cyrilzakka/clinical-trials huggingface dataset:
Biomarkers in Predicting Response to Treatment in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This research trial is studying biomarkers in predicting response to treatment in bone marrow samples from young patients with acute myeloid leukemia.

OBJECTIVES:

Primary

* To validate the accuracy of a pre-specified acute myeloid leukemia (AML) induction response classifier or the My Profile™ AML Induction Therapy Assay (run in a Good Laboratory Practice \[GLP\] laboratory using Good Manufacturing Practice \[GMP\] reagents) in predicting response to cytarabine-based induction chemotherapy in pediatric patients with non-M3 AML.

Secondary

* To validate the continuous score from the pre-specified induction response classifier as a predictor of response to induction chemotherapy, after controlling for the simultaneous effects of clinical variables at base-line and/or pre-induction therapy (e.g., age, WBC, and percentage \[%\] of blasts), and tests commonly available after the start of induction therapy (e.g., cytogenetics and molecular markers).
* To validate the accuracy of the pre-specified induction response classifier as a binary predictor of induction response using a pre-specified cutpoint to assign patients to no response (NR) or complete response (CR) groups.
* To validate the accuracy of the pre-specified induction response classifier as a binary predictor of induction response using a pre-specified cutpoint to assign patients to NR or CR groups, after controlling for the simultaneous effects of clinical variables at base-line (pre-induction therapy) (e.g., age, WBC, % blasts) and clinical variables, including tests commonly available after start of induction therapy (e.g., age, WBC, cytogenetics).

OUTLINE: Cryopreserved bone marrow mononuclear cell specimens are analyzed by cell networking profiling assays. Results are then compared with patient outcomes and demographics from COG-AAML03P1 and COG-AAML0531 studies.

Molecular markers analyzed include Flt3ITD, NPM1, CEBPA, and MRA.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia (AML)

  * Non-M3 AML
* Cryopreserved bone marrow mononuclear cell specimens from patients enrolled on COG-AAML03P1 and COG-AAML0531 collected prior to cytarabine-based induction therapy

  * Patient samples from COG-AAML0531 must come from the control arm (i.e., no gemtuzumab ozogamicin induction therapy)

PATIENT CHARACTERISTICS:

* No Down syndrome

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques

This study will measure the effects of soft surgical techniques on vestibular function and quality of life in patients pre- and post-cochlear implant (CI) surgery. Additionally, the investigators will attempt to systematically evaluate the utility of different electrophysiological measures of vestibular system function in surgical ears.

Vestibular system function in CI patients will be evaluated pre-surgically and twice post-surgically, at 3 months and again at 1 year post-surgery. Traditional test techniques - such as VNG, rotational testing, and air conduction VEMPs - will be compared to and cross-checked with newer techniques including video head impulse testing (vHIT) and bone conduction VEMPs.

Design \& Procedures: The current standard of care for CI patients includes a pre-op evaluation of the vestibular system. For this study, the investigators will compare subjects' routine pre-op test results to two additional post-op assessments performed for study purposes: one in the short term (\~3 months post-op) and one in the long-term (\~1 year post-op).

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Only patients implanted with the MED-EL CI device within the last 90 days will be eligible for this study.

Exclusion Criteria:

* Patients \< 18 years of age
* Patients implanted with a cochlear implant device other than MED-El CI
Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis

The purpose of this study is to evaluate if Etanercept administered at a higher initial dose provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower initial dose.

This study will assess the effects of the 2 Etanercept regimens on fingernail psoriasis over 24 weeks among patients with both skin and fingernail symptoms who have previously failed at least one therapy for nail psoriasis. The endpoint of 24 weeks was chosen to allow sufficient time for normal nail growth.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Active, stable plaque psoriasis defined by the following criteria:

  * Body surface area (BSA) ≥ 10 % at screening and baseline
  * Or, PASI \>10 at screening and baseline
  * Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline
  * Or, DLQI \> 10 at baseline
* Active fingernail psoriasis defined as target fingernail NAPSI ≥ 2 and overall NAPSI \> 14 - Target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. Should more than one fingernail have the same score, the target fingernail will be chosen by the investigator.
* Failure of at least one systemic psoriasis therapy for nail psoriasis
* Eligible to receive biologic therapy for psoriasis in accordance to local guidelines

Exclusion Criteria:

* Evidence of Skin conditions other than psoriasis
* Psoralen plus ultraviolet radiation (PUVA), cyclosporine, alefacept, methotrexate, acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug initiation
* Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?

The purpose of this study is find out if we can use simple tests (biomarkers) to tell us if a specific child would benefit most from CBT or from the low FODMAPs diet.

AIM 1: We will categorize children ages 7-12 yrs. of age with FGIDs (n=250) as to whether they have/do not have one or more of the following abnormal physiologic changes: a) Autonomic Nervous System imbalance as indicated by low heart rate variability; and/or (b) Abnormalities in gut physiology: Impaired gut barrier function (increased permeability); and/or increased abundance of species of Gammaproteobacteria and/or Clostridia; and/or Gut neuroimmune dysfunction (increased fecal chromogranin A and secretogranin 2 concentrations).

AIM 2: Children will be randomized to the two treatments most commonly used in clinical practice: CBT or a low FODMAP diet for a 3-week treatment period. We will compare the response to the treatments in those with/without abnormal physiologic biomarkers at 3 weeks, 3 months, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* A child 7-12 years of age with a FGID will be recruited if the medical evaluation reveals no organic reason for the abdominal pain and the child has abdominal pain that meets the definition of a FGID (i.e., IBS, functional abdominal pain) according to the pediatric Rome III criteria (Rome IV will be substituted when validated). Parents and children must speak and understand English because of the psychological assessment and CBT requirements.

Exclusion Criteria:

* Children who have: had past bowel surgery; documented GI disorders (e.g., Crohn's disease); a serious chronic medical condition (e.g., diabetes); weight and/or height \< 2 SD for age; chronic conditions with GI symptoms (e.g., cystic fibrosis); autism spectrum disorder, significant developmental delay, psychosis, or a history of bipolar disorder; been treated with antibiotics/probiotics within 2 mo. (because of effects on gut microbiome analysis), and children who for some reason could not be randomized to the low FODMAP diet.Vegetarian; children who are currently on the FODMAP Diet or receiving CBT Children who speak only Spanish are not eligible because the Rome questionnaire and psychological testing are not available in Spanish. Despite this, a large proportion of the children enrolled will be Hispanic.
Effect of Lighting Supplementation on Daytime Cognition

The aim of the study is to examine the efficacy of supplementing sub-optimal ambient room lighting with a task lamp on working memory and procedural learning.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-30 years;
* Healthy (no medical, psychiatric or sleep disorders;
* Non-smoking for at least 6 months;
* Body Mass Index of \>18 or \<30 kg/m2;
* Able to maintain 7-hour consistent sleep schedule during the study
* Able to refrain from caffeine, alcohol, medication and supplements during the study

Exclusion Criteria:

* History of alcohol or substance abuse;
* positive result on drugs of abuse urine toxicology;
* Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, narcolepsy, insomnia, or any significant sleep complaint
* Psychiatric disorder, or first degree relative with a psychiatric disorder
* Recent acute or chronic medical disorder
* Use of drugs or medication (birth control OK) likely to affect sleep, alertness or light sensitivity, as determined by the investigators
* Visual disorder, including but not limited to color blindness, or family history of glaucoma
* Pregnancy or lactation
* Shift work (\> 2 nights / week in the last 3 months and not during the study)
* Transmeridian travel (2 or more time zones) in the past 3 months
* Any other reason as determine by the Principal Investigator
Interprofessional Rehabilitation for Adults With Chronic Non-specific Low Back Pain

The primary aim of the study is to analyse the long-term effectiveness of an interprofessional and interdisciplinary rehabilitation program named "PASTOR", with a biopsychosocial approach for participants with chronic non-specific low back pain (CLBP) compared to the standard inpatient multidisciplinary orthopaedic rehabilitation (MOR) in Germany. The investigators hypothesize that in adults with CLBP the rehabilitation program PASTOR would result in a significantly higher increase in functional ability 12 months after completion of the program in comparison to the standard inpatient MOR. The investigators further hypothesize that PASTOR would lead to significantly larger improvements regarding pain-related cognitions, pain coping strategies, physical activity, health-related quality of life, and back pain episodes compared to the standard inpatient MOR.


Eligibility Criteria:
Inclusion Criteria:

* M51.2 Other specified intervertebral disc displacement
* M51.3 Other specified intervertebral disc degeneration
* M51.4 Schmorl's nodes
* M51.8 Other specified intervertebral disc disorders
* M51.9 Intervertebral disc disorder, unspecified
* M53.8 Other specified dorsopathies
* M53.9 dorsopathy, unspecified
* M54.4 Lumbago with sciatica
* M54.5 Low back pain
* M54.6 Pain in thoracic spine
* M54.8 Other dorsalgia
* M54.9 Dorsalgia, unspecified

Exclusion Criteria:

* age below 18 years or over 65 years
* specific underlying diagnosis of back pain (e. g. radicular symptoms, myelopathy)
* considerably reduced health status (e.g. comorbidity)
* considerably reduced sight and hearing (not corrected)
* severe psychiatric condition as secondary diagnosis
* inability to speak German
* current application for early retirement or invalidity pension (§51 SG V - german law)
Study of Atelectasis by Electrical Impedance Tomography

The goal of this interventional study is to learn about the effects of different positions on the occurrence, regional distribution and reversibility of atelectasis by using a PulmoVista 500 monitor (Dräger. 23542 Lübeck), during general anesthesia with mechanical ventilation.

The main questions it aims to answer are:

* The increase in atelectasis after induction of general anesthesia in supine and Trendelenburg position compared with baseline (spontaneous breathing)
* The eventual possibility of reversal of atelectasis caused by general anesthesia and Trendelenburg position by reverse Trendelenburg position and recruitment manœuvre.

Participants will be adult, autonomous and able to express their will, undergoing elective gynecological or urological surgery in the extended Trendelenburg position.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects over eighteen years old;
* Requiring laparoscopic gynecological, urological or digestive surgery;
* Surgery requiring Trendelenburg position and tracheal intubation.

Exclusion Criteria:

* Emergency operation;
* Thoracic surgery;
* Pulmonary, cardiac pathology;
* Pregnant woman;
* BMI \> 30;
* Comorbidities defined as an American Society of Anesthesiologists physical condition greater than 2;
* Language barrier;
* Refusal of consent.
Dose Escalation Study of Nintedanib (BIBF 1120) in Japanese Patients With Hepatocellular Carcinoma

The aim of the study is to investigate the safety, tolerability, efficacy and pharmacokinetics (PK) for Japanese hepatocellular carcinoma which are not amenable to curative surgery or loco regional therapy


Eligibility Criteria:
Inclusion criteria:

1. Histologically/cytologically confirmed hepatocellular carcinoma not amenable to curative surgery or loco-regional therapy
2. Age 20 years or older
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
4. Child-Pugh score of 7 or less
5. Life expectancy more than 3 months
6. Time interval from last loco-regional therapy more than 4 weeks
7. Written informed consent in accordance with good clinical practice (GCP)

Exclusion criteria:

1. More than one line of prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (HCC)
2. Fibrolamellar HCC
3. Uncontrolled or refractory ascites
4. Inadequate organ function
5. Variceal bleeding within 6 months or the presence of inappropriate varices
6. History of major thrombotic (except portal vein thrombosis) or clinically relevant major bleeding event in the past 6 months
7. Major surgery within 4 weeks
8. Known inherited predisposition to bleeding or thrombosis
9. Significant cardiovascular diseases
Impact of Ultra-Early Intracranial Aneurysm Treatment in SAH

This is the first prospective study in Hong Kong that recruit patients with poor neurological status after intracranial aneurysm rupture in all seven public neurosurgical services in Hong Kong. This study assesses whether ultra-early aneurysm treatment improves outcomes in patients with poor neurological status after intracranial aneurysm rupture in Hong Kong. These data are essential to understand the impact of the disease and for future service development in Hong Kong.

Objectives:

1. To evaluate outcomes in patients admitted with poor neurological status after intracranial aneurysm rupture in Hong Kong;
2. To evaluate whether ultra-early aneurysm treatment improves outcomes in patients admitted with poor neurological status after intracranial aneurysm rupture.

Hypothesis to be tested: Ultra-early aneurysm treatment increases chance of favorable outcomes in in patients admitted with poor neurological status after intracranial aneurysm rupture.

Design and subjects: Prospective observational study to recruit consecutive poor grade aneurysmal subarachnoid hemorrhage patients in the seven public neurosurgical services in Hong Kong.

Study instruments: Modified Rankin Scale, Montreal Cognitive Assessment, Stroke-Specific Quality of Life, Short Form-36, Return to Work, and hospital resource utilization.

Groups: Ultra-early (within initial 24 hours) and non-ultra early aneurysm treatment.

Main outcome measures: Favorable outcome at six months. Data analysis and expected results: Comparisons are carried out with adjustments for age, sex, admission Glasgow Coma Scale, hypertension, and modality of aneurysm treatment with appropriate regression analyses.

Eligibility Criteria:
The inclusion criteria for this study are:

1. Adult patients (aged \>18 years) with spontaneous subarachnoid hemorrhage
2. Admission into Hospital Authority neurosurgical services
3. The Glasgow Coma Scale on admission ≤12 (World Federation of Neurosurgical Societies Grade 4-5)

The exclusion criteria for this study are:

1. Patients are likely to leave Hong Kong shortly after episode
2. Patients (or next-of-kin as appropriate) refuse to participate into the study
Mepivacaine Vs. Bupivacaine Spinal for TKA

This study will enroll patients 18-75 years of age who are undergoing elective primary total knee replacement. The patients will be randomized to receive one of two spinal blocks: 1) mepivacaine or 2) bupivacaine. The primary goal is to determine which group arrives at recovery of motor function first. Ultimately, this study will explore if mepivacaine leads to earlier return of motor function and ultimately earlier movement and discharge times following total knee replacement.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-75 years of age
* Undergoing elective primary total knee arthroplasty

Exclusion Criteria:

* Inability to ambulate or impaired motor function in lower extremities prior to surgery
* Contraindication to spinal anesthetic
* Taking over 30mg oxycodone per day (or calculated MME equivalent)
* Subjects that are unable or choose not to give informed consent
* Known preoperative substance abuse
* Pregnant women
* Allergy to all opioids
Antistax® in Patients With Chronic Venous Insufficiency

Study to determine the efficacy and tolerability of two dose levels of Antistax relative to placebo in patients suffering from CVI grade I or incipient grade II


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Between 25 and 75 years of age
* CVI I or CVI II (without expanded trophic disturbances)
* Willing and able to give written informed consent prior to participation in the study

Exclusion Criteria:

Concomitant disease(s) exclusion criteria:

* Decompensated cardiac insufficiency
* Edema not due to venous disease of the legs (e.g. latent cardiac insufficiency, renal insufficiency, lymph edema, etc)
* Peripheral arterial disease (ankle/arm pressure index \< 0.9)
* Current acute phlebitis or thrombosis
* Renal insufficiency (Serum creatinine \> 1.5 mg/dl)
* Liver disease (SGPT (ALAT) \> 3x upper limit of normal)
* Other diseases: insulin-dependent diabetes mellitus, neuropathies, hyper- or hypocalcaemia, malignancies
* Anamnestic indications of diabetic microangiopathy or polyneuropathy
* Drug and/or alcohol abuse
* Severe climacteric complaints
* Immobility
* Avalvulia
* Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)
* State after pulmonary embolism
* Recognized hypersensitivity to the trial drug ingredients
* Current florid venous ulcus
* Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compressive treatment, phlebectomy, etc.

Previous treatment(s) exclusion criteria:

* Treatment with venous drugs within the last 4 weeks
* Treatment with laxatives which affect fluid or electrolyte balance within the last 8 days
* Changes in or unstable response to treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors or calcium antagonists within the last 8 days
* Changes in post-menopausal Hormone replacement within the last 2 months

Concomitant treatment/non-drug therapy exclusion criteria:

* Other venous drugs apart from the trial medication
* Compression therapy
* Venous surgery at the leg(s)
* Extensive use (on more than a total of 6 days during the entire trial) of laxatives which affect fluid or electrolyte balance
* Major surgery requiring full anesthesia

Other exclusion criteria:

* Previously studied under this protocol
* Participation in another clinical trial within the previous 90 days or during the present study
* Patients who have visited a sauna or had other thermal applications in the previous day before any visit
* Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only)
* Patients considered as mentally ill as well as unable to work or with limited working ability, or unable (or only partially able) to follow the spoken or written explanations concerning the trial
* Patients in a bad general health state according to the investigator's judgment
Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Kidney Transplant Recipient.

Islet transplantation is associated with a benefit on glycaemic control compared to optimized insulin therapy in recent clinical trials. However, there is a lack of evidence concerning the long-term impact of islet transplantation on type 1 diabetic kidney transplant recipients' prognosis. The objective of the study is to assess the impact of islet transplantation in patients with type 1 diabetes and a kidney transplantation on the risk of graft failure. Every type 1 diabetic recipient transplanted with a kidney in France between 2000 and 2017 is included. Patients transplanted with pancreatic islets are compared to controls treated with insulin alone according to a matching method based on time-dependent propensity scores which allow to ensure patients comparability at the time of islet transplantation. Time-dependent propensity scores are built according to variables associated with both the probabilities of being transplanted with islets and the outcome of interest. These variables are assessed by a direct acyclic graph. The primary outcome consists in death-uncensored graft survival, defined by death or return to dialysis. Secondary outcomes include the risk of death, or the risk of death-censored graft survival.


Eligibility Criteria:
Inclusion Criteria:

* Patient is aged over 18
* With type 1 diabetes
* With End-Stage Renal disease
* Transplanted with a kidney
* Between 2000 and 2017

Exclusion Criteria:

* Patients with type 2 diabetes
* Patients with a previous pancreatic transplantation with a pancreatic graft functioning at the time of kidney transplantation.