cyrilzakka/clinical-trials huggingface dataset:
Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma

Oral clofarabine is related to two intravenous chemotherapy drugs used for this disease and works in two different ways. It affects the development of new cancer cells by blocking two enzymes that cancer cells need to reproduce. When these enzymes are blocked, the cancer call can no longer prepare the DNA needed to make new cells. Clofarabine also encourages existing cancer cells to die by disturbing components within the cancer cell. This causes the release of a substance that is fatal to the cell.

This trial studies the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin lymphomas.

* Each treatment cycle lasts four weeks during which time the participant will be taking study drug for the first three weeks only. Participants will be supplied with a study medication-dosing calendar for each treatment cycle.
* Clofarabine is a tablet that will be taken orally in the morning once daily on days 1 through 21 of each 28-day cycle. Participants can receive up to a total of 6 cycles if they do not experience any unacceptable side effects and if their cancer does not get worse.
* The following tests and procedures will be performed at specified intervals through out the treatment period: blood tests, physical examinations, vital signs, radiological exams and urine tests.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed relapsed or refractory NHL that includes: follicular lymphoma of any grade; marginal zone lymphoma; small lymphocytic lymphoma/chronic lymphocytic leukemia; mantle cell lymphoma; lymphoplasmacytic lymphoma; low-grade B-cell lymphoma not otherwise specified; diffuse large B-cell lymphoma, anaplastic large cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma.
* One or more prior line of chemotherapy, immunotherapy, or radioimmunotherapy.
* Measurable disease on cross sectional imaging of at least 2cm.
* ECOG Performance Status 0-2
* 18 years of age or older
* Life expectancy of greater than 3 months
* Normal organ and marrow function as outlined in the protocol
* Must agree to use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria:

* Patients who have had chemotherapy, rituximab, or radiotherapy within 4 weeks, or radioimmunotherapy within 8 weeks prior to entering the study
* Receiving any other investigational agent
* Known brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Clofarabine
* Systemic fungal, bacterial, viral, or other infection not controlled
* Pregnant or lactating
* Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for over one year
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Prior allogeneic stem cell transplantation
Family Spirit Strengths

This project addresses the disproportionate morbidity and mortality associated with mental and behavioral health problems in American Indian and Alaska Native communities. Access to culturally competent and effective behavioral health services is limited in many of these communities. The investigators aim to address this gap by testing the effectiveness of a trans-diagnostic secondary prevention program, Family Spirit Strengths (FSS) that can be embedded within home visiting services. The FSS program is a skills-based program that incorporates elements of evidence-based practice, the Common Elements Treatment Approach (CETA), and materials informed and developed based on an Indigenous advisory group. The FSS program aims to help participants build self-efficacy and coping skills, as well as build stronger connections to others, the participants' community, and cultural resources. The investigators will use a randomized controlled trial, whereby half of the participants will receive FSS and the other half will receive an evidence-based nutrition education program. The investigators' study is grounded in participatory processes and led by a team of Indigenous and allied researchers.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as female; and
* Pregnant or be a primary caregiver of a child that is 24 months or younger; and
* 14 years or older at time of enrollment; and
* Report a family history of high-risk substance use and/or report high-risk levels of personal substance use; and
* Have elevated symptoms of depression and/or anxiety and/or risk of substance use disorder; and
* Be part of the service population of one of the participating sites.

Exclusion Criteria:

* Profound disability that limits the ability to participate in assessments or interventions; and
* Unlikely to be residing in or near the research service area for the next 6 months.
Influence of Head Positioning on the Movement of the Endotracheal Tube

The purpose of this study is to evaluate and measure the movement of the endotracheal tube depending on the type and the amount of movement of the head of the patient intubated using a flexible fiberoptic.

We performed a maximal head-neck movement trial on 50 adult patients, American Society of Anaesthesiologists 1 or 2. Patients with body mass index N35 kg · m-2, height b150 cm, airway malformations, pulmonary diseases, difficulties in neck flexion or extension, previous ENT surgery or radiotherapy, gastroesophageal reflux, or dental instability were excluded from the study.

We measured the change in distance between the ETT tip and the carina, using a fiberscope through the ETT.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 16 years
* ASA 1-2
* Elective surgery

Exclusion Criteria:

* Pathological changes of the trachea.
* Less than BMI 35 kg/m2.
* Patients with rheumatoid arthritis or other limitation to cervical mobility.
* Emergency surgery.
* Individuals measuring less than 150 cm.
Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis

This study is designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of chronic pain. Participants will be patients with Multiple Sclerosis suffering from chronic pain of neurological origin.

On the one hand, Multiple Sclerosis (MS) is the most frequent chronic disease generating neurological disability in young adults. Among the many types of disabilities associated with MS, chronic pain is very frequent, especially neuropathic pain. This type of pain is often treatment resistant. Moreover, abnormal intra-cortical excitability has been described in MS patients.

On the other hand, repetitive Transcranial Magnetic Stimulation (rTMS) has shown an analgesic effect in various chronic pain conditions (fibromyalgia, post-stroke, peripheral neuropathic pain). Three groups have shown that analgesia was correlated to defective intra-cortical excitability restoration.

The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation.

Patients will benefit from 1 daily session per day for 5 consecutive days and from a total follow up of 4 weeks. Pain will be assessed each day and several other signs and symptoms will be repeatedly assessed.

Eligibility Criteria:
Inclusion Criteria:

* relapsing-remitting Multiple Sclerosis
* 18 to 60 years
* central neuropathic pain with a DN4 score of 4 or more out of 10
* average pain of at least 4/10
* presence of pain at least 4 days per week
* presence of pain for at least 3 months
* stable analgesic treatment

Exclusion Criteria:

* relapse during the previous 30 days
* contraindication for rTMS
* peripheral neuropathic pain
* severe depression
* epilepsia
* resting motor threshold above 75%
Polytrauma and Resuscitation Impact on Innate Immunity

Major trauma can lead to a dysregulated response to secondary infection. Severe injuries are accompanied by pro- and antiinflammatory changes that affect both adaptive and innate immunity. In this study we aim to assess cellular immuno-competence early during treatment in an attempt to identify signs of immuno-suppression.

Polytrauma represents one of the most challenging critical conditions for caretakers worldwide and involves multiple damages of different anatomical regions. Severe traumatic injuries are among the primary causes of death among young people under the age of 45 and half of them are due to uncontrollable bleeding. In the acute injury phase of trauma, severe blood loss is often accompanied by biochemical, cellular and physiological dysfunctions leading to an inflammatory response, infections and in some cases coagulopathy. We aim to identify immuno-suppression by analyzing phagocytic capacity, leukocyte subsets, surface molecule expression and extracellular vesicles in the peripheral blood of severly injured patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Injury Severity Score (ISS) \> 15
* Incident to admission time \< 3h

Exclusion Criteria:

* Preexisting condition
* Pregnancy or breastfeeding
* Diabetes
* Coronary Heart Disease
* Intake of antiphlogistic medication
* Neoplasm
Long-Term Follow-Up Study of Patients With Osteoarthritis of the Knee Treated With UBX0101 or Placebo

A follow-up study to assess the long-term safety of intra-articular (IA) administration of UBX0101 in patients with painful knee osteoarthritis (OA).

This is a blinded, multi-center study to provide approximately 1 additional year of follow-up for patients with knee OA who participated in a randomized placebo-controlled study of IA UBX0101. No intervention is planned and patients will have 4 scheduled visits to collect follow-up assessments. The primary objective is to evaluate long-term safety and tolerability of IA administration of UBX0101 in patients with painful knee OA.

Eligibility Criteria:
Inclusion Criteria:

* Patients with knee OA who have completed a randomized placebo-controlled study of UBX0101.
* Patients who are willing and able to consent to having blinded, long-term follow-up; consent via legally authorized representative is not accepted.

Exclusion Criteria:

* Patients with any condition that, in the opinion of the Investigator, would likely interfere with adhering to the study schedule of visits for 12 months.
* Patients who are scheduled to undergo knee arthroplasty on either knee during the study.
* Patients who anticipate arthroscopic surgery on either knee at any time during the study.
* Patients who plan to receive treatment with an anti-nerve growth factor agent during the study.
* Patients who plan to participate in another investigational study (including interventional studies of investigational drugs and investigational treatments \[e.g., braces, stem cells, and procedures\]) during the study.
Effect of Dalfampridine in Patients With Hereditary Spastic Paraplegia

There are limited but encouraging results supporting the use of dalfampridine in patients with hereditary spastic paraplegia. The investigators aimed to investigate the effects of dalfampridine on walking speed, muscle length, spasticity, functional strength, and functional mobility in patients with hereditary spastic paraplegia. In this triple-blinded, randomized, placebo-controlled trial, 4 patients with hereditary spastic paraplegia received dalfampridine (10 mg twice daily) plus physiotherapy (2 times per week), and 4 patients received placebo plus physiotherapy for a total duration of 8 weeks. The assessor and treating physiotherapists, and patients were masked to the group allocation. The primary outcome was Timed 25-foot Walk Test at the end of the 8-week treatment. The secondary outcome measures were functional mobility, functional muscle strength, muscle length, and spasticity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hereditary Spastic Paraplegia at least 1 year ago

Exclusion Criteria:

* Having another neurological disorder
* An orthopedic deformity in the lower extremity
* Having a serious cognitive impairment
Improving Physician Vaccine Recommendation Using Social Norms, Trust, and Presumptive Language

This research examines vaccination recommendation perceptions and behaviors of physicians and advanced practice providers.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be physicians, advanced practice providers, medical students, nurses/nurse practitioners, or medical fellows.
* Must be in a position to be authorized to recommend vaccines to patients in their official professional capacities/responsibilities.

Exclusion Criteria:

* Students or employees under the supervision of the PI who meet inclusion criteria for the study
Efficacy of Transcranial Direct Current Stimulation for Severe Primary Dysmenorrhea

Primary Dysmenorrhea (PDM), defined as menstrual pain without discernable organic causes, is inexorably common in adolescent women, about 40-90% of women may suffer from it, and 20% of them can be severe in the context of being refractory to medication, daily function impairment, and having pain of severe degree. Novel therapeutic method is in need for pain alleviation for this particular phenotype. We have previously reported that PDM females may engage motor-cortex based descending pain modulation system in our resting-state functional Magnetic Resonance Imaging (rs-fMRI) and thermal pain-activation fMRI studies. Based on the reported analgesic efficacy of transcranial Direct Current Stimulation (tDCS) on the motor cortex for various experimental painful conditions and clinical pain disorders, we reason that tDCS can be effective for the severe and medication-refractory PDM patients. This study aim to investigate the analgesic efficacy of tDCS in severe PDMs and to elucidate the dynamic brain neuroplasticity in the context of functional connectivity (FC) of pain matrix after tDCS intervention. We will recruit 30 severe PDMs and randomly allocate them to either real or sham group in a triple-blind manner. rs-fMRI for functional connectivity analysis will be performed before and after the tDCS intervention. The imaging data will be correlated with behavioral and psychological measurements. This is the first study in the literature investigating the tDCS efficacy for severe PDM. The result can promise a new possibility for clinical application.


Eligibility Criteria:
Inclusion Criteria:

* 20-35 years old PDM patients
* Right-handedness
* A regular menstrual cycle: 27-32 days
* Cramping pain during the menstrual period in the last 6 months , VAS ≧ 7
* Abstinence for daily activities due to PDM
* Need analgesic or Physical therapy despite of no prominent effect

Exclusion Criteria:

* History of head injury
* Pathological pituitary gland disease
* Organic pelvic disease, psychiatric disorder
* Pregnancy, childbirth
* A metal or pacemaker implant.
* Take hormone agents within 6 months
Atrial Fibrillation Recurrence in Sleep Apnea

This randomized, controlled trial is designed to test whether treatment of sleep disordered breathing (SDB) with positive airway pressure (PAP) therapy alters the natural history of atrial fibrillation (AF). Patients with recent AF who are now in sinus rhythm, and found to have SDB (obstructive and/or central sleep apnea) by formal sleep study but without complaints of daytime sleepiness, are randomized to PAP therapy to eradicate SDB or to usual care (medical management as prescribed by the patient's cardiologist).

Sleep apnea is a common disorder which is increasingly implicated in the pathogenesis of cardiovascular disease. Observational data suggest that sleep apnea may play a role in the development of atrial fibrillation (AF), and may even predispose to recurrence of AF following electrical cardioversion (DCCV). Because of biases and confounders inherent to observational studies, we propose a randomized clinical trial to assess the effects of treatment of sleep apnea in subjects with AF treated with DCCV. Following polysomnography, subjects with sleep apnea will be randomized to positive airway pressure (PAP) or usual medical care and followed for up to one year to compare a primary outcome of AF recurrence rate.

Eligibility Criteria:
Inclusion criteria:

1. Age \>18 yrs
2. Successful electrical or chemical cardioversion within previous 2 weeks
3. Greater than 2 episodes symptomatic AF in previous 6 months

Exclusion criteria:

1. Currently on PAP therapy
2. Moderate to severe pulmonary disease
3. Neurologic impairment (h/o cerebrovascular accident (CVA), transient ischemic attack (TIA), neuromuscular disease, diaphragmatic paralysis)
4. Severe cardiac disease (LVEF\<40%, greater than mild to moderate valvular disease)
5. Post cardiac surgery AF
6. Congenital heart disease
7. Renal disease (Scr \> 2.5)
8. Excessive ethanol (EtOH) use (\>2 drinks/day)
9. Anatomically fixed nasal obstruction (severe septal deviation, uncontrolled rhinitis)
10. History of motor vehicle or occupational accident related to sleepiness.
11. Epworth Sleepiness Scale score \>18 (out of maximum score of 24).
Non Ablative Fractional Laser Treatment of Burn Scars

BACKGROUND: Increasing evidence appears for non-ablative fractional laser (NAFL) to remodel mature burn scars.

OBJECTIVES: To investigate long-term clinical and histological appearance of mature burn scars after NAFL-treatment.

HYPOTHESIS: That NAFL can modulate mature burn scars with subsequently improved cosmetic and functional appearance.

METHODS: Study patients with burn scars at trunk or extremities. Side-by-side test areas are randomized to three monthly 1,540 nm NAFL-treatments or control, followed by blinded evaluations at 1, 3, and 6 months using mPOSAS (modified Patient and Observer Scar Assessment Scale; 1 = normal skin, 10 = worst imaginable scar).


Eligibility Criteria:
Inclusion Criteria:

* legally competent adults aged 18-60 years
* Fitzpatrick skin type I-III
* burn scar 1 year or older
* total scar area allowing selection of two similar side-by-side test areas of minimum 1.5 × 3 cm for study purpose

Exclusion Criteria:

* pregnancy or lactation
* suntan
* wounds or infections in study area
* tendency to form hypertrophic scars or keloids
* oral retinoids, anti-inflammatory or immunosuppressive drugs within the last six months
* current anticoagulants
* previous treatments in test area with laser, Intense Pulsed Light, dermabrasion, chemical peel or filler.
Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties

The study hypothesis is that some children with Attention-Deficit-Hyperactivity-Disorder (ADHD) who also have sleep onset difficulties will improve with Melatonin treatment to an extent similar to that of stimulants treatment.

In order to check this hypothesis children with a new ADHD diagnosis who also have sleep difficulties will be treated with either Melatonin or with stimulants (Methylphenidate) for one month. The main outcome will be improvement of the ADHD symptoms.


Eligibility Criteria:
Inclusion Criteria:

* children 6-18 years old with a new ADHD diagnosis who are candidates for treatment with stimulants
* Also they suffer from sleep onset insomnia or difficult awakening

Exclusion Criteria:

* Drug treatment for ADHD or for sleep problems in the last 6 months
* Any other chronic medical treatment
* Sleep disorder requiring a different treatment
* Asthma in the last 2 years
The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation

All the data of patients with patellar dislocation will be collected to evaluate the anatomic deformities. The data includes X-ray, CT, MRI examinations, medical records, and physical examination information. Finally, we correlate the anatomic deformities with clinical efficacy. To search for the risk factors that lead to patellar dislocation and influence the therapeutic effect.


Eligibility Criteria:
Inclusion Criteria:

-Patients with patellar dislocation.

Exclusion Criteria:

* Patients with significant ligamentous knee injury.
* Previous fracture or surgery of the lower limb.
* Patellar dislocation caused by car accidents or other high-energy force directly on the patella.
Study to Improve Scientific Understanding of the Cardiovascular Actions of Cocaine

The purpose of this study is to improve the scientific understanding of the cardiovascular actions of cocaine, in particular the ability of cocaine to increase blood pressure.

Cocaine abuse has emerged as a major cause of life-threatening cardiovascular emergencies but our understanding of the underlying mechanisms mediating the adverse effects of cocaine is far from complete. Our previous studies in cocaine-naive human subjects have demonstrated that intranasal cocaine acutely stimulates the human cardiovascular system by a novel central mechanism of action.We are currently investigating a central sympatholytic drug,dexmedetomidine, in reversing the sympathomimetic effects (increase in blood pressure, heart rate and coronary vasoconstriction) of intranasal cocaine.This drug may be a new pharmacologic agent in the treatment of acute cocaine intoxication in humans.

Eligibility Criteria:
Inclusion Criteria:

* Cocaine naive healthy volunteers

Exclusion Criteria:

* Any evidence of cardiopulmonary disease by history or physical examination
* History of hypertension or 24 hour blood pressure averaging \>135/85 mmHg
* Any history of substance abuse (other than tobacco)
* Diabetes mellitus or other systemic illness
* Individuals with a history of pseudocholinesterase deficiency
* Pregnancy