cyrilzakka/clinical-trials huggingface dataset:
Multi-level Determinants of Implementation and Sustainment in the Education Sector

The purpose of this study is to learn more about teachers' sustainment of use of core components of BEST in CLASS in a follow-up study.

The goal of this study is to help understand how to successfully implement and sustain evidence based programs (EBP) in the education sector. The study will look at how questions such as what teacher, program, and school characteristics impact sustainment of the EBP BEST in CLASS, what modifications to BEST in CLASS represent a sustained program, and how do teacher, program, and school characteristics influence sustainment of BEST in CLASS.

Eligibility Criteria:
Inclusion Criteria:

Teacher participants

* teach in general education Kindergarten, 1st, 2nd, or 3rd grade
* consent to participate
* proficient in English
* participated as a BEST in CLASS teacher who received coaching in the prior year

Family participants

* proficient in English
* have a school-age child or children
* consent to participate

Children participants

* enrolled in a general Kindergarten, 1st, 2nd or 3rd grade classroom
* proficient in English
* at elevated risk for EBD
* demonstration of externalizing behaviors that interfere with participation in the classroom (e.g., disruption, aggression) as indicated by teacher rating
* parental/guardian consent to participate

Exclusion Criteria:

Teacher participants

* do not teach in general education Kindergarten, 1st, 2nd, or 3rd grades
* were not part of the BEST in CLASS intervention condition in the year prior
* do not consent to participate
* do not speak fluent English
* do not have at least one student that meets the inclusion criteria

Family participants

* do not speak proficient English
* do not provide consent
* do not have elementary aged children will be excluded.

Children participants

* caregivers do not provide permission for participation
* caregiver(s) do not speak proficient English
* are not proficient in English
* do not screen in as demonstrating risk for EBD
Parkinson´s Disease, Aerobic Exercise and Photobiomodulation

The aim of the present study was to assess the effects of a combined therapy of aerobic exercise and transcranial photobiomodulation upon the cardinal motor sympomts of Parkinson´s disease of a group of Parkinson´s disease patients. It was hypothesized that aerobic exercise and transcranial photobiomodulation would yield significant benefits in the cardinal motor sympomts of the illness.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with idiopathic PD and rated 1-2 on the Hoehn and Yahr Scale.
* No type of dementia as assessed by the mini-mental state examination.
* Able to stand for 2 min without assistance.
* Able to walk 10 m without assistance.

Exclusion Criteria:

* Individuals were excluded if they suffered a neurological disease other than PD, if the subject has an implant of any kind in the head (e.g., stent, clipped aneurysm, embolized arteriovenous malformation, implantable shunt - Hakim valve) or if they did not meet the eligibility criteria.
Relations Between Pelvic Floor, Diaphragm and Trunk Muscles

The present study evaluates the functional relations of pelvic floor, diaphragm, and torso muscles, their variation and correlations with urinary incontinence while separately training physical characteristics of the mentioned muscles in men after radical prostatectomy.

During the last two decades, the connection between pelvic floor muscles (PFM) and abdominal muscles or diaphragm has been detected: PFM contract and relax during the inhalation and exhalation in pace with the diaphragm; the activity of the PFM increases with the increase of intra-abdominal pressure during forced exhalations or cough. The role of pelvic floor is essential for the synergy of diaphragm and abdominal muscles in maintenance of intra-abdominal pressure. According to the aforementioned physiological functional relationships, the investigators have postulated a hypothesis that diaphragm muscles training and abdominal muscles training could have similar effect as direct PFM training on pelvic floor muscles strength and pelvic floor muscles endurance measured using perineometer in men after radical prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* stable somatic state
* written informed consent.

Exclusion Criteria:

* chronic obstructive pulmonary disease,
* surgical interventions in abdominal area,
* complains in lower back,
* acute musculoskeletal injuries in last 6 months
* cognitive dysfunction
Study on Migraine and Headache in Epileptic Patients

The purpose of this study is to collect data from patients who are diagnosed with epilepsy and are followed up in epilepsy clinics.

Headaches and epilepsy are chronic disorders with episodic manifestations characterized by recurrent attacks of nervous system dysfunction with a return to baseline between attacks. Although it is not uncommon that patients with epilepsy suffer from headaches, the relations between seizures and headaches is multi-factorial. Headaches may occur immediately before (preictal), during (ictal), or after (postictal) a seizure. In addition to seizure-associated headaches, patients often experience headaches that are not temporally related to seizures-interictal headaches. Moreover, epidemiological studies indicate an association of migraine and epilepsy with an increased prevalence of migraine in patients with epilepsy. Up to now, there is still limited information about the relationship between the frequency of seizure attacks and headache occurrences. Thus, we purpose this study to investigate the incidence of headaches, to explore the relationship between seizure attacks and headache occurrences, to classify the headache, and to document the frequency, characteristics, and effects of migraine and headaches among patients with epilepsy. This study is a multi-centre survey to collect data from patients who are diagnosed with epilepsy and are followed up in epilepsy clinics. Patients can only participate in this study after signing and dating the inform consents. There are two stages of this study: Stage I: On enrollment, data on demographic characteristics, epilepsy profile, seizure frequencies, and epilepsy treatment would be obtained. Body weight and height would be measured. Information of prior headache occurrences and their relationships with seizures would also be collected. Stage II: Patients enrolled into this study will be divided into three group: patients who are seizure free for past 6 months, patients with \> 1 attack every month within past 6 months, and other patients. Participants of each group will be enrolled into Stage II for 24-week follow-up. Information of seizure attacks, headache occurrences, and treatment will be collected. This is an observational study and no study drug is administered.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with epilepsy
* Patients or parent(s)/caregiver(s) have signed and dated an informed consent.

Exclusion Criteria:

* Patients who have non-epileptic events in addition to epilepsy, such as pseudoseizures or an acute symptomatic cause of seizures (e.g., a metabolic disturbance, toxic exposure, active CNS infection)
* Patients with progressive or degenerative neurological disorder
* Patients with an active malignancy
* Patients or parents/caregivers with known or suspected psychotic disease, mental retardation, or any mental situation which may cause the concern to properly complete this survey.
Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by documenting the procedural parameters, major complications and recurrence of AF after ablation using Cool Flex ablation catheter for the treatment of paroxysmal atrial fibrillation.

This study is an observational clinical study which is not based on any specific endpoints.


Eligibility Criteria:
Inclusion Criteria:

* A signed written Informed Consent form
* 18 years of age or older
* Agrees to comply with follow-up visits and evaluation
* Candidate for catheter ablation for the treatment of paroxysmal atrial fibrillation as per the hospital standard of care.

Exclusion Criteria:

* Persistent or Long standing AF
* CABG procedure within the last 180 days (six months).
* Documented left atrial thrombus on imaging \[e.g. Transesophageal echocardiogram (TEE)\].
* History of blood clotting or bleeding abnormalities.
* Contraindication to anticoagulation (i.e. heparin or warfarin).
* Enrollment in another investigational study evaluating device or drug that might impact the results of this study.
* Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
* Acute illness or active systemic infection or sepsis.
* Life expectancy less than 12 months.
* Uncontrolled heart failure or NYHA class IV heart failure.
* Myocardial Infarction within 8 weeks of enrollment or unstable angina
ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000

This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures. The Enable Aortic Valve is an equine pericardial stented bioprosthesis.

The ATS 3f Enable Aortic Bioprosthesis is intended for those patients whose prognosis without surgical replacement of the diseased natural valve is unacceptably poor in terms of survival and/or quality of life in the opinion of the attending physicians. For these patients, there are a number of widely accepted prosthetic heart valves in use.

Eligibility Criteria:
Inclusion Criteria:

* The patient requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve repair. (The three remaining valves must be of native tissue).
* The patient is geographically stable and willing to return to the implant site for follow-up visits.
* The patient has been adequately informed of risks and requirements and consent to his/her participation in the clinical study.
* If this patient is female and of childbearing potential, patient has a negative pregnancy test within seven (7) days prior to the study procedure.

Exclusion Criteria:

* The patient requires replacement of two or more valves.
* The patient is \< 20 years of age.
* The patient has a non-cardiac major or progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 24 months.
* The patient is an intravenous drug and/or alcohol abuser.
* The patient presents with active endocarditis or other systemic infection.
* The patient has had previous valve replacement surgery, including previous implant and then explant of the ATS 3f Enable Aortic Bioprosthesis (Model 6000) or placement of a rigid annuloplasty ring in the mitral position.
* The patient is participating in concomitant research studies of investigational products.
* The patient presents with dilatation of the ascending aorta, Marfan Syndrome, Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging.
* The patient has chronic renal failure.
A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects.

AD 452 is a new drug which is being developed for use in adult patients with RA. It is believed that AD 452 may modify the underlying disease of RA as well as improving RA symptoms, and in order to establish its efficacy and safety, AD 452 is being tested in a 3 month study. Patients enrolled in this study will already be taking methotrexate for their RA and they will remain on methotrexate throughout the study. An earlier clinical study in 98 subjects with RA on stable background therapy investigated the pharmacokinetics, safety and tolerability of AD 452 taken for one month. The drug was well tolerated and no significant drug related adverse events were reported.


Eligibility Criteria:
Inclusion Criteria:

* Male/female age 18 -75
* RA diagnosed for at least 6 months
* Taking methotrexate for at least 6 months
* Must have at least 4 swollen/tender joints

Exclusion Criteria:

* Must not be pregnant/breastfeeding
* Must not have history of other inflammatory disorders
* Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitus, malignant melanoma, HIV, active infection, hepatitis B/C, cardiac conduction disorders, hepatic/renal insufficiency, active depression/anxiety/psychosis/schizophrenia or convulsions.
Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)


Eligibility Criteria:
Inclusion Criteria:

* Confirmed squamous cell head and neck cancer
* Widespread (metastatic) disease, or returned after previous treatment (recurrent)
* Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV \[Human Papilloma Virus (oropharynx only)\]
* Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)

Exclusion Criteria:

* Previous treatment for metastatic or recurrent disease
* Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
* Any non-squamous subtype
* Active autoimmune disease
* Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus
* Previous treatment with checkpoint inhibitor drugs
* Active CNS metastases or carcinomatous meningitis

Other protocol-defined inclusion/exclusion criteria apply
Positive Airway Pressure on Pleural Effusion After Drainage

The purpose of this study is to determine if the addition of intermittent positive airway pressure breathing (specific lung expansion technique) to conventional chest physiotherapy chest drainage is effective to accelerate the reabsorption of pleural effusion and consequently decrease the duration of chest tube drainage and respiratory system impairment. These effects would decrease hospital stay lengths and the incidence of pulmonary complications.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* presence of pleural effusion
* have undergone chest drain for fewer than 24 hours

Exclusion Criteria:

* contraindication to the use of non-invasive equipment that generates positive airway pressure (such as: intolerance, phobia, drowsiness, restlessness, confusion, hemodynamic instability requiring vasopressor therapy, systolic blood pressure \< 90 mmHg, facial trauma, ineffective cough or inability to swallow, nausea or vomiting, upper gastrointestinal bleeding, acute myocardial infarction within the last 48 hours, pneumothorax or bullous emphysema)
Technologies to Improve QoL of Prostate Cancer

The M.I.O Project, which stands for Comprehensive Oncological Medicine, aims to comprehensively and multidisciplinary address the effects of prostate cancer, specifically in patients with hormone-sensitive metastatic prostate cancer (HSMPC), an advanced stage of the disease that still offers prolonged survival due to new medications. The proposal seeks to develop a healthcare approach that promotes self-care and improves the physical and mental health of patients.

Despite growing scientific evidence supporting an integrative approach in oncological care, the provision of personalized options for exercise, nutrition, and psychological therapy before, during, and after diagnosis remains limited. The project proposes to develop tools such as a dedicated mobile application that provides HSMPC patients access to various resources and therapies to improve their health, focusing on nutrition, exercise, and emotional well-being.

M.I.O represents an innovative and holistic approach to addressing these patients' needs and improving their overall well-being. The main goal is to measure the quality of life of the application users through validated questionnaires in a randomized health education study to assess if there is a substantial improvement in their well-being.


Eligibility Criteria:
Inclusion Criteria:

* Patients histologically diagnosed with prostate cancer
* Metastases confirmed by validated imaging studies
* Not meet criteria for castration resistance.

Exclusion Criteria:

* Do not have a smartphone device
* Refuse to participate
* Not sign the informed consent.
Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France.

Coronary calcified lesions will have an increasing impact in the daily practice of coronary angioplasty, considering the epidemiological explosion of factors favoring coronary calcifications, first of all diabetes. Moreover, calcified lesions are underestimated in angiography and associated with an increase in angiographic complications, as well as with a worse clinical prognosis. The usual techniques for the preparation of calcified plaque, in particular rotary atherectomy, have a low penetration rate in France (3% of procedures) and are associated with an increase in per-procedural complications without clinical evidence of effectiveness4. A new device has been developed by Schockwave Medical Inc. for the treatment of calcified lesions to facilitate stent delivery: the C2 Shockwave Medical® Coronary Lithotripsy System (IVL), Inc. This system uses the principle of lithotripsy to induce microfractures in the calcified plaque prior to low-pressure balloon dilatation. The objective of the study is to evaluate the safety and performance of the C2 Shockwave Medical® (IVL), Inc. coronary lithotripsy system in coronary angioplasty in the general population in France.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient affiliated to the National Health Insurance System
* Patient for whom a coronary angioplasty procedure is performed using the Shockwave Medical C2 Coronary Lithotripsy System
* For indications of stent malexpansions, stent malexpansion must be defined by: a) angiography: stent malexpansion \>30% (QCA and/or stent magnification) b) endocoronary OCT/IVUS imaging with MSA (Minimal Stent Area) \<4.5 mm2 or a ratio of MSA/MLA on reference segment\<0.8
* Patient willing to participate in the registry

Exclusion Criteria:

* Patient under 18 years of age
* Pregnant or breastfeeding patient
* Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or legal guardianship)
Efficacy and Safety of TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Breast Cancer

Select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At the same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and safety of TAC and Exemestane.

The investigators select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At the same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and safety of TAC and Exemestane.

Eligibility Criteria:
Inclusion Criteria:

1. Karnofsky ≥ 70
2. Provision of informed consent
3. Pathological confirmation of invasive ductal carcinoma and estrogen receptor is positive
4. Tumor stage(TNM):T2-4bN0-3M0
5. Premenopausal woman
6. Not previously received treatment with bisphosphonate
7. Laboratory criteria:

   * PLT ≥ 100\*109/L
   * WBC ≥ 4000/mm3
   * HGB ≥ 10g/dl
   * GOT,GPT,ALP ≤ 2\*ULN
   * TBIL,DBIL,CCr ≤ 1.5\*ULN

Exclusion Criteria:

1. Pregnant or lactation woman
2. History of organ transplantation
3. With mental disease
4. With severe infection or active gastrointestinal ulcers
5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
6. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)
7. With heart disease
8. Experimental drug allergy
The Effect of Kinesiological Taping Applied to the Tibialis Anterior Muscle on Gait Parameter in Stroke Patients

The effect of kinesiological taping applied to the tibialis anterior muscle on gait parameter in stroke patients: Sham controlled study

Objective: The aim of this study was to compare the immediate effect of kinesiological and / or sham taping to the tibialis anterior muscle on walking parameters in stroke individuals.

Methods: The study included 28 adults stroke patients . The subjects who received scores of 7 or more in the Hodkinson Mental Test and 3 and above in the Functional Ambulation Classification with subjects who gastrocnemius muscle spasticity 2 and below points according to Modified Ashworth Scale were included in the study. The walking parameters of the participants were evaluated with the BTS G-Walk Spatio-Temporal Walking Analysis System. The walking parameters of the participants who were selected by randomization method were evaluated separately by applying kinesiological taping and sham taping or without any taping or interference on a 10 meter track.

Eligibility Criteria:
Inclusion Criteria:

* 28 stroke individuals (hemiplegic / hemiparetic) who were treated in the Adult
* Neurological Rehabilitation Unit of Pamukkale University Medical Faculty Hospital were included in the study.
* Being between the ages of 25-70
* Volunteers with written consent
* With a 1-year history of stroke
* Who had a stroke for the first time
* Having a lesion in one brain hemisphere

Exclusion Criteria:

* Having neurological or orthopedic comorbid disease
* Patients with a gastrocnemius spasticity greater than 2 according to the modified ashworth scale
* Patients with communication problems
* Patients with cognitive functions below 7 points according to the Hodkinson Mental Test
* Patients with ambulation level below 3 according to Functional Ambulation Classification