their study visit
* Continuous complete remission and undergone no bone marrow transplantation or cranial radiation therapy
* Fluent in English (a subject and one parent) for test completion
* Signed informed consent

Exclusion Criteria:

* Inability to complete the phenotyping tests
* Down Syndrome diagnosis
Clinical Investigation of Two Different Wound Dressings

The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings

The secondary objectives are to evaluate pain before, during, and after dressing removal from baseline to termination

A prospective randomized clinical investigation will be conducted at two sites in Sweden.

Male or female, 18 years or older with following wound types:

* traumatic, surgical or dehisced wounds,
* venous leg ulcer or pressure ulcer will be included into the clinical investigation.

  32 evaluated subjects (i:e 16 subjects per arm) will be followed during maximum three weeks. The treatment arm (either silicon adhesive dressing or acrylic adhesive dressing). Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of skin (normal/dry/flaky/oily/moist) and age. Eligible patients will be randomized to receive either silicon adhesive dressing or acrylic adhesive dressing in a ratio of 1:1 provided.

Eligibility Criteria:
Inclusion Criteria:

1. Traumatic, surgical or dehisced wounds, Venous Leg Ulcer, Diabetic Foot Ulcer or Pressure Ulcer indicated for treatment with NPWT therapy
2. In case of multiple wounds the target wound must be ≥10 cm distant from other wounds. Selection of the target wound is according to the investigator's preference.
3. Peri-wound skin assessable and 5 cm of peri-wound skin present around the wound
4. Male or female, 18 years of age and above
5. Signed Informed Consent

Exclusion Criteria:

1. Dressing sizes does not fit the target wound
2. Unexplored blind tunnels or non-enteric fistula
3. Untreated osteomyelitis
4. Malignant wounds
5. Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent.
6. Wounds with necrotic tissue or eschar (if not adequately debrided)
7. Significantly bleeding wounds, as judged by the investigator
8. Subject not suitable for the investigation according to the investigator's judgment
9. Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
10. Known allergy/hypersensitivity to any of the components included into the investigation.