cyrilzakka/clinical-trials huggingface dataset:
Intravenous Iron in Combination with Standard of Care Immunotherapy in Melanoma

Anemia is a common complication among cancer patients and is negatively associated with overall prognosis and therapeutic outcomes. The purpose of this study is to see if giving a dose of iron prior to any standard of care chemotherapy treatment will affect the cells that are believed to make treating melanoma harder, making melanoma more responsive to the standard of care immunotherapy.

This is a pilot single arm, non-randomized study involving adult patients with melanoma receiving standard of care treatment with hemoglobin levels less than 13 g/dl, ferritin levels below 100 ng/ml, and transferrin saturations of less than 30%.

Cancer-associated anemia remains an underestimated and inadequately treated chronic condition that adversely affects the quality of life and overall prognosis in cancer patients. The correction of anemia in cancer patients would be a clinically applicable strategy to prevent and/or mitigate the expansion of tumor promoting erythroid progenitor cells (EPCs). Iron is an essential functional component of erythrocyte hemoglobin and is a crucial regulator of erythropoiesis. Strategies to therapeutically target the immunosuppressive machinery have emerged as a promising approach for cancer treatment. By promoting EPCs differentiation/maturation in anemic melanoma patients, immunosuppression could be mitigated and the therapeutic activity of immune checkpoint inhibitors enhanced.

A dose of intravenous iron will be given one week prior to standard of care chemotherapy and antibodies CD71 and CD235a will be used to detect EPCs in circulation and tumor microenvironment.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old adults at the time of informed consent
2. Ability to provide written informed consent and HIPAA authorization
3. Biopsy confirmed melanoma
4. Eligible for standard of care treatment
5. Plan to undergo immunotherapy in neoadjuvant or metastatic setting
6. ECOG performance status 0-2
7. Anemia defined as hemoglobin \< 13 g/dl in addition to ferritin \< 100 ng/ml and/or transferrin saturation \< 30%

Exclusion Criteria:

1. History of anaphylactic reaction to intravenous iron or any proposed standard of care treatments
2. Diagnosis of hemoglobinopathies
3. Therapeutic Iron supplementation in the past 3 months (oral iron as part of MVI allowed)
4. Diagnosis of hemochromatosis
5. Symptomatic brain metastases that require local treatment (brain metastasis which will be treated with systemic immunotherapy or treated metastasis with without need for steroids for symptomatic management are eligible).
6. Pregnant or lactating female adults
7. Active infections which in research teams' opinion increases risk for toxicities
8. Any condition that in the opinion of PI may interfere with patient being able to complete the required procedures.
Application of UCAD for Diagnosing Urothelial Carcinoma.

Chromosomal instability (CIN) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. CIN is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. Analyzing CIN of the DNA extracted from urothelial cells in urine samples seems a promising method for diagnosing, monitoring, and predicting the prognosis of bladder cancer patients. CIN can be assessed using experimental techniques such as bulk DNA sequencing, fluorescence in situ hybridization (FISH), or conventional karyotyping. However, these techniques are either time-consuming or non-specific. We here intend to study whether a new method named Ultrasensitive Chromosomal Aneuploidy Detection (UCAD), which is based on low-coverage whole-genome sequencing, can be used to analyze CIN thus help diagnosing and treating bladder cancer patients.

CIN results from errors in chromosome segregation during mitosis, leading to structural and numerical chromosomal abnormalities. It will generate genomic heterogeneity that acts as a substrate for natural selection. Furthermore, it is proved that tumors with aneuploidies and polyploidy resulting from whole-genome doubling are related with metastasis, treatment resistance, and decreased overall survival. It is estimated that 60%-80% of human tumors exhibit chromosomal abnormalities suggestive of CIN. CIN positively correlates with tumor stage and is enriched in relapsed as well as metastatic tumor specimens. Due to the ubiquity of CIN in cancer cells, it is a potentially non-invasive way to detect CIN in the urothelial cells from the urine sample for diagnosing and monitoring bladder cancer patients. UCAD is a new method to detecting CIN in the DNA sample from patients, including extracting DNA from urine, analyzing DNA by low-coverage whole-genome sequencing, processing the data by bio-information techniques, and finally optimizing the management of bladder cancer patients.

The investigators intended to conduct a prospective study by analyzing urine samples from bladder cancer patients and control groups that without any tumor in the urinary system or other organs to compare the specificity and sensitivity of UCAD test for diagnosing urothelial carcinoma to other modalities, such as urine cytology or fluorescence in situ hybridization (FISH).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with urothelial carcinoma and planned to undergo surgery.
* Participants without any tumor disease and willing to attend the study by providing morning urine.
* Male or female patients aged \>= 18 years.
* Participants signed informed consent form.

Exclusion Criteria:

* Age under 18 years
* Individuals unwilling to sign the consent form or unwilling to provide morning urine for test or unwilling to provide the medical record.
* Individuals unwilling to participate in this trial.
National Fallen Firefighter Foundation's (NFFF) Stress First Aid Intervention

Purpose \& Aims: Behavioral health interventions implemented to mitigate negative outcomes linked to trauma in the fire service have had limited or iatrogenic effects on firefighters. The National Fallen Firefighters Foundation (NFFF) and the national fire service community have invested considerable resources developing a new behavioral health model to address exposure to traumatic events. The proposed randomized controlled trial will be the first to determine the efficacy of the NFFF's Consensus Protocol on Firefighter Behavioral Health Stress First Aid Intervention (SFAI), as well as evaluating its implementation and acceptability.

Relevance: The SFAI was the result of one of the 16 Firefighter Life Safety Initiatives developed in consultation with the leading fire service organizations in the United States and experts from the traumatic stress research community. Failing to effectively address grief and trauma incidents or symptoms can have devastating effects for firefighters, fire departments, and families. The SFAI was developed to be the national model of trauma intervention to ensure that evidence-based cost-effective care is available to all firefighters.

Methods: Using a cluster randomized clinical trial design (CRCT), experienced scientists and fire service personnel will evaluate the implementation, acceptability, and initial efficacy of the SFAI compared with usual care (i.e., delayed intervention) with 10 fire departments (8 Career, 2 Volunteer) located across the country. Study outcomes include measures assessing implementation of SFAI components, acceptability among firefighters and department leadership, changes in knowledge about and self-efficacy for managing trauma, changes in department morale, and individual firefighter behavioral health outcomes such as symptoms of PTSD and personal growth through coping with traumatic events.

Projected Results \& Conclusions: Findings will provide the empirical basis for the newly developed SFAI.

Ten fire departments from across the nation (8 career, 2 volunteer) were recruited for this study. In Aims 1 and 2, program evaluation methods were used to examine the implementation and acceptability of the SFAI intervention components. These evaluation methods were based on standard practices which employs a systematic method for collecting, analyzing, and using information to answer questions about the implementation and acceptability of the SFAI. In Aim 3 a pilot CRCT was conducted comparing the SFAI versus control (delayed treatment) on key behavioral health outcomes. Four career departments were randomized to the SFAI condition and 4 to the control condition. Statistical power analysis was based on these 8 career departments and will provide the primary project outcomes. Between groups outcomes were assessed at 12-months.

Eligibility Criteria:
Inclusion Criteria:

* Firefighters over the age of 18 willing to complete surveys
* Active in a department selected for the study

Exclusion Criteria:

* Those under the age of 18
Outcome of Children With Eosinophilic Esophagitis

The investigator would like to create a prospective cohort of patients in order to describe eosinophilic esophagitis with the specificities corresponding to our geographical territory, and to study their evolution at 3 months, 6 months, 12 months, 18 months and 24 months.

This study would also enable us to investigate the quality of life of these chronically ill patients

The investigator would like to create a prospective cohort of 16 patients included over 2 years in order to determine the rate of complete remission (clinical, endoscopic and histological) at 3 months, 6 months, 12 months, 18 months and 24 months of treatment initiation. It is also planned to describe this cohort of pediatric EO patients at inclusion and throughout follow-up, and to study their quality of life.

Follow-up visits is organized every 3 months with a gastropediatrician, who assesses the patient's symptoms (PEESS score) and quality of life (PedsQL eosinophilic esophagitis module and PedsQL 4.0 Generic Core Scales).

If treatment needs to be introduced or changed, a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OE according to the diagnostic criteria of the PNDS published in July 2022
* Due to start treatment.
* informed consent from one of the 2 parents or the representative of parental authority.
* Membership of a social security scheme.

Exclusion Criteria:

-
Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods

The endotracheal intracuff pressure is to be maintained at a low level to prevent trachea and nerve damages, and yet be high enough to secure air sealing. The objective of the study is to compare minimal occlusive volume technique (MOVT) and expired volume/inspired volume ratio (VE/VI ratio) from a spirometer method of endotracheal tube (ETT) cuff inflation with respect to the cuff pressure required to seal the airway during a laparoscopic surgery under general anesthesia. A study design is a randomized crossover trial in 35 patients. The primary outcome is the intracuff pressure of an endotracheal tube. The study consists of two cuff sealing methods separated by a period of 10 minutes.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I, II
* Body mass index \< 30 kg/m2
* Elective laparoscopic gynecologic surgery under general anesthesia in the Trendelenburg position

Exclusion Criteria:

* History of airway-related or pulmonary diseases/abnormalities
* When difficult intubation is anticipated
* History of general anesthesia within the past 3 months
* Pregnancy
* History of smoking
Thalidomide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Phase II trial to study the effectiveness of thalidomide in treating patients with recurrent or metastatic head and neck cancer. Thalidomide may stop the growth of head and neck cancer by stopping blood flow to the tumor.

OBJECTIVES:

I. Determine the effect of thalidomide on survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

II. Determine clinical response rates following this therapy in these patients. III. Determine the toxic effects of thalidomide in these patients. IV. Determine the effect of thalidomide on tumor angiogenesis in these patients.

OUTLINE:

Patients receive 4-20 capsules of oral thalidomide once daily. Dose is escalated in individual patients on a weekly basis for the first 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity, or for 12 months past complete response.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven squamous cell carcinoma of the head and neck
* Recurrent disease OR metastatic disease at initial diagnosis or at recurrence
* Initial therapy of surgery and/or radiotherapy, induction chemotherapy, or concurrent chemotherapy and radiotherapy allowed
* No more than one prior regimen of chemotherapy or biologic therapy for metastatic disease
* Recurrence after adjuvant or induction chemotherapy may have received one additional course of chemotherapy or biologic therapy

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: Zubrod 0-2
* Life expectancy: At least 3 months
* WBC at least 3000/mm3
* Platelet count at least 100,000/mm3
* Hematocrit at least 30%
* Bilirubin no greater than 1.5 times normal
* SGOT/SGPT no greater than 1.5 times normal
* Creatinine no greater than 1.5 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile women must use 2 methods of effective contraception, 1 barrier and 1 hormonal, beginning at least 4 weeks before study and continuing during and for 1 month after study
* Men must use effective barrier contraception during and for 1 month after study
* No grade 2 or greater peripheral neuropathy
* No serious infection or other concurrent illness requiring immediate therapy
* Must be able to take oral medications
* No medical or social factors that would interfere with compliance

PRIOR CONCURRENT THERAPY:

* Any number of courses of one regimen of chemotherapy allowed
* No concurrent cytotoxic chemotherapy
* No concurrent radiotherapy
Effect of Bright Light on Mood and Sleep in Parkinson's Disease

The purpose of this clinical trial is to investigate whether light therapy is a suitable treatment option for depression and insomnia in Parkinson's disease.

The quality of life of patients with Parkinson's disease and their caretakers is mainly influenced by so called non-motor symptoms. This includes neuropsychiatric consequences of the disease like depression and sleeping problems. The incidence of depressed mood in patients with Parkinson is approximately 50%, the incidence for sleeping problems is 90%. These symptoms are often overlooked and even if recognized, inadequately treated. The treatment of mood and sleep disturbances in Parkinson patients is hampered by adverse effects, incomplete responses to the usual treatments and the absence of specific treatment options for these symptoms in Parkinson's disease. On the basis of the hypothesis of disturbed functioning of the suprachiasmatic nucleus in Parkinson's disease it is expected that stimulation of this nucleus by bright light therapy will result in improved functioning on multiple different domains: mood, sleep, motor functions, quality of life and circadian rhythms. Because there are virtually no side effects and the possibility of home treatment, light therapy is expected to be highly appreciated by the patients.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* depression

Exclusion Criteria:

* psychosis
* mania
* suicidality
* retinopathy
* previous light treatment
* use of photosensitising medication
Chung-ju Metabolic Disease Cohort (CMC) Study

This is an observational study on the prevalence and incidence of diabetes and osteoporosis in a rural area of Korea.

Diabetes, metabolic syndrome and dyslipidemia are common and rapidly increasing in Asia. Our group constructed a cohort in Chung-ju city, a rural area in Korea, to observe the prevalence of metabolic diseases and its risk factors since 2003. About 12,000 subjects participated in this cohort study till 2006. Now, we are planning to follow-up these subjects and provide health examinations from May, 2007 to Feb, 2011. The prevalence and incidence of metabolic diseases including diabetes, hypertension, metabolic syndrome, dislipidemia and osteoporosis will be observed.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 30 years of age living in Chung-ju city (who participated in 2003-2006 cohort study)

Exclusion Criteria:

* age under 30
* subjects with known diabetes
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, safety, tolerability, immunogenicity and activity of zilucoplan (ZLP) in pediatric study participants with generalized myasthenia gravis (gMG).


Eligibility Criteria:
Inclusion Criteria:

United States of America (USA) specific inclusion criterion:

- Participant must be 12 to \<18 years of age at the time of signing the Informed consent/assent according to local regulation

Rest of world (ROW) specific inclusion criterion:

- Participant must be 2 to \<18 years of age at the time of signing the Informed consent/assent according to local regulation

Global inclusion criteria:

* Participant has a diagnosis of generalized myasthenia gravis (gMG) confirmed by a prior positive serologic test result to acetylcholine receptor (AChR) prior to Screening
* Participant meets the criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IV at Screening
* Participants with gMG, including:
* An MG-activities of daily living (MG-ADL) total score of 6 or more in adolescents from 12 years to \<18 years of age at Screening
* Documented weakness in at least 1 limb, neck, or bulbar muscle in children from 2 years to \<12 years of age at Screening (does not apply to US)
* Documented vaccination against meningococcal infections within 3 years prior to study start. If not fully vaccinated, participants must receive appropriate prophylactic antibiotic treatment until at least 2 weeks after the initial dose of vaccine(s)

Exclusion Criteria:

* Participant has known positive serology for muscle-specific kinase
* Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study
* Participant has had a thymectomy within 6 months prior to Baseline
* Participant has minimal Manifestation Status of MG based on the clinical judgement of the Investigator
* Current or recent systemic infection within 2 weeks prior to Baseline or infection requiring intravenous antibiotics within 4 weeks prior to Baseline
Embryo Aneuploidies and Morphokinetics in Ovarian Stimulated and Non Stimulated IVF Cycles

The purpose of this study is to compare the number of euploid embryos obtained per metaphase II oocyte in unstimulated (modified natural cycles) and stimulated IVF cycles.

Effects of ovarian stimulation on human embryo quality is still a subject of study. When natural and stimulated cycles have been compared, no differences have been observed in terms of embryo cleavage capacity, oocyte and embryo aneuploidy rate or incidence of aneuploidy in aborted foetuses. When mild and conventional doses of gonadotropins have been compared, a higher proportion of good morphological quality embryos are observed in the former. On the contrary, we showed that ovarian stimulation does not increase significantly the embryo aneuploidy rate in IVF derived human embryos when unstimulated and stimulated cycles were compared in oocyte donors. In this study, we want to compare the embryo aneuploidy rate between unstimulated and stimulated cycles in infertile patients, subjected to both IVF cycles with blastocyst biopsy and NGS-PGS. A comparison of the morphokinetics will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* Women
* 30-38 years old (inclusive)
* with regular menstrual cycles (25-35 days)
* AntiMülleriana Hormone \>5 pmol/L.
* Undergoing IVF treatment

Exclusion Criteria:

* BMI \>30 kg/m2
* repeated miscarriages
* implantation failure
* uterine or adnexal pathology
* Unable to be treated with gonadotrophins for the ovarian hyperstimulation
* history of low response to ovarian hyperstimulation
* participation in another study with PGS for monogenic pathology
* Cryptozoospermia in male partner
Phase II Image Guided Stereotactic Ablative Radiotherapy for Non-Small Cell Lung Cancer

This study will help researchers learn about the best dose of radiation to be used when treating large early stage non-small cell lung cancer (NSCLC) with a treatment called stereotactic ablative radiotherapy (SABR). Current treatments with SABR for early stage NSCLC show positive response. But, for large early stage NSCLC it may be better to give different SABR doses than what is used in routine early stage NSCLC treatment. It is not understood which dose is best for treating large early stage NSCLC. Therefore, this study can help researchers learn if giving a higher dose using SABR over a period of 5-10 treatment days can increase the chance of cure for large early stage NSCLC.

Treatment Plan:

7.5 Gy x 10 daily fractions delivered with volumetric modulated arc therapy (VMAT) or regular intensity-modulated radiation therapy (IMRT).

* Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal planning target volume (PTV) coverage is achieved; but the 7.5 Gy x 10 daily fractions schedule is preferred.
* All doses are prescribed to the tumor periphery.

For this protocol, patients will be followed only up to 2 years post radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Non-Small Cell Lung Cancer
* T2N0M0 or T3(PL3)N0M0 or Locally recurrent ≤ 7 cm
* Surgically inoperable
* ECOG Performance 0-2

Exclusion Criteria:

* Pacemaker on the same side of the tumor
* Pregnant
* Infection that requires IV antibiotics
* Concomitant or adjuvant anti-neoplastic chemotherapy