cyrilzakka/clinical-trials huggingface dataset:
Epacadostat, Cladribine and Cytarabine (ECC) in AML

This trial assess the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the cladribine/cytarabine chemotherapy in relapsed / refractory AML patients fit for intensive treatment

Background and Rationale:

Epacadostat (INCB024360) is an Inhibitor of Indoleamine 2,3- dioxygenase 1 (IDO1). Indoleamine 2,3- dioxygenase 1 (IDO1) is a 403 amino acid cytosolic haem enzyme encoded by the INDO gene on human chromosome 8p22. IDO1 is responsible for the catabolism of the essential amino acid tryptophan (trp) to kynurenine (kyn) within immune cells and a subset of tumor cells resulting in inhibition of antitumor cell-mediated immune responses. Increased IDO activity correlates with lower CR rates and shorter OS in AML.

Objective:

The primary objective is to determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the cladribine/cytarabine chemotherapy in relapsed / refractory AML patients fit for intensive treatment

Study Duration:

Phase I part will last from 3 to 18 months (permitting the enrolment of minimum of 3 and a maximum of 24 patients).

Eligibility Criteria:
Inclusion Criteria:

* Relapsed/refractory AML (according to the 2016 World Health Organization (WHO) classification definition of ≥ 20% blasts; Arber et al, 2016) after at least one line of treatment and suitable for intensive treatment (including stem cell transplantation) without severe concurrent infections.
* Patients must be aged \> 18 years, and must have given voluntary written informed consent.
* Women of childbearing potential having a negative serum pregnancy test at screening or at least within 48 hours before start with epacadostat, and willing to use an effective contraceptive method (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) during the study and for at least 6 months after the last study drug administration
* Men willing to use an effective contraceptive method (eg, condom, vasectomy) during the study and for at least 6 months after the last study drug administration.

Exclusion Criteria:

* Prior or concurrent malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the subject has been disease-free for more than 6 months.
* APL (acute promyelocytic leukemia) or AML type M3, are excluded from the trial
* Treatment with any investigational product within 4 weeks before the first administration of epacadostat (INCB024360)
* Abnormal organ function if not caused by the underlying disease as considered by the treating physician
* Use of immune-suppressive agents for the past 4 weeks before the first administration of epacadostat (INCB024360). For regular use of systemic corticosteroids, subjects may only be included after stepwise discontinuation to be free of steroids for a minimum of 5 days before the first administration of epacadostat (INCB024360)
Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.

The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.

Esomeprazole (NEXIUM™) is indicated for the maintenance of healing of endoscopy-verified erosive esophagitis (EE) in children 1 to 11 years of age in a number of countries worldwide, but not in the United States (US). The current study has been designed, in discussions with the Food and Drug Administration (FDA), to further evaluate the safety and efficacy of NEXIUM given as maintenance of healing of EE in children 1 to 11 years of age

Safety assessments will include the monitoring of adverse events throughout the study, clinical laboratory testing (including hematology, clinical chemistry, urinalysis), vital signs (including blood pressure and pulse), and physical examination including weight.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be 1 to 11 years of age
2. Patients must have a clinical history of GERD for at least 3 months before the start of study
3. For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase.
4. For the maintenance phase: Patients must have completed the healing phase and have endoscopy-verified healed EE at the 8-week endoscopy visit.
5. Patients must weigh ≥ 10 kg.
6. Patients may be male or female.
7. All postmenarcheal female patients must have a negative pregnancy test (urine) before starting treatment.
8. Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of study intervention.
9. Patient's guardian must be capable of giving signed informed consent

Exclusion Criteria:

1. Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar
2. Significant clinical illness within 4 weeks prior to the start of treatment
3. Any conditions that are predicted to require a surgery during the study period (from the day of informed consent to the day of the last scheduled visit)
4. Previous total gastrectomy
5. Anticipated need for concomitant therapy with PPIs (except for the IMPs), H2-receptor antagonists and other drugs outlined in EC#5 after enrollment in this study
6. Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment.
7. Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product
8. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
9. Judgment by the Investigator that the patient should not participate in the study if the patient or guardian is unlikely to comply with study procedures, restrictions, and requirements
10. Previous screening, or enrollment and randomization in the present study
Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia

The purpose of this study is to explore changes in efficacy, cognitive functioning, and safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies
* Would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry
* Are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by all of the following:
* Positive and Negative Syndrome Scale (PANSS) Total Score of ≥ 80
* Score of ≥ 4 on two or more of the following PANSS items at screening: hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness
* Clinical Global Impression - Severity of Illness Scale (CGI-S) score ≥ 4 (moderately ill)

Exclusion Criteria:

* Are presenting with a first episode of schizophrenia based on the clinical judgment of the investigator
* Have been hospitalized \> 21 days for the current acute episode at the time of the baseline visit
* Have a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders; also borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders or mental retardation.
* Improvement of ≥ 20% in total PANSS score between the screening and baseline assessments.
Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma

The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC). The study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. The safety endpoint is complications and adverse effects.

The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the local recurrent rate.


Eligibility Criteria:
Inclusion Criteria:

* historically diagnosed advanced non-small lung cancer
* has surgery indication
* age 18 years old or greater
* life expectancy greater than 12 weeks
* ECOG: 0-2
* no prior chemotherapy, radiotherapy in 2 weeks
* Neutrophils≥1.5×10\^9/L,platelet≥80×10\^9/L, Hb≥≥80g/L,bilirubin≤1.5×2mg/dl, ALT and AST≤2×institutional upper limit of normal,Cr≤1.5×institutional upper limit of normal,coagulation tests(INR and PTT)within normal range
* subject provides signed informed consent

Exclusion Criteria:

* hypersensitive to study drug
* with a coagulational test unnormal or a bleeding disorder
* infections
* with serious condition which can't stand a surgery
* pregnant or lactating
* principle investigator consider not suitable
FIM-BR - First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent

This is a single center, non-randomized study. Patients will be treated with the sirolimus coated Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will have a repeat angiography at four months and will be followed for twelve months post-procedure.

This is a single center, non-randomized study of the Bx VELOCITY Balloon-Expandable Stent coated with sirolimus (140µg/cm2) and formulated for fast or slow release. The sirolimus coated stent is mounted on the Raptor OTW SDS. Approximately 30 patients with de novo or restenotic native coronary artery lesions \<=18mm in length and \>=3.0 to \>=3.5 mm in diameter by visual estimate who meet all eligibility criteria will be treated with the sirolimus coated Bx VELOCITY stent(s). Patients will be followed for five years post-procedure and will have a repeat angiography at 4 months, 12 months, 24 months, and 48 months.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS) or a positive ischemia study;
2. Single de novo or restenotic lesion requiring treatment in a major native coronary artery;
3. Target lesion is \<=18mm in length (visual estimate);
4. Target lesion is \>=3.0mm and \<=3.5mm in diameter (visual estimate);
5. Target lesion stenosis is \>50% and \<100% (visual estimate);

Exclusion Criteria:

1. A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
2. Unprotected left main coronary disease with \>=50% stenosis;
3. Have an ostial target lesion;
4. Angiographic evidence of thrombus within target lesion;
5. Calcified lesions which cannot be successfully predilated;
6. Ejection fraction \<=30%;
7. Target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch);
8. Totally occluded vessel;
Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

Hypertension (HTN) affects up to 75% of kidney transplant recipients and is associated with premature death. Nocturnal HTN is a common complication of ongoing essential HTN or a secondary cause of HTN. Both the non dipping of systolic blood pressure (SBP) at night time and the reverse dipping is associated with increased target organ damage and adverse cardiovascular outcomes and possibly allograft survival. Treatment of Nocturnal HTN is critical. Chronotherapy has been shown to be effective in halting progression in patients with diabetic nephropathy and chronic kidney disease. There is not enough data on prevalence and management of nocturnal HTN in transplant patients, which is the object of this study.


Eligibility Criteria:
Inclusion Criteria:

1. Renal transplant more than 1 year ago and not on dialysis.
2. Age between 18 years to 70 years.
3. Known history of HTN on one or more anti-hypertensive medication.
4. Stable anti-hypertensive regimen for past 2 months
5. One of the anti-hypertensive regimen must include an ACE inhibitor, or an angiotensin receptor blocker, calcium channel blocker, alpha or beta blocker.
6. Stable immunosuppressive regimen with no dose changes in past 3 months.
7. No hospitalizations for previous 2 months

Exclusion Criteria:

1. Inability to consent
2. History of falls
3. Presence of AVF or AVG in both the arms
4. Inability to follow up in renal transplant clinic.
5. History of Atrial fibrillation.
6. Pregnant Women
7. Parkinson's Disease
8. Severe orthostatic Hypotension
9. Severe autonomic dysfunction
10. History of other transplanted organs
Evaluation of Respiratory Mechanics in Supine and PARK-bench Positions (SPARK)

The primary objective of this prospective observational physiological study is to evaluate the variation in regional distribution of intrapulmonary volume in the dependent and non-dependent lung regions in patients undergoing neurosurgical intervention between supine and Park-Bench position.

The Park-Bench position is a variant of the lateral position used in neurosurgical interventions where lesions of the posterior cranial fossa and ponto-cerebellar angle need to be approached. The patient is placed in a lateral-oblique position with the arm on the side they are lying on extending out of the operating bed and supported by an external support. The head is fixed in flexion and rotation with the Mayfield headrest immobilizing the head, allowing exposure of the surgical region of interest.

In the lateral decubitus position, several factors contribute to changing respiratory mechanics: airway resistance increases and compliance decreases.

Furthermore, the gravitational gradient is altered, which is one of the main factors in the regional distribution of intrapulmonary air volume and tidal volume distribution: the phenomenon of overdistension of the non-dependent lung and collapse of the dependent lung could occur.

Fully understanding these physiological changes could optimize mechanical ventilation settings and thus avoid causing damage to lung parenchyma (Ventilator-Induced Lung Injury).

The primary hypothesis of this physiological study is to evaluate changes in regional distribution of intrapulmonary volume when transitioning from the supine position to the Park-Bench position.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Patients scheduled for elective neurosurgery in Park-Bench position.

Exclusion Criteria:

* Age \< 18
* BMI \> 30 kg/m2
* Obstructive or restrictive lung disease with oxygen supplementation
* Pacemaker
* Pregnancy
* Absence of history of pulmonary embolism, thoracic surgery or chest wall abnormalities, organ transplant, lung metastases
* New York Heart Association \>2 or hemodynamic instability (Mean Arterial Pressure\<60mHg)
Genetics and Shared Decision Making in Improving Care for Patients With Stage IVA-C Non-small Cell Lung Cancer

This trial studies the use of genetics and shared decision making in improving care for patients with stage IVA-C non-small cell lung cancer. Developing educational tools may help patients with non-small cell lung cancer to increase patient treatment knowledge, reduce decisional conflict, and promote treatment shared decision making with their health care providers.

PRIMARY OBJECTIVES:

I. Use the information on genomic tumor diagnostics, provider treatment recommendations, and patient and provider feedback on the treatment decision making process, which will be used to develop materials and methods to adapt an existing decision counseling program (DCP) for use with patients diagnosed with advanced non-small cell lung carcinoma (NSCLC) as a standard component of clinical care.

SECONDARY OBJECTIVES:

I. Pilot test the adapted DCP in a subset of patients to determine the feasibility of delivering the DCP session.

II. Assess DCP effects on patient treatment knowledge and decisional conflict. III. Assess treatment choice.

OUTLINE:

PHASE I: Use physician input to develop draft treatment education materials and use patient input to adapt an online decision counseling application for use in helping patients clarify treatment preference.

PHASE II: Patients complete a treatment decision counseling session/interview about genetic testing and supportive/palliative care with a qualified member of the research team in-person or via telephone. Health care providers receive a 1-page summary of session results for use in treatment shared decision making at the next office visit.

After completion of study, participants are followed up at 30 and 60 days.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with advanced NSCLC (stage IV a-c) that are wild-type for activating genetic alterations (EGFR, ROS 1, and ALK).
* May or may not be candidates for immune checkpoint therapy.
* May have had 1-any number of prior systemic therapy regimens.
* If prior systemic regimen, must have progression disease at time of evaluation.
* Untreated brain metastases permitted.
* Completed pathological analysis of tumor tissue.
* Patients who have exhausted targeting therapy options.
* Can speak and read English.
* All participants must be willing to comply with all study procedures and be available for the duration of the study.
* Providers: Those who treat NSCLC patients as described above.

Exclusion Criteria:

• There are no specific exclusions in this trial for particular medical conditions, comorbidities, or performance status. Any patient deemed appropriate to be considered for evaluation and/or treatment would be appropriate to include in this trial.
Comparison of Co2 Laser Versus Co2 Laser With PRP in Scars

Objective: To compare the effect of Fractional Carbon dioxide Laser (FCL) Vs Fractional Carbon dioxide Laser with platelet rich plasma (PRP) in management of Scars.

Study design: Randomized-controlled trial (RCT). Study setting and duration: Dermatology Department, CMH-Abbottabad, November 2022/April 2023.

Methodology: The sample size of 60 patients, age 18 to 50 years, was calculated by using Openepi app and the non-probability consecutive sampling technique was used. Patient in group A received FCL treatment's four sessions with four weeks apart, whereas Group B received four PRP and FCL sessions. The Quartile grading scale (score 0 is \<25%, score 1 is 25-50%, score 2 is 51-75% and score 3 is \>75% improvement) was used to assess the patient's clinical improvement at 4 weeks after each session. To determine statistical significance χ2-square test, taking p-value \<0.05 as significant, was used.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-50 years
* Fitzpatrick skin type III-V
* Presented with post-acne, post traumatic or post burn scars
* all those patients emotionally balanced with realistic expectations were included in the study.

Exclusion Criteria:

* scar that was less than 6 months old
* if they had an active infection or inflammatory skin condition
* having a history of malignancy
* a known connective tissue illness
* history of excessive bleeding or keloids
* unrealistic expectations
* pregnant or breastfeeding.
Eye and Growth in Adolescents Born Moderate-to-late Preterm

During recent years, the interest in studying the risks of being born moderate-to-late preterm (MLP), defined as birth between gestational week 32 to 36, has increased. Today the investigators know that morbidity and mortality are significantly higher in these individuals compared to individuals born full-term. However, few studies have focused on the development of the eye in MLP individuals. The purpose of the study is to evaluate eye morphology and visual function in relation to growth, metabolism, blood pressure, neuropsychiatric factors, and quality of life in adolescents born MLP. The results of the examinations will be compared to an age-matched control group. The study will evaluate the structural, functional, and metabolic aspects of the eye with the hypothesis that early eye abnormalities may detect the risk of developing metabolic and cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

* Born moderate-to-late preterm.
* Born in Gothenburg, Sweden.
* Born between years 2002 and 2004.

Exclusion Criteria:

* Chromosomal abnormalities.
* Syndromes.
* Severe malformations.
* Asphyxia.
* Language difficulties.
* Psychosocial problems at birth.
* Severe maternal illness.
Vitamin A Status in Patients With Vocal Fold Leukoplakia

This study will determine systemic vitamin A status and lesion histopathology of participants with vocal fold hyperkeratosis resulting in clinical leukoplakia.

The investigator's overarching goal is to determine if there is a pathophysiologic rationale for vitamin A supplementation in the treatment of vocal fold hyperkeratosis. Vocal fold hyperkeratosis is an accumulation of epithelial surface keratin resulting in clinical leukoplakia. It is primarily managed using destructive techniques that risk iatrogenic injury, fibrosis, and voice impairment. Given the potential morbidity of biopsy and lesion removal, there is a need for new approaches to the prevention and treatment of vocal fold leukoplakic disorders that are non-destructive. Vitamin A is a key regulator of epithelial health and systemic vitamin A deficiency could directly contribute to hyperkeratosis. Based on vitamin A's importance to vocal fold stellate and epithelial cell biology and its direct relevance to vocal fold hyperkeratosis, this study will assess vitamin A status in participants with vocal fold hyperkeratosis. An association would suggest further study on the effects of vitamin A optimization and/or supplementation in patients with leukoplakia, as well as an adjuvant therapy in participants for whom surgical treatment is indicated.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to provide informed consent.
2. Willing to comply with all study procedures and be available for the duration of the study.
3. Ability to take oral medication.
4. At least 18 years of age.
5. Leukoplakia study groups:

   1. Leukoplakia due to hyperkeratosis with dysplasia: biopsy-confirmed diagnosis of hyperkeratosis with dysplasia.
   2. Leukoplakia due to hyperkeratosis with no dysplasia: biopsy-confirmed diagnosis of hyperkeratosis with no dysplasia.
6. Control group: Laryngoscopy showing no evidence of vocal fold epithelial disease.

Exclusion Criteria:

1. History of malignant vocal fold epithelial pathology.
2. History of metabolic or liver disorder.
3. History of anorexia or bulimia.
4. Pregnant, lactating, or planning on becoming pregnant during the study period.
5. History of \>4.5 kg weight loss in the past 90 days.
6. Medical or other inability to complete an 8 hour fast.
7. Acute respiratory or gastrointestinal illness.
8. Currently incarcerated.
9. Impaired decision-making capacity.
10. No or limited English speaking ability; illiterate or low-literacy ability.
11. Profound visual or hearing impairment that limits written or verbal communication.
12. Status relationship with a member of the study team.
13. Not suitable for study participation due to other reasons at the discretion of the investigators.