cyrilzakka/clinical-trials huggingface dataset:
CMA-676 in Treating Patients With Acute Myeloid Leukemia in First Relapse

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating patients with acute myeloid leukemia in first relapse.

OBJECTIVES: I. Assess the efficacy of CMA-676 in terms of the number of patients with acute myeloid leukemia attaining a complete remission. II. Assess the safety of CMA-676 in this patient population.

OUTLINE: This is an open label, single arm, multicenter study. Patients receive CMA-676 IV over 2 hours on day 1. Patients may receive 1 additional dose of therapy 15 to 28 days later. Patients who achieve complete or morphologic remission are followed for an additional 6 months and every 3-6 months thereafter until relapse and/or death.

PROJECTED ACCRUAL: 55 evaluable patients will be accrued. Enrollment will then be extended for up to an additional 55 patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically diagnosed CD33 positive acute myeloid leukemia (AML) in first relapse At least 6 months of complete remission No CNS leukemia No AML secondary to exposure to chemotherapy or toxins

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC less than 30,000/mm3 at time of CMA-676 administration Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No severe cardiac disease Pulmonary: No severe pulmonary disease Other: Not pregnant or nursing Fertile patients must use an effective method of contraception Not known to be HIV positive No prior myelodysplastic syndrome No other active malignancy No uncontrolled infections Able to obtain bone marrow aspirate

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation No prior anti-CD33 antibody therapy Chemotherapy: No prior chemotherapy for AML in first relapse except hydroxyurea At least 24 hours since prior hydroxyurea Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 4 weeks since prior investigational agents
Psychological, Neurological and Immunological Changes Following a Meeting With a Chaplain Coupled With Biblical Readings

The aim of the "HEALING" " (Hospital-based Ecumenical And Linguistic Immuno-NeuroloGic) Study was to examine immunological and neurological changes in hospitalized participants after meeting a chaplain and Biblical listenings, in order to evaluate whether these meetings affect the course of the disease.

The authors pre-screened hospitalized participants to find those who were the most in need of an intervention by a chaplain. A passage from the Bible was read to the participants during a meeting with the chaplain at the bedside, or in the chapel of the hospital. No meeting occurred in the randomized control group, which was compiled in a way to get a group of participants with an approximatively similar pattern of diagnoses and treatment days than the intervention groups. The pace of enrollment was deliberately slow in order to assure the authenticity of the visits ("slow science"). Blood samples were taken 30 minutes prior, and 60 minutes after the meeting to measure White Blood Cell (WBC)-, lymphocyte counts, interferon gamma (IFN-γ)-, immunoglobulin M (IgM)-, immunoglobulin A (IgA)-, immunoglobulin G (IgG)-, and complement C3 levels. A subgroup of the visited participants was subjected to functional Magnetic Resonance Imaging (fMRI), where they were played an audiotape of readings of the same passage from the Bible. Associative tests, paired-samples t-test, network analysis was performed to search for any correlation between psychological and immunological parameters, completed with Statistical Parametric Mapping to search for correlations of the above with neurological parameters.

Eligibility Criteria:
Inclusion Criteria:

* adult age (\>18 years)
* the condition of being hospitalized
* the ability for verbal communication
* alertness, orientation
* no sign of psychosis in their medical history
* willingness to participate in the study after written, informed consent

Exclusion Criteria:

* the inability to communicate verbally
* psychotic state, altered mental state
* unwillingness to participate
* active and treated malignant disease
* steroid, NSAID or metamizole- sodium use
Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty

Early neonatal cheiloplasty is modified surgery protocol applied in the first week of newborn's life used for treating orofacial cleft patients. This prospective study analyzes the effects of early neonatal cheiloplasty on the growth and development of maxilla and palate during the observed period of one year.

Multidisciplinary treatment of patients with orofacial clefts begins immediately after birth. The first surgical procedure is early neonatal cheiloplasty applied in the first week of the newborn's life, which has been practiced in the Czech Republic for many years. It is a popular parental choice and has a lot of benefits compared to classic cheiloplasty performed between 3-6 months. Unrestricted growth of jaws is essential for the successful therapy of aesthetics and functions. Although there are known a lot of benefits to this surgery, its influence on facial growth is still being studied.

The methodology of this study is based on modern three-dimensional imaging methods and will be evaluated by classic and geometric morphometric analysis of virtual dental models. The existing database includes 137 virtual dental casts (complete and incomplete bilateral or unilateral cleft lip and palate).

The main aim is to verify that the effects of early neonatal cheiloplasty on the facial or palatal growth are minimal in affected individuals and therefore the subsequent development of these structures can be predicted at a later age. Other goals are to evaluate palatal morphology before and one year after early neonatal cheiloplasty, to assess growth of maxilla and palate using classic and geometric morphometry, to assess morphological differences between cleft types and to compare the results with previously published data of neonates operated by later operation protocol and noncleft control groups.

Eligibility Criteria:
Inclusion Criteria:

* Nonsyndromic orofacial cleft
* Czech origin
* Operated by the same surgeon
* Following same surgery protocol (modified Veau surgery protocol)
* Excellent body temperature, blood pressure, oxygen saturation, heart function
* Performing of early neonatal cheiloplasty

Exclusion Criteria:

* Poor health
* Syndromic orofacial cleft
* Operated by later operation protocol (3-6 months)
* Non-Czech origin
Assessment of Knowledge, Attitude and Practice of Eligible Couples Regarding Eugenics

A Descriptive study to assess the knowledge, attitude and practice regarding eugenics among eligible couples of selected area of Ambala, Haryana, India. Eligible couples were the married couples where wife is in the age group of 15-45 years planning for conception, have conceived and may or may not have any living child.Eugenics are to methods that are adopted by eligible couples for having physically and psychologically healthy conception and pregnancy.

To assess the knowledge, attitude and practice the structured knowledge questionnaire, attitude 5-point likert scale and expressed checklist tool were prepared. A sample size of 318 was calculated by power analysis and eligible couples were selected by Purposive sampling technique from rural and urban area of Ambala Haryana, India.

Each eligible couples (separately husband and wife) data was collected through Self- Report technique.one time assessment only done.

Eligibility Criteria:
Inclusion Criteria:

* who were present at the time of data collection
* who were willing to participate in the study
* who can read and write English/Hindi

Exclusion Criteria:

* who have more than 2 children
* who had undergone permanent sterilization
Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children

Visual cognitive deficits in children are frequent, with an impact on working and daily activities. Optometric therapy may improve those functions, however few studies have been performed.

We aim to evaluate the efficacy of such therapy by a comparative study between two groups of children aged between 5 and 12 after 6 months of rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* visual cognitive deficits
* normal intelligence

Exclusion Criteria:

* cerebral palsy
* mental deficiency
* visual acuity deficit
Pilot Trial: the Safety and Feasibility of Losartan for Pulmonary Vein Stenosis

This pilot study evaluates the safety and feasibility of losartan in pediatric patients with pulmonary vein stenosis.

It is an open label single arm interventional study. The patient population involves pediatric patients with stenosis in 2 or more pulmonary veins. Patients will be given losartan for 1 year. Outcomes include measures of safety/adverse events and progression of pulmonary vein stenosis.

This pilot study evaluates the safety and feasibility of losartan in pediatric patients with pulmonary vein stenosis.

Large animal studies have demonstrated that losartan can ameliorate the progression of pulmonary vein stenosis in a surgical model of pulmonary vein stenosis.

There is no safety data for losartan in children \< 6months of age or in children with pulmonary vein stenosis. Therefore, this study will test the safety and feasibility of losartan in children in an open label single arm interventional study.

Patient inclusion criteria includes stenosis involving 2 or more pulmonary veins. Patients who are consented into the trial with be on losartan therapy for one year. They will undergo study visits every 3 months. Patients will be screened for adverse events through biochemical tests, routine clinical tests and questionnaires.

An exploratory efficacy analysis will compare progression of pulmonary vein stenosis in children enrolled in losartan to a contemporary cohort of children with pulmonary vein stenosis, who did not receive losartan.

Eligibility Criteria:
Inclusion Criteria:

* Stenosis involving 2 or more pulmonary veins
* Consent of parent/legal guardian or child(when appropriate)

Exclusion Criteria:

* History of angioedema or allergic reaction to angiotensin converting enzyme inhibitors
* corrected gestational age of less than 40 weeks
* severe renal dysfunction
* pregnancy
Macrophage Activation Markers in COVID-19 Patients

This study is aiming to find the relation between the severity of COVID-19 in diabetic and obese patients and the high serum levels of matrix metalloproteinase-7 (MMP-7),matrix metalloproteinase-9 (MMP-9), TGF-β and PDGF Macrophage Activation Markers

Acute respiratory distress syndrome (ARDS) commonly occurs in COVID-19 patients who are diabetic and obese, ARDS is characterized by inflammation and pulmonary fibrosis mediated by cytokines and biomarkers released from activated alveolar macrophages, also cytokine storm may occurs leading to multiple organ failure. These sequelae of COVID-19 disease in obese and diabetic patients are attributed to elevated plasma lipopolysaccharide which is the main activator of M1 and M2 macrophages. chronic activation of macrophages leads to production of profibrotic markers as transforming growth factor-β (TGF-β), platelet-derived growth factor (PDGF), matrix metalloproteinase-7 (MMP7) and matrix metalloproteinase-9 (MMP9) which promote fibrogenesis. In this research, we measure circulatory alveolar macrophage activation markers in COVID-19 obese patients with type 1 and type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Overweight patients with body mass index higher than 25 and obese patients with body mass index higher than 30 were selected to be included
* Type one and type two diabetes mellitus patients were also included

Exclusion Criteria:

-
MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics

The purpose of this study is to evaluate noninvasive hemodynamics with MultiPoint™ Pacing (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in patients receiving cardiac resynchronization therapy (CRT).


Eligibility Criteria:
Inclusion Criteria:

* Be scheduled to undergo de novo implant of a St. Jude Medical CRT-D system
* Be in NYHA II or III functional class with approved standard indication by ESC/EHRA Guidelines
* Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule

Exclusion Criteria:

* Have persistent or permanent atrial fibrillation
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 12 months
* Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months prior to enrollment
* Have had intravenous inotropic support in the last 30 days
* Be scheduled or considered for heart transplantation over the next 12 months
* Be less than 18 years of age
* Be pregnant or plan to become pregnant over the next 12 months
Comparison of Three Methods of Anesthesia to Achieve a Nerve Block Anesthesia.

Evaluation of three methods for the realization of a neuronal blockade.

Evaluation of three methods during the realization of a neuronal blockade. The three stimulations were: 1) echography, 2) echography and neurostimulation, and 3) echography, neurostimulation, and active mobilization by the patient.

Eligibility Criteria:
Inclusion Criteria:

* 216 consecutive adult patients scheduled for an elective hand surgery

Exclusion Criteria:

* Patient refusal
Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus

This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).


Eligibility Criteria:
Inclusion Criteria:

* Eligible male and female subjects, aged 18 years or older
* Must have at least moderately active SLE, as defined as SLE Disease Activity Index-2000 (SLEDAI-2K) score greater than or equal to \[\>=\] 6 at screening visit
* At least 4 of the 11 American college of rheumatology (ACR) classification criteria for SLE (diagnosed \>= 6 months prior to the screening visit)
* Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibodies
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Subjects have demyelinating disorder
* Severe central nervous system SLE
* Use of cyclophosphamide within 3 months of the screening visit
* Urine protein:creatinine ratio (UPCr) \>= 2 milligram per milligram (mg/mg) per day
* Other protocol defined exclusion criteria could apply
A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil

This study will be a single-center, open-label, drug-drug interaction study in healthy male and female subjects. The study will consist of 3 parts: A, B, and C. In Part A, the effect of itraconazole or rifampin on the pharmacokinetics (PK) of E2609 and metabolites will be assessed. Approximately 32 subjects will be assigned to 1 of 2 treatment groups (itraconazole or rifampin) in equal numbers, with approximately 16 subjects per group. In Part B, the effects of steady-state dosing of E2609 on the PK of digoxin will be assessed in approximately 18 subjects. In Part C, the effects of donepezil administered in combination with, or 2 hours after, E2609 dosing on the PK of E2609 and metabolites, will be assessed in approximately 24 subjects.


Eligibility Criteria:
Inclusion Criteria

1. Healthy male or female subjects aged 18-55 years inclusive at the time of informed consent
2. Provide written informed consent
3. Willing and able to comply with all aspects of the protocol

Exclusion Criteria

1. Any history of seizures or epilepsy (not including a history of simple febrile seizures in childhood) or disturbance of consciousness likely to be due to seizures
2. A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by the mean of triplicate electrocardiograms (ECGs), recorded at least 1 min apart, at Screening or Baseline Periods
3. Evidence of clinically significant disease (eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system) that in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments or subjects who have a congenital abnormality in metabolism within 4 weeks before dosing.
4. Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment
5. Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing
Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

The purpose of this study is to determine if replacing melatonin function with a melatonin agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia) helps to alleviate self-reported sleep disruption.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older, male or female veterans of any racial or ethnic group
* Neurologically complete (Frankel A or B) damage to the lower (C4-C8) cervical spinal cord
* Absence of melatonin production
* Time since SCI is greater than 6 months \[no cases of acute spinal cord injury\]
* Subjective complaint of sleep disruption

Exclusion Criteria:

* Current use of fluvoxamine (Luvox , antidepressant), rifampin (antimycobacterial), ketoconazole (Nizoral , antifungal), or fluconazole (Diflucan , antifungal) \[these interact with the same liver enzyme that is the primary metabolizer of ramelteon\]; use of sleep medications is okay
* Hepatic dysfunction
* Concomitant use of over-the-counter melatonin
* Pregnancy or breast feeding
* Currently or have within the past six months met DSM-IV (Diagnosis and Statistical Manual IV) criteria for drug or alcohol abuse or dependence or AUDIT score \>19
* Acute illness or unstable chronic illness. Use of continuous positive airway pressure (CPAP) for treatment of sleep apnea is acceptable.
* No travel across three or more time zones within three weeks or during the protocol
* Illiterate or unable to read or write English or are judged by the investigator to be unable or unlikely to follow the study protocol
A Korean Cohort Study of TDF Rescue Therapy for Difficult-to-treat CHB Patients: a Comparison Between TDF Monotherapy and TDF-based Combination Therapy

Antiviral resistance remains an important issue for long-term NA therapy. For lamivudine (LAM), the rtM204V/I and rtL180M mutations occur in more than 70% after 5 years of therapy. In Korea, primarily owing to limited subsidization policy in the health insurance system, many patients with LMV-resistance had been treated with either rescue ADV or ETV 1.0 mg monotherapy, ultimately leading to the higher prevalence of MDR strain. For those patients, rescue therapies of combining ADV with either ETV or LAM had been tried, but frequently with suboptimal responses. Rescue TDF monotherapy or TDF-based combination therapy are available in Korea for patients who had "difficult-to-treat" antiviral resistance owing to prior treatment failures. However, which is the better has not been evaluated yet. A long-term efficacy and safety of TDF-based rescue therapies in real practice for those patients should be necessary to revise the Korean guideline for the treatment of chronic hepatitis B in near future.


Eligibility Criteria:
Inclusion Criteria:

* more than 20 years old adults
* chronic hepatitis B
* the patients treated by tenofovir alone or tenofovir based combination therapy because of the previous treatment failure
* the patients who agree and singed on the consent form

Exclusion Criteria:

* co-infected patients with HCV, HDV or HIV
* pregnancy or breast feeding woman or female patients who are planning to be pregnant
* past history with hepatocellular carcinoma
* combined with other liver disease including wilson, alcoholic, NASH, alpha-1 antitrypsin deficiency liver disease.
* patients with hypersensitivity for drugs
* patients who were enrolled in other clinical study within 60 days
* patients who were eligible for the clinical study according to the investor
"Atriogenic Tricuspid Selected, Omics Profile, Multimodality Imaging and Clinical Outcomes"

The aim of our study is to investigate the molecular mechanisms underlying remodeling of the tricuspid valve apparatus in patients with ITF and isolated AF, in comparison with patients with ITF from right ventricular remodeling, patients with atriogenic MI and left ventricular remodeling. To achieve these aims, markers obtained from cardiovascular imaging methods, such as 3D echocardiogram, and biomarkers isolated from the peripheral blood of the study participants will be considered.

Advances in echocardiography and, in particular, the development of three-dimensional echocardiography have allowed a more accurate analysis of the morphology of the tricuspid valve and a detailed understanding of the mechanisms underlying its insufficiency. From a clinical point of view, ITF is divided into a primary form, less frequent (8-10%), caused by primary alterations of the tricuspid valve apparatus, acquired or congenital, and in a "functional" form, the most frequent, conventionally associated in most cases with coexisting pathologies of the left heart or primitive pathologies of the right heart. More recently, long-lasting persistent atrial fibrillation (AF) has been associated with the development of ITF in the presence of structurally normal valve leaflets, preserved right ventricular size and function, and right atrial dilatation. This form of ITF, defined as "atrial functional", could benefit from a different therapeutic management compared to the classic form, more commonly caused by right ventricular dilatation and dysfunction ("ventricular functional" IT). However, not all patients with AF and tricuspid annulus dilatation develop valvular insufficiency and, on the other hand, with the same valvular annulus dilatation and right atrial size, the prevalence of severe IT forms is extremely variable.

This could depend on different adaptive mechanisms implemented by the valve leaflet tissue that lead to their growth or not in response to atrial remodeling and valve annulus dilatation, representing a key factor in the development and progression of the disease. Atriogenic ITF. If confirmed, these observations could lead to a better prognostic classification and different therapeutic perspectives for patients with AF at risk of developing forms of severe ITF and congestive heart failure.

Eligibility Criteria:
Inclusion Criteria:

- Admitted to the Department of cardiological, neurological and metabolic sciences of the San Luca hospital with a diagnosis of persistent atrial fibrillation

Exclusion Criteria:

* Patient aged \<18 years;
* Pregnancy;
* Chronic inflammatory diseases;
* Autoimmune diseases;
* Tumor diseases;
* Chronic renal failure with eGFR \< 30 mL/min;