cyrilzakka/clinical-trials huggingface dataset:
Trial of PXD101 (Belinostat) in Combination With Idarubicin to Treat AML Not Suitable for Standard Intensive Therapy

An open-label, non-randomized, multi-centre, Phase I/II trial to assess the efficacy and safety of 2 schedules of PXD101 in combination with idarubicin in patients with AML not suitable for standard intensive therapy.

This trial is an open-label, multi-centre, dose-escalation Phase I/II study to evaluate safety, explore efficacy, pharmacodynamics, and pharmacokinetics of the combination of PXD101 with idarubicin administered in two different schedules in patients with AML. The PXD101 plus idarubicin treatment will be repeated at suitable intervals (target is every 3 weeks for schedule A and every 2 weeks for schedule B) depending upon toxicities or disease progression. Safety and efficacy assessments will be performed at every cycle.

Schedule A uses PXD101 by 30 min infusion daily for 5 days every 3 weeks with escalating doses of idarubicin.

Schedule B uses escalating doses of continuous infusion (48h) of PXD101 alone or in combination with idarubicin.

In both regimens the trial may be expanded at the Maximum Tolerated Dose (MTD).

Eligibility Criteria:
Inclusion Criteria: (abbreviated)

1. Signed consent
2. AML patients:

   1. above 60 years in first relapse or refractory.
   2. 18-60 years 2nd relapse or refractory to at least two intensive chemotherapy regimens.
   3. above 60 years with high risk features (cytogenetics, secondary or treatment related AML) d) above 60 years with myelodysplastic syndrome with \>10% blasts in bone marrow (WHO RAEB-2 (Refractory anemia with excess blasts-2)). For patients below 60 years potential curative treatments should have been exhausted.
3. Performance status (ECOG) ≤ 2
4. Age ≥ 18 years
5. Acceptable liver, renal and bone marrow function as defined
6. Serum potassium within normal range.
7. Acceptable coagulation status as defined
8. Precautions for female patients with reproductive potential as defined

Exclusion Criteria:

1. Treatment with investigational agents within the last 4 weeks
2. Prior treatment with HDAC (Histone deacetylases) inhibitors including valproic acid
3. Prior anti-leukemic therapy (except hydroxyurea) within the last 3 weeks of trial dosing
4. Co-existing active infection (including HIV) or any co-existing medical condition likely to interfere with trial procedures, including significant cardiovascular disease
5. Altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures.
6. Concurrent second malignancy.
7. History of hypersensitivity to idarubicin
8. Cumulative idarubicin dose exceeding 100 mg/m², or a (with respect cardiotoxicity) corresponding dose of other anthracyclines
9. LVEF (left ventricular ejection fraction) below normal range (\< 45% )
10. Known Central Nervous System (CNS) leukemia
Combined Effects of Early Behavioral Intervention and Propranolol on ASD

The purpose of this study is to explore the effects of propranolol in combination with early intensive behavioral intervention on social interaction, and secondarily on language, anxiety, adaptive behaviors, and global function in children with autism in a double-blinded, placebo-controlled pilot trial.

The investigators' specific aim is to examine the effects of serial doses of propranolol in combination with early intensive behavioral intervention on social interaction, and secondarily on language tasks, anxiety, adaptive behaviors, and global function in children with autism in a double-blinded, placebo-controlled trial. The investigators will also examine whether response to treatment can be predicted based upon markers of autonomic functioning, such as pupillary light reflex and heart rate variability, and whether anxiety predicts treatment response. The investigators' hypothesis is that propranolol will augment the effects of behavioral therapy on social functioning and language abilities. The investigators have demonstrated benefits of propranolol on social functioning and language in previous single-dose studies in adults and adolescents with autism. The investigators also predict that those with the greatest degree of autonomic dysregulation will demonstrate the greatest benefit from the drug.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism spectrum disorder (ASD), defined in this study by the DSM-V criteria plus Autism Diagnostic Observation Schedule (ADOS) criteria for Autism.
* Aged 3-8
* Participants must also be enrolled in an early behavioral intervention program at the Thompson Center or another institution in Missouri for the duration of the study.

Exclusion Criteria:

* Non-autism learning disability (e.g. dyslexia)
* Major psychiatric diagnosis (e.g. major depression, schizophrenia, bipolar disorder)
* Other neurological diagnosis
* Major head trauma
* Any of the following exclusionary criteria related to propranolol (diabetes, reactive airway/pulmonary disease, thyroid disease, bradyarrhythmias, unexplained syncope, narrow angle glaucoma, known hypersensitivity/adverse reaction to beta-blockers, potentially interacting drugs, underweight \< 15 kg)
* Any of the following exclusionary criteria related to the use of electrocardiogram (history of rash from adhesives)
* Any of the following exclusionary criteria related to the pupillary reflex measurement (uncorrectable visual acuity impairment).
* Participants with a heart rate of less than 60 or a systolic blood pressure of less than 75 at the outset of the study will be excluded.
A PK/PD Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression

The overall goal of this investigator-initiated trial is to evaluate the impact of platform algorithm products designed to rapidly identify pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation on treatment outcome of depression in adolescents. This new technology may have the potential to optimize treatment selection by improving response, minimizing unfavorable adverse events / side effects and increasing treatment adherence

Treatment seeking adolescent patients with a moderate to severe major depressive episode defined as a 40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R) will be invited to participate in this study evaluating the GeneSight® platform. This new technology can rapidly assess PK and PD genetic variation that can potentially impact antidepressant, anti-psychotic, and stimulant treatment selection. These patients will have GeneSight® testing and will be randomized to one of two groups. In Group 1 (n=138), GeneSight® testing results will be available to the patient's treating clinician prior to treatment selection. In Group 2 (n=138), testing results will not be available to the patient's research treating clinician. However, all testing results will be made available to all participants and clinicians after the 8-week trial (upon completion of blinded assessments at week 8). The patients and the clinical raters will be blinded to group assignment.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-18, male or female, any race/ethnicity
* Treating clinician, patient, and family feel that pharmacotherapy is indicated as part of a comprehensive treatment plan.
* Major depressive episode diagnosis or bipolar disorder based on KSADS-PL semi-structured psychiatric interview with a severity criteria-40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R)
* Ability to provide informed consent

Exclusion Criteria:

* Inability to speak English
* Inability or lack of willingness to provide informed consent and assent.
* Axis I diagnoses: Autism Spectrum Disorder, Anorexia Nervosa, Schizophreniform, and Schizophrenia.
* Psychotropic medication change (including dosage) between screening \& randomization visits.
* Patients who meet DSM 5 criteria for any significant current substance use disorder other than nicotine, caffeine, or cannabis. Must have at least early, partial or full, remission X 3 months
* Serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator.
* Significant unstable medical condition.
* Anticipated inability to attend scheduled study visits.
* Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol.
* Cytochrome (CYP) \& serotonin transporter genomic testing within 5 years.
CAR - γ δ T Cells in the Treatment of Relapsed and Refractory CD7 Positive T Cell-derived Malignant Tumors

This is a study on the clinical application of chimeric antigen receptor modified γδ T cells (CAR - γδ T cells) in relapsed and refractory CD7 Positive T cell-derived malignant tumors.The main purpose of this study was to evaluate the efficacy of car - γ δ T cell infusion in patients with relapsed and refractory CD7 Positive T cell-derived malignancies.

γδT cells are known as "a great candidate for car-t cells". Although they only account for 2% - 5% of all T cells in our body, they are a natural killer.

CD7 is recognized as a sensitive marker of T-ALL, and its expression level on T-ALL cells is opposite to CD3: compared with normal T cells, the expression level of CD7 on T-ALL cells is significantly increased (P \< 0.001), while the expression level of CD3 on T-ALL cells is significantly decreased (P \< 0.001). At the same time, CD7 expression is absent in about 10% of normal T cells, and these CD7 negative T cells have the ability of normal T cells to express cytokines. Therefore, CD7 has become a potential target for the treatment of T-ALL because of its specificity and safety.

Eligibility Criteria:
Inclusion Criteria:

1. the patients must be patients with relapsed or refractory CD7 Positive T cell-derived malignancies, who have at least one course of standard regimen chemotherapy and one course of salvage regimen chemotherapy and have poor effect;
2. Researchers believe that there is no other feasible and effective alternative treatment, such as hematopoietic stem cell transplantation;
3. Patients should have indicators for detection or evaluation of disease, including detection of minimal residual disease (MRD) by immunophenotyping, cytogenetics or PCR;
4. They are 14-70 years old, regardless of gender or race;
5. Physical condition: ECoG score 0-2;
6. Cardiac function: left ventricular ejection fraction greater than or equal to 40%;
7. The expected survival time was \> 12 weeks;
8. Serum creatinine (CR) ≤ 1.5 × ULN (upper limit of normal value), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN;
9. Patients have self-knowledge ability and can sign informed consent;
10. The guardian of the child patient agreed to sign the informed consent.

Exclusion Criteria:

1. pregnant or lactating women;
2. Uncontrolled infection;
3. Active HBV or HCV infection;
4. People living with HIV;
5. Less than 100 days after allogeneic hematopoietic stem cell transplantation;
6. Patients with acute GVHD or chronic GVHD after allogeneic hematopoietic transplantation;
7. Patients receiving GVHD treatment.
Understanding and Treating Heart Failure With Preserved Ejection Fraction: Novel Mechanisms, Diagnostics and Potential Therapeutics

The objectives of this study are: 1) to design new diagnostic criteria used to accurately define heart failure with preserved ejection fraction (HFpEF); 2) to better define the risk factors associated with HFpEF; 3) to elucidate the clinical, cellular and molecular mechanisms involved with the development and progression of HFpEF; 4) to design and test new therapeutic strategies for patients with HFpEF.


Eligibility Criteria:
Inclusion Criteria:

* Group 1 No clinically overt heart failure
* Group 2 Known coronary artery disease
* Group 3 Known heart failure with preserved ejection fraction
* Group 4 Known heart failure with reduced ejection fraction
* Group 5 Healthy age-matched controls

Exclusion Criteria:

* Age \<18 years
* Known malignancy with expected survival \<1 year
* Pregnant or recent pregnancy \<6 months
* Recent event (\<2 weeks since Acute Coronary Syndrome, Heart failure or other admission
* Severe mitral or aortic stenosis
Surface Refractive Index Shift and Lens Absorption/Adsorption of Tear Components of Kalifilcon A Lenses vs Dailies Total1 and Precision1

Approximately 10 habitual soft contact lens wearing participants will be enrolled in this bilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, participants will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.


Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years or older and have full legal capacity to volunteer.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.
A Study of RO5285119 in Healthy Volunteers

This two-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each subject.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male adults, 18 to 45 years of age (Part 1) or healthy male or female adults, 18 to 65 years of age (Part 2)
* Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive
* Female subjects must be surgically sterile or postmenopausal
* Male subjects must use a barrier method of contraception for the duration of the study and for the three months after the last dosing

Exclusion Criteria:

* History or presence of any significant disease or disorder
* Positive for hepatitis B. hepatitis C or HIV infection
* History of drug or alcohol abuse or suspicion of regular consumption of drugs of abuse
* Participation in an investigational drug or device study within 3 months prior to first dosing
* Donation of blood within 3 months prior to first dosing
* Regular smoker (\>5 cigarettes, \>3 pipe-fulls, \>3 cigars per day)
* History of hypersensitivity or allergic reactions
* Part 2: Contraindications for MRI scans
DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension

This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed the Treatment Period of clinical trial DAR-311
* Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic

Exclusion Criteria:

* Subjects who discontinued treatment with study drug prior to the end of the Treatment Period of DAR-311 due to a study drug-related adverse event (AE)
* Treatment with another endothelin receptor antagonist within 6 months of study entry
Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients

The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to \<11 years.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria:

* Confirmed HIV-1 infection diagnosed by protocol criteria
* Screening HIV RNA level ≥1000 copies/mL
* ≥3 months to \<11 years of age at time of first treatment
* Antiretroviral-naive or -experienced
* At screening, all participants must have genotypic sensitivity to atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which must be approved for pediatric use at the local country.
* Antiretroviral-experienced patients must also have documented phenotypic sensitivity at screening to atazanavir (Fold Change in susceptibility \<2.2) and to at least 2 NRTIs that are approved in their country

Key Exclusion Criteria:

* Experienced participants who received atazanavir or atazanavir/ritonavir at any time prior to study enrollment or who have a history of 2 or more protease inhibitor failures
* Antiretroviral-naïve or -experienced HIV-1-infected patients with contraindication to study medications
* Cardiac rhythm abnormalities
* Need for tenofovir
* Weight \<5 or ≥35kg
* \>Grade 2 abnormality in aspartate transaminase/alanine transaminase levels
* Coinfection with either hepatitis B or C virus
* Any active Centers for Disease Control and Prevention Category C clinical condition
Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure

The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence.

The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence. We hypothesized that performing internal sphincterotomy in a point midway between the standard lateral position and the posterior midline position would confer better healing and relief of symptoms with less incidence of fecal incontinence while avoiding the development of keyhole deformity.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both genders with chronic posterior anal fissure were included to the study.

Exclusion Criteria:

* Patients with anterior or lateral anal fissure,
* patients with previous anal surgery,
* patients with concomitant anorectal pathology,
* patients with secondary anal fissure due to Crohn's disease or other specific etiology,
* patients with any degree of fecal incontinence,
* patients with active anorectal sepsis.
Neuropsychoanalytic Treatment of Failed Back Surgery Syndrome-Opioid Dependence

Opioid Dependent Patients who have failed back surgery syndrome are detoxified and treated with a neuropsychoanalytic paradigm.

Patients were detoxified from opioid analgesics and treated with NSAIDs and other non-opioid analgesics, received neuropsychoanalytic therapy and low dose naltrexone. Patients kept a daily diary of: 0 - 10 pain, 0 - 10 function, hours worked, amount of alcohol drunk, illicit and licit drug use, number of health care provider appointments attended, number of self-help groups meetings attended across each of the six months of study. Six month outcomes of this approach with primary outcomes being sobriety, pain scores and function scores.

Eligibility Criteria:
Inclusion Criteria:

1. Have failed back surgery syndrome.
2. Have evidence of Opioid Dependence by meeting DSM-IV criteria and by Drug Abuse Screening Test \> 4. (In case of a difference in these two measures, clinical staff will talk with the patient to adjudicate the difference.)
3. Over 18
4. Be able to understand spoken and written English
5. Reside within 30 miles of the site of treatment for ease of followup
6. Have health insurance or other ability to pay for treatment

Exclusion Criteria:

1. Homeless
2. Unable to give consent (e.g. neurological disorders, dementia, psychosis)
3. Co-occurring incapacitating psychiatric disorder such as schizophrenia
4. Pregnant
5. Financial incentive to stay ill, such as a pending disability claim
6. Member of a vulnerable population, including prisoners
COVID-19 and Acute Invasive Fungal Rhinosinusitis

Data for acute invasive rhinosinusitis was obtained from the Otorhinolaryngology departments at our tertiary hospital at the period from January 2017 to December 2020. Then the risk factors of comorbid diseases and fungal types between post-Covid-19 and non-Covid-19 groups regarding the incidence of invasive rhinosinusitis are compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients of any age and sex. invasive rhinosinusoitis diagnosis based on clinical , endoscopic diagnosis
* Positive findings for acute sinusitis on sinus computed tomography (CT) scan in addition to fungal determination by histopathological examination of specimen of affected tissues for detection of the type of fungi.
* Positive PCR was confirmed from the patient's files at the isolation hospitals for COVID 19 group.

Exclusion Criteria:

* Patients who completed management outside our hospital
Laryngeal Mask in Morbid Obesity

Investigators study the performance of both masks, Proseal Laryngeal Mask Airway (PLMA) and I-gel, as temporary ventilatory supraglottic airway devices (SGDs) before tracheal intubation in morbidly obese patients. Data are lacking in such population of patients

The available data regarding SGDs in morbidly obese patients have focused mainly on PLMA. In general, SGDs have been successfully used as temporary ventilatory devices before laryngoscope-guided tracheal intubation, conduits for endotracheal tube insertion, and primary airway devices during surgery. Second-generation SGDs are preferred for both rescue airway and routine use, compared with first-generation, non-gastric access devices. Data on comparison PLMA vs. I-gel in morbidly obese patient are lacking.

The PLMA is a second generation gastric access SGD. PLMA is composed of an airway tube that connects to a mask which, after insertion through the patient's mouth and inflation of cuff, forms an airtight seal on top the glottis allowing a secure airway to be managed by a health care provider. PLMA can be autoclaved and reused many times. I-gel is a new type of single use, second generation, gastric access SGD and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure, it exactly adapts to the supraglottic tissue by binding with body temperature, thus minimising air leakage.

The aim of this study is to compare PLMA and I-gel regarding insertion success rate, the time of insertion, gastric access tube positioning, oropharyngeal leak pressure, assessment of position by fiberoptic, ventilatory parameters and hemodynamic, and complications for each device placed before tracheal intubation in morbidly obese patients.

This study is conducted at University Medical Hospital of Padova, with approval from Hospital research Ethical Committee and written informed consents from patients,. Patients are randomly allocated into 2 equal groups, according to the inclusion and exclusion criteria.

PLMA (n=35) in which PLMA is used for ventilation. I-gel (n=35) in which I-gel is used for ventilation.

I

Eligibility Criteria:
Inclusion Criteria:

* morbidly obese patients scheduled for elective bariatric surgery under general anesthesia

Exclusion Criteria:

* nonfasting; symptoms or endoscopic evidence of gastroesophageal reflux, of gastric ulcer, or oropharyngeal pathology; known or predicted difficult airway; allergy to anesthetic and nonsteroidal antiinflammatory drugs; or inability to provide informed consent.