cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute myeloid leukemia.

OBJECTIVES:

* Determine the complete remission rate in patients with acute myelogenous leukemia treated with induction chemotherapy comprising mitoxantrone hydrochloride, cytarabine, and etoposide.
* Determine the feasibility and toxicity of this regimen when given to patients with newly diagnosed acute myelogenous leukemia.

OUTLINE: Patients receive induction chemotherapy comprising mitoxantrone hydrochloride IV on days 1-3, cytarabine IV continuously over 72 hours on days 1-3 and 8-10, and etoposide IV continuously over 72 hours on days 8-10. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 4 and continuing until blood counts recover.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia

  * Previously untreated disease

    * Previous hydroxyurea and/or corticosteroids are acceptable
* No preexisting history of a hematologic disorder

  * Myelodysplastic features allowed
* No acute leukemia secondary to previous therapy
* No leukemic meningitis

PATIENT CHARACTERISTICS:

* Bilirubin \< 2.0 mg/dL (unless felt to be increased because of hepatic infiltration with leukemia)
* Creatinine \< 2.0 mg/dL
* Pregnant or lactating patients are ineligible
* Fertile patients must use effective contraception
* No history of or active congestive heart failure

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
GOALIE: Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent RHD Trial

The goal of this clinical trial is to determine if twice daily oral penicillin prophylaxis is non-inferior to monthly IM penicillin prophylaxis in preventing latent Rheumatic Heart Disease Progression in children between the ages of 5-17 years. The main objective is to compare the proportion of children aged 5-17 years with latent RHD receiving oral penicillin prophylaxis who progress to worse valvular disease at 2-years compared to children who receive IM penicillin prophylaxis.

GOALIS is a randomized controlled trial developed to provide high quality contemporary evidence on the efficacy of oral penicillin as RHD prophylaxis.

Aim 1: To compare the proportion of children aged 5-17 years with latent RHD receiving oral penicillin prophylaxis who progress to worse valvular disease at 2-years compared to children who receive IM penicillin prophylaxis.

Aim 2: To evaluate the economic equivalence and cost-effectiveness of oral penicillin compared to IM penicillin, after echocardiographic screening for latent RHD detection.

Aim 3: Compare patient-reported outcomes (treatment acceptance, treatment satisfaction, and health-related quality of life) between children receiving oral and IM penicillin prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* Has a new diagnosis of latent RHD detected through primary or secondary school echocardiographic screening.
* Has agreed to participate in the study via the study's informed consent/assent process.

Operational Definition of Latent RHD Borderline RHD or Mild Definite RHD (to include no more than mild regurgitation at the mitral or aortic valve, normal mean mitral and aortic valve gradients, normal bi-ventricular function) according to the 2012 WHF consensus criteria.

Exclusion Criteria:

* Known history of ARF or RHD
* Newly diagnosed RHD by echo screening considered to be "missed clinical RHD" as compared to true latent RHD including: \> mild pathological valvular regurgitation at the mitral valve or aortic valve, mitral stenosis (mean MV gradient ≥ 4mmHg) (definite B61), aortic stenosis (mean AV gradient ≥ 20mmHg)
* Structural or functional cardiac defects, other than those consistent with RHD, that were known prior to or detected through echo screening (except patent foramen ovale, small atrial septal defect, small ventricular septal defect, small patent ductus arteriosus)
* Self-report of prior allergic reaction to penicillin
* Any known conditions predisposing to thrombocytopenia or hypercoagulability, or other contraindications to intramuscular injection
* Any known co-morbid conditions (ex. HIV, renal deficiencies, severe malnutrition) that have resulted in prescription of regular antibiotic prophylaxis)
Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers

The aim of this study was to identify and validate novel biomarkers for predict acute kidney injury (AKI) subphenotype, major adverse kidney events and other poor outcomes.

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a serious condition that is associated with increased mortality and morbidity. However, the current criteria for assessing the severity of AKI may not adequately capture the heterogeneity of this condition. This can lead to difficulties in identifying treatment effects in specific patient subgroups, which may contribute to the growing number of negative interventional trials in AKI. To address this issue, researchers have developed and validated two subphenotypes of AKI: resolving and nonresolving. These subphenotypes are based on the trajectory of serum creatinine (SCr) levels in the first 3 days after hospital presentation. By stratifying AKI patients based on these subphenotypes, we can better assess their risk and predict outcomes.

Several novel biomarkers have been developed to aid in the early detection of AKI, discrimination of its underlying causes, and prediction of outcomes. However, it remains unclear whether these biomarkers can accurately predict the development of a nonresolving AKI subphenotype. In our present study, we aim to address this gap in knowledge by conducting a large cohort study. Our goal is to identify and validate novel biomarkers that can effectively detect the resolving subphenotype of AKI, as well as predict major adverse kidney events and other poor outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery who experienced AKI within 48 hours of cardiac surgery were screened.

Exclusion Criteria:

* History of End Stage Renal Disease or on Dialysis;
* prior kidney transplantation;
* patients with a DNR order;
* patients without written informed consent;
* pregnancy;
* moribund patients with expected death within 24 h or whose survival to 28 days was unlikely due to an uncontrollable comorbidity (i.e., end-stage liver or heart disease, untreatable malignancy)
Camrelizumab Utilization on Patients With Advanced Liver Cancer

To observe and evaluate the safety and efficacy of camrelizumab in advanced liver cancer

camrelizumab ， a humanized monoclonal antibody against PD-1, has been shown to block the binding of PD-1 to PD-L1, thereby inhibiting the immune escape of tumor cells. It has a high affinity for PD-1 (KD = 3.31 nmol/L), a high acceptor proportion (85% at 200 mg) of circulating T lymphocytes, and binds to epitopes different from Nivolumab and pembrolizumab，Phase 1 clinical trials have shown that camrelizumab is well tolerated and has antitumor activity in patients with advanced solid tumors.camrelizumab has been approved for indication for advanced hepatocellular carcinoma The main objective of this study was to observe and evaluate the safety and efficacy of treatment regiments containing Camrelizumab in advanced liver cancer。 The subjects included people over 18 years old， For men and women with advanced liver cancer confirmed by histopathology or cytology;

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more;
* For both men and women;
* Patients with advanced liver cancer confirmed by histopathology or cytology; .Volunteer to join the study, sign the informed consent, good compliance, and cooperate with the follow-up.

Exclusion Criteria:

* A known allergy to the study drug or any of its excipients; Or had a severe allergic reaction to other monoclonal antibodies;
* Patients who are ready for or have previously received an organ or allogeneic bone marrow transplant;
* Pregnant or lactating women;
* According to the judgment of the researcher, the patients should not be included in this study
TENS Effect on Gait and QoL in Stroke.

A study was conducted to investigate the additional effect of TENS applied to acupuncture points to the physical therapy program on gait and quality of life in stroke patients.

Thirty stroke patients from both sexes aging from 40 to 65 years were randomly assigned into two equal groups: study group and control group. The study group received TENS plus the designed physiotherapy program and the control group received only the same designed physiotherapy program. The outcome measures concerned with spasticity, gait and QoL.

A RCT study conducted to investigate the additional effect of TENS applied to acupuncture points to the physical therapy program on gait and quality of life in stroke patients. The study was conducted at the outpatient clinic of Faculty of Physical Therapy, Cairo University and Kasr El-Ainy Hospitals, Faculty of Medicine, Cairo University, Egypt.

Forty subjects were screened for eligibility but only thirty stroke patients from both sexes aging from 40 to 65 years who were included and randomly assigned into two equal groups: study and control group. The study group received TENS plus the designed physiotherapy program and the control group received only the same designed physiotherapy program. Patients were treated three times weekly for four weeks.

The outcome measures included the Modified Ashworth Scale (MAS) for assessing spasticity, the WHOQOL-BREF scale for evaluating QoL and the Biodex Gait Trainer for measuring the gait kinematics. Evaluation of all variables took place pretreatment and post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic stroke disease (6-8- months)
* Age 45-60 years old
* Mild to moderate spasticity
* Can walk 10 meters independently
* Sufficient cognitive abilities

Exclusion Criteria:

* Other neurological diseases
* Severe spasticity
* Cognitive impairments
* Medical instability
* Sever arthritis or contractures
* Cardio-pulmonary disorders
Comparison of Three Liraglutide Formulations in Healthy Volunteers

This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments.
* Body Mass Index (BMI) of 18-27 kg/m\^2, both inclusive

Exclusion Criteria:

* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal,
* metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders
* that may interfere with the objectives of the study, as judged by the investigator
* Family or personal history of Primary hyperparathyroidism or pheochromocytoma or thyroid malignancy or multiple endocrine neoplasia
* Impaired renal function
* Uncontrolled treated/untreated hypertension
* Any clinically significant abnormal ECG
* Active hepatitis B and/or active hepatitis C
* Positive HIV (human immunideficiency virus) antibodies
* Known or suspected allergy to trial product(s) or related products
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
* Prescription or non-prescription medication, except for paracetamol and vitamins
* History of alcoholism or drug abuse during the last 12 months
* Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
Buprenorphine Maintenance for Cocaine Abusing Opioid Addicts - 1

The purpose of this study is to compare the clinical efficacy of maintenance on low and high doses of buprenorphine with methadone for cocaine abusing opiate addicts.


Eligibility Criteria:
Please contact site for information.
myHealthHub for Older Adult Inpatients

This study will assess "myHealthhub" in hospitalized older adults throughout 5 days of their hospital stay. The investigators propose a mixed method randomized controlled trial (RCT) comparing myHealthHub platform vs. a simplified HealthHub system that provides only TV access, in order to evaluate patients' loneliness, stress, quality of life, patient engagement, and other mental health outcomes in n=60 older adult inpatients. The investigators will also use qualitative methods to assess user and stakeholder experience, and engagement.


Eligibility Criteria:
Quantitative Component:

Inclusion Criteria:

* ≥60 years old
* Admitted to non-surgical hospital unit
* Speak English or French
* Capable of giving consent

Exclusion Criteria:

* Delirium
* Active suicidal ideation
* Moderate/severe dementia diagnosis

Qualitative Component:

Inclusion Criteria:

* Participants from quantitative component
* Hospital staff, nurses, clinicians facilitative use of the service
* ≥18 years old
* Speak English or French

Exclusion Criteria:

• Hospital staff, nurses, clinicians who do not have experience with the service
The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Study

This study is a pilot study to assess the effectiveness of erector spinae (ESP) nerve blocks for postoperative pain control following bariatric surgery. Currently, there are mainly case series/pilot studies describing the use of ESP nerve blocks for postoperative pain control in abdominal procedures; of these only one uses this treatment modality for bariatric procedures. The population undergoing bariatric surgery poses specific challenges to postoperative pain management. They often have comorbid obstructive sleep apnea, which puts them at greater risk for ventilatory depression when treated with parenteral opioids. This risk can be reduced with regional techniques. The ESP nerve blocks provide visceral and somatic pain coverage as opposed to the more commonplace transversus abdominis plane nerve block which only provides somatic coverage. This means that the ESP nerve blocks will cover incisional pain as well as the discomfort associated with the pain from the procedure itself. This study intends to build on current knowledge by proving that the use of ESP in the post-operative are providing a significant reduction in pain scores as well as reducing the need for parenteral opioids. Thus, decreasing the risk of postoperative ventilatory complications.

In preparation for this study, three pilot studies were reviewed. The studies assessed the usefulness of ESP nerve blocks on patients undergoing abdominal surgery. Single-shot bilateral ESP blocks were performed in the first two studies. One of the studies, patients undergoing ventral hernia repair and the other for patients undergoing bariatric surgery. The third pilot study used bilateral ESP blocks followed by a continuous infusion on one patient undergoing an open prostatectomy with bladder reconstruction. All the ESP blocks were placed preoperatively at the T7 transverse process. In the studies using a single shot technique 20-30 ml of ropivacaine 0.5% was used. For the continuous ESP catheter an initial bolus of bupivacaine 0.25% 10 mls followed by continuous infusion rate of 6 ml/hr bilaterally. All showed a significant reduction numerical rating scale (NRS) as a primary outcome. The secondary outcome of reduced 24-hour parenteral opioid consumption was also achieved by all three studies.


Eligibility Criteria:
Inclusion Criteria:

* Age range 21 - 70.
* ASA II: A patient with mild systemic disease-ASA III: A patient with severe systemic disease
* Patients included are those immediately postoperative from bariatric surgery who have an NSR pain score \>5

Exclusion Criteria:

* Patients excluded are those who are ASA IV or greater, refuse nerve block intervention,
* Diagnosis of any coagulopathy disorder,
* Allergy to local anesthetics,
* Have active infection over proposed injection sites.
* Patients with ASA \>III was excluded due to overall health concerns of poorly controlled chronic disease.
A Study of Caregiver Connections Via Technology in Dementia

This research is being done to develop a unique matching process for caregivers of persons living with dementia, such as Alzheimer's disease, Lewy body dementia, frontotemporal degeneration, or other dementia syndromes. Dementia caregivers often assume greater caregiving burden than do non-dementia caregivers, and the caregiving duration tends to be longer. Many caregivers do not have the adequate support they need. Peer-to-peer support has been shown to improve quality of life, more engagement with services, improve caregiver health, and reduce hospitalizations in the person they are caring for. This study will help determine whether caregivers of persons with dementia would find a technology-based caregiver matching program valuable for the purpose of emotional support.


Eligibility Criteria:
Inclusion Criteria:

* The participant must have a family member that has been diagnosed with one of the following forms of dementia: Parkinson's/Lewy body dementia, any frontotemporal lobar degeneration dementia, or Alzheimer's dementia.
* The participant must identify as a care partner or caregiver who has contact with their loved one with dementia, in person or by phone, and provides social/emotional support and full or partial assistance with daily activities at least 3 days per week.
* The participant must have been caring for their loved one with dementia for at least 3 months.
* All participants must have access to a computer and be able to use the internet.
* All participants must be English speaking.
* All participants must agree to participate in the 15-month study, which includes completing questionnaires, brief "virtual" interactions with the study coordinator quarterly, and actively interacting with the website and potential matches.
* All participants must agree to follow-up contact throughout the duration of the study, which is anticipated to last 3 years.

Exclusion Criteria:

* Caregiver's loved one does not have a confirmed diagnosis of dementia.
* Caregiver is unable to provide consent.
* Caregiver was or has been in that role for less than 3 months.
Study About Treatment of Newly Diagnosed Non Cutaneous Peripheral T Cell Lymphoma

This is a multicenter randomized trial evaluating induction treatment with VIP-reinforced-ABVD (VIP-rABVD) versus CHOP/21 in patients with newly diagnosed peripheral T cell lymphoma.

Induction therapy:

ARM 1: 6 Chemotherapy courses = 3 VIP alternated with 3 ABVD ARM 2: 8 Chemotherapy courses = CHOP every 21 days

Consolidation therapy:

For all patients if CR = radiotherapy 40GY / 5X1,8 GY per week

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed untreated PTCL
* age 18 and 70 years
* performance status ≤ 2
* Ann Arbor stage I to IV
* normal cardiac ventricular ejection fraction over 50%
* normal hepatic function (asat, ALAT, PAL \< 2.5 ULN)

Exclusion Criteria:

* cutaneous form of PTCL
* previous treatment
* age \< 18 and \> 70
* performance status \> 2
* abnormal cardiac or hepatic functions
* HIV-, HCV- or HBV- positivity
Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis

CONTEXT AND OBJECTIVE: Osteoarthritis causes pain and disability in a high percentage of elderly people. The aim of the present study was to compare the analgesic effect of intra-articular bupivacaine and morphine in patients with knee osteoarthritis.

DESIGN AND SETTING: A randomized and double-blind study was performed at a Pain Clinic of São Paulo Federal University.

METHODS: Thirty-nine patients with pain for more than 3 months and an intensity higher than 3 on a numerical scale (zero to 10) were included. G1 patients received 1 mg (1 ml) morphine diluted in 9 ml saline by the intra-articular route, and G2 patients received 25 mg (10 ml) 0.25% bupivacaine without epinephrine. Pain was assessed on a numerical scale and knee flexion and extension angles were measured after administration of the drugs at rest and during movement. The total amount of analgesic complementation with 500 mg paracetamol was also determined.

Among the 39 patients selected, two patients from group 1 and five from group 2 were excluded from some of the analyses because they did not return on the day of assessment or because they used a complementary analgesic different from that standardized in the study

Eligibility Criteria:
Inclusion Criteria:

* Older than 50 years with a radiological confirmation of chronic knee osteoarthritis
* Pain lasting for more than 3 months either at rest or under strain, morning stiffness
* Absence of heat at the site
* Crepitation during movement and a pain score ranging from three to ten.

Exclusion Criteria:

* Patients with coagulopathy
* Infection or malignant disease
* Patients who underwent knee or hip surgery; AND
* Patients using opioids 24 hours prior to the study
Wearable Assisted Viral Evidence (WAVE) Study A Decentralized, Prospective Study Exploring the Relationship Between Passively-collected Data From Wearable Activity Devices and Respiratory Viral Infections

The goal of this decentralized, observational study is to enroll and observe adults in the contingent United States during the 2023-2024 flu season. The main study objectives are to create a dataset of paired wearable data, self-reported symptoms, and respiratory viral infection (RVI) from PCR testing during the 2023-2024 flu season and to develop algorithm that is able to accurately classify asymptomatic and symptomatic RVI and understand the algorithm's performance metrics.


Eligibility Criteria:
Inclusion Criteria:

* Lives in the United States
* Speaks, reads, and understands English
* Currently owns and uses a consumer wearable device (Apple Watch, Garmin, or Fitbit) with necessary step and heart rate data at minimum or willing to wear a study-provided device and download the Fitbit app
* Willing to connect their wearable device to the Evidation platform and wear it daily for at least 10 hours for the duration of the study
* Owns a smartphone with Apple iOS 15 installed or higher OR Android version 9.0 installed or higher or willing to update
* Willing to respond to daily and weekly questionnaires for a 10-week period
* Willing to complete at-home nasal swab tests and return the nasal swab samples within 24 hours of being asked to complete it
* Meets data density requirements for wearable devices

Exclusion Criteria:

* Self reported diagnosis of both flu and COVID by a healthcare professional or using an at-home test in the past 3 months
* Currently enrolled in another interventional study to prevent or treat COVID-19 or another flu-related program being conducted by Evidation (individuals currently participating in Evidation's FluSmart program will be told that their participation will be paused)
* Has a primary mailing address that is a P.O box, Army Post Office (APO), Fleet Post Office (FPO), or Diplomatic Post Office (DPO) address, or U.S. military base located overseas, or U.S. territories (Puerto Rico, U.S. Virgin Islands, Guam, Northern Mariana Island, or American Samoa)