cyrilzakka/clinical-trials huggingface dataset:
Circulating Melanoma Cells in Metastatic Patients Treated With Selective BRAF Inhibitors

The purpose of this study, is to evaluate Circulating Melanoma Cell (CMC) changes in Metastatic Melanoma (MM) patients, undergoing treatment with selective inhibitors of mutated BRAF.

This is an observational prospective pilot study aimed to investigate the association between changes of total and apoptotic CMC count and disease progression in MM patients undergoing treatment with selective inhibitors of mutated B-RAF.

Eligibility Criteria:
Inclusion Criteria:

* Fourth stage Melanoma patients with both measurable and not measurable lesions undergoing treatment with selective B-RAF inhibitors will be included. To determine the prevalence of CMC-positive patients in IV stage Melanoma, patients without mutated B-RAF undergoing chemotherapy and/or vaccines will be also enrolled at baseline, as part of study protocols approved and activated in the participating centers.
* Informed written consent.

Exclusion Criteria:

* Inadequate compliance to multiple blood draws (baseline, 15 days, 1th month, 4th month, and/or at progression) as scheduled in this adjunctive biologic study for patients carrying B-FAF mutation; inadequate compliance to adjunctive blood draws, as scheduled at baseline for BRAF wild-type
* Previously exposure to immunological treatment.
Effects of Complementary Therapies in People With Mild to Moderate Parkinson's Disease

The aim of this study was to compare the effects of Hatha Yoga versus Stretching on physical outcomes, quality of life, physical activity and motor examination in persons with Parkinson Disease.

The hypothesis of this study is that Hatha Yoga will improve more than Stretching on physical outcomes, quality of life, physical activity and on motor examinations in persons with parkinson Diseases

Individuals diagnosed with Parkinson 's disease, signed up at the Parkinson's association in Asparbi (Bilbao, Basque Country), and meeting the inclusion criteria were included in the study. These individuals were randomly assigned (in a 1:1 ratio) through sealed opaque envelopes to either to Hatha Yoga group and Stretching group by coin tossing sequence generation

Both programs consisted of one weekly session for a total of eight weeks.

Hatha Yoga group performed warm-up exercises for 10 minutes, standing, sitting and supine positions of Hatha yoga (30 minutes), and relaxation and breathing exercises (20 minutes).

Stretching group performed warm-up activities (10 minutes), and analytic stretching exercises targeting the following muscles: sternocleidomastoid, splenius, trapeze, triceps, posterior shoulder capsule, paravertebralis, hamstrings, quadriceps, gastrocnemius, soleus and tibialis anterior (40 minutes). Two repetitions of 15 seconds of each stretch were performed, with 15 seconds interval between repetitions. The sessions ended with diaphragmatic breathing exercises (10 minutes).

Demographic information form was filled out by patients including information about: age, height (cm), weight (kg). Additionally, the following measures are going to be measured:

* Postural control is assessed with a stabilometric platform.
* Flexibility ( Back Scratch Test and Chair Sit and Reach Test)
* Time Up and Go test (TUG)
* 5 Times Sit to Stand Test
* Walking speed
* Unified Parkinson´s Diseases Rating Scale III (UPDRS-III)
* International Physical Activity Questionnaires (IPAQ)
* Parkinson´s Disease Questionnaires- 39 (PDQ-39)

SPSS version 22 program was used in the analysis of the data. Mann Whitney U test, Wilcoxon test, Student T test and two-way mixed Anova were used to analyse the results.

Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of Parkinson's disease
* Stages I to III on the Hoehn and Yahr scale
* Ability to stand upright unaided and walk with or without technical support

Exclusion Criteria:

* Participate in another directed physical exercise program during the Project.
* Moderate or severe cognitive decline.
Quit or Switch: E-cigarette Study

The majority of smokers try to quit each year, and the majority of quit attempts fail, even when the most effective FDA-approved pharmacotherapies are used. Non-combustible tobacco products emit fewer harmful chemicals than cigarettes, and thus for smokers who cannot quit smoking, switching completely to a less harmful product is likely to improve their risk of cancer and other deleterious health outcomes. E-cigarettes, the most commonly used non-cigarette tobacco product, have been shown to deliver sufficient nicotine, be appealing to smokers, and reduce cigarette smoking when provided to smokers to use ad libitum. For smokers who have failed to quit with traditional methods, trying to switch to a less harmful product may be more likely to help them stop smoking than trying to quit using tobacco altogether repeatedly with pharmacotherapy. The proposed trial evaluates the potential of e-cigarettes to serve as harm reduction tools for current smokers who have already tried, and failed, to quit with traditional methods. Current smokers who failed to quit with FDA-approved pharmacotherapy within the past year (N=30) will be randomly assigned to either 1) switch completely to e-cigarettes (Switch Group, n=20), or 2) try to quit again using pharmacotherapy (Meds Group, n=10). Thus, our design is strengthened by a strong active control group. Participants will select a Target Switch / Quit Date on which they will stop smoking. Participants in the Switch group will receive a 5-week supply of JUUL e-cigarettes, the most popular e-cigarette currently available. Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge). Participants will use 1-week of their tobacco product or medication ad libitum while continuing to smoke in advance of their Target Switch / Quit Date, and 4-weeks as instructed following a Target Switch or Quit Date. Behavioral outcomes of interest include smoking reduction \> 50% and biochemically-confirmed abstinence from cigarette smoking at 4-weeks. The proposed trial addresses a highly significant research question using a rigorous design and is supported by a strong investigative team.


Eligibility Criteria:
Inclusion Criteria:

1. At least 21 years old
2. Smoking at least 5 cigarettes per day for 1 year
3. A quit attempt using an FDA-approved pharmacotherapy in the past year that resulted in abstinence of at least 24 hours
4. Intention to quit smoking within the next month
5. Access to daily e-mail or a smartphone that receives text messages

Exclusion Criteria:

1. use of non-cigarette tobacco products in the past 30 days
2. current use of pharmacotherapy for smoking cessation
3. pregnant, breastfeeding, or trying to become pregnant
4. household member currently enrolled in the study
5. contraindicated for NRT
6. planning to move out of the area within the next 6 months.
Clinical Effect of the Axillary Approach to Glenoid Fractures

Glenoid fractures result in glenohumeral post-trauma arthritis and instability. Operative treatment is indicated for severe fractures. The traditional deltopectoral approach, which requires detachment of the subscapularis, has many drawbacks, including loss of external rotation and suboptimal fixation. Arthroscopic techniques also cannot allow anatomic reduction and biomechanical stability for large fractures. We describe an alternative approach that enters from the axilla through the interval between the rotator cuff and the inferior glenoid, neck and lateral border of the scapula without detachment of the rotator cuff.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic and closed fractures
* Fracture type conforms to Ideberg Ia classification or AO/OTA F1.1 classification
* Fracture displacement ≥4mm, the area of involvement ≥20%.

Exclusion Criteria:

* Severe multiple trauma
* Pathological fracture
* Unable to tolerate surgical treatment
* The interval between injury and operation was \> 2 weeks
The Effectiveness of Using Empathy Courses to Guide OT Students in Case-base Clinical Reasoning

Clinical reasoning is an important cognitive process in medical decision making. In recent years, medical education advocates holistic medicine, but systematic learning is rare in school education.Therefore, this study used an empathy experience course to conduct a case-oriented clinical reasoning training course to improve the empathy and clinical reasoning skills of pre-clinical students in occupational therapy through four sessions.

Objective: To investigate effectiveness of using empathy experience courses to guide the students who prior to occupational therapy(OT) practice in case-base clinical reasoning.

Materials and Methods: 30 students were recruited from 8 universities in Taiwan and randomly divided into an experimental group and a control group. The experimental group was given four 3-hour training sessions over 2 weeks, which included group instruction on empathy experience, clinical reasoning, and functional therapy case-oriented learning, while the control group was given case studies. Tests were administered before and after the series of sessions, including case report writing, C-JES-HPS, SACRR, and a follow-up visit at the end of the first phase of clinical practice using the C-JES-HPS and SACRR; course satisfaction surveys were completed after each session and at the follow-up visit to observe course satisfaction, usefulness, and recommendations. Data were analyzed using SPSS (version 20.0) with a significance level of 0.05. Univariate analyses with repeated measures 2-way analysis of variance were used to compare changes in empathy and clinical reasoning ability between the two groups of subjects and course satisfaction was presented as descriptive statistics. It was hypothesized that a case-oriented clinical reasoning training program using an empathy experience program would improve empathy and clinical reasoning skills in pre-practicum students in occupational therapy.

Eligibility Criteria:
Inclusion Criteria:

* Occupational therapy students from National Taiwan University, Kaohsiung Medical University, Sun Yat-sen Medical University, National Cheng Kung University, Chang Gung University, IShou University, Fu Jen Catholic University, and Asia University who have completed their major credits and will be interning in a clinical hospital.
* Must be at least 20 years old and under 65 years old.

Exclusion Criteria:

* Those who are unable to attend the whole course.
* Those who have not completed their school credits and are unable to go to the clinical hospital for internship.
* Those who do not speak Chinese or English as their native language.
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection

This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. ICU patient
3. Primarily bedbound subjects
4. Able to be monitored for a minimum of approximately 8 hours

Exclusion Criteria:

1. Pregnancy
2. Prisoner status
3. Pressure injury stage 2, 3, or ungroupable
4. Has a pacemaker or internal defibrillator
5. Has a history of complications with a similar study
6. Has any medical condition which in the judgment of the Investigator, renders them inappropriate for participation in this study
Burden of Respiratory Illnesses in Pediatric Intensive Care Unit and Its Outcome

Acute respiratory infections (ARI) are an important cause of mortality and morbidity among children; one-fifths of under-five mortality being contributed by them (predominantly pneumonias ).

About 11.9 million episodes of severe and 3.0 million episodes of very severe acute lower respiratory infections (ALRI) result in hospital admissions in young children worldwide.

Respiratory infections and illnesses in children thus form a substantial disease burden in Pediatric intensive care unit. With this is mind, we studied clinical profile and risk factors contributing to mortality, and outcome of children with acute respiratory infections.


Eligibility Criteria:
Inclusion Criteria:

Children with pneumonia, bronchiolitis, bronchial asthma, chemical pneumonitis, cystic fibrosis and other respiratory diseases, Cardiorespiratory cases and Neurological cases with respiratory illness

Exclusion Criteria:

Post trauma case. Postoperative cases (developing respiratory complications during PICU stay).
Prospective Study on Swallowing/Breathing Interactions in Severe Guillain Barre Syndrome.

To estimate, in a longitudinal and not invasive way, in patients with SGB at respiratory risk, the function of respiratory muscles and that of the upper airways muscles by investigating the force of the tongue, the gulp, and the breath during the sleep to be able to detect bulbar impairment and establish correlations enter the various parameters to estimate better the interactions between the dysfunction of the respiratory muscles and that upper airways muscles and so determine the risk acute respiratory failure.

Context: the syndrome of Guillain Barré ( SGB) is the first causes of extensive paralysis of medical origin in industrial nations. A third of these patients going to require mechanical invasive ventilation during their stay in ICU. This population of ventilated presents the strongest risk of infectious respiratory patient complications and death. The respiratory impairment is a progressive weakness of inspiratory and expiratory muscles. The monitoring of the respiratory muscular infringement is usually made by the repeated measure of vital capacity and the maximal respiratory pressures. The occurrence of bulbar impairment is an aggravating element entailing dysfunction of the upper airways muscles detected often late in front of aspiration. Besides the arisen of sleep apneas was never sought in this context. This dysfunction of the upper airways muscles could be more detected prematurely by objectivizes measures of them performances.

Method: longitudinal observational and in a one center study. The respiratory impairment will be estimated by the measure of the vital capacity, maximal respiratory pressures and of the debit of cough. The existence of a bulbar infringement will be sought by the measure of the force of the tongue, an objective measure of gulp performances and a polysomnographic recording.

Criterion of selection: patient admitted in ICU with GBS and respiratory risk. Number of patients, centre: 40 patients admitted in the intensive care unit of the hospital RAYMOND POINCARE and 20 controls.

Duration of the study: 24 months Perspectives: better anticipate acute respiratory failure and the indication of an invasive ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Guillain Barré Syndrome
* Presenting a risk of mechanical ventilation(breakdown): presence of 2 among the following 5 criteria

  * Deficit evolving for less than 7 days
  * Impossibility to stand up
  * Impossibility to raise the head
  * ineffective Cough
  * Vital capacity\< 60 %

Exclusion Criteria:

* MAJOR confusions of gulp (spontaneous) at admittance
* Respiratory distress syndrome and intubation at admission buccal dental lesions
* Not membership to a regime of Social Security (beneficiary or legal successor)
* Patient under guardianship or custody
End-range Mobilization on Knee Osteoarthritis

Different manual therapy techniques and conservative therapy have been used separately for alleviation of pain and improvement of physical function in patients with knee osteoarthritis (KOA). However, no study has reported the effect of combination of these treatment modalities in the management of KOA. The aim of this study was to investigate the effect of end-range mobilization added to conservative therapy versus conservative therapy alone on decrease of pain and improvement of functional status in KOA.

Knee osteoarthritis (KOA) is a musculoskeletal condition affecting older people. It is characterized by pain and loss of physical function, which has a negative impact on patients' quality of life. The different international guidelines recommend several non-invasive treatment modalities for the management of KOA. Conservative therapy including land-based exercises, aquatic exercises, Transcutaneous Electro Neuro Stimulation (TENS) therapy and balneotherapy has been reported positively in the management of patients with KOA (1, 2). Manual therapy is also a preferred treatment modality with the aim of alleviation of pain, improvement of joint mobility and therefore the physical condition (1, 2). Out of manual therapy techniques, end-range mobilization is a well applied treatment technique in the management of different musculoskeletal conditions (3). Till date, the effect of end-range mobilization has not been investigated so far in knee OA.

Therefore, the aim of this study was to investigate the effect of end-range mobilization added to conservative therapy versus conservative therapy alone on decrease of pain and improvement of functional status in KOA.

Eligibility Criteria:
Inclusion Criteria:

* KOA according to the American College of Rheumatology
* categorization as End Of Range Problem based on Maitland's classification.
* at least half year existing and at least 3 pain scores measured with Visual Analogue Scale (VAS) during weight-bearing activities
* bilateral, moderate-to-severe symptomatic tibiofemoral knee OA with radiographic evidence
* at least 90 degree passive knee flexion range
* sufficient mental status

Exclusion Criteria:

* acute inflammation of the knee
* intraarticular injections within the last 3 months
* total knee replacement in the opposite side
* class II. obesity (body mass index, BMI\>35kg/m2)
* severe degenerative lumbar spine disease (e.g. spondylolisthesis)
* systemic inflammatory arthritic or neurological condition
* physiotherapy and other balneotherapy attendance within 6 months
* contraindication for conservative and manual therapy
* unstable heart condition
* complex regional pain syndrome
Clearance of NNAL and Cotinine From Second-hand Smoke in Hair and Urine

This study will investigate how long it takes for NNAL and cotinine, markers of second hand smoke, to clear the human body.

The purpose of the study is to investigate how long it takes for NNAL and cotinine, both specific markers of second hand tobacco smoke exposure to clear the human body.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasians and African-Americans 19 years of age or above, how are ready to quit smoking

Exclusion Criteria:

* Anyone who is not a Caucasian or an African-American, below 19 years of age, and is currently taken prescription medication.
Stress and Rest Myocardial Tomoscintigraphies Using Mono- or Double-isotope Protocol With a Semiconductor Camera

The purpose is to demonstrate the concordance of diagnostic information obtained with:

1. a conventional examination with 2 distinct recordings on D.SPECT camera after 99mTc-sestamibi injections, the first post-stress and the second at rest, 2 to 3 hours later,

   and
2. a double isotope examination with a supplementary recording after injection of a little activity of thallium-201 at rest after the first recording and before the second injection of 99mTc-sestamibi for conventional recording at rest,

in patients showing abnormalities of myocardial perfusion in stress myocardial tomoscintigraphy.

Myocardial perfusion tomoscintigraphy is very used for diagnosis and characterization of abnormalities of stress and rest myocardial perfusion. This examination can be performed with semiconductor gamma cameras that are more performant than conventional cameras regarding spatial resolution, detection sensitivity and energy resolution.

The amelioration of energy resolution could allow the realization of simultaneous recordings of a dye injected at rest and another injected during stress (double isotope recording), while conventional examination needs 2 different recordings, stress and rest, separated from several hours.

In this study patients undergo a conventional examination with D.SPECT camera with 2 recordings, the first after injection of a little activity of 99mTc-sestamibi at stress (≤ 100 MBq) and the second, 2 hours later, after injection at rest of a 3 time bigger activity of 99mTc-sestamibi (≤ 300 MBq). An activity of thallium-201(≤ 50 MBq) is injected at rest after the first recording of stress. 5 minutes later, a supplementary double isotope recording is realized with D.SPECT camera (99mTc-Sestamibi-stress / thallium201-rest).

The demonstration of the hypothesis of this study could considerably diminish the duration of the examination (from 3 to 4 hours to less than 1 hour).

Eligibility Criteria:
Inclusion Criteria:

* \> 18, without guardianship, signed informed consent
* Without contraindication for myocardial perfusion tomoscintigraphy and stress technique (dipyridamole and/or effort), according to common criteria to French Societies of Cardiology and Nuclear Medicine, as it is requested for all patients needing this routine examination
* Not in life-and-death emergency, with a stable clinical state (without cardiac insufficiency or instable coronary, without hypertension not well-stabilized under treatment)
* Effective contraceptive method for women of childbearing potential
* Weight ≤ 100 kg (\> 100 kg patients need higher injected activities in order to obtain adequate image quality)
* Perfusion abnormalities on stress images

Exclusion Criteria:

* \< 18
* Contraindications to stress test (effort and/or dipyridamole)
* Hypersensibility to thallium201 chloride or one of excipients
* Claustrophobic patient or incapable to stay lying down for 30 minutes
* Pregnancy or doubt of pregnancy
* Breastfeeding woman
* Weight \> 100 kg
* Non affiliation to social security plan
Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.

The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.

Eligibility Criteria:
Inclusion Criteria:

* are healthy males or females between the ages of 18 and 75 years of age;
* have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, involving 25%-67% of the nail, without lunular or proximal involvement;
* positive mycology results (ie, KOH test and culture of a dermatophyte) from the target great toenail;
* refrain from using any lotions, creams, liquids, or polish on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator;
* are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails; or systemic antifungals for the duration of the study;

Exclusion Criteria:

* females who are pregnant, plan to become pregnant during the study, or are nursing a child;
* are hypersensitive to topical creams, ointments, medications, or surfactants;
* have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study; or
* have taken any investigational drug within 4 weeks prior to the start of the study.

Other protocol-defined inclusion/exclusion criteria may apply.