cyrilzakka/clinical-trials huggingface dataset:
Improving Cognition and Behavior in Pediatric Cancer Survivors Using a Novel Mindful Attention Training

This pilot study will evaluate the cognitive and behavioral outcomes of using a novel, adaptive attention training in pediatric cancer survivors.

Pediatric cancer survivors (PCS) often experience attentional difficulties that have downstream effects on their quality of life, academic achievement, and future occupational attainment. As such, the primary goal of this project is to examine the outcomes of a novel, mindful attention training in this population and assess the feasibility of recruitment, retention, and adherence. Specifically, PCS will be randomly assigned to one of two adaptive attention training groups ('Engage') and complete tasks on the device for up to 8 weeks. Participants will also complete pre- and post-training assessments of cognition and behavior.

An additional cohort of no-contact participants will be asked to complete the assessments at baseline and end of study only to assess the feasibility and reliability of the assessment measures. This cohort will be enrolled separately and not randomized.

The investigators hypothesize that completion of 'Engage' training for the randomized cohorts will result in enhanced attentional control beyond the active comparator group that extends to other aspects of cognition in PCS.

Eligibility Criteria:
Inclusion Criteria:

1. Age 7-17 at the time of enrollment.
2. Able to understand study procedures and to comply with them for the entire length of the study.
3. Ability of individual and legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
4. Normal or corrected-normal vision and hearing.
5. English language fluency (minor participant and parent/guardian).
6. Received radiation therapy to the brain or neck between age 7-17.
7. Patients not on current cancer-related treatment (except supportive care) or those on other current treatments that would not hinder study participation. Patients currently on cancer-related treatments will be discussed with the study team (co-PI Mueller).

Exclusion Criteria:

1. Contraindication to any study-related procedure or assessment.
2. Motor/perceptual difficulties that prevent computer or tablet use.
3. Current cancer-related treatments that would impact the ability to participate in the study (e.g., current inpatient chemotherapy or intrathecal chemotherapy). Patients on other current treatments will be discussed with the study team (co-PI, Dr. Mueller)
Social Interaction and Compassion in Depression

The purpose of this study is to determine how a CBCT® (Cognitively Based Compassion-Training) for couples affect aspects of health and especially social interactions in depressed female patients and their romantic partners. compare healthy and depressed couples during an instructed positive real-time social interaction in the laboratory.

Furthermore the investigators aim to examine how social behavior and psychobiological indicators of health during real-time social interaction in the laboratory might be improved through CBCT® for couples.

Objects:

Will a CBCT® (Cognitively Based Compassion-Training) for couples reduce the depressive symptomatic and the partners´ burden as well as improve behavioral, endocrine, physiological and immune responses during a real time social interaction in the laboratory.

Do couples with a depressed female partner differ from healthy control couples in behavioral, endocrine, physiological and immune responses during a instructed positive real-time social interaction in a laboratory setting?

Eligibility Criteria:
General inclusion criteria:

* being in a heterosexual relationship for two years or more
* agreement to participate in the study
* recurrent depression (ICD-10 F33.0 or F33.1, depressed females of the patient couples only)
* agreement of the patient couples to be randomized into the two treatment arms
* no mental disorders (healthy control group only)

General exclusion criteria:

* severe acute and chronic psychological ( suicidal tendency, acute affective bipolar disorders) or physical disorder (chronic diseases, severe diseases such as endocrinological, neurological, nephrological or hepatic disorders)
* being pregnant
* heavy smoking (more than 20 cigarettes daily) or alcohol abuse
* substance related abuse and addiction
* enrolling current couple therapy
* enrolling current individual therapy (except of probatory phase)
* enrolling current mindfulness or compassion based group training
Determinants of Neonatal Anemia in Women Carrying Multiples

Multiple births in the United States are rapidly increasing in large part due to assisted reproductive technologies. Recent data indicate that multiple births now comprise 3-4.5% of all births in the United States. Pregnant women are at risk for iron (Fe) deficiency anemia yet there are virtually no data on Fe status in women carrying multiples and current recommendations do not necessitate Fe screening among this high risk group. Maternal anemia is known to increase the risk of adverse birth outcomes including preterm birth and low birth weight. Moreover, the developing brain is increasingly recognized to be susceptible to Fe insufficiency in utero and growing data support that suboptimal Fe stores at birth are associated with long-term irreversible cognitive deficits in the offspring. To address these gaps in knowledge the investigators will monitor weight gain, hematological measures, Fe status indicators and serum hepcidin across pregnancy in approximately 120 women carrying twins and triplets. Determinants of maternal anemia will be identified. Neonatal hematological measures will be assessed in cord blood from each neonate at birth for assessment of hematological measures, Fe status and hepcidin. Determinants of neonatal anemia will be identified. Inflammatory markers will be measured in all blood samples and related to outcomes. Stable iron isotopes will be given to a subset of women to assess maternal Fe absorption and fetal Fe uptake.

Pregnant women (n=100-125) carrying multiples (twins and triplets) will be identified when entering prenatal care. Women will be invited to participate in a longitudinal study of Fe homeostasis across pregnancy and at delivery in the maternal / neonatal dyad. In all maternal and cord blood samples obtained, whole blood will be analyzed for hemoglobin, hematocrit, reticulocyte count, erythrocyte count, mean corpuscular hemoglobin, mean corpuscular Hb concentration, mean corpuscular volume, and red cell distribution width using standard procedures. Circulating Fe status indicators (serum iron, ferritin, C-reactive protein, IL-6, erythropoietin, transferrin receptor and hepcidin) and serum folate and vitamin B12 will be measured. Distributions of each variable will be examined and associations among variables will be explored. Multiple linear regression models will be constructed to examine specific relations between a) determinants of Fe deficiency anemia in the mother; b) Fe status indicators in the mother vs. those in the neonate; c) Fe status indicators in the mother and neonate with placental Fe binding proteins; and d) neonatal Fe status between siblings.

Eligibility Criteria:
Inclusion Criteria:

* The investigators anticipate that the majority of these women will be recruited early in gestation because many of these pregnancies are a result of assisted reproductive technology.
* Eligible volunteers will be otherwise healthy and have no diagnosed, preexisting medical conditions known to impact iron homeostasis

Exclusion Criteria:

* Hemoglobinopathies,
* Preexisting diabetes,
* Malabsorption diseases
Single Incision Laparoscopic Varicocelectomy

Conventional laparoscopic varicocelectomy using 3 ports has been used for treatment of varicocele in our department since the nineties. However, the relatively several trocar wounds represent a big challenge against its acceptance by many of our patients who prefer the open approach with one or at least two wounds.

Single incision laparoscopic surgery (SILS), since its introduction in 2007, has been proven to be feasible and effective, with high patient satisfaction rates regarding improved cosmotic outcomes, reduced postoperative pain, and rapid return to normal activities. (10, 11) SILS for varicocelectomy has been reported to be safe and effective alternative to conventional laparoscopic varicocelectomy in a few studies.


Eligibility Criteria:
Inclusion Criteria:

* patients with palpable varicoceles

Exclusion Criteria:

* unfit for anesthesia or laparoscopy
Physiologic Measure of VIPN

The purpose of this study is the development of a physiologic endpoint using a novel technology that would provide an objective, easy to use and more sensitive assessment of VIPN in children and adolescents. The ability to more easily detect and monitor VIPN, even before it is clinically evident, would facilitate optimizing the dosing of vincristine for maximal disease response while minimizing the risk of lifelong functional deficits affecting quality of life. This approach would also enable the development of specific therapies to minimize or eliminate the occurrence of VIPN in children and adolescents. This is a single site study that aims to develop a novel device to evaluate and characterize vincristine-induced neuropathic pain. The investigators will enroll patients with ALL following the Delayed Intensification (DI) phase of treatment. At each study visit, the investigators will evaluate the nPRD as well as the TNS-PV. The nPRD will inform the neuropathy index which will be used to compare to the TNS-PV. We anticipate a correlation between the two.


Eligibility Criteria:
Inclusion Criteria:

* 6-18 years of age at the start of the study, are receiving vincristine in DI (clinical study population) and are willing and able to provide informed consent or assent to study participation.

Exclusion Criteria:

* have eye pathology which precludes pupillometry, are hemodynamically unstable, or are pregnant.
Monoferric for Prenatal Iron Deficiency

A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.

Intravenous therapy (IV) Monoferric (ferric derisomaltose), is a single-dose, rapid infusion formulation that has the potential to reduce both time and cost barriers, though its efficacy and safety in pregnant women has not been well studied. Thus, we propose to study the safety and efficacy of single dose, monoferric 1,000 mg IV in a cohort of pregnant participants with iron deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Participants 18 years of age or older between 14 to 42 weeks gestation who are deemed appropriate for IV iron by their treating provider as part of their standard of care treatment.
* Iron deficiency anemia, defined as second or third trimester (14 weeks or more) hemoglobin less than or equal to 10.5 g/dL or less than or equal to11 g/dL, respectively, and ferritin less than 50 μg/L
* Experience intolerance to oral iron or are greater than 28 weeks gestation
* Willing to participate in the study

Exclusion Criteria:

* Known infectious, inflammatory, or malignant conditions that may confound iron repletion and outcome analysis
* Prior IV iron intolerance or hypersensitivity reaction
THE EXPERIENCES OF PROFESSIONALS WITH REFUGEE PATIENTS

This study was conducted to examine the experiences and feelings of health professionals while providing care to refugee children and families in pediatric emergency service.


Eligibility Criteria:
Inclusion Criteria:

* Health professionals who worked in the pediatric emergency department for at least 1 year were included.

Exclusion Criteria:

-
Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma

The purpose of this study is to test the safety and effectiveness of erlotinib and chemoradiotherapy in patients with unresectable esophageal or gastro-esophageal squamous cancer .


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of esophagus or Esophagogastric Junction
2. Age \>= 18
3. ECOG PS 0-2
4. Ineligibility for surgery
5. No prior palliative therapy
6. At least one bidimensionally measurable disease as defined by RECIST ver 1.1
7. Adequate organ function for treatment

   * Absolute neutrophil count (ANC)\>=1000cells/mm3
   * Platelets \>=100000 cells/mm3
   * Estimated creatinine clearance\>=50mL/min, or serum creatinine\<1.5 x institution upper limit of normal
   * Bilirubin=\<1.5 x upper limit of normal(ULN)
   * AST(SGOT)=\<2.5 x ULN (5.0xULN if hepatic metastases)
   * ALT(SGPT)=\<2.5 x ULN (5.0xULN if hepatic metastases)
   * 12-Lead electrocardiogram(ECG) with normal tracing or non-clinically significant changes that do not require medical intervention
   * QTc interval =\<470 msec and without history of Torsades de Points or other symptomatic QTc abnormality
   * LVEF (by MUGA or echocardiogram) of \>=50%.
8. The patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing.

Exclusion Criteria:

1. Previous treatment with small molecule EGFR tyrosine kinase inhibitors
2. Any major operation within 4 weeks of baseline disease assessment
3. Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
4. CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment
5. Patients with known interstitial lung disease
6. Patients with uncontrolled or significant cardiovascular disease (AMI within 12 months,Unstable angina within 6 months, NYHA Class III, IV Congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, Congenital long QT syndrome, Any significant ventricular arrhythmia, Any uncontrolled second or third degree heart block, Uncontrolled hypertension)
7. Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to study entry.
8. Pregnant or breast-feeding women
9. Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.
Improvement of Language Disturbances After Stroke by Intensive Training and Electrical Brain Stimulation

The study aims to identify if intensive language training, consisting mainly of computer-based object naming, together with electrical brain stimulation, will lead to an improvement of language functions in patients that suffer from language disturbances after a stroke.


Eligibility Criteria:
Inclusion Criteria:

* chronic stroke (\> 1 year after event)
* aphasia due to stroke with naming impairment
* German as first language
* first-ever stroke

Exclusion Criteria:

* more than 1 stroke
* progressive stroke
* history of severe alcohol or drug abuse, psychiatric illnessess like severe depression, poor motivational capacity
* dementia
* contraindications for Magnetic Resonance Imaging
Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

It is already known that the local treatment with Alphagan eye drops (a drug commonly used by glaucoma patients) reduces ocular blood flow. In-vitro studies suggest that the vasoconstrictive effect of Alphagan is more pronounced when this drug is combined with a prostaglandin analogue (eg. Xalatan eye drops). The investigators also question whether this effect is more pronounced in subjects suffering from a primary vascular dysregulation (PVD). To test for the effect of these drugs on PVD and non-PVD subjects the investigators will take measurements of corneal temperature as surrogate for ocular blood flow.

The investigators would like to investigate the effect of Alphagan eye drops, Xalatan eye drops and their combination (both Alphagan and Xalatan) on corneal temperature in healthy subjects with and without a primary vascular dysregulation (PVD).

The investigators would like to answer the following questions:

1. Do the individual drugs influence the circulation to the eye as quantified indirectly via corneal temperature?
2. Does the combination of Alphagan and Xalatan give an additive or even potentiated effect?
3. Is the sequence of application of drugs of relevance (Alphagan applied first, Xalatan second, or vice versa)?
4. Do PVD and non-PVD subjects respond differently to these drugs?

20 healthy non-PVD subjects and 20 healthy PVD subjects in the age range from 20-40 years will be recruited. Recruited subjects will have all measurements: corneal temperature, intraocular pressure (IOP), ear temperature, blood-pressure. Both prior to and after instillation of eye drops (Xalatan, Alphagan and placebo).

Eligibility Criteria:
Inclusion Criteria:

* healthy
* age 18-48 years
* normal findings on ophthalmological examination

Exclusion Criteria:

* history of ocular or systemic disease
* chronic or current systemic or topical medication
* drug or alcohol abuse
* art. hypertension
HDR Brachytherapy Plus Stereotactic Ablative Prostate Radiotherapy for Patients With Intermediate and High-risk Prostate Cancer

Dose escalation is nowadays a standard strategy in radiotherapy for prostate cancer. Besides, it is believed that due to the radiobiology characteristics of prostate cells (low alpha/beta ratio), the delivery of higher radiation doses per fraction could theoretically improve the efficacy of the treatment. In this context, the combination of prostate brachytherapy and external beam radiotherapy (EBRT) has proven to be the most effective method of dose escalation significantly improving disease control in randomized clinical trials. Unfortunately, this strategy is also associated with an increased risk of acute and late adverse events compared to conventional EBRT alone. It has been proposed that this increase in adverse events could be related to the use Low-Dose-Rate (LDR) brachytherapy and that High-Dose-Rate (HDR) brachytherapy (a more modern and accurate procedure) could reduce this risk.

On the other hand, Stereotactic Ablative Radiotherapy (SABR) is a high-precision radiation technique that allows the delivery of higher doses per fraction in fewer sessions, reducing the total treatment time.

The investigators hypothesized that the combination of two highly conformal radiation techniques (HDR brachytherapy and SABR) could be well tolerated, while reducing total treatment time and therefore improving patient quality of life.

This is a single arm Phase II clinical trial designed to test the feasibility, tolerability and impact on quality of life of the combination of High-Dose-Rate prostate brachytherapy and SABR for patients with intermediate and high-risk prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of adenocarcinoma of the prostate.
* Intermediate or high-risk disease (as per NCCN criteria):

  * Intermediate risk:
* Clinical stage ≤ T2c
* Gleason score 7 and initial PSA ≤ 20 ng/ml.
* Gleason score ≤ 6 and initial PSA \> 10 and ≤ 20 ng/ml.

  * High risk,at least one of the following:
* Clinical stage T3a-b.
* Gleason score 8-10.
* Initial PSA \> 20 ng/ml.
* Life expectancy of more than 10 years
* Able and willing to complete Expanded Prostate Index Composite (EPIC) end EORTC questionnaires
* Eastern Cooperative Oncology Group (ECOG) of 0 - 2.
* Willing to give informed consent to participate in this clinical trial
* Give competent informed consent to participate in this trial.

Exclusion Criteria:

* Documented nodal or distant metastases.
* Previous pelvic radiotherapy.
* Clinical stage T4.
* Clinical stage T3a or T3b in which the coverture of the extraprostatic disease is not feasible (as deemed by the treating physician).
* Prostate volume \> 70 cc (measured on MRI).
* Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>17
* Contra-indication to radical prostate radiotherapy
* Significant medical co-morbidity rendering patient unsuitable for general anaesthetic
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)

This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder. Study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 to 65 years, inclusive.
* Diagnosed with Major Depressive Disorder (MDD) based on structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD.
* Current major depressive episode.
* With inadequate response to 1-3 first-line antidepressants administered at an adequate and stable dose

Exclusion Criteria:

* Any current and primary psychiatric disorder other than Major Depressive Disorder.
* Severe alcohol or substance use disorder.
* History of bipolar I and II disorder, psychosis, and/or mania.
* Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
* Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.
Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma

Surgery (esophagectomy or removal of the esophagus)has been the standard treatment for cancer of the esophagus. However, evidence suggests that preoperative chemotherapy and radiation therapy may add benefit. The purpose of this study is to determine if a treatment program of combined chemotherapy and radiation therapy prior to surgery and chemotherapy after surgery will delay or eliminate recurrence of the cancer.


Eligibility Criteria:
Patient Eligibility:

1. Histologically confirmed squamous cell carcinoma, adenocarcinoma, or mixed adeno/squamous of the the esophagus or gastroesophageal junction.
2. Disease limited to the esophagus and regional lymph nodes. However, celiac node enlargement will be acceptable for tumors of the distal esophagus, because they will be included in the radiation field.
3. Disease must be able to be encompassed in a single radiation field.
4. No medical contraindication to surgery.
5. All treatment is to be administered at the University of Michigan Medical Center
6. Karnofsky Performance Status \> 60%
7. Ages 18-75
8. Adequate renal function (BUN \<1.5 x N; creatinine \<1,5 mg/dl, or measured creatinine clearance\>60 ml/min.).
9. Adequate bone marrow reserve (WBC\>3500/ul; Platelets\>100,000/ul.).
10. Adequate hepatic function (Bilirubin\<1.5x N; AST \<2 x upper limit of normal).
11. Prior malignancy is acceptable if the patient is considered to be cured. In most cases this will mean a 5 year disease-free period.
12. Ability to give informed consent.

Exclusion Criteria:

1. Patients with active infection, pregnancy, lactating females, serious inter-current medical conditions including congestive heart failure, cardiac arrhythmias, or symptomatic coronary artery diseases are ineligible.
2. No prior treatment allowed. No prior thoracic radiation.