cyrilzakka/clinical-trials huggingface dataset:
Melphalan in Patients With Neoplastic Meningitis

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of melphalan in patients with persistent or recurrent neoplastic meningitis.

OBJECTIVES: I. Determine the maximum tolerated dose of intrathecal melphalan (L-PAM) in patients with neoplastic meningitis. II. Determine the CSF and serum pharmacokinetics of L-PAM administered via an Ommaya reservoir to these patients.

OUTLINE: This is a dose escalation study. Patients receive melphalan (L-PAM) intrathecally (IT) via lumbar puncture or Ommaya reservoir twice a week for 2 weeks. Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 4 of 6 patients experience dose-limiting toxicity. At least 3 patients receive L-PAM via Ommaya reservoir at the MTD. Patients with objective or significant clinical response may receive additional L-PAM IT once a week for 2 consecutive weeks, every other week for 2 doses, and then monthly thereafter. Patients are followed every 12 weeks for 1 year or until disease progression.

PROJECTED ACCRUAL: A minimum of 3 children and 3 adults per dose level will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed malignancy that is metastatic to the CSF or leptomeningeal/subarachnoid space, including the following: Leukemia Lymphoma Germ cell tumors Persistent or recurrent disease required Cytologic evidence of malignancy in CSF or evidence of leptomeningeal tumor by CT or MRI No obstructive hydrocephalus or complete block of spinal CSF pathways on pre- study MRI or CT No rapidly progressing or deteriorating neurological deficit

PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 60-100% (age 10 and over) OR Lansky 60-100% (age under 10) Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count greater than 1,000/mm3\* Platelet count greater than 100,000/mm3\* \* Lower values allowed with approval of the investigator Hepatic: Bilirubin less than 3.0 mg/dL Renal: Creatinine less than 2 mg/dL Blood urea nitrogen less than 30 mg/dL Electrolytes (including calcium, magnesium, phosphate) normal Other: No active infection Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior systemic chemotherapy within 3 weeks of entry allowed at investigator's discretion At least 3 weeks since prior intrathecal chemotherapy No other concurrent intrathecal chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy to the CNS No concurrent radiotherapy to the CNS Surgery: Not specified
Effects of Rosa Damascena and Frankincense Essential Oils in Labor

This randomized controlled study aims to compare effects of different essential oils in labor pain, anxiety and childbirth comfort. The main questions it aims to answer are:

Is it effective using rosa damascena oil during labor? Is it effective using frankincense oil during labor? Which essential oil is more effective during labor Researchers will compare aromatherapy oils groups to see labor pain, anxiety and childbirth comfort levels of pregnant women.

During childbirth; pain, anxiety, and comfort level of women have a critical importance for a positive childbirth experience. So this study aims to compare the effects of different essential oils on labor pain, anxiety and labor comfort. In some studies, rosa damascena was found effective for labor pain. However, there are limited studies about comfort level and anxiety level of women during labor. So we aimed to investigate whether rosa damascena oil was effective for labor comfort and anxiety level or not. Samely it will be investigated frankincense oil was effective for labor comfort and anxiety level or not. Also which essential oil was more effective during labor will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

- Pregnant women who are at latent phase of labor

Exclusion Criteria:

* Complicated pregnancy (preeclampsia, hypertension, diabetes etc.)
* Women who will have planned cesarean section
* Asthma or any other respiratory disease
* Allergies to Rosa Damascena or Frankincense oil
An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

The purpose of this study was to assess and compare the effect of the repeated usage of 2 different care systems (one hydrogen peroxide based cleaning and disinfecting system and one PHMB containing multipurpose system) with ACUVUE® 2® and AIR OPTIX® AQUA contact lenses worn on a daily wear basis for a 3-month period.

This study was divided into 2 periods, a Screening Phase and an Investigational Phase. During the Screening Phase, subjects were fitted and dispensed with either ACUVUE® 2® (for current hydrogel wearers) or AIR OPTIX® AQUA (for current silicone hydrogel wearers) contact lenses and used COMPLETE® MPS Easy Rub® Formula to clean and disinfect their lenses. At the completion of the Screening Phase, the symptomatic status of the subjects was re-assessed. Those subjects who qualified proceeded to the Investigational Phase and were dispensed with new pair of study contact lenses identical to the lenses they wore during the Screening Phase to use in conjunction with the allocated study care product, CLEAR CARE® /AOSEPT® Plus or ReNu MultiPlus®.

Eligibility Criteria:
Inclusion Criteria:

* Read and understand the Participant Information Sheet;
* Read, sign, and date an Informed Consent;
* Successfully wearing a frequent replacement hydrogel or silicone hydrogel contact lens brand under a frequent replacement (biweekly or monthly) daily wear modality;
* Classified as symptomatic according to protocol-specified criteria;
* Agree to wear study contact lenses as directed for the duration of the study;
* Best corrected visual acuity (BCVA) of 6/9 or better in each eye;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
* Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
* History of seasonal allergies, which may have an adverse impact on contact lens wear, or data and information obtained in this study;
* Systemic disease or use of medication which might interfere with contact lens wear or produce dry eye side effects;
* Ocular allergies or ocular disease which might interfere with contact lens wear or data and information obtained in this study;
* Active ocular infection;
* Use of any concomitant topical ocular medications during the study period;
* Significant ocular anomaly;
* Previous ocular surgery;
* History of recent, significant changes in visual acuity;
* Any medical condition that might be prejudicial to the study;
* Pregnant, planning to be become pregnant, or lactating at time of enrollment;
* Any infectious disease (e.g. hepatitis, tuberculosis), immunosuppressive disease (e.g. HIV), or diabetes;
* Participation in an investigational drug or device study within 30 days of entering study;
* Other protocol-defined exclusion criteria may apply.
A Skills-based RCT for Physical Activity Using Peer Mentors

This approach will train peer mentors to deliver a culturally appropriate intervention and provide social support that is critical for facilitating and sustaining health behavior change. The objective is to compare the efficacy of an innovative healthy lifestyle skills mentoring program (Mentored Planning to be Active \[MBA\]) to a teacher led program (PBA) for increasing physical activity in Appalachian high school teens. MBA emphasizes the social determinants of health by using a social networking approach that trains peer mentors to support targeted teens

The goal of this study is to positively impact the physical activity patterns to improve health outcomes including the high rates of obesity in Appalachian teens. The approach will train peer mentors to deliver the culturally appropriate intervention and provide social support that is critical for facilitating and sustaining health behavior change. The primary objective is to compare the efficacy of an innovative healthy lifestyle skills mentoring program (Mentored Planning to be Active \[MBA\]) to a teacher led program (PBA) for increasing physical activity in Appalachian high school teens. MBA emphasizes the social determinants of health by using a social networking approach that trains peer mentors to support targeted teens. Refined over the course of 3 studies,2-4 PBA is a ten-lesson unit delivered over 10 weeks and designed to teach self-regulation of physical activity among teens. Expanding PBA to mentors via MBA has the potential to promote and sustain adoption of daily regular physical activity through self-regulation of physical activity in discretionary time. With MBA delivery, physical activity is tailored to personal interests, talents, and neighborhood environment. MBA empowers students to plan and evaluate their own personal activity plan. It is predicted that by serving as role models, peer mentors will improve their own lifestyle behaviors, providing a double-edged intervention. It is also predicted that providing intense and structured social support to teens via peer mentors will result in better health outcomes compared to teacher-based support alone (usual care). The plan is to conduct a group randomized controlled trial to evaluate the effects of a culturally and theoretically based behavioral intervention delivered by peer mentors (MBA) on adolescent healthy behaviors (daily physical activity, regular exercise, and sedentary behaviors) and physical health outcomes (BMI, body fat) compared to PBA delivered in a classroom setting by a teacher.

Eligibility Criteria:
Inclusion Criteria:

* 9th or 10th grade students as participants
* 11th or 12th grade students as mentors
* Classroom teachers who instruct health education or physical education to 9th and 10th grade students.
* Not expected to move from school prior to conclusion of study
* Speaks English

Exclusion Criteria:

* Peer mentors with a BMI (for age and gender) above the 85th percentile or below the 5th percentile at the start of the study
Pilot Project of Forest Bathing for Promoting Health

An exploratory trial using a cuasi-experimental design aimed to improve the quality of life of people with intellectual disabilities. The intervention consists of 11 consecutive sessions of forest bathing (one session per week), each one lasting about 2 hours. Each session involves an easy walk through a forest area, interspersed with non-intrusive activities of contact with the surrounding nature aimed at fostering mindfulness and the use of the five senses. Data were collected at baseline, post intervention, and 7 months of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adults with intellectual disability enrolled in a specific occupational center.
* Being informed about the study and having signed the informed consent document.

Exclusion Criteria:

* Having stated their not willing to participate in the study
Interoceptive Training Enhanced Mindfulness

This pilot randomized controlled trial will compare a novel mindfulness training to interoceptive exposure to establish feasibility and acceptability as an intervention for anxiety sensitivity.

Anxiety sensitivity (AS), which involves fear that arousal related symptoms will have negative physical, social or psychological ramifications, is an important driver of anxiety, trauma-related and somatic disorders. Cognitive behavioral therapy (CBT), particularly involving interoceptive exposure (IE; i.e., exposure to unwanted internal sensations), has the greatest demonstrated efficacy at reducing AS but can be hard to tolerate. Conversely, mindfulness is sought out for management of multiple mental health problems, but the observed clinical effects are often modest. A hybrid of these two approaches may capitalize on the strengths of each approach. Mindfulness training (MT) may increase the tolerability of exposure, enhance compliance and support extinction learning through increased engagement with the feared stimulus and heightened awareness of the nonoccurrence of feared outcomes. This project will evaluate the feasibility and acceptability of a novel hybrid intervention, Interoceptive Training Enhanced Mindfulness (ITEM), which combines IE with MT, evaluate its feasibility and acceptability. Forty-eight Veterans will be randomized to receive ITEM or IE in six one-on-one sessions delivered via telehealth. They will complete assessments before and after the 6-week intervention period. Outcomes related to engagement and compliance with ITEM and IE will be the primary focus. Because multiple mental health (e.g., anxiety, posttraumatic stress disorder, eating disorders and depression) and physical health (e.g., chronic pain, conditions related to toxic exposure) problems are driven by maladaptive reactions to interoceptive cues, this intervention has the potential to ultimately produce wide-spread mental and physical health benefits.

Eligibility Criteria:
Inclusion Criteria:

* Veteran status
* able to read and speak English
* ASI-3 score of 23 or higher
* clinically meaningful distress/impairment related to an emotional or somatic complaint as determined by a Clinical Global Impression Scale (CGI) of 4 or greater
* Internet access via a device that can support remote study activities and ability to attend in person appointments

Exclusion Criteria:

* serious mental illness, including bipolar disorder or psychotic illness
* current, untreated alcohol or substance use disorder
* moderate-severe suicidality that would likely result in the need for urgent intervention in the next 2 months
* current regular meditation practice or treatment for AS-related condition
* cognitive dysfunction that interferes with the ability to engage in treatment
Radiological Response of Pancreatic Neuroendocrine Tumors: Comparison Between the Choi and the RECIST Criteria

The Response Evaluation Criteria in Solid Tumors (RECIST), based on differences in tumor size, has been considered as a reproducible method that facilitates not only the measurement of the mass but the evaluation of response to given treatments; while classic chemotherapy induces a reduction of the tumor, new target therapies frequently produce the stabilization of the disease or a delayed progression. These new therapeutic alternatives have shade light on the limitations of the RECIST criteria, since the response to these type of treatments are basically associated with changes on the radiological characteristics of the tumor, as well as other findings in functional imaging.

This study is aimed to compare the response rates according both Choi and RECIST criteria.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a pancreatic neuroendocrine tumor with a Ki67 index \<20%, who accept to participate and sign the consent form. In case of death patients, waiver of consent has been considered.
* Patients who, according daily clinical practice, have been treated with sunitinib between February 2012 to end of inclusion period, with a follow up of at least 6 months.
* Patients with a baseline imaging study (TC with arterial phase) and, at least, a 6-months follow-up evaluation. Patients with progression or exitus before the first imaging evaluation will not be included.

Exclusion Criteria:

* Patients with a follow-up of \<6months because of any other cause beyond progression of disease or exitus.
* Patients without a baseline radiological evaluation or at 3/6 months.
* Patients who do not accept to participate in the study.
* Patients with anti-angiogenic treatment within 3 months prior to the start of sunitinib treatment.
* Patients treated with sunitinib plus any other anti-proliferative agent beyond ASS.
CARA Treatment Pilot Study for Breast Positioning

CARA is a novel Carbon-fibre Adjustable and Re-usable Accessory for supine breast positioning during radiation therapy. CARA was developed at BC Cancer. In this study, twenty patients will be planned and treated with CARA positioning to establish safety and workflow measures of this novel device. The device is designed to remove the infra-mammary skin fold and lateral breast droop which can lead to unwanted dose to normal tissue.

This pilot study will investigate the safety and potential benefits of CARA breast positioning by treating 20 patients using the device. Patients will be planned with CARA positioning and standard of care positioning. CARA plans will be evaluated to ensure all treatment planning goals are met and patients will proceed to treatment with CARA positioning. This pilot study will ensure that patients can be safely treated with the CARA and provide us with valuable information from therapists, oncologists and patients about the performance of the current design. This will also inform the direction of design improvements and the production of educational materials for training practitioners in the use of the device. Overall, this will prepare us for a randomized clinical trial of the CARA positioning technique versus current standard of practice to assess whether reduced toxicity can be achieved using the CARA technique.

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with completely excised stage I or II invasive breast cancer, or ductal carcinoma in situ (DCIS), who have undergone breast-conserving surgery and are scheduled to undergo adjuvant breast radiotherapy;

Any breast size with a skin fold of depth 1 cm or greater at the infra-mammary crease at the time of radiation treatment planning, or brassiere cup size equal to or larger than D;

Patients undergoing nodal radiotherapy are eligible if the above criteria are met;

Patients undergoing boost radiotherapy are eligible if the above criteria are met, but only if the surgical scar does not extend inferior to the nipple line of the breast;

Language is not a barrier if there are interpreters/family members to translate;

Patients having had chemotherapy are eligible for this study;

Exclusion Criteria:

Inability to give informed consent or comply with requirements of the trial;

Failure of healing of the surgical scar or significant post-operative wound infection;

Prior radiotherapy to either breast or to the chest;

Presence of significant connective tissue disease (e.g. systemic sclerosis); known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia);

Inability to return for assessment at both one week and two weeks following completion of radiotherapy;

Breast reconstruction;

Use of Mepitel® wound dressing product.
Modified Diabetes Prevention Program in Ecuador

This pilot study will evaluate the use of a modified (cultural and language) adaptation of the National Diabetes Prevention Program in a cohort in Quito Ecuador.

This pilot study will evaluate the use of a modified (cultural and language) adaptation of the National Diabetes Prevention Program in a cohort in Quito Ecuador. People who took the program had the option to participate in the research component. All participants selected the research component.

Adaptations- the coaches will be physicians from PUCE and they will administer this program for eligible employees who have biochemical prediabetes.

The program will be modified to be able to fit within the school curriculum. The diabetes prevention program will be offered in Spanish and the content modified to better fit the cultural norms for the Quito Ecuador population.

Participants will be adults with prediabetes as screened by the CDC Diabetes Risk Test and confirmed by HbA1c.

Outcome measures will include change in mean HbA1c, change in weight, physical activity, and attendance to the program.

Eligibility Criteria:
Inclusion Criteria: Adults who worked at the university and had biochemical prediabetes.

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Exclusion Criteria: Those with known diabetes, those unwilling to complete a 6 month intervention.

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Modulating Neuropathic Pain With Transcranial Direct Current Stimulation

This study will examine whether a form of non-invasive brain stimulation can help reduce pain in people with persistent neuropathic pain.

This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of three groups by chance. Two groups will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Have chronic (\>12 months) neuropathic pain, including but not limited to complex regional pain syndrome, phantom limb pain, or pain of neurogenic origin following spinal cord injury

Exclusion Criteria:

* History of seizures or epilepsy
* Addition or change in the dosage of drugs now to interfere with pain within 1 month of enrollment
* Untreated depression
* History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness
* Positive pregnancy test or being of childbearing age and not using appropriate contraception
* Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain
Interactions Between Drug Effects and Environments II

The purpose of the study is to determine how associations between drugs and the places where they are experienced influence drug seeking, mood and acute drug responses.

Learned associations between drug effects and the people, places, and paraphernalia (cues) linked with drug experiences are a major barrier to the treatment of drug addiction. These links are remarkably persistent and can cause relapse to drug taking even after long periods of abstinence. They are also key features in some of the foremost theories of addiction, yet there is little clinical evidence of how these associations are formed and how they come to profoundly control behavior. The long-term goal of this research is to understand how drug cues become powerfully linked with drug experiences and their influence on mood and behavior. In the proposed project, the investigators will use a de novo conditioning paradigm to examine the influence of drug contexts on drug seeking, mood and acute drug responses. The hypothesis is that drug-paired contexts gain motivational salience, induce approach, and alter acute subjective responses to the drug.This knowledge will lead to novel treatment strategies to counteract the effects of drug cues on mood and behavior, and also to prevent relapse.

Eligibility Criteria:
Inclusion Criteria:

* past use of stimulants
* bmi 19-26
* hormonal birth control for women

Exclusion Criteria:

* current or recent (Past year) history of major axis I disorder