cyrilzakka/clinical-trials huggingface dataset:
Triple P to Improve Behaviour in Children

Joint research (quantitative and qualitative methodology) with quasi-experimental design, before-after without control group to evaluate the pilot implementation of Positive Parenting Program (Triple P) in the context of primary health care in Chile. The hypothesis is that the program is feasible and acceptable to the Chilean population.

General Purpose:

● Evaluate the pilot implementation of the Triple P program in the context of primary health care in Chile.

Specific Objectives:

1. To assess the fidelity of implementation of the Triple P program
2. Analyze the perception of participants, providers and organization on determinants of program implementation.
3. Identify barriers and facilitators to plan future implementation of Triple P program in contexts similar to those in the study.
4. To estimate the magnitude of change in children's behavior, emotional difficulties and rearing practices of caregivers before and after participation.

Eligibility Criteria:
Inclusion Criteria:

* Parents or caregivers of children from 2 to 10 years old attending primary care clinic
* Parents or caregivers must be worried about child behaviour or their parenting skills and be willing to get professional help

Exclusion Criteria:

* Children: Pervasive Developmental Disorder, severe intellectual disability or severe psychopathology
* Caregivers: illiteracy, decompensated severe psychopathology or current psychotherapy
A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies

The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a continuous IV infusion is safe and tolerable in adult subjects that have myeloid malignancies, and to determine the maximum tolerated dose and/or a biologically active dose. The study will be conducted in multiple sites and test increasing doses of AMG 330. The safety of subjects will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests.


Eligibility Criteria:
Inclusion criteria:

* Informed consent provided
* 18 years or older
* Relapsed/refractory AML: AML as defined by the WHO Classification persisting or recurring following one or more treatment courses except promyelocytic leukemia (APML)

Exclusion criteria:

* Active extramedullary AML in testes or central nervous system (CNS)
* Known hypersensitivity to immunoglobulins or to any other component of the IP formulation (eg, sucrose, captisol, potassium, polysorbate 80, citrate, lysine)
* Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for \> 1 years before screening
Comparison of the Efficacy for Stress Ulcer Prophylaxis Between the Patients Received Lansoprazole OD and Control Group Weaning From Mechanical Ventilator in Respiratory Care Center: a Randomized Control Trial

The purpose of this study is to determine whether lansoprazole administered nasogastrically is effective for stress ulcer prophylaxis in respiratory intensive care unit.

Although stress ulcer is a complication that can cause mortality and morbidity in critical patients, there is still lack of consensus about its prophylaxis. There is also few data available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less associated nosocomial pneumonia. Recently, proton pump inhibitors were shown to have good prophylactic effects for stress ulcer. Lansoprazole has good acid suppression effect and the tablets are soluble for the use of tube feeding. There was no data about the prophylaxis of stress ulcer development during the program of weaning from the mechanical ventilators. Therefore, we conduct a study of the comparison of lansoprazole administered nasogastrically and control group for stress ulcer prophylaxis in respiratory intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

1. Initial ICU admission, APACHE II score ≥25。
2. Evidence of IICP ( ICP monitor proved or brain CT proved edema)。
3. Evidence of peptic ulcer disease ( A or H) proved by PES more than 3 months ago without PPI or H2 blocker agents therapy in recent one week。
4. UGI bleeding history in ICU before transferring to RCC (proved by NG aspirate coffee ground substance or fresh blood ≥ 60 ml)。Not received PPI or H2 blocker agents in recent one week.
5. Received NSAID for more than 7 days。
6. Bleeding tendency or with major disease patients: coagulopathy, ESRD (CCR\<10), hematologic malignancy, liver cirrhosis Child C。

Exclusion Criteria:

1. Age \< 18 y/o, pregnancy。
2. Active UGI bleeding and under PPI or H2-blockers。
3. Family unwillings。
Registry of Pancreatic Disease

This clinical data registry records information about the health status and healthcare performances received by participants affected by every type of pancreatic disease or disorder. All data (demographic, clinical, biochemical, radiological, pharmacological, genetic...) and audio and/or video recording from operative room are collected in order to be used for prospective or retrospective studies.


Eligibility Criteria:
Inclusion Criteria:

* any type of pancreatic disease: inflammatory and neoplastic (including solid and cystic lesions)

Exclusion Criteria:

* physically or mentally inability to provide consent
Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder

The purpose of this study is to determine whether there is a difference between the result of treatment of shoulder osteoarthritis with two different shoulder prostheses.

In this randomized study, we wish to investigate with the use of clinical and radiological parameters whether there is a difference between the result of treatment of shoulder osteoarthritis with the Copeland resurfacing prosthesis and the Global CAP resurfacing prosthesis.

Clinical parameters with the help of the Constant Shoulder Score (CSS) and Western Ontario Osteoarthritis of the Shoulder Index (WOOS):

1. Pain
2. Activities of Daily Living (ADL)
3. Range of Motion (ROM)
4. Muscle strength

Radiologic parameters:

1. Migration of resurfacing prostheses with use of MB-RSA
2. Bone density around the prosthesis measured with Dual Energy X-ray Absorptiometry (DEXA)
3. Correlation between bone density and prosthesis migration

Eligibility Criteria:
Inclusion Criteria:

1. Patients with shoulder osteoarthritis with cartilage defect of the caput humeri and not the glenoid cavity
2. Aged 18 years or older and fit
3. Informed, written consent -

Exclusion Criteria:

1. Patients found unsuitable preoperatively for a resurfacing prosthesis
2. Patients aged 85 or older
3. Patients with rheumatoid arthritis
4. Patients who previously had undergone shoulder alloplasty or other major shoulder surgery (more than just diagnostic arthroscopy)
5. Patients unable to avoid NSAID after surgery
6. Patients requiring regular systemic steroid treatment
7. Female patients taking hormone substitution
8. Patients with metabolic bone disease
9. Severe shoulder instability with large rotator cuff defect ( will often necessitate special prosthesis components or even major soft-tissue surgery)
10. Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings) -
A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee

PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. The purpose of this study is to test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the knee by itself or with naproxen, particularly to test if patients have less pain.

This study has been terminated in response to a reported serious adverse event (SAE). The sponsor's assessment of the limited data available at the time of the initial SAE report was that the SAE may alter the potential benefit - risk profile of the study medication.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a diagnosis of osteoarthritis based on the American College of Rheumatology criteria confirmed by an X-ray
* Subjects must be willing and able to stop all current pain therapy for the duration of the study
* Subjects must be willing and able to complete a daily diary

Exclusion Criteria:

* BMI of \>39 kg/m2
* Known allergy or hypersensitivity to naproxen
* Any condition or medical history that might interfere with the subject's ability to complete the study visits and assessments
Conventional Versus Ultrasound-guided Transbronchial Needle Aspiration for the Diagnosis of Hilar/Mediastinal Lymphadenopathies

The main purpose of the present study is to assess whether the sensitivity of Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is superior to that of conventional TBNA in the diagnosis of hilar/mediastinal adenopathy and lung cancer staging.

The role of transbronchial needle aspiration (TBNA) for the diagnosis of hilar/mediastinal adenopathy and lung cancer staging is well established. However, it is a blind procedure and its diagnostic yield seems to be related to the operator experience, as well as to the size and location of lymph nodes. In the recent years, there has been increased interest in imaging-assisted TBNA and the endobronchial ultrasound has been suggested to be feasible and to improve the diagnostic yield.

Another technique able to optimize the performance of transbronchial aspirations is the rapid on-site cytological examination (ROSE), allowing to assess the adequacy of samples collected. In this context, no comparative studies between standard TBNA and EBUS-TBNA have been performed. It is very important for clinical practice to definitively assess the possible superiority of EBUS-TBNA in terms of sensitivity, and to provide information regarding safety, procedural time and costs to define the best diagnostic strategy.

The study is focused on 252 patients who have at least one hilar/mediastinal lymph node \> 1 cm on CT scan in at least one approachable lymph nodal station (except 2R and 2L) for which a diagnostic cyto-histological assessment is required for clinical purpose. Patients will be randomized 1:1 (control : intervention) by a computer-generated random-allocation system to undergo EBUS-TBNA or conventional TBNA. In case of failure of conventional TBNA, the operator will shift to EBUS procedure. Moreover,a subgroup analysis will be perform to assess the potential impact of lymphnode size and position on final results(univariate analysis).

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18years;
* presence of at least one hilar/mediastinal adenopathy \>1 cm on short axis assessed by contrast-enhanced CT scan in at least one approachable stations other than 2R and 2L;
* ability to give an informed consent.

Exclusion Criteria:

* presence of mediastinal adenopathy in stations 2R and 2L;
* coagulopathy or bleeding diathesis that cannot be corrected;
* severe refractory hypoxemia;
* unstable hemodynamic status;
* inability to give an informed consent.
Three-Arm Trial of Novel Treatment for Tinea Pedis

This is a three-arm randomized controlled trial to assess the efficacy of an experimental treatment in the treatment of tinea pedis (athlete's foot). The experimental treatment will be tested against a vehicle control to determine efficacy and safety, and against an active comparator to evaluate the success of the treatment relative to an existing gold-standard treatment. Patients will be treated for four weeks, with their condition being assessed at the end of treatment and two weeks after the end of treatment. The primary endpoint for this study is effective treatment rate at the week 6 evaluation, defined as a mycological cure and minimal clinical signs \& symptoms. Secondary endpoints include safety and patient evaluation of treatment.


Eligibility Criteria:
Inclusion Criteria:

* male or female, aged 18 or above
* clinical diagnosis of tinea pedis
* diagnosis confirmed with potassium hydroxide microscopy
* availability for the duration of the study (6 weeks)
* willingness to comply with study protocol
* informed consent

Exclusion Criteria:

* moccasin-type tinea pedis
* severe maceration of interdigital spaces
* severe fissuring
* history of dry feet, cracking, fissuring
* concurrent onychomycosis
* serous exudate or pus
* topical antifungal treatment in the past 2 weeks
* systemic antifungal treatment in the past 4 weeks
* concurrent immunosuppressive or antimicrobial therapy
* liver disease
* pregnancy or breastfeeding
* known hypersensitivity to any ingredients of trial agents
Cereset Research for Performance Improvement in a Hospital Nursing Unit

The purpose of this study is to explore whether an implementation process composed of offering CR to staff in a single hospital nursing unit has any potential impact on unit-level quality measures post-implementation.

This is a pre-post design quality improvement project and implementation study, evaluating implementation measures, group level quality measures using QI methodology, and individual-level behavioral and performance measures before and after implementation of the Cereset Research (CR) evidence-based intervention among nursing unit staff. Individual-level behavioral symptoms and a nursing performance metric will be evaluated among healthcare workers in the nursing unit in the pre- and post-implementation timeframes among individuals who consent to participate in these evaluation activities. Up to 40 members of the unit will have the opportunity to enroll in the acoustic echoing neurostimulation intervention during the implementation timeframe. The neurostimulation intervention consists of 4 Cereset Research sessions of audible tones echoing current brainwave activity, and individual level behavioral symptoms will be collected following the last intervention session.

Eligibility Criteria:
Inclusion Criteria:

* Ability to comply with basic instructions and be able to sit still, comfortably during sessions.
* Healthcare worker in the Orthopedic Trauma Unit at Atrium Health Wake Forest Baptist, aged 18 years and older.

Exclusion Criteria:

* Unable, unwilling, or incompetent to provide informed consent.
* Physically unable to come to the study visits.
* Severe hearing impairment (because CR involves acoustic stimulation that participants would need to be able to hear).
* Weight is over the chair limit (400 pounds).
* Currently enrolled in another Cereset Research study.
* Use of the following modalities within one month before enrollment: electroconvulsive therapy (ECT), prior use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, eye movement desensitization and reprocessing (EMDR), brain spotting, neurofeedback, biofeedback, or deep brain stimulation (DBS). Individuals will be given the opportunity to discontinue these techniques for one month and then enroll.
* Known seizure disorder.
* Thoughts of active suicide within the last 3 months.
Assessing Body Posture and Postural Balance Among Young Adults With Bronchial Asthma

The purpose of the study is to assess the relationship between body posture and dynamic balance in adults with childhood-onset asthma and compare them to a non-asthmatic control group matched for gender, age, weight, and height.

Participants will sign a consent form and provide personal information such as gender, age, weight, and height for calculating BMI, pulmonary function test, and respiratory muscle strength test, as well as their asthmatic/clinical history. After collecting demographic information and obtaining consent from participants, they will be asked to remove their T-shirts and stand in the usual relaxed standing position facing the opposite side of the machine's window. When the machine is properly positioned, it will take photographs. which will then be converted into three-dimensional images on the computer for further analysis. When the participant is fully dressed and ready, the second test will be performed using the Biodex balance machine. The parameters and testing mode to begin the dynamic balance test will be entered into the machine, and the procedure will begin. The participants will be thanked for their participation and contribution to our study

Eligibility Criteria:
Inclusion Criteria:

* For the healthy subjects referred by a consultant pulmonologist/physician
* age- and gender-matched volunteers were recruited from the community

Exclusion Criteria:

* Other health issues, such as cardiorespiratory issues, neurological deficits
* musculoskeletal problems and peripheral vascular diseases\& pregnancy may affect test performance
Performance of PET 18 F-FDG Coupled to CT With Contrast Injection Iodized in the Diagnosis of Early Recurrences of Head and Neck Carcinoma Treated With Concurrent Chemoradiation. Comparison With 18F-FDG PET Coupled With CT Not Injected With Filling CT Standard Injection

Early detection of viable residual tumor or early neoplastic recurrence represents a real challenge in monitoring patients treated with concomitant chemoradiotherapy squamous cell carcinoma of the upper aerodigestive tract.

The locoregional recurrence rate is indeed high (up 40%) over the first two years of this therapeutic method.

The conventional imaging methods such as CT and MRI appear limited in terms of sensitivity because of the many post-treatment changes are fibrosis, tissue edema and the tissue distortion.

PET-CT 18F-FDG proves to be a non-invasive, reliable for the detection of residual tumor and metastasis, even in the absence of clinical signs.

To date, the acquired CT examination in the same time and in the same position that PET is performed without iodinated contrast injection, used for anatomical identification and attenuation correction of PET fused images. The patient usually has a second CT imaging, centered on the neck with contrast injection iodized within the radiology department.

To date, no team has yet studied the interest of the PET-CT 18F-FDG coupled with a CT scan with contrast injection iodized in the diagnosis of early recurrence in head and neck malignancies while interest of the contrast agent injection has been demonstrated in ovarian neoplastic recurrence research, pancreatic and colon.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years
* Squamous cell carcinoma of head and neck
* neoplastic Location: oropharynx, oral cavity, hypopharynx, larynx
* New Patients treated with concomitant radiochemotherapy
* Treatment with chemoradiotherapy ended 3 months ago
* Affiliation to a social security scheme
* Patient who provided written informed consent

Exclusion Criteria:

* During Pregnancy or absence of effective contraception in reproductive years
* Breastfeeding
* Creation of a cervical CT with injection of iodinated contrast, in the therapeutic monitoring, dated less than 14 days
* Other history of malignancy, including head and neck carcinomas previously treated outside the basal cell cancer or cervical cancer, treated and cured
* uncontrolled Infectious diseases
* Allergy to iodine
* Severe renal impairment (renal clearance \<30ml / min according to Cockcroft)
* No consent
* Patient deprived of liberty, under guardianship
* Any medical or psychological condition associated that might compromise the patient's ability to participate in the study
* Failure to submit to medical monitoring study for geographical, social or psychic
Biofeedback to Ameliorate Freezing of Gait

The freezing burden will be quantified in subjects with Parkinson's Disease (PD)before and after 6 weeks of training. Two types of interventions (20 subjects in each group) will be tested: 1) Open-loop group (OLG); 2) Closed-loop group (CLG). Each session of the OLG training includes walking courses aimed at provoking freezing episodes. The experimenter will trigger an auditory rhythmic stimulation (RAS) in walking conditions likely to invoke freezing (e.g., turning) and the subject will learn to synchronize his/her gait with the auditory cues, i.e., to keep the walking pace and coordination and, as a result, to avoid freezing. Similar principles will apply for the CLG training; however, the RAS will be elicited automatically by a device that recognizes an approaching freezing episode.

The freezing burden will be quantified in subjects with PD before and after 6 weeks of training. Two types of interventions (20 subjects in each group) will be tested: 1) Open-loop group (OLG); 2) Closed-loop group (CLG). Each session of the OLG training includes walking courses aimed at provoking freezing episodes. The experimenter will trigger an auditory rhythmic stimulation (RAS) in walking conditions likely to invoke freezing (e.g., turning) and the subject will learn to synchronize his/her gait with the auditory cues, i.e., to keep the walking pace and coordination and, as a result, to avoid freezing. Similar principles will apply for the CLG training; however, the RAS will be elicited automatically by a device that recognizes an approaching freezing episode.

We anticipate that after intensive training, the central nervous system (CNS) of subjects with PD will be able to anticipate impending freezing episodes based on awareness of the environmental conditions (e.g., an approaching turn) and/or based on sub-conscious response to a deteriorating gait pattern. As a result, an automated motor response that paces and coordinates gait will be internally triggered by the CNS and the approaching freezing episode will be averted. The overall freezing burden will therefore decrease in trained subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of PD.
2. Suffer from the freezing of gait (FOG) symptoms. Subjects must score 2 or more on item #3 of the subjective FOG questionnaire (FOG-Q) and exhibit two or more FOG episodes during a short, functional FOG evaluation procedure that includes FOG-provoking conditions (e.g., turns, doorways) and 5 laps of walking in a figure 8 shaped trajectory.
3. Able to walk unassisted for at least 5 minutes with ample rest.

Exclusion Criteria:

1. Having serious co-morbidities or acute illness that would make training inappropriate.
2. Have had brain surgery.