cyrilzakka/clinical-trials huggingface dataset:
WT1 for the Detection of Minimal Residual Disease

The purpose of this study is to determine if WT1 is an adequate measurement of minimal residual disease in leukemic patients.

Patients with acute Leukemia may have a large number of leukemic cells at the time that leukemia is evident clinically. At the time that we determine that a patient is in complete remission (CR) the patient may still have leukemic cells present in smaller quantities. One of the most important factors in the successful treatment of patients with leukemia is the ability to determine if the eradication of leukemia has been achieved. The determination of Minimal Residual Disease may be important in the determination of the therapy that a given patient will receive as determined by the level of residual disease.

WT1 gene function and expression. The WT1 gene is a candidate gene for Wilms tumor, which is thought to arise as a result from inactivation of both alleles of the WT1 gene located at chromosome 11p13. The WT1 gene has been considered a tumor suppressor gene because intragenic deletions or mutations are found in tumors, germline mutations have been found in-patients with leukemia, and mediates growth suppression of Wilms tumor cells expressing a WT1 splicing variant.

Eligibility Criteria:
Inclusion Criteria:

* Age less than 21 years of age.
* Patients with the following diseases: Acute lymphoblastic Leukemia (ALL) at the time of diagnoses or relapse, Acute non-lymphoblastic leukemia (ANLL) at diagnosis or after relapse and Chronic Myelogenous leukemia in chronic or accelerated phase.
* Patients will be eligible for any of the available treatment protocols or protocols for stem cell transplantation, regardless of the source of stem cells.
* Patients or legal guardians will sign an Institutional Review Board (IRB) approved informed consent.
* Patients will have venous access or peripheral vein for sampling.
ATX Study:A Study of Avastin (Bevacizumab), Tarceva (Erlotinib) and Xeloda (Capecitabine) in Patients With Locally Advanced and/or Metastatic Pancreatic Cancer

This 2 part study will evaluate the safety and efficacy of a combination of Avastin, Tarceva and Xeloda (ATX) as second-line treatment in patients with locally advanced and/or metastatic pancreatic cancer. In the first part of the study, cohorts of patients will receive escalating doses of combination treatment to determine the maximum tolerated dose. The recommended dose will be used in the second part of the study to determine the efficacy of the ATX regime, in terms of its effect on disease progression. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* pancreatic cancer with locally advanced and/or metastatic disease (stage IV);
* chemonaive for metastatic or locally advanced disease;
* ECOG performance status of 0-2.

Exclusion Criteria:

* local (stage IA to IIB)and locally advanced (stage III) pancreatic cancer;
* previous exposure to Avastin, Tarceva or Xeloda;
* other primary tumor within the last 5 years prior to enrollment, except for adequately treated cancer in situ of cervix, or basal cell skin cancer;
* current or recent chronic use of aspirin (\>325 mg/day) or full therapeutic dose of anticoagulants or thrombolytic agents.
Validation of the Utility of Ophthalmology Intelligent Diagnostic System

The prevention and treatment of diseases via artificial intelligence represents an ultimate goal in computational medicine. Application scenarios of the current medical algorithms are too simple to be generally applied to real-world complex clinical settings. Here, the investigators use "deep learning" and "visionome technique", an novel annotation method for artificial intelligence in medical, to create an automatic detection and classification system for four key clinical scenarios: 1) mass screening, 2) comprehensive clinical triage, 3) hyperfine diagnostic assessment, and 4) multi-path treatment planning. The investigator also establish a telemedicine system and conduct clinical trial and website-based study to validate its versatility.


Eligibility Criteria:
Inclusion Criteria:

* Patients and residents who underwent ophthalmic examination of the eye and recorded their ocular information in the outpatient clinic and community.
Impact on Muscle Strength, Quality of Life and Functionality in Individuals Submitted to Hip Arthroplasty: a Prospective Study.

Introduction: Total hip arthroplasty has been increasingly used as a means of treating the various pathologies of this joint. However, this surgical reconstruction initially brings important deficits in subjects submitted, such as: inhibition of muscle strength, limitation of range of motion and functional deficit. Therefore, an immediate physiotherapeutic treatment is necessary in the short and long term, taking into account both biomechanical issues and the quality of life of these individuals.

Objective: To evaluate the clinical evolution of individuals submitted to total hip arthroplasty in the ten year period.

Method: Twenty individuals submitted to unilateral total hip arthroplasty will be evaluated by the medical group of hip surgeries of the Brotherhood of Santa Casa de Misericórdia of São Paulo, during a period of ten years. These individuals will undergo a primary clinical evaluation and after signing the consent form, will be evaluated functionally with the HARRIS HIP SCORE and WHOQOL-bref questionnaires and physically with the analysis of muscular strength through manual dynamometry to measure the strength level of the Muscles involved in the bilateral coxo-femoral joint, such as abductors, adductors, flexors, extensors, internal rotators, external rotators, knee joint, such as extensors and flexors, and ankle, plantar flexors. Finally, they will be referred to the kinematic gait analysis, to identify the functional characteristics of these individuals, through reflexive markers at specific anatomical points, where they will walk for 5 minutes on a treadmill at a speed of 1.5km per hour.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria in the study will be: patients submitted to total hip arthroplasty between 2 years (24 months - 35 months), 5 years (60 months - 71 months) and 10 years (120 months - 131 months), age between 50 and 80 years and sign the terms of free and informed consent

Exclusion Criteria:

* The exclusion criteria will be: patients with a history of prosthesis dislocations or revision of the arthroplasty, pain in the hip or lower limb region, asymmetry of the lower limbs greater than 2 centimeters, previous surgeries in the lower limbs, limitation of range of motion in the joint (Impossible to perform muscle strength tests), use of antidepressive drugs or analgesics of continuous use, chronic diseases not controlled (Hypertension, rheumatoid arthritis and diabetes) and the presence of neuromuscular pathologies
Does Hydroxyzine Decrease Anxiety in Underweight Patients Diagnosed With an Eating Disorder

The purpose of this study is to determine the effectiveness of hydroxyzine in the treatment of meal-related anxiety in adolescents and young adults 8 to 25 years of age diagnosed with an eating disorder who are underweight. The investigators want to find out if hydroxyzine given before meals will improve meal-related anxiety compared to no hydroxyzine.

This study is a practiced-based pilot study in follow-up to clinical observations made by our treatment team that hydroxyzine attenuates meal-related anxiety and improves treatment adherence in patients with a diagnosis of Anorexia Nervosa (AN) (excluding the amenorrhea criterion) or Eating Disorder Not Otherwise Specified (EDNOS) specifically with low BMI (≤ 18). To our knowledge, hydroxyzine has never been formally investigated in treating meal-related anxiety and improving outcomes in patients with AN or EDNOS specifically with low BMI (≤ 18).

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the Intensive Structured Living Unit (ISL) at Melrose Institute for treatment of an eating disorder that meets DSM-IV criteria for Anorexia Nervosa (excluding the amenorrhea criterion), or Eating Disorder Not Otherwise Specified, specifically with BMI (≤ 18)
* Age 8-25 years old at admission to ISL.
* Weight ≥ 15 kg at admission to ISL.
* Stable psychotropic and/or sedative medications for at least (≥) 6 weeks

Exclusion Criteria:

* Age \< 8 years
* Age ≥ 25 years
* Weight \< 15 kg at admission to ISL
* Prolonged QT interval on ECG at admission to ISL
* Current substance or alcohol abuse or dependence
* Malabsorption syndrome or inability to take oral medications
* History of hydroxyzine intolerance or hypersensitivity
* History of Type 1 Diabetes Mellitus
* History of angle closure glaucoma
* Currently on another clinical trial
* Pregnancy
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy

The purpose of this study is to increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualized intensification of the 6MP-dosage days 30-85.

20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.

The specific and primary objectives of the randomised study is:

To increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85. We will additionally measure EFS and toxicity as secondary end points of effect.

Eligibility Criteria:
Inclusion Criteria:

* Childhood ALL
* All mandatory biological data are available6
* Written informed consent has been obtained

Exclusion Criteria:

* Mixed lineage ALL
* Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
* ALL predisposition syndromes
* Previous cancer
* Off protocol administration of additional chemotherapy during induction therapy
* Sexually active females not using contraception
* TPMT-deficiency
A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia

The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein (LDL-C) levels compared with placebo in participants with dyslipidemia. The effect of AZD0780 versus placebo on other lipid parameters and inflammatory markers is also investigated. The concentration of AZD0780 in blood at specific timepoints is measured, and the safety and tolerability of AZD0780 will be evaluated. There is a follow-up after end of treatment, but expanded access is not available. The primary hypothesis is that at least one of the investigated doses of AZD0780 is superior to placebo in lowering LDL-C level, in percent change from baseline up to week 12.


Eligibility Criteria:
Inclusion Criteria:

* Males, and females of non-childbearing potential 18 to 75 years of age, inclusive, at the time of signing the informed consent.
* Participants with a fasting low-density lipoprotein cholesterol (LDL-C) higher than or equal to 70 mg/dL (1.8 mmol/L) and lower than 190 mg/dL (4.9 mmol/L) at screening.
* Participants with fasting triglycerides lower than 400 mg/dL (lower than 4.52 mmol/L) at screening.
* Should be receiving moderate or high-intensity statin therapy for more than or equal to 2 months prior to screening.
* There should be no planned medication or dose change during study participation.
* Body mass index at or above 19.0 kg/m\^2.

Exclusion Criteria:

* History or presence of gastrointestinal, hepatic or renal disease or any other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any uncontrolled or serious disease, or any medical (e.g., known major active infection or major hematological, renal, metabolic, gastrointestinal, respiratory, or endocrine dysfunction) or surgical condition that, in the opinion of the investigator, may either interfere with participation in the clinical study and/or put the participant at significant risk.
* Poorly controlled type 2 diabetes mellitus, defined as hemoglobin A1c (HbA1c) greater than 10 percent at screening.
* Acute ischemic cardiovascular event in the last 12 months.
* Heart failure with New York Heart Association (NYHA) Class III-IV.
* Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or Stage 1 prostate carcinoma) within the last 10 years.
* Recipient of any major organ transplant, e.g., lung, liver, heart, bone marrow, renal.
* LDL or plasma apheresis within 12 months prior to randomization.
* Uncontrolled hypertension.
* Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG as judged by the investigator.
Mind Programme for Women With Breast Cancer

The Mind programme for cancer patients was developed by this project PI through the integration of ACT, mindfulness and CFT components specifically adapted to the needs of a cancer population. This intervention aims at improving well-being, preventing subsequent distress, and promoting adaptation to the disease and posttreatment period. A recent pilot study presented preliminary findings on this intervention, suggesting high acceptability and efficacy in improving self-reported psychological health in breast cancer patients undergoing Radiotherapy treatment. Nevertheless, this study's small sample size, methodology (inactive control group), and exclusive reliance on self-reported data limit the interpretation and generalization of results, creating an avenue for the optimization and further testing of the programme through more robust and reliable methods. The aim of this project is therefore to optimize the Mind programme taking into consideration the results from its pilot study and to conduct a Randomized Controlled Trial on the efficacy of the intervention in improving not only mental health outcomes but also biological markers, as well as on its cost-effectiveness, in women with breast cancer. The superiority of the Mind programme will be compared to a support group intervention through the analysis of changes in cancer-specific quality of life, depressive symptoms and anxiety severity, psychological experiences, and immunological and epigenetics markers related to mental health and breast cancer prognosis. All participants will receive the intervention that shows better results.


Eligibility Criteria:
Inclusion Criteria:

1. age between 18-70;
2. primary diagnosis of BC (stages between I and III);
3. undergoing radiotherapy treatment at CHUC;
4. able to understand and answer to self-report questionnaires in Portuguese.

Exclusion Criteria:

1. currently undergoing any form of psychological intervention;
2. current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation;
3. diagnosis of neurological disease.
Reconstruction of a Neurocutaneous Defect of the Proximal Phalanx With a Heterodigital Arterialized Nerve Pedicle Flap

Complex digital injuries involving soft tissue loss and digital nerve defect pose challenging problems for hand surgeons. This study uses the heterodigital arterialized nerve pedicle flap including the dorsal branch of the digital nerve for reconstructing a digital neurocutaneous defect of the proximal phalanx.


Eligibility Criteria:
Inclusion Criteria:

* a neurocutaneous defect at the proximal phalanx
* a soft tissue defect on the volar, dorsal, and contiguous lateral aspects of adjacent fingers .associated digital nerve defect.

Exclusion Criteria:

* an injury involving the course of the arterial or venous pedicle; an injury involving donor site or donor nerve
* a soft tissue defect on the noncontiguous lateral aspects of adjacent fingers
* a nerve injury that is able to be repaired by primary neurorrhaphy
Study of Health Behavior in Patients After Heart Valve Replacement： Longitudinal Studies

To investigates the influencing factors and the pathways of health behavior in patients after heart valve replacement.

Currently, the prevalence of heart valve disease is 2.0% to 13.2%, and heart valve replacement is the most important treatment to address heart valve disease. Heart valve replacement surgery is highly traumatic and risky, and the recovery of physiological, psychological, and social functions of postoperative patients is challenging, affecting the recovery process of patients. Healthy behavior is a lifestyle that can effectively reduce risk factors for adverse events and complications at the physiological, psychological, and social levels to slow disease progression, which can help promote patient recovery and improve prognosis. Therefore, this study investigates and analyzes the health behaviors of postoperative patients in different periods, explores their influencing factors and analyzes their pathways of action.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. VHD diagnosed by echocardiography;
3. Received HVR treatment;
4. able to communicate normally.

Exclusion Criteria:

1. Those with a conscious disorder or mental illness;
2. Those with severe organic diseases or comorbidities;
3. Those with cardiac function class IV;
4. Those who could not complete the questionnaire correctly independently or under the guidance of the researcher.
Observational Study of Meloxicam in Mexican Patients With Rheumatic Diseases

Observational study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with rheumatic diseases


Eligibility Criteria:
Inclusion Criteria:

* Age of 12 or older and rheumatologic disease

Exclusion Criteria:

* Hypersensitivity to meloxicam
* Hypersensitivity to other Non-steroidal anti-inflammatory drugs (NSAIDS)
* History of asthma, angioedema or urticaria secondary to NSAIDS
* Pregnancy or lactation
* Recent or current history of peptic ulcer disease, severe renal failure and severe hepatic failure
Assessment of VMCore Biopsy Versus Standard of Care Biopsy

Prostate biopsy is the definitive test to establish the diagnosis of prostate cancer. The standard of care biopsy needles do not predictably obtain full cores of tissue and what tissue obtained is often fragmented, making pathologic review a challenge. The VMCore Biopsy System has a geometry in the tip of its biopsy needles that capture more tissue in a single sample. This study is to compare the characteristics of tissue captured by either standard of care needles and the VMCore needle.

This post-market study is being conducted in order to assess the capability of the VMCore biopsy needle to capture prostate tissue in subjects consenting to the use of both the VMCore needle and the urological practice's standard of care needle for twinned samples during a routine prostate biopsy procedure. The primary endpoints are to success in tissue core sampling, safety of the sampling, and subject's tolerance to the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Scheduled for a prostate biopsy
* Able and willing to provide verbal assessment of his condition 5 days post-procedure

Exclusion Criteria:

* Unable or unwilling to provide consent
Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures

The purpose of this study is to examine the effectiveness of a novel patient education strategy, compared to a standard diabetic foot education. The proposed diabetic foot care education uses personal computer-animated plantar pressure data to educate patients on why and how they should care for their feet.

Using block randomization, subjects with diabetes were assigned to either the standard or the enhanced education group. The effectiveness of enhanced education was evaluated as measured by foot care behavior score, patient's interpretation of neuropathy scores, and the incidence of diabetic foot complications over a course of 1-year.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 21 and 75 years (inclusive)
* Documented type 1 or type 2 diabetes mellitus
* Demonstrates peripheral neuropathy (defined as vibration perception threshold (VPT) ≥ 25 volts at the hallux, as quantified by a BioThesiometer, or unable to perceive a 10 gram Semmes-Weinstein monofilament in one four sites on the feet)
* Able to walk independently without the use of walking aids (cane, crutches, or walker)
* Able to speak and understand English
* Able to understand the information in the informed consent form and willing and able to sign the consent form

Exclusion Criteria:

* Amputation of either foot proximal to midfoot
* Presence of cutaneous ulceration in the lower extremity
* History of or active Charcot neuroarthropathy of either foot
* Severe peripheral vascular disease (ie. ischemic rest pain, 2-block claudication or gangrene)
* End stage kidney disease requiring hemodialysis, stroke, or widespread malignant disease
* Pregnant or nursing
* Life expectancy \< 12 months
* Not willing or able to make the required follow-up visits
* Insufficient (corrected) vision to complete the questionnaires
Establishment and Preliminary Evaluation of Digital Three Level Linkage Whole Process Diabetes Management System

This study used Nan'an District of Chongqing, China as a pilot project to improve the comprehensive compliance rate of diabetic patients in China, and reduce the physical and economic harm caused by complications.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 2 diabetes.
2. Aged 18-70;
3. HbA1c ≥ 8.0%

Exclusion Criteria:

1. Pregnancy;
2. Chronic kidney disease (CKD stage 5);
3. Senile dementia patients;
4. With malignant tumor;
5. Moderate and severe anemia;
6. Severe liver dysfunction;
7. Hemolytic anemia, aplastic anemia, massive blood loss or transfusion, chronic malaria;
8. In the recent one week, large doses of salicylate, erythropoietin, antiretroviral drugs, ribavirin and other drugs that have an impact on the detection of glycosylated hemoglobin were used
Five-Year Observation of Remicade Treatment for Plaque Psoriasis in Austria (Study P04900)

Prospective, open-label-, 1-arm, multicenter observational study to determine the dose and interval of Infliximab infusions for subjects with plaque psoriasis.

This study population was chosen from a non-probability sample.

Eligibility Criteria:
Inclusion Criteria:

* According to the European Summary of Product Characteristics (SPC): Adult subjects with moderate-to-severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapy including cyclosporine, methotrexate, or Psoralen-ultraviolet-A light (PUVA).

Exclusion Criteria:

* According to the European SPC:

  * Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
  * Subjects with moderate-to-severe heart failure (New York Heart Association (NYHA) class III/IV).
  * Subjects with a history of hypersensitivity to Infliximab or to other murine proteins or to any of the excipients.
  * Subjects with elevated liver enzymes (\>5 upper limit of normal (ULN)).