cyrilzakka/clinical-trials huggingface dataset:
PinPointe FootLaser for the Treatment of Onychomycosis

To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.

The study is a multi-center controlled study evaluating laser treatments of infected great toes in a randomized blinded study of approximately 125 subjects. Right and left great toes are randomized to treatment or no treatment. Samples from infected areas are sampled and evaluated for presence of fungus with KOH, PCR and culture tests. Nail bed clearing and nail plate growth are measured from high resolution photographs by a blinded evaluator. Subjects will be evaluated at baseline and at 8, 16, 24 and 48 weeks for safety and effectiveness of study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers of either sex,
* 18-80 years of age,
* Both great toes with clinical signs of infection.
* Positive KOH or culture test

Exclusion Criteria:

* Existing or history of cancer/skin malignancy,
* Use of oral antifungal agents in past 6 months,
* Use of topical antifungal agents in past 1 month,
* Loss of protective sensation in either foot,
* Infection involving lunula of either great toe,
* Longitudinal streaks/spikes of either great toenail,
* Distal nail thickness \> 2 mm of either great toe,
* Prior surgical treatment of either great toe in past 12 months,
* Participation in another medical device/pharmaceutical study,
* Condition that investigator determines makes it unsafe for subject to participate,
* Pregnancy, breastfeeding or plans to become pregnant.
Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants

This study will explore the a Qigong based exercise intervention, here referred to as Meditative Movement (MM), to ameliorate the symptoms associated with chronic obstructive pulmonary disease (COPD) and its co-morbidities. It tests the hypothesis that MM will have a beneficial effect on COPD in FA, particularly on functional ability, respiratory symptoms, affective state, inflammation, and autonomic imbalance. If the hypothesis is correct, MM could be rapidly and inexpensively taught to FA with COPD and other COPD patients to slow degeneration and improve quality of life.

The study has three phases.

Phase 1 will identify the best MM practices and their impact on a test group of affected FA. Phase 2 will develop a video to apply what is learned in Phase 1 to a larger group of affected FA, and will document the resulting impact on various aspects of pulmonary dysfunction and its comorbidities. Phase 3 is to refine the protocols and methods developed in earlier phases.

Phase 1: To identify the best set of MM exercises for improving COPD-related symptoms. This will be done by conducting a 12-week in-person MM program that will be held in one or more locations in the Northeastern region of the US and possibly other regions of the country.These training sessions will be used to determine precisely which MM exercises are most appropriate for this group. Selection will be based on professional judgment, participant feedback, and objective pre- and post-intervention measurements taken at the beginning and end of the 12-week program.

Phase 2: To use an RCT to evaluate the effectiveness of the exercises selected in Aim 1, as delivered by video only. We will design and produce an instructional DVD based on the findings in Aim 1.In the RCT we will test the hypothesis that targeted MM training and practice using the DVD alone will improve QOL, exercise tolerance, autonomic balance and pulmonary function, and reduce fatigue, in flight attendants with a COPD diagnosis. Pre- and post-intervention measurements will be compared, and to outcomes from a control group of flight attendants who will be wait listed for later participation in the study.

Phase 3: The videos used to train subjects in Phase II will be refined and the order of introduction of training modules will be adjusted. Efficacy will again be tested in newly recruited subjects. This is also a RCT.

Eligibility Criteria:
Inclusion Criteria:

* Occupation as a flight attendant for at least 5 years
* No history of significant tobacco use
* Occupational controls

Exclusion Criteria:

* Inability to give consent
* History of tobacco habituation
Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival \[PFS\], disease control rate, best response rate, time to treatment failure \[TTTF\], overall survival \[OS\] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is of nonsquamous histology and not amenable to curative therapy.
* Failure of previous treatment with one prior platinum-based chemotherapy regimen.
* Good performance status.
* Adequate bone marrow reserve, renal and hepatic functions.

Exclusion Criteria:

* Serious concomitant systemic disease.
* Inability to take oral medication.
* Inability or unwillingness to take vitamin supplementation and corticosteroids.
* Pregnancy / Breast-feeding.
* Treatment with certain medicines that prevent blood from clotting.
Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease

Small exploratory pilot study to assess effects of a transcutaneous vibro-acoustic therapy device (Apollo Neuro) in people with Parkinson's disease (PD).

The overarching goal of this study is to investigate changes in anxiety, nighttime heart rate variability, and fear of falling in people with PD before and after 3-months usage of a transcutaneous vibro-acoustic therapy device. Positive findings in this small exploratory pilot trial may support future studies of transcutaneous vibro-acoustic therapy for individuals with PD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson's Disease (Hoehn and Yahr stage 2 or higher)
* Individuals on or off dopaminergic therapy
* Present of anxiety or panic disorder
* Fear of falling
* Understanding of use and care of smart phones and devices

Exclusion Criteria:

* Presence of significant dementia
* Disorders which may resemble PD, such as dementia with Lewy bodies, vascular dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism.
* Patients with a cardiac pacemaker
* History of brain surgery or placement of a deep brain stimulator
* Psoriasis vulgaris (or other inflammatory skin condition) on or near skin where the vibro-acoustic device and sleep tracking ring will be donned.
* Patients on beta-blockers, benzodiazepines, antipsychotics, and stimulants (except for the treatment of attention deficit disorder/ADHD).
* Pregnancy
* Patients who begin cognitive behavioral therapy or a selective serotonin reuptake inhibitor (SSRI) medication for an anxiety disorder or other psychiatric disorder after the baseline clinical assessment.
Descriptive Observational Study of the Evolution of the Lifestyle Alteration in Patients With Breast Cancer

Scientific context: With more than one million cases per year, breast cancer is the most common female cancer. All treatments such as surgery, chemotherapy, radiotherapy or hormone therapy lead to major changes patients' lifestyle. These treatments can lead to a decrease of physical activity due to fatigue and also changes in the diet. Sometimes, chemotherapy induces nutritional aversions and can cause weight gain that is known to increase the risk of recurrence. Cognitive complaints are also frequent, in particular in patients who received chemotherapy and can also lead to quality of life's alteration

Fatigue assessed with prevalence between 70 % and 100 % is usually a part of a series of symptoms including anxiety, depression, pain, sleep disturbance, decreased activity level, nutritional changes and pre-existent comorbidities. These symptoms can lead to an alteration of the quality of life. The chemotherapy involves disturbances at physiological, psychological and social levels and eating disorders leading to changes in eating habits which can lead to weight loss or weight gain. To limit these deleterious changes in lifestyle, increased physical activity, specialized counseling and nutritional monitoring may be recommended.

According to current knowledge there is no prospective study that evaluated different lifestyle changes according to different types of patients and the appearance of the installation of these symptoms during the patient pathway.

Research hypothesis: the study hypothesis is that description of the evolution of the quality of life and, physical, nutritional and cognitive parameters in a population of patients with non-metastatic breast cancer will better characterize these patients in order to propose an appropriate and personalized rehabilitation intervention.The investigators propose this feasibility study consisting of 2 cohorts of patients according to the adjuvant therapy given (+/- chemotherapy) after the primary breast surgery.


Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 65 years old
* Breast invasive or in situ cancer (all histology), unilocal or multilocal tumor
* Treatment by first surgery and adjuvant radiotherapy validated at the multidisciplinary consultation meeting with +/- adjuvant chemotherapy (all chemotherapy)
* Patient reading and understanding the French language
* Non-opposition of patient

Exclusion Criteria:

* Patient with a history of treated breast cancer
* Presence of metastasis
* Other cancer or severe disease under evaluation or treatment at baseline (to avoid selection bias)
* Patient with psychiatric disorders
* Patient under protection status
* Pregnant or nursing women or absence of contraception in a patient of childbearing age

Withdrawal Criteria :

- Other cancer or severe illness diagnosed during the study
Casting Vs Bracing for Idiopathic Early-Onset Scoliosis

Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis

This study uses a multicenter, prospective hybrid research design, which will combine two methods of treatment assignment (randomized and parent preference) and an embedded internal pilot study for sample size re-estimation. Patients will be treated either with serial casts or a full-time brace and followed until curve resolution, failure or palliation (neither resolution nor failure after 2 years of treatment). Results of this study will provide clinicians and families with evidence to support informed treatment decisions.

Eligibility Criteria:
Will enroll both patients with scoliosis and 1 of their parents/guardians

Inclusion Criteria:

Patient Inclusion

* Diagnosis of idiopathic early-onset scoliosis
* Child standing independently but not older than 3 years of age
* 20≤ Cobb angle ≤70° (largest structural curvature)
* Rib-vertebral angle difference (RVAD) greater than 20 degrees or Rib Phase II
* Parental consent to participate

Parent Inclusion

* Parent or guardian of the minor subject
* Consent to participate
* Able to complete surveys

Exclusion Criteria:

Patient Exclusion

* Previous operative or non-operative treatment for idiopathic early-onset scoliosis
* Not independently walking by 18 months of age or other signs/symptoms indicative of developmental delay
Study of Magnetic Brain Stimulation in Treatment of Obsessive Compulsive Disorder

In a preliminary pilot study, the investigators tested the efficacy of rTMS over the medial prefrontal cortex in symptom profiles of obsessive compulsive disorder (OCD) patients. This study revealed considerable benefit in using rTMS for the treatment of OCD.

In the current proposal, in a randomized clinical trial, the investigators aim to further evaluate the efficacy of rTMS in OCD in a larger sample size and for a longer period. Studies into the efficacy of rTMS in other psychiatric disorders such as depression have consistently shown that extension of the treatment to four weeks significantly increased the effect size. In the pilot study, the investigators applied rTMS for only two weeks. Although all patients consistently showed improvement in their symptoms, none of them showed complete remission of their OCD. Here, the investigators hypothesize that longer duration of rTMS treatment will have greater benefit in OCD symptom reduction.

The purpose of study is to examine the efficacy of rTMS over the medial prefrontal cortex in the treatment of OCD.

rTMS will be provided to OCD patients in a randomized double blind controlled setting, and the investigators hypothesize that in this setting the treatment group would still show significant improvement in OCD symptoms as compared to the sham group.

rTMS will be applied for four weeks on OCD patients and the investigators will assess improvement after four weeks of rTMS. The investigators hypothesize that patients will show significantly greater improvement after four weeks of rTMS vs. two weeks of rTMS.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed obsessive compulsive disorder
* Not currently receiving cognitive behavioural therapy
* Not currently on any medication or only taking one selective serotonin reuptake inhibitor (SSRI)

Exclusion Criteria:

* History of psychotic episodes
* History of neurological illness
* Previous head injury
* Active alcohol or substance abuse
* History of seizure disorders
* Currently pregnant
Antitumor T Cell Responses in Patients With Bladder Cancer

The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing transurethral resection of the bladder (TURBT) for a tumor detected by cystoscopy with a histological diagnosis of a non-infiltrating or muscle-infiltrating tumor
* For muscle-invasive tumors: localized tumors (T2-T3N0M0) or locally advanced (T4N0M0)
* Written informed consent

Exclusion Criteria:

* History of TURBT for a bladder tumor whatever the stage
* Stages N1-3 or M1 on initial assessment
* Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
* History of cancer in the last 3 years other than basal cell carcinoma or non-invasive cervical cancer
* HIV, hepatitis C or B infection
* Patients with any medical or psychiatric condition or disease,
* Patients under guardianship, curatorship or under the protection of justice.
the Efficacy and Safety of Sugammadex in Children 0-2 Years Old

Sugammadex is a selective antidote to muscle relaxants rocuronium bromide and vecuronium bromide. Sugammadex is a modified gamma-cyclodextrin, a compound that selectively binds rocuronium bromide and vecuronium bromide. It forms a complex with them in the blood plasma, which leads to the decrease in the concentration of muscle relaxant binding to nicotinic receptors in the neuromuscular synapse. The result is the the elimination of neuromuscular blockade caused by rocuronium bromide or vecuronium bromide. Sugammadex is used to eliminate neuromuscular blockade caused by rocuronium bromide in children aged 2 years and adolescents in standard clinical situations. The aim of the study is to prove the efficacy and safety of sugammadex in children under 2 years

Nowadays muscle relaxants are widely used in pediatric practice, but their use is fraught with numerous risks and complications. The main ones are the residual neuromuscular block and the possibility of developing a recurrence in the patient. In connection with this, the development and introduction into practical anesthesiology of new, more effective drugs for arresting the action of muscle relaxants is still relevant.

One of the them, sugammadex was recently introduced into clinical practice and provided a fundamentally new approach to the recovery of neuromuscular conduction. Often, children under two years of age need general anesthesia for MRI (prolonged stay in the device, apnea to get a high-quality image without respiratory artifacts, severe pain syndrome, severe neurological deficit, etc.). The aim of the study is the evaluation of the efficacy of sugammadex, estimated by restoring neuromuscular conduction within 0-120 seconds after bolus administration, and the safety and tolerability of sugammadex in children under two years of age. Children will be observed in the hospital during 24 hours. A group of patients from 2 to 18 years of age, in whom the drug sugammadex is used as standard therapy will be taken as a comparison group .

Eligibility Criteria:
Inclusion Criteria:

* Children 0 to 2 years (0 - 24 months, inclusive) in the study group; children from 2 to 18 years in the comparison group (control group)
* Patients with malignant neoplasms of the liver, malignant neoplasms with metastatic liver damage, beta-thalassemia
* Informed consent of the patient and / or parents or trustee of the patient

Exclusion Criteria:

* kidney failure
* liver failure
* critical conditions
* septicemia
* severe and decompensated diseases of the cardiovascular system
* refusal of the patient and / or his parents or trustee to participate in the study.
Pain Relief Intervention of Meditation in Renal Disease (PRIMER)

Kidney Disease subjects will be recruited to take part of a mindfulness-based stress reduction intervention for 8-10 sessions. All subjects will complete a baseline interview, one follow-up at 3 months and the close out interview at 5 months.

Kidney Disease subjects will be recruited from multiple locations within the Rogosin Institute Dialysis Center to take part of a mindfulness-based stress reduction intervention. The intervention consists of meet with a researcher and/or research assistant on a weekly basis. Dialysis patients will receive the intervention individually while on dialysis. Dialysis is an optimal time for conducting interventions as patients are there for 3-4 hours every 3 days. For 8-10 weeks (which will begin the week after the baseline interview). Chronic Kidney Disease (CKD) patients will receive the intervention in group setting. Key components of what the intervention consists relate to stress management, breathing, and meditation exercises, as well as, techniques aimed at improving relations with others, sense of mastery and purpose in life. Additionally, during every point of contact, will be asked how often they utilized the strategies they were taught. This information will be helpful in understanding each person's individual level of mastery and proficiency in Mindfulness-Based Stress Reduction (MBSR). All subjects will complete a baseline interview, one follow-up at 3 months and the close out interview at 5 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Chronic Kidney Disease (CKD) and ESRD on dialysis for over 6 months and who are willing to consent. English speakers only, 18 years of age or older

Exclusion Criteria:

* Patients with severe cognitive or psychiatric impairment will be excluded. Patients who are not willing to provide consent.
Lifestyle, Adiposity and Cardiovascular Health in Youths

To determine the influences of diet and physical activity (PA) on total body fatness and regional fat distribution and the relationship of these to risk factors of cardiovascular disease during adolescence.

BACKGROUND:

Adult studies have shown that adiposity, especially visceral adipose tissue, and cardiovascular (CV) fitness are key links between lifestyle factors like diet and exercise on one hand, and CV disease on the other. However, very little is known about these links during the juvenile years, when the processes leading to CV disease are at an early stage of development.

The study is in response to a Program Announcement issued in March 1998 on Diet and Cardiovascular Disease Risk in Children and Adolescents. The Program Announcement, jointly issued by the National Institute of Nursing Research and the NHLBI, sought to encourage research relevant to the development and/or testing of dietary interventions to improve the cardiovascular disease (CVD) risk profiles in children and adolescents, especially those at increased risk for CVD or for development of CVD risk factors because of genetics, family history, socioeconomic status (SES), race/ethnicity, levels of blood cholesterol or blood pressure, or other factors.

DESIGN NARRATIVE:

The study determines the relations of free-living diet and exercise to total body percent fat ( percent BF), visceral adipose tissue and CV fitness in black and white boys and girls of varying socioeconomic status (SES). The study also determines the relations of fatness and fitness to different CVD risk factors. A total of 800 15 to 18 year olds, 200 in each ethnic and gender subgroup will be recruited. Diet will be assessed with seven 24-hour recalls, and exercise with two seven-day recalls and heart rate monitoring. Percent body fat will be measured with dual-energy x-ray absorptiometry, visceral adipose tissue with magnetic resonance imaging and CV fitness with a multi-stage treadmill test. Measurements will be made of major fatness- and fitness-related CV disease risk factors (e.g., total cholesterol:HDL cholesterol ratio, insulin, systolic blood pressure, left ventricular mass indexed to height, fibrinogen). Multivariate and univariate analyses will be conducted to determine relationships.

Eligibility Criteria:
No eligibility criteria