cyrilzakka/clinical-trials huggingface dataset:
Effects of Trap and Reggaeton Music on Movement Velocity, Power and Muscular Endurance in the Lower Limbs of Physically Active Women

The influence of music on movement velocity and power during strength training have been poorly investigated, and specifically in women there is no evidence of an increase in strength performance due to the influence of music.

Hypothesis: Listening to trap or reggaeton music will improve jumping ability, as well as movement velocity and power, muscular endurance, motivation and perception of effort in trained women during the performance of back-squats.

The investigators pretend to conduct an experimental trial with a randomised crossover design in 28 participants physically active young adults with strength training experience aged 18-30 years. The study will be conducted in the laboratory of Physical Activity and Sport Sciences of the University School of Osuna.

In this way, at the end of the study the investigatos will have contrasted scientific information on the effects of music on the following variables of speed of execution in the back squat exercise.

back.

Eligibility Criteria:
Inclusion Criteria:

* more than 6 months performing strength training programmes
* familiarity with back squat exercises
* no consumption of any type of nutritional supplement or anabolic substances in the three months prior to or during the same study period; v) absence of musculoskeletal injuries that may interfere with the exercise protocol during the investigation
* absence of musculoskeletal injuries that may interfere with the exercise protocol during the investigation
* normal hearing ability

Exclusion Criteria:

* in addition to the above inclusion criteria, the following shall be excluded from the study participants who do not sign the informed consent form.
Intraperative Assessment of Renal Perfusion Using Infrared Imaging

Current assessment of organ tissue viability by surgeons in the operating room is limited to crude estimates such as overt physical examination, measurement of laboratory values and physical measurements of vascular flow and resistance. The ability to non-invasively measure tissue perfusion and oxygenation would provide the surgeon an improved means to assess if an injured organ will survive. The recent development of real time infrared (IR) and Near Infrared Imaging Spectroscopy (NIRIS) digital cameras has allowed for the determination of tissue perfusion and oxygenation in a non-invasive fashion. Although in the early stages of development, the application of infrared and NIRS technology holds great promise to permit the surgeon to better assess the viability of tissues in ways that have not been possible. We propose to evaluate infrared and NIRS technology in the assessment of kidney allografts using data previously collected during recipient operations at the NIH.

Current assessment of organ tissue viability by surgeons in the operating room is limited to crude estimates such as overt physical examination, measurement of laboratory values and physical measurements of vascular flow and resistance. The ability to non-invasively measure tissue perfusion and oxygenation would provide the surgeon an improved means to assess if an injured organ will survive. The recent development of real time infrared (IR) and Near Infrared Imaging Spectroscopy (NIRIS) digital cameras has allowed for the determination of tissue perfusion and oxygenation in a non-invasive fashion. Although in the early stages of development, the application of infrared and NIRS technology holds great promise to permit the surgeon to better assess the viability of tissues in ways that have not been possible. We propose to evaluate infrared and NIRS technology in the assessment of kidney allografts using data previously collected during recipient operations at the NIH.

Eligibility Criteria:
* INCLUSION CRITERIA:

NIH Transplant Reccipients of living related, living unrelated, and cadaveric kidney transplants who underwent intra-operative IR/NIRS imaging.

EXCLUSION CRITERIA:

None
Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines

Currently, nasopharyngeal carcinoma (NPC) patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II will be recommended to receive level Ib-covering IMRT according to the International Guidelines. Our previous study, which retrospectively analyzed a cohort of 390 patients, indicated that it should be safe and feasible for patients who only had at least one of the above two radiological features. Thus, the investigators conduct this non-inferior phase 3, randomized trial to further determine the feasibility of sparing level Ib in patients who had level II involvement with ECE, and/or had a MAD of greater than 2cm in level II.

Currently, nasopharyngeal carcinoma (NPC) patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II will be recommended to receive level Ib-covering IMRT according to the International Guidelines. Our previous study, which retrospectively analyzed a cohort of 390 patients, indicated that it should be safe and feasible for patients who only had at least one of the above two radiological features. Thus, the investigators conduct this non-inferior phase 3, randomized trial to further determine the feasibility of sparing level Ib in patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II.

Eligibility Criteria:
Inclusion Criteria:

1. newly diagnosed, non-metastatic nasopharyngeal carcinoma histologically confirmed by biopsy;
2. the following conditions: ① involvement of level II LNs with extracapsular extension(ECE); ② level II LNs involvement with maximum nodal axial diameter (MAD) greater than 2 cm;
3. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.

Exclusion Criteria:

1. level Ib involvement with positive pathological results;
2. submandibular glands (SMGs) involvement;
3. involvement of structures that drain to level Ib as the first echelon site (the oral cavity, anterior half of nasal cavity involvement);
4. previous malignancy or other concomitant malignant disease.
Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis

This study aims to compare the Cone Beam and the multi-detector computed tomography for diagnosis and pre-operative evaluation of otosclerosis in patients addressed for conductive hearing loss with intact tympanic membrane. The study aims to show that the Cone Beam offers equivalent performances with lower radiation dosage in this indication

Otosclerosis is an inflammatory bone remodeling disorder of the otic capsule, characterized by spongiotic new bone formation, causing stamped ankylosis that can result in conductive hearing loss. Until now, the gold standard imaging technique for diagnosis and pre-operative evaluation of otosclerosis has been multi-detector computed tomography (MDCT). Cone Beam computed tomography is a relatively recent imaging modality. It is associated with a lower radiation dosage compared to MDCT, and a high spatial resolution that allows a more precise analysis of bone structures. During the last 15 years, its use has been increasingly common in odontology and craniofacial surgery. Several studies have already studied the utility of Cone Beam for temporal bone pathologies, including recent retrospective studies that showed satisfying diagnostic performances for otosclerosis. Up to now, very few prospective studies have compared those two imaging modalities for otosclerosis diagnosis and pre-operative evaluation.

Therefore, those two exams will be performed in patients addressed to the hospital for conductive hearing loss with intact tympanic membrane. Thus, the performance of Cone Beam will be compared to MDCT, regarding the positive diagnosis of otosclerosis, the analysis of anatomical structures of the temporal bone for pre-operative evaluation, and also the benefits in terms of irradiation. The MDCTs will include fewer slices than routine MDCTs and will be centered on the area of interest, in order to keep a total radiation dosage smaller or equivalent to routine care

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years and older)
* Requiring radiological assessment for conductive hearing loss with intact tympanic membrane, confirmed by otoscopy and audiogram
* Signed informed consent
* Affiliated or beneficiary of health insurance

Exclusion Criteria:

* Absence of otosclerosis on the MDCT
* History of middle ear surgery
* Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
* Patient under legal protection
Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures

Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of epilepsy with uncontrolled partial onset seizures, whether or not secondarily generalized, and the diagnosis was \>= 6 months before the Selection Visit
* epilepsy was classifiable according to the ILAE Classification
* \>= 4 partial onset seizures during the 4 weeks preceding the Selection Visit and were required to have \>= 4 partial onset seizures during each 4-week interval of the Baseline Period to qualify for randomization
* unsatisfactory current AED treatment in terms of efficacy and/or safety
* stable AED treatment consisting of no more than two AEDs

Exclusion Criteria:

* treatable seizure etiology
* epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
* history of status epilepticus which required hospitalization during 3 months prior to the Selection Visit
* history of or the presence of pseudo seizures
* current diagnosis of Lennox-Gastaut syndrome
Breast Stimulation Versus Pitocin for Induction of Labor

The purpose of the trial is to compare nipple stimulation with a breast pump to pitocin for induction of labor in term pregnancies.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* completed 37 weeks gestation
* singleton pregnancy
* reassuring fetal heart rate at admission monitor

Exclusion Criteria:

* multiple pregnancies
* known fetal malformations
* non reassuring NST
* polyhydramnios (AFI\>220)
* oligohydramnios
* PET
* IUGR
* macrosomia (EFW \>4000g)
* antepartum bleeding
* maternal fever
Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection

Aim of the study is to gain more knowledge about efficacy of CELSENTRI® in daily clinical practice and obtain information about the quality of life of patients using CELSENTRI®.

Non interventional study, inclusion and exclusion criteria defined by the labelling of Celsentri (Maraviroc).

Eligibility Criteria:
Inclusion Criteria:

HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient,

Exclusion Criteria:

X4 or D/M tropic virus. Therapy-naive patients.
Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy

The purpose of this study is to determine whether patients with asthma are better able to manage and control their symptoms by using one inhaler daily that both prevents as well as treats the symptoms of an asthma exacerbation.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18
* Confirmed diagnosis of mild to moderate asthma by doctor
* Currently receiving inhaled corticoid-steroid medicine for treatment of asthma and requiring a review of current asthma treatment

Exclusion Criteria:

* Women who are pregnant, breast-feeding, or planning pregnancy
* Patients with a history of chronic obstructive pulmonary disease
* Patients using any beta blocker therapy
* Patients receiving steroid tablets or steroid injections
Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

The primary objective of this study is to develop normative hemodynamic data (means and standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and 3D-echocardiographic analyses.


Eligibility Criteria:
Inclusion Criteria:

* Male or females between 18-75 years of age
* NYHA Class III-IV heart failure at the time of MEGA deployment
* Stage C-D systolic heart failure
* Non-ischemic cardiomyopathy
* Preserved right ventricular function defined by 2D-echocardiography
* Clinically indicated left and right heart catheterization and MEGA-IABP placement
* Clinically indicated MEGA-IABP support for 12 hours minimum

Exclusion Criteria:

* Ischemic cardiomyopathy
* Active myocardial ischemia or acute coronary syndrome
* Severe peripheral vascular disease
* Severe aortic or mitral valve insufficiency
* Severe aortic or mitral valve stenosis
* Right ventricular failure
* Inability to tolerate left and right heart catheterization
* Severe hemodynamic instability defined as a systolic BP \<80mmHg despite vasopressor/inotropic support
* Sustained ventricular tachycardia (\>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours
* Pacemaker dependent rhythm
* Left ventricular thrombus
* Rapid atrial fibrillation (HR\>120 bpm)
* Unable to provide informed consent
* Pregnancy
The Effects of Resilience and Mental Health of Abused Psychiatric Nurses: An Intervention With Biofeedback Training

The investigators provide biofeedback training to assist the abused PW nurses to reduce WPV-related stress and achieve better resilience and mental health. The research project will assess the participants' physiological indices prior to the intervention as well as their levels of resilience and mental status.

This was a quasi-experimental study, structured questionnaires of Resilience Score, The Center for Epidemiologic Studies Depression (CES-D) and Occupational Stress Indicator-2 were used in this study before and three months after intervention. A total of 112 abused psychiatric nurses were randomly assigned to 3 groups. The biofeedback group (n=40) received the biofeedback training and the self-training group received video relaxation training by Line (n=44). The control group (n=28) did not receive any intervention.

Biofeedback training is an effective intervention to enhance abused PW nurses' resilience and lower their depressive symptoms. Video relaxation self-training is also an effective way to strengthen abused psychiatric nurses' resilience.

Eligibility Criteria:
Inclusion Criteria:

* abused psychiatric ward (PW) nurses

Exclusion Criteria:

-
Support for Perinatal Adherence and Depression

The main aim was to conduct a pilot field test of a group-based depression and adherence counseling intervention with HIV-infected women in the perinatal period. Participants were HIV-infected women living in KwaZulu-Natal, South Africa.

The main aim of this study was to conduct a pilot field test of a group-based counseling intervention with HIV-infected women in the perinatal period as delivered by a lay counselor. The primary goal of the intervention was to reduce symptoms of perinatal depression and increase adherence to antiretroviral therapy among HIV-infected women during pregnancy and the postpartum period.

Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant
* HIV-infected and diagnosed with HIV during the index pregnancy
* Meet criteria for a major depressive episode
* Currently on antiretroviral therapy
* Receiving antenatal care at PMMH Gateway clinic
* Primary language English or isiZulu
* Access to a phone and willing to give researchers permission to reach them via phone
* Resident of Umlazi

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Active untreated, major mental illness (untreated psychosis, bipolar disorder, dementia, or active suicidality) that would interfere with study participation
* Less than 18 years of age
Workplace Tobacco Cessation And Oral Cancer Screening Study

Tata Memorial Hospital has initiated Workplace Tobacco Cessation and Oral Cancer Screening Programme in Chemical Industry at Khed, Ratnagiri. Appropriate interventions for tobacco cessation will be carried at monthly intervals for twelve months duration. The tobacco cessation rates based on history will be validated with the urinary cotinine levels.

The prevalence of tobacco use in India among men has been reported to be high in most parts (generally exceeding 50%). It's use is more common in rural areas as compared to urban areas. Oral cancer, the main cause of which is tobacco, is common in men in developing countries and the most common cancer among men in India. The five year survival rate for oral and pharyngeal cancers even in premier institute like the Tata Memorial Hospital ranges from a poor 8% (hypo pharynx) to 43% (lower lip). Evidence has shown that cessation is the only intervention with the potential to reduce tobacco related mortality in the short- term and medium- term. An emphasis on prevention of tobacco consumption will, in the short run, only have a limited positive effect on tobacco related morbidity and mortality, as prevention strategies do not affect existing consumers. Workplace tobacco cessation activities in India are still in rudimentary stage.

In the proposed study of one year duration, professional help in the form focus group discussion, one to one counseling and pharmacotherapy will be provided to the employees by a team of doctors and counsellors from Tata Memorial Hospital. Self reporting of tobacco history will be validated with Biochemical test. This will add objectivity to the programme, so that, if successful, it can be replicated as a model to promote tobacco control activities at other workplaces. Naked eye examination of oral cavity of all employees for detection of oral pre-cancers and cancers will be done by doctors from the Tata Memorial Hospital. The employees with lesions may be referred for further management, if required. Nursing staff and Doctors attached to the industry and from the local referral hospital will be invited to participate as trainees during the active intervention sessions.

The long term objective of this initiative is to establish a model workplace tobacco cessation and oral cancer screening programme. It will contribute to the human resource and infrastructure development for tobacco cessation services at the industrial unit and at the local referral hospital. Proposed tobacco cessation services in the chemical industry would be of great help for boosting Anti - Tobacco Activities not only in the particular factory unit but also in the nearby industrial and residential zone.

Eligibility Criteria:
Inclusion Criteria:

* All 104 employees working in the chemical industrial unit at Khed, Ratnagiri, are eligible to participate.

Exclusion Criteria:

* There are no exclusion criteria.
Use of NERv's Inline Device as an Early Diagnostic Method for Anastomotic Leak.

NERv's early feasibility clinical trial is a first-in-human, multi-center, pre-market, non-randomized clinical trial intended to evaluate the safety and collect preliminary data necessary for the detection of clinical post-operative anastomotic/intraperitoneal leakages.

NERv's Inline Device attaches to existing catheters or peritoneal drains that are currently being used in the medical industry. This allows the device to measure the pH and conductance of intraperitoneal fluids that typically get drained through peritoneal drains.

The purpose of NERv's feasibility clinical trial is to collect pH and conductance readings by analyzing peritoneal drainage fluid. Upon analyzing data collected from NERv's Inline Device a clinical model of pH and conductance will be created. The clinical model can then be used to determine if a complication is developing. For instance, boundaries (reading thresholds) can be established where if the signal goes outside the boundaries a complication could be identified. Specifically the ability to detect a post-operative complication known as anastomotic leakage; which is a dreaded complication associated with abdominal surgeries; will be the main focus of the study.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years - male or female
* Subject understands and has voluntarily signed and dated Informed Consent Form (ICF)
* Subjects must be willing to comply with trial requirements
* Subject has a peritoneal drain attached post-surgery

Exclusion Criteria:

* Plans that the subject will be discharged less than 8 hours post-surgery
* Involvement in the planning and conduct of the clinical investigation
* Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
* Subject is consuming steroid or anti-inflammatory medication
International Multicenter Study on Lipin-1 Deficiency

LIPIN1 is an international registry that allows the collection of data on the follow-up, management and treatment of patients with Lipin-1 deficiency.

This study evaluates survival, cardiac function, quality of life, fatigability, treatment tolerance and comparison of the efficacy of different current treatments in patients with Lipin-1 deficiency.

Eligibility Criteria:
Inclusion Criteria:

Patient at least 12 months with Lipin1 deficiency confirmed by molecular biology (two causal mutations in the LPIN1 gene)

Exclusion Criteria:

Opposition of the patient or his parents to participate to the study
Study to Evaluate Dietary Supplementation With a Version of Anatabloc(R) in Subjects With Alzheimer's Disease

To explore whether dietary supplementation with a version of Anatabloc(R) exerts an effect on blood levels of amyloid beta (Aβ), or impacts global or functional measures of Alzheimer's Disease (AD) in subjects with mild to moderate AD.


Eligibility Criteria:
Inclusion Criteria:

* At least 65 years old.
* Have a diagnosis of probable AD or a concurrent diagnosis of probable AD and possible or probable vascular dementia.
* Score 16 or more on the Mini-Mental State Examination (MMSE).
* Otherwise stable medical history and general health.
* Weigh between 45 kg and 120 kg inclusive.

Exclusion Criteria:

* Have contra-indications, allergy, or sensitivity to the study products or their components.
* Be currently taking any of the following medications: systemic (oral or injectable) glucocorticoids; interferon-alpha; anti-CD20 antibody (e.g., rituximab); or anti-CTLA-4 antibody (e.g., ipilimumab).
* Be a current smoker or smokeless tobacco user.