cyrilzakka/clinical-trials huggingface dataset:
Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as ixabepilone and ketoconazole, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving ixabepilone with ketoconazole may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving ixabepilone together with ketoconazole and to see how well they work in treating patients with advanced solid tumors.

OBJECTIVES:

Primary

* Determine the effect of ketoconazole on the pharmacokinetics of ixabepilone in patients with advanced solid tumors.

Secondary

* Determine the safety of ixabepilone when administered alone and in combination with ketoconazole in these patients.
* Determine, preliminarily, the antitumor activity of this regimen in these patients.

OUTLINE: This is an open-label, dose-escalation study of ixabepilone.

During course 1, patients receive oral ketoconazole on days 0-5 and ixabepilone IV over 3 hours on day 1. During course 2 and subsequent courses, patients receive only ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of at least 3 patients receive escalating doses of ixabepilone during course 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity. At least 12 patients are treated at the MTD.

PROJECTED ACCRUAL: A total of 3-35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed solid tumor
* Unresponsive to currently available therapy OR no known effective treatment exists
* Measurable or nonmeasurable disease
* Brain metastases allowed, provided the following criteria are met:

  * Completed cranial radiotherapy at least 4 weeks ago
  * Stable or reduced brain metastases by brain imaging\*
  * Clinically stable disease AND no steroid therapy within the past 2 weeks (Baseline brain imaging is not required for patients with no signs or symptoms of brain metastasis)

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Eastern Cooperative Oncology Group (ECOG) 0-1

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No more than 3 prior chemotherapy regimens
* No other concurrent chemotherapy (standard or investigational)

Endocrine therapy

* See Disease Characteristics

Radiotherapy

* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to \> 25% of major bone-marrow containing areas (e.g., pelvis or lumbar spine)

Surgery

* At least 1 week since prior minor surgery and recovered
* At least 3 weeks since prior major surgery and recovered

Other

* More than 2 weeks since prior drugs that would inhibit or stimulate drug metabolism
Communication Intervention for Toddlers With Autism

The goal of this study is to conduct an efficacy trial to determine whether an early communication intervention which blends two evidence-based interventions, Enhanced Milieu Teaching (EMT) and Joint Attention, Symbolic Play and Regulation Intervention (JASPER), improves social communication in toddlers with Autism Spectrum Disorder (ASD).

This study tests the blended intervention (J-EMT) in a parent-plus-therapist-implementation model that has been demonstrated to be effective with other populations.

The J-EMT communication intervention is tailored to the specific social communication characteristics of children with ASD and is delivered during a critical period in early communication development for these children.

In this study, the investigators compare this blended intervention (J-EMT) to a business as usual (BAU) comparison group. Children assigned to the J-EMT group will receive a total of 48, 1-hour direct intervention sessions over six months that will include teaching their parents to implement J-EMT procedures across daily activities.

The investigators will examine social communication and child vocalizations, expressive and receptive language, symbolic play, and symbol-infused joint engagement to determine whether J-EMT changes both a primary functional outcome and the underlying specific skills that contribute to effective social communication in children with ASD.

Results from this study will indicate the efficacy of this variation of parent-plus-therapist-implemented EMT (i.e., J-EMT) specifically tailored to the characteristics of young children with ASD.

Eligibility Criteria:
Inclusion Criteria:

* Between 24 and 36 months of age
* A diagnosis of ASD as confirmed by the ADOS-2 (module 1)
* Signed informed consent
* Parent willing to be trained

Exclusion Criteria:

* Other diagnosis or disability
* Abnormal hearing and/or vision
* Language other than English is the primary language spoken at home
Ultrasound Guided Peripheral Intravenous Catheter Insertion in the Hospitalized Patient: Long vs. Short Axis Placement

Comparison of peripheral IV catheters inserted by ultrasound using the long axis vs. the short axis technique. Our hypothesis is that long axis ultrasound placement will increase the longevity of the IV catheter.


Eligibility Criteria:
Inclusion Criteria:

* A patient who needs PIV access for intravenous medications and resuscitation either on a medical-surgical floor or in the ICU
* After floor team (including RN and/or house staff) and IV Nurse have attempted and failed or is not available

Exclusion Criteria:

* Need for vasopressors
* Need for TPN
* Need for hemodynamic monitoring
* Non English speaking patient
* Patients who are unable to consent
A Pilot Drug Trial That Evaluates the Whitening Potential of Nicotine Gum

The purpose of this research study is to evaluate the effects on existing tooth stain of nicotine gum. The study will enroll adults who have visible tooth staining.

This was a 6-week, open-label, single-center study conducted in 78 subjects who were smokers with visible staining of teeth and who were motivated to quit smoking through use of Nicorette Freshmint gum.

The subjects were assigned, per label instructions, to either Nicorette Freshmint gum 2 mg or 4 mg based on the number of cigarettes smoked per day. Subjects who smoked at least 25 or more cigarettes per day were assigned to the 4 mg gum group; those who smoked less than 25 cigarettes per day were assigned to the 2 mg gum group.

A total of 3 study visits were planned: Screening/Baseline, Week 2 and Week 6. A telephone screening prior to Baseline and the Screening/Baseline visit was performed to confirm subject eligibility. At each visit an oral examination, including a stain index measurement used to rate tooth-staining (MacPherson Modification of the Lobene Stain Index), was conducted; and smoking status and motivation to quit smoking were assessed. The safety evaluation at each visit included an oral tissue assessment in addition to assessment for any adverse events.

Eligibility Criteria:
Inclusion Criteria:

* daily smokers for at least one year
* motivated to quit smoking
* normal chewing ability
* willing to refrain from a dental prophylaxis for the duration of the study
* total extrinsic facial tooth stain score \> or = to 28, according to the MacPherson Modification of the Lobene Stain Index

Exclusion Criteria:

* \< 20 natural teeth
* inadequate oral hygiene
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)

EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)

The investigator proposes a study investigating the use of restrictive transfusion triggers and administration of single preoperative high dose shot of epoetin alfa (rhEPO) in a young (age \< 65 years of age) population undergoing cardiac surgery. The investigator believes that participants can tolerate a lower Hemoglobin (Hgb). Therefore, the control group will benefit from a restrictive transfusion trigger and experimental group will benefit from EPO providing a synergistic stimulus for erythropoiesis. This proposed study has potential to reduce overall transfusion utilization in cardiac surgery and improve standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Be male or female and 18 years of age or older, but less than 65 years of age
* Be willing to performed written informed consent prior to study initiation
* Be willing and able to comply with the protocol for study duration
* Be scheduled to undergo elective cardiac surgery requiring CPB and including: coronary artery bypass graft (CABG), aortic, mitral, or tricuspid valve replacement or repair, replacement of more than one cardiac valve, or CABG with combined cardiac valve replacement or repair.

Exclusion Criteria:

* Over the age of 64 years
* Patients who receive allogeneic transfusion 60 days prior to surgery
* Hgb \> 15g/dl
* Patients who are pregnant or currently lactating
* Women of childbearing potential (e.g. those not surgically sterilized or not post-menopausal) must use 2 methods of contraception including at least one barrier method.
* End-stage renal disease requiring renal replacement therapy or dialysis
* Hepatic dysfunction (defined as total bilirubin value \> 1.5 mg/dl)
* Off-pump (no CPB) cardiac surgery
* Emergency surgical procedure
* Inability to receive blood products
* Endocarditis as defined my Modified Duke Criteria
* Any congenital coagulation disorder
* Chronic anemia (defined as preoperative Hgb concentration \< 10 g/dl)
* Low platelet count (defined as preoperative platelet count less than 150 x 103/μl)
* Not a surgical candidate due to high risk of morbidity or mortality
* Surgery for aneurysm repair, dissection, or other thoracic aortic procedure
* Congenital heart surgery
* Cardiogenic shock or hemodynamic instability within 24 hours prior to surgery, as defined by systolic blood pressure \< 80 mmHg and heart rate \> 120 beats per minute
* Known malignancy within the past 5 years
* Life expectancy \< 12 months
* Current active infection requiring antibiotic treatment
* Inability to comply with study protocol
* Contraindication to Epogen
* Hypersensitivity to epoetin or any component of the formulation
* Pure red cell aplasia (due to epoetin or other epoetin protein drugs)
* Contraindication to Ferrous Sulfate
* Hypersensitivity to iron salts or any component of the formulation
* Hemochromatosis
* Hemolytic anemia
* In the opinion of the Principle Investigator (PI) any specific disease process or confounding variables that may inappropriately alter the outcome of the study
A Brief MI Intervention in the ED to Increase Child Passenger Restraint Use

This study involves an emergency department (ED)-based intervention utilizing Motivational Interviewing (MI) techniques and patient-centered (e.g., tailored) print materials to promote the correct and consistent use of size-appropriate child passenger restraints (car seats, booster seats, and seat belts). This study is designed as a randomized pilot trial.

Motor vehicle collisions (MVCs) remain a leading cause of death among children after the first year of life despite substantial improvements in passenger safety. Deaths and severe injuries from MVCs can be reduced significantly through the consistent use of size-appropriate child passenger restraints. Still, 10% of children ride completely unrestrained and roughly one-quarter do not use the recommended restraint for their size. New approaches are needed to motivate behavior change among parents who do not consistently use size-appropriate passenger restraints for their children from birth through age 10. Emergency department (ED) visits represent unique opportunities to reach vulnerable children and their parents who have difficulty accessing the primary care settings where childhood injury prevention information is commonly provided. Motivational interviewing (MI) in the ED has been used to encourage a variety of health behaviors among at-risk patients. However, MI has not been previously evaluated for child passenger safety promotion programs. This study will involve an ED-based intervention utilizing MI techniques and patient-centered (e.g., tailored) print materials to promote the correct and consistent use of size-appropriate child passenger restraints. This study is designed as a randomized pilot trial of the intervention utilizing a 2x2 factorial design to examine the independent and additive effects of ED-based MI and tailored print materials on the consistent use of size-appropriate child passenger restraints. Aim 1) To assess the feasibility and acceptability of the ED-based intervention among parents of children from birth through age 10; Aim 2) To determine the impact of the intervention on child passenger restraint attitudes and practices at 6-month follow-up in comparison to baseline assessments.

Eligibility Criteria:
Inclusion Criteria:

* Must be an adult (18+ years) parent or caregiver who regularly drives with their child,
* are able to speak and read English,
* who is presenting to the ED with their child age birth to 10 years.
* Child must be \<4'9" in height.

Exclusion Criteria:

* Adult participants must be able to speak and read English
Laparoscopic Therapy of Endometrioma: Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans

The aim of this prospective randomized study is to compare laparoscopic sclerotherapy to cystectomy in following: AMH dynamics, endometrioma recurrence, complications, pregnancy rate, assisted reproduction methods success rate, live birth rate

Only patients who sign informed consent will be included. Only patients wishing for future pregnancy will be involved in the study. Expected number of enrolled subjects is 160 ( 80 in each arm) Patients with endometrioma and planned surgery to remove it will be randomized either to laparoscopic sclerotherapy with 96% ethanol or cystectomy. First AMH sample will be taken day before surgery. If other endometriosis lesions (deep or superficial) are present, they may be also resected during this surgery.

Ethanol sclerotherapy description: classical laparoscopic approach - small (max1cm) fenestration of endometrioma - aspiration of endometrioma contents- foley catheter insertion- ballon inflation inside of the cyst- instillation with 96% ethanol which is left in the cyst for 10min- aspiration of ethanol and flushing with saline.

Cystectomy: classical laparoscopic approach- large fenestration of endometrioma - aspiration of endometrioma contents- indentification of ovary/ endometrioma tissue and plane between the ovarian capsule and cyst wall is developed using a mix of blunt and sharp dissection - if bleeding is present it is stopped by cautious bipolar coagulation

visit 1 - surgery time (AMH day before surgery, age, BMI, endometriosis extent, gravidity/ parity, endometriosis residue after surgery, pain levels) visit 2- 3 months after surgery : Ultrasound, complications, pregnancy, asissted reproduction, pain levels visit 3+4 - 6/12months after surgery: AMH, Ultrasound, complications, pregnancy, asissted reproduction, pain levels visit 5- 24 months after surgery: Ultrasound, complications, pregnancy, asissted reproduction, pain levels

Eligibility Criteria:
Inclusion Criteria:

* IOTA benign endometrioma
* bilateral or unilateral endometrioma measuring 30 or more milimeters
* patients with unfinished reproductive plans

Exclusion Criteria:

* bilateral recurrence of endometrioma
* recurrent endometrioma if the other ovary is not present or patient had cystectomy on the other ovary
* suspision for ovarian malignancy
* signs of inflammatory pelvic disease
* disagreement with participation in the study
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ulcerative colitis for greater than/equal to 3 months.
* Moderate to severe active ulcerative colitis
* Inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.

Exclusion Criteria:

* Pregnant or breastfeeding
* Clinical findings suggestive of Crohn's Disease
* History of bowel surgery within 6 months
IPT-A for Adolescents With PTSD Symptoms

In the present study, the investigators propose to 1) adapt Interpersonal Psychotherapy for Adolescents (IPT-A) as an intervention for adolescents who report elevated symptoms of posttraumatic stress disorder (PTSD) and/or meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for PTSD; and 2) conduct a small open pilot study of IPT-A for PTSD. Ten adolescents ages 13 to 18 who meet DSM-5 criteria for a PTSD diagnosis or have elevated symptoms of PTSD (Child PTSD Symptom Scale \[CPSS-5\] ≥ 31) will be treated with 14-16 weeks of an adapted version of IPT-A. If participants have evidenced a decrease in PTSD symptoms (CPSS-5 \< 31) they will also receive 3 months of once a month maintenance treatment and be assessed by a clinician evaluator at the conclusion of the 3 monthly sessions. If participants have not evidenced a decrease in PTSD symptoms (CPSS-5 ≥ 31), they will be referred for alternative treatments in the community and be assessed by a clinician evaluator 3 months following the completion of IPT-A. All evaluations and therapy sessions will be done over telehealth platform until able to be done in person.

Please see the brief summary for study description.

Eligibility Criteria:
Inclusion Criteria:

1. Adolescents who meet criteria for DSM-5 diagnosis of PTSD or have elevated PTSD symptoms
2. English speaking adolescent and parent
3. Males and Females ages 13-18 years
4. Mild to moderate impairment in functioning

Exclusion Criteria:

1. Severe impairment in functioning
2. Diagnoses of substance abuse, Schizophrenia, Bipolar Disorder, Conduct Disorder, primary eating disorder, psychotic symptoms
3. Engagement in significant self-injurious behavior in the past 3 months
4. Active suicidality - presence of plan and/or intent
5. Intellectual disability or severe learning disability
6. Medical illness that may interfere with treatment
7. Current physical or sexual abuse
8. Open Administration for Children's Services (ACS) case
9. Currently receiving treatment for depression and/or PTSD or have begun a medication trial for another diagnosis within the previous three months
MOTO Post-marketing Surveillance Study

The prospective, multicentric, observational study has the aims to monitor the performance of the MOTO medial unicompartmental knee system in the treatment of patients with knee disease requiring a UKA. 150 patients will be recruited in 18 months and will be reviewed until 5 years follow-up visit after surgery. The primary objective of the study is to evaluate the prosthesis survival at 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unicompartmental tibiofemoral osteoarthritis (OA) of the knee that meet the indications for use of Medacta implant included in this study (on-label use);
* Patients suffering from unilateral osteoarthritis or osteonecrosis of a single knee compartment;
* Frontal deformity \< 10° (evaluated on weight-bearing long-axis x-rays);
* Flexion contracture \< 10°;
* Intact ligaments;
* Patients willing and able to provide written informed consent for participation in the study;
* Patient's age over 18 years old;
* Patient with BMI \< 40 kg/m2;
* Patients willing to comply with the pre and post-operative evaluation schedule.

Exclusion Criteria:

* Patients with one or more medical conditions identified as a contraindication in the labelling on any Medacta implants used in this study;
* Any patient who cannot or will not provide informed consent for participation in the study;
* Patients who need a revision surgery;
* Patients who had previously undergone high tibial osteotomy or anterior cruciate ligament (ACL) reconstruction;
* Patients with BMI ≥ 40 kg/m2;
* Patients unable to understand and take action;
* Any case not described in the inclusion criteria.
Study of Attention and Memory Treatments for Cancer Survivors

This clinical trial investigates if certain electronic games may be effective in improving attention and memory function in cancer survivors. Cancer related cognitive impairment (CRCI) is an issue experienced by many cancer patients/survivors. CRCI includes perceived or objective problems with memory, executive function, and attention/concentration. CRCI has a negative impact on survivors' ability to work, carry out routine activities, and engage in social and family relationships. CRCI may result in significant distress and reduced quality of life. Certain electronic games may help improve attention and memory function in cancer survivors and reduce symptoms of CRCI.

PRIMARY OBJECTIVES:

I. Determine the recruitment and retention rates for both arms of this study. II. Determine the effect size for changes in cognitive function (i.e., Test of Variables of Attention (TOVA) \[i.e. attention\], Adaptive Cognitive Evaluation (ACE) \[i.e. working memory\]) in the intervention group compared to the control group following the 4-week study.

III. Evaluate adherence rates for and satisfaction with the interventions. IV. Evaluate for treatment-related adverse events (e.g., nausea, motion sickness).

SECONDARY OBJECTIVE:

I. To determine effect sizes for depression, fatigue, and sleep disturbance, by comparing changes in the intervention group to changes in the control group, following the 4-week study.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients play Endeavor over 25 minutes daily 5 days a week for 4 weeks.

ARM II: Patients play Words! over 25 minutes daily 5 days a week for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Attention Function Index (AFI) score of \< 7.5
* Are able to read, write, and understand English
* Ability to understand an electronic informed consent document, and the willingness to sign it
* Have a Karnofsky performance status (KPS) score of \>= 50
* Have access to WiFi connection

Exclusion Criteria:

* Receiving active treatment for cancer recurrence
* Have significant cognitive impairment
* Have sensory or motor deficits that prevent them from doing the assessment and using the application
Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy

An expanded access/compassionate use protocol that allows access to Mylotarg for relapsed/refractory AML CD33 positive patients in the USA.

Contact: B1761026@iconplc.com

Contact:

B1761026@iconplc.com

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of relapsed/refractory AML (defined as \>=5% marrow blasts by morphology), including MDS, with persisting rising blasts and no other comparable or satisfactory alternative therapy available. If bone marrow has \<5% blasts by morphology but the patient has evidence of relapse with extra-medullary disease progression. In select cases presenting with conversion of MRD from negative to positive, treatment with GO may be allowed where no alternative treatments are feasible.

OR

* Confirmed diagnosis of relapsed or refractory APL with persisting or rising leukemic burden (either by morphology, cytogenetic analysis or by molecular techniques), and no other comparable or satisfactory alternative therapy available.
* Documentation that malignant cells express CD33

  4) Age \>=3 months

  5) Adequate non-hematologic organ function

Exclusion Criteria:

* Untreated AML and MDS or AML and MDS in complete remission.
* Patients with a known history of VOD/SOS.
* Patients with a known hypersensitivity to Mylotarg or its parts: hP67.6 antibody, calicheamicin derivatives or other ingredients.
* Participation in other studies involving investigational drug(s) (Phases 1-4) during study participation.