cyrilzakka/clinical-trials huggingface dataset:
S9031-S9126-S9333-S9500-B Biomarker Expression in Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of bone marrow 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 biomarker expression in bone marrow samples from patients with acute myeloid leukemia.

OBJECTIVES:

* Estimate the distributions of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms (SNPs) in patients with newly diagnosed acute myeloid leukemia (AML).
* Estimate the distributions of mutations in TOP2 phosphorylation sites (by SNP analysis) in these patients.
* Investigate whether expression of TOP2 or mutations in TOP2 phosphorylation sites vary with patient or disease characteristics in these patients.
* Test whether TOP2 expression correlates with complete remission rates, relapse-free survival, and overall survival of these patients.
* Conduct preliminary analyses to estimate the distributions of TOP2 expression and mutations in TOP2 phosphorylation sites (by SNP analysis) in patients with relapsed and/or refractory AML.
* Investigate whether expression of TOP2 and mutations in TOP2 phosphorylation sites vary with patient or disease characteristics in patients with relapsed and/or refractory AML.
* Test whether TOP2 expression and mutations in TOP2 phosphorylation sites differ between previously untreated and relapsed/refractory AML patients.

OUTLINE: This is a multicenter study.

Archived RNA specimens are analyzed for topoisomerase 2 transcriptional expression by quantitative real-time polymerase chain reaction (PCR) and for mutations within TOP2 phosphorylation sites by single nucleotide polymorphism analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia

  * All subtypes allowed (except acute promyelocytic leukemia \[M3\])
  * Previously untreated OR relapsed/refractory disease
* Isolated RNA specimens from bone marrow aspirate samples available from patients who participated on SWOG-9031, SWOG-9333 (cytarabine/daunorubicin hydrochloride induction arm only), SWOG-9500, or SWOG-9126

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
TCD Monitoring Technology Guides the Precise Control of Blood Pressure After EVT

Investigators hypothesized that the precise regulation of blood pressure based on the changes of cerebral blood flow parameters under TCD monitoring can better improve the state of cerebral blood flow, reduce the risk of early neurological deterioration and improve the prognosis of the patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* accept EVT treatment within 6 hours of symptoms onset;
* In selected patients with AIS within 6 to 16 hours of last known normal who have LVO in the anterior circulation and meet other DAWN or DEFUSE 3 eligibility criteria..
* In selected patients with AIS within 6 to 24 hours of last known normal who have LVO in the anterior circulation and meet other DAWN eligibility criteria.

Exclusion Criteria:

* Pre - onset mRS\>2;
* severe dementia;
* threatening life diseases (such as malignant tumor, etc.);
* non acute ischemic cerebrovascular disease patients undergoing selective intravascular treatment;
* related sound window closure can not be monitoring with TCD.
To Investigate the Effect of PEMF for Pateitns After Anterior Cruciate Ligament Reconstruction With Hamstring Autograft

Anterior cruciate ligament (ACL) tear is common. It accounts for over 50% of all knee injuries. Anterior cruciate ligament reconstruction (ACLR) with hamstring tendon (HT) autograft is the common graft choice for ACLR. However, the outcomes of donor site healing and recovery of muscle strength of HT are not satisfactory, resulting in hamstring muscle weakness and hamstring strength deficit during deep knee flexion, which may lead to hamstring strain after ACLR. Moreover, activation of the hamstring muscle is vital for maintaining dynamic knee joint stability and preventing excessive ACL shear forces. The presence of hamstring muscle deficits after surgery therefore affects the function of the reconstruction ACL. A previous study has reported that the hamstring muscle showed nearly 20% strength deficit at 4 months after ACLR with hamstring autograft

Pulsed electromagnetic field (PEMF) treatment is a non-invasive therapy that has been shown to enhance muscle cell activity and accelerate tissue repair. In clinic, PEMF treatment has been reported to be safe.

This study aims to conduct a double-blinded, placebo-controlled randomised clinical trial to investigate the effects of PEMF therapy for improving the tissue regeneration and strength of the HT donor site in ACLR patients with HT autograft.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female with age ≥ 18 years at the time of surgery
2. First ACLR with HT autograft
3. Both knees without a history of injury/prior surgery
4. LSI for hamstring strength \<85% of contralateral leg at 4-month isokinetic assessment (70)
5. Voluntarily agreed to participate and signed the informed consent form

Exclusion Criteria:

1. Any concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-op
2. Preoperative radiographic signs of arthritis
3. Other associated injuries (fractures and other ligament involvement such as neurovascular bundles injury)
4. Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
5. Pregnant or breastfeeding
6. Inability to give informed consent
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide

The purpose of this project is to conduct a randomized control trial with 470 Veterans to examine the impact of a revised version of Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) on risk for suicide attempts and suicidal ideation when compared to high quality usual care.

Research suggests that treatments to reduce suicidal behavior may need to focus on both the motivation to live and the motivation to die to obtain optimal effects. The PI developed a revised version of Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) to help Veterans resolve ambivalence about living by increasing the motivation to live, that consists of three sessions delivered in-person, virtually, or by telephone. Enhanced usual care (EUC) for high-risk Veterans includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline. In a preliminary randomized controlled trial (RCT) in psychiatrically hospitalized Veterans, MI-SI-R plus EUC was associated with 50% fewer suicide attempts and 41% lower likelihood of suicidal ideation compared to EUC alone. The investigators are proposing an RCT comparing MI-SI-R plus EUC (MI-SI-R+EUC) to EUC alone in a sample of 470 high-risk Veterans with recent suicidal crises from three VHA Medical Centers, with "high-risk" defined as a suicide attempt within a month or suicidal ideation \> 5 on the Beck Scale for Suicidal Ideation. Half (n = 235) will be randomized to MI-SI-R+EUC (three sessions in-person, via Video Connect, or telephone) and the remaining participants (n = 235) will receive EUC alone. All participants will be asked to complete telephone follow-up assessments at 1, 3, 6, and 12-months after randomization. This will allow the investigators to determine the efficacy of MI-SI-R+EUC in reducing risk for suicide attempts (Aim 1) and reducing overall suicidal ideation (Aim 2) when compared to EUC alone.

Eligibility Criteria:
Inclusion Criteria:

* Veteran status,
* admitted to an inpatient unit, referred by a suicide prevention coordinator, or identified as high-risk via data extraction,
* age 18 and over,
* English speaking and reading, and
* ability to understand the study and provide informed consent,
* high-risk status confirmed by suicide attempt within a month on the Columbia- Suicide Severity Rating Scale or a score \> 5 on the Scale for Suicidal Ideation

Exclusion Criteria:

* current psychosis,
* active mania,
* dementia,
* impaired decision making capacity, and
* institutionalization due to hospitalization in a non-VA facility, jail, or prison.
Influence of Different Ankle Positions on Nerve Conduction Parameters of Deep Peroneal Nerve

BACKGROUND:

The deep peroneal nerve arises as a branch of the common peroneal nerve which courses around the neck of the fibula. The motor component of deep peroneal nerve is responsible for innervating the anterior compartment of the lower leg which includes the tibialis anterior, extensor hallucis longus, extensor digitorum longus, and peroneus tertius muscles.

Nerve conduction velocity shortly known as "NCV" tests are used determine the speed of the electrical signals moving along a specific peripheral nerve .This will be helpful in localizing the site of entrapment of peripheral nerves and useful for assessing both recovery and prognosis of any injury to peripheral nervesthere are numerous aspects that could influence nerve conduction study.

Although changes in joint position have been reported in several studies to affect nerve conduction velocity of peripheral nerves. the effect of changing ankle joint position on deep peroneal NCV has not been repor Purpose

This study will investigate the effect of different ankle positions on:

1. Deep peroneal nerve distal motor latency across ankle joint.
2. Deep peroneal nerve sensory onset latency across ankle joint

31healthy subjects of both genders with age ranging from 20to 40years old were examined for motor distal latency and sensory onset latency at three different ankle positions :neutral,20degrees dorsiflexion and 40degrees plantar flexion

Eligibility Criteria:
Inclusion criteria:

* Healthy subjects.
* Age ranges from 20 to 40 years because longer latencies and slower nerve conduction velocity are seen significantly with increasing age.
* All participants will be selected with body mass index (BMI) between 18.5 and 24.9kg/cm2 .

Exclusion criteria:

* Elderly subjects.
* Pregnant women.
* Subjects with history of or risk factors for peripheral nerve lesions.
* Obese subjects.
* Subjects with any foot deformity.
* History of lower limb fractures.
* History of surgery to lower limbs
* Diabetic patients.
* Patients with cardiovascular disorders.
* Hypertensive patients.
* Women wearing high heeled shoes.
Nasal Continuous Positive Airway Pressure (CPAP) in Chronic Fatigue and Sleep-disordered Breathing

Chronic fatigue (CF) and chronic fatigue syndrome (CFS) are disabling disorders that may be induced or aggravated by underlying sleep disturbances. The relationship between sleep quality and fatigue is still not fully elucidated. To evaluate the effect of improved sleep quality on fatigue, a randomized controlled and cross-over trial with nasal continuous positive airway pressure (nCPAP) is carried out in patients who present with a primary complaint of chronic disabling fatigue and who are found to have an apnea-hypopnea index (AHI) \>= 15 on polysomnography (PSG).

The aim of this study is to address the issue of Continuous Positive Airway Pressure-responsiveness regarding fatigue as a presenting symptom in CF and CFS patient with obstructive sleep apnea (OSA), in the absence of underlying medical or psychiatric illness. The answer to this question may shed further light on the enigmatic relationship between sleep and fatigue. We also want to investigate the Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population. Zero-hypothesis: there is no effect.


Eligibility Criteria:
Inclusion Criteria:

* Patients primarily referred for disabling, unexpected fatigue.
* According to the Fukuda criteria, diagnostic work-up yields a final diagnosis of chronic fatigue (CF) or chronic fatigue syndrome (CFS).
* 18 \<= age \<= 65
* Polysomnography Test (PSG) demonstrates an apnea-hypopnea index (AHI) \>=15, as evidence for obstructive sleep apnea (OSA).
* Female patient of childbearing potential (premenopausal female biologically capable of becoming pregnant) has a confirmed negative pregnancy test at the start of the Continuous Positive Airway Pressure (CPAP) trial and has to employ an acceptable method of birth control.
* Written, signed and dated informed consent must be obtained from each patient.
* Patient able to understand and follow the requirements of the study and to comply.
* Willing to abstain from taking any medication or treatment prohibited in the protocol.

Exclusion Criteria:

* Patients primarily referred for Excessive Daytime Sleepiness (EDS) or snoring.
* Fatigue that is explained by medical or psychiatric causes.
* 18 \> age \> 65
* Apnea-Hypopnea Index (AHI) \< 15
* Body Mass Index (BMI) \>= 40, calculated as weight(m)/(height (m))²
* Parasomnia
* Severe sleepiness with (Epworth Sleepiness Scale) ESS \>= 16 (=15% of the Chronic fatigue syndrome (CFS) population)
* Tonsillar hypertrophy (Friedman grade III and IV tonsils)
* Signs of nasal obstruction, including chronic use of topical nasal drugs.
* Earlier CPAP treatment
* Physical and mental disability that compromises the normal use of CPAP
* CPAP intolerance
* Current use of sedative (benzodiazepine and non-benzodiazepine GABA-esgic agonist) or antidepressant medication for a time period inferior to 3 weeks.
* Female patient who is pregnant, lactating or has a positive pregnancy test result.
A Randomized, Double-blind, Flexible Dose, Multicenter Study to Evaluate the Effectiveness and Safety of Galantamine IR in Mild to Moderate Alzheimer's Disease

The purpose of this randomized, double-blind, active-controlled, flexible dosage, multicenter study is to evaluate the effectiveness and safety of galantamine tablet (16-24mg/day) for 16 weeks in the treatment of mild to moderate Alzheimer's Disease (AD) comparing with Donepezil.

This is a randomized, double-blind, active-controlled, flexible dosage, multicenter study to evaluate the effectiveness and safety of galantamine tablet in the treatment of mild to moderate AD. The comparator is Donepezil tablet. At least 206 patients were to be randomized in the study. The study consisted of 3 phases: a screening phase, a single-blind run-in phase and a double-blind treatment phase. Screening phase is less than 2 week for eligible assessment; If the patient was taking any anti-dementia drug at screening, he/she had to stop these drugs and enter into the single-blind run-in phase. The patient who did not take any anti-dementia drug can enter into baseline directly. During the single-blind run-in phase, all eligible patients will take placebo twice daily for 4 weeks. Double-blind treatment phase is 16 weeks. At baseline, all patients who are still eligible for inclusion/exclusion criteria will be randomized to either galantamine group or donepezil group at 1:1 ratio, drugs will be taken twice daily by a flexible dose for 16 weeks. Dose will be titrated during the first 9-12 weeks. Dose will be fixed to 16mg/day or 24mg/day based on tolerability of the patient judged by the investigator. The primary effectiveness endpoint is changes in ADAS-cog/11 at week 16 from baseline, secondary endpoint is responder rate in term of ADAS-cog/11. Safety evaluation included adverse events, physical examination, ECG, and safety laboratory tests. Study drug are taken orally twice a day. The treatment duration was 16 weeks. Initial galantamine dose is 8 mg/day, dose was increased to 16mg/day at week 5 and to 24 mg/day at week 9. At week 12, dose was fixed to either 16mg/day or 24mg/day at the discretion of investigators. Initial donepezil dose is 5mg/day, dose was then increased to 10mg/day at week 9. At week 12, dose was fixed to either 5mg/day or 10mg/day at the discretion of investigators.

Eligibility Criteria:
Inclusion Criteria:

* Out-patients diagnosed with mild to moderate probable AD. The diagnosis should have been established in accordance with the classification for probable AD of NINCDS-ADRDA
* MMSE score of 10-24 (inclusive) at screening
* Patients who lived with or had regular daily visits from a responsible caregiver
* .Has signed the informed consent form by subject and assent form by care-giver

Exclusion Criteria:

* Patients with neurodegenerative disorders such as Parkinson's disease
* Patients with some conditions possibly resulting in cognitive impairment, e.g. acute cerebral trauma, infection
* Has evidence of multi-infarct dementia or clinically active cerebrovascular disease.
CIBMTR Research Database

The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation and cellular therapies.

A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries.

Objectives:

To learn more about what makes stem cell transplants and cellular therapies work well such as:

* Determine how well recipients recover from their transplants or cellular therapy;
* Determine how recovery after a transplant or cellular therapy can be improved;
* Determine how a donor's or recipient's genetics impact recipient recovery after a transplant or cellular therapy;
* Determine how access to transplant or cellular therapy for different groups of patients can be improved;
* Determine how well donors recover from the collection procedures.


Eligibility Criteria:
Eligibility to Participate in the Research Database

Recipient Eligibility Criteria:

* Any recipient of an unrelated or related donor or autologous HSC transplant in a CIBMTR center is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children.

Individual with Marrow Toxic Injury Eligibility Criteria:

* Any individual who is treated for a marrow toxic injury at a center participating in the NMDP's Radiation Injury Transplant Network (RITN) is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children. Eligible individuals may have received supportive care only, growth factor support, HSC transplant or other appropriate medical treatment for marrow toxic injury. Treatments applied are at the discretion of the care facility, and are not determined by the NMDP or CIBMTR.

Unrelated Donor Eligibility Criteria:

* All donors registered on the NMDP Registry who have been requested to donate a product for a recipient are eligible to participate in the Research Database.
* All maternal cord blood donors are enrolled in the NMDP Cord Blood Bank Investigational New Drug (IND) protocol, and sign an informed consent document specific to that protocol. Data collected as part of the Cord Blood Bank protocol are included in the Research Database.
The Rates of Overtreatment and Deintensification in Patients With Diabetes Mellitus

This study evaluates the overtreatment and deintensification rates of antidiabetic and antihypertensive medications in patients with diabetes mellitus in Turkey.

Diabetes mellitus is one of the most common chronic diseases which lead to serious public health problems and a significant economic burden worldwide. The prevalence of diabetes in elderly patients is very high and is predicted to increase dramatically.

Prior studies have generally been concerned with the inadequate treatment of diabetes however, over the last few years the overtreatment of diabetes has also come to the fore. Unfortunately, there are very few data worldwide and no data in Turkey about the overtreatment of patients with type 2 diabetes.

This study aimed to assess the rates and predictors of overtreatment and undertreatment of glycemia and blood pressure in older adults with T2DM. Treatment deintensification or intensification by the physicians were also investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Diabetes Mellitus type I or II
* Age 65 years or older
* To be under follow-up in the same center for at least one year.

Exclusion Criteria:

* Younger than 65 years old
* having decompensated liver disease
* psychiatric disorders interfering cognition or compliance
* having bariatric surgery or on renal replacement therapy
Point of Care Early Infant Diagnosis Patient Impact Study

In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories. However, test volumes are growing and many parts of the country do not have close or easy access to laboratories. Test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country. There are growing numbers of high quality Point-Of-Care (POC) diagnostic technologies available and there is increasing interest in using these technologies to alleviate critical testing needs. This protocol describes an observational study looking at the patient impact of implementing POC EID technologies within the routine standard of care at seven facilities.


Eligibility Criteria:
Inclusion Criteria:

* Younger than 12 months of age
* Clinical or other indication for an EID test (screen or confirmation), such as birth to an HIV-positive mother

Exclusion Criteria:

* Older than 12 months of age
* Serious medical conditions which would make testing dangerous for the infant, or disrupt the accuracy of normal laboratory analysis and its interpretation
* Already initiated ART
Interventions for Enhancing Adherence to Syphilis Treatment and Follow-up: Study Protocol for the Health Information and Monitoring of Sexually Transmitted Infections (SIM) Randomized Controlled Trial

The SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance. The recruitment of participants will be done by invitation, and tests will be performed in a mobile unit in locations accessible to large populations. The goal is to perform 10,000 quick tests, with results confirmed by venereal disease research laboratory (VDRL) tests. Patients with a confirmed diagnosis according to VDRL test results will be randomized in one of three monitoring arms: follow-up by telephone, follow-up via a game in a smartphone app, or conventional follow-up by a health professional. All analyses will follow the intention-to-treat principle.


Eligibility Criteria:
Inclusion Criteria:

* All adults aged 18 years and older with sorologic test positive for syphilis

Exclusion Criteria:

* Participants who did not return after three contact attempts will be excluded from the study,
* pregnant women
* participants who are not able to provide contact information
* participants who are illiterate
* participants those who underwent syphilis treatment within the previous three months.