cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral Abdomen

This study will evaluate the clinical efficacy and performance of the BTL-899 device for changes in subcutaneous fat and muscle tissue in the lateral abdomen region (also referred to as flanks or "love handles"). The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.

At the baseline visit, MRI imaging will be performed; the subject's weight and waist circumference will be recorded. Digital photographs of the treated area will be taken.

The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the area of flanks. The device will induce visible muscle contractions along with heating of the subcutaneous fat. Each therapy session will last 30 minutes.

At the last therapy visit, the subject's weight and waist circumference will be recorded, and digital photographs of the treated area will be taken. In addition, subjects will receive Therapy Comfort and Subject Satisfaction Questionnaire to fill in.

Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all of the follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Age 22 years and older
* Voluntarily signed an informed consent form
* BMI ≤ 35 kg/m2
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
* Subjects willing and able to maintain their regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation

Exclusion Criteria:

* Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
* Metal implants
* Drug pumps
* Malignant tumor
* Pulmonary insufficiency
* Injured or otherwise impaired muscles
* Cardiovascular diseases
* Disturbance of temperature or pain perception
* Hemorrhagic conditions
* Septic conditions and empyema
* Acute inflammations
* Systemic or local infection such as osteomyelitis and tuberculosis
* Contagious skin disease
* Elevated body temperature
* Pregnancy, postpartum period, nursing, and menstruation
* A metal-containing intrauterine device (IUD)
* Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area
* Graves' disease
Neurofeedback & Alcohol Dependence

The study aims to examine whether the neurofeedback method (based on functional magnetic resonance imaging \[fMRI\]) can help patients with alcohol dependence to control their urges to drink alcohol and thus to remain abstinent. Potential effects of neurofeedback on abstinence and drinking behaviour will be evaluated based on the comparison between a group of patients receiving multiple sessions of neurofeedback training and a group of patients receiving treatment as usual over the same period of time.

Neurofeedback is a non-invasive neuroscientific tool in which participants receive real-time feedback about their brain activity while undergoing functional magnetic resonance imaging. Previous research has shown that participants can successfully use the feedback to self-regulate their brain responses. In this study patients who have successfully completed a detoxification programme will be trained to down-regulate/upregulate responses of motivational brain regions that are activated during exposure to alcohol/life goal-related stimuli (pictures of alcoholic drinks/life goals related). The investigators hypothesise that learning to self-regulate these neural responses will enable patients to better control craving responses to environmental alcohol cues after detoxification treatment. Patients in the intervention group will undergo 6 neurofeedback training sessions, spread across 4 months. Outcomes of the training will be compared with a group of patients who will not do the neurofeedback training but receive standard treatment (e.g. support groups and medication).

Eligibility Criteria:
Inclusion Criteria:

* Successful completion of detoxification programme within a time window of 1 to 6 months before the recruitment
* Abstinence since detoxification treatment

Exclusion Criteria:

* Ongoing regular abuse of illicit substances except cannabis
* History of psychotic disorders not related to alcohol
* IQ \< 70
* Involvement in other interventional research in the past 6 months
* MRI counter-indications, e.g. claustrophobia, pregnancy, active medical implants, passive implants deemed unsuitable, metallic dust in the eyes, certain types of metal prostheses, surgical clips, previous experience with metalworking without eye protection
Study of Tumor and Blood Samples From Postmenopausal Women With Primary Breast Cancer Enrolled on Clinical Trial CAN-NCIC-MA27

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tumor and blood samples from postmenopausal women with primary breast cancer enrolled on clinical trial CAN-NCIC-MA27.

OBJECTIVES:

Primary

* To identify genetic variation, as measured by single nucleotide polymorphisms, that is associated with musculoskeletal adverse events in specimens from postmenopausal women with hormone receptor-positive primary breast cancer receiving adjuvant aromatase inhibitors and enrolled on clinical trial CAN-NCIC-MA27.

OUTLINE: This is a multicenter study.

DNA from tumor tissue and blood specimens that have been previously collected from patients are analyzed for single nucleotide polymorphisms.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed invasive breast cancer

  * Complete resection of primary tumor
  * Stage I-III (T1-3, N0-3, M0) disease
* Enrolled in clinical trial CAN-NCIC-MA27.
* No locally recurrent or metastatic breast cancer
* Hormone receptor status:

  * Estrogen receptor- or progesterone receptor-positive disease

PATIENT CHARACTERISTICS:

* Postmenopausal status, defined as one of the following:

  * At least 60 years old
  * Age 45-59 years with spontaneous cessation of menses for \> 12 months prior to chemotherapy or study randomization
  * Age 45-59 years with cessation of menses for \< 12 months or secondary to hysterectomy AND a follicle-stimulating hormone (FSH) level in the postmenopausal range (or \> 34.4 IU/L)
  * Age 45-59 years on hormone replacement therapy (HRT) and discontinued HRT at diagnosis of breast cancer AND FSH level in the postmenopausal range (or \> 34.4 IU/L)
  * Bilateral oophorectomy

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers

The purpose of the study was to compare the clinical effectiveness of bonded versus vacuum-formed retainers regarding their retention capacity; periodontal health; survival rates; and patients' perception after 12 months of removal of fixed appliances.

The null hypotheses considered that there was no differences between the retainers in relation to the aspects evaluated.

This single-center randomized controlled trial was performed at the Department of Orthodontics, Bauru Dental School, University of São Paulo, Brazil.

A total of 50 patients completing orthodontic treatment were recruited. The patients were prospectively and randomly allocated into two groups. The first group consisted of 25 patients with canine-to-canine V-bend bonded retainers; while the second group comprised 25 patients with vacuum-formed retainers. In both groups, the same retainers were installed in the maxillary and mandibular arches.

Patients were evaluated at deboning (T0), after 3 months (T1), 6 months (T2), and 12 months (T3). In each appointment, digital models were obtained and the other clinical variables were evaluated. The primary and secondary outcomes were compared between retainers in the time-points evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the proper completion of orthodontic treatment and correction of the initial malocclusion.
* Acceptable oral hygiene (assessed through clinical examination).
* Presence of all teeth up to the second molars.
* Clinically acceptable teeth alignment.

Exclusion Criteria:

* Patients with any systemic condition that may have an influence on periodontal health.
* Patients with facial deformities.
* Initial malocclusion that required extreme corrections, large transverse expansions or orthognathic surgery.
* History of periodontal diseases.
MIld to MOderate Acute Pancreatitis: Early naSogastric Tube Feeding Compared With pAncreas Rest (MIMOSA)

Pain relapse during oral refeeding occurs in at least one-fifth of patients with acute pancreatitis. The study hypothesis is that early administered enteral tube feeding might reduce a risk of pain relapse and shorten the length of hospital stay in patients with acute pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of acute pancreatitis
* age 18 years or older
* written informed consent

Exclusion Criteria:

* \> 96 hours after onset of symptoms
* \> 24 hours after hospital admission
* organ failure by the time of randomization
* infectious complications before randomization
* received artificial nutrition before randomization
* previously enrolled into the trial
* chronic pancreatitis
* post-ERCP pancreatitis
* intraoperative diagnosis of acute pancreatitis
* pregnancy
* malignancy
An Exercise Facilitator to Activate Simple Training Programs in the Dialysis Center

Low physical activity levels and progressive poor functional capacity affect quality of life and clinical outcomes of Chronic Kidney Disease (CKD) patients. Interventions to prevent the functional decline associated with a sedentary lifestyle or to relief from deconditioning are crucial, considering the significant beneficial effects of exercise in all CKD patients, especially in End-stage Kidney Disease patients (ESKD). Unfortunately, physical and psychological barriers to exercise are present and physical activity management is not routinely addressed in the patient's care.

For the first time the project aims to test the impact of the regular presence of an exercise specialist in the Nephrology Unit.

This facilitator, evaluating capacity, motivation and preferences of each patient, will design tailored solutions and assess the related outcomes. Several design of training programs will be proposed to dialysis patients, that can choose the exercise option that best fits their needing.

The study will determine the feasibility of the project, the patients' adherence and the effectiveness of the programs proposed to improve the patients' lifestyle.

The assumption underlying the project is that a wider participation to physical activity programs (PAPs) of ESKD patients may be facilitated by the presence in the Renal Unit of an exercise specialist able to design tailored programs and that this intervention may lead to measurable benefits on physical fitness, quality of life and general health.

The possible different solutions offered by an expert of exercise in chronic diseases might reduce most of the barriers to exercise responsible of the sedentary behavior of the ESKD patients. Aim of the project is to test the impact of the regular presence of this facilitator in a Nephrology Unit in terms of applicability and feasibility as well to identify the preferred and the most effective pathways for the patients.

The identification of a novel cost-effective intervention may represent an important step to manage the change of lifestyle of ESKD patients, to slow down their physical and QoL decline and to reduce hospitalizations and negative outcomes affecting this population.

Eligibility Criteria:
Inclusion Criteria:

* male and females aged \> 18 years;
* ability to walk assisted or unassisted at least for 6 meters;
* cognitive functioning to give informed consent identified by a Mini Mental Status Examination score ≥18/30.

Exclusion Criteria:

* severe cardio-respiratory (e.g. unstable angina; severe heart failure identified by New York Heart Association class III or IV);
* neurological or musculoskeletal conditions (e.g. above knee amputation) contraindicating or inhibiting exercise training.
Ascending Dose Study of the Safety and Tolerability of REGN728 in Healthy Volunteers

This study will test the safety and tolerability (how the body reacts to the drug) of REGN728 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by subcutaneous injection (under the skin) at the clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs (blood pressure, temperature, breathing and heart rate) will be checked, blood and urine samples will be collected at some or all visits.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 to 65 years of age.
* Weight\> 50 kg and \<95 kg inclusive
* For men of childbearing potential, willingness to utilize adequate contraception and not have their partner\[s\] become pregnant during the full duration of the study.
* Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
* Able to read, understand and willing to sign the informed consent form.

Exclusion Criteria:

* Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.
* Women of childbearing potential, pregnant and breast-feeding women are excluded. Women are considered to be of childbearing potential until they have been amenorrheic for at least 12 months or have had surgical sterilization.
* Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
* Hospitalization for any reason within 60 days of screening.
* Known history of Human Immunodeficiency Virus (HIV) antibody; and/or positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit.
* Previous exposure to any therapeutic or investigational biological agent.
* History of alcohol or substance abuse within a year prior to the screening visit.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Multimodal Platform Combining VR and TENS for Stroke Rehabilitation

Stroke is a disabling medical condition annually affecting up to 15 million people worldwide. It leads to upper-limb impairments encompassing motor and sensory deficits together with cognitive self-body and space misrepresentation, overall limiting the functional independence of 70% of stroke survivors. On the motor side, stroke could account for hemiparesis (weakness or paralysis affecting the side contralateral to the brain lesion), muscle weakness, spasticity, loss of coordination, and others. On the sensory side, especially in the first stages after the stroke occurs, stroke could account for sensory loss, with the patient not being able to perceive what he's touching with the impaired arm.On a cognitive level, it has been shown that chronic stroke patients have distorted body representation and space representation. They perceive their impaired arm as shorter and the impaired hand as larger.

Despite initial evidence of the crucial role of sensory-motor integration toward a restored body representation to promote effective rehabilitation, conventional approaches suffer from the bias of prioritizing motor recovery, while disregarding stroke-induced sensory and body representation deficits.

In this view, the creation of a virtual reality (VR) scenario in which the person is fully immersed, could potentially play a significant role in improving stroke patients' rehabilitation.

Taking this into consideration, this project aims to assess whether a multimodal platform combining VR with TENS inducing full-body illusion toward a virtual avatar could positively impact motor performances, sensory assessments, and self-body and space representation of stroke patients.

More into detail, the intervention will consist of the patient performing some task-oriented movement within the virtual reality and congruently tactile receiving feedback through transcutaneous electrical nerve stimulation. The subject will receive clear instruction within the virtual reality scenario to perform specific actions toward a final goal. These actions will be designed to make the subject repeat some crucial movements in their rehabilitation process. Depending on the motor impairment of the patient, the investigators will adapt the characteristics and the difficulty of the task accordingly.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic or haemorrhagic stroke patient
* At least 3 months after the stroke incident
* 10 \<= FMUE \<= 60 (motor function)

Exclusion Criteria:

* Prior neurological or psychiatric disorders
* Severe cognitive impairment (MoCA score \<10)
* Epilepsy
* Pacemakers or other electronic implants
* Unable to give an informed consent form
Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD)

The purpose of this study is to compare the effects of pitavastatin and atorvastatin on adiponectin percentage change in patients with hypercholesteremia comorbid stable CAD.

The efficiency of lipid lowering therapy was already proven by the clinical trials of statins. According to these results, the target value of LDL-C is recommended under 100mg/dL in the Japan Atherosclerosis Society Guidelines. However, the efficiency of intensive therapy to lower LDL-C more than 100mg/dL has not been proven yet.

Eligibility Criteria:
Inclusion Criteria:

* Patients with dyslipidemia as defined by any of the parameters:

  * HDL-C \< 50 mg/dL
  * LDL-C ≥ 140 mg/dL
  * LDL-C ≥ 100 mg/dL and cholesterol-lowering treatment is necessary in accordance with the investigator's judgement
* Patients who passed three months or more after acute myocardial infarction
* Patients who passed one month or more after unstable angina
* Patients who passed one month or more after PCI
* Patients with written consent by their own volition after being provided sufficient explanation for the participation into this clinical trial

Exclusion Criteria:

* Patients with any allergy to pitavastatin or atorvastatin
* Patients with familial hypercholesterolemia
* Patients receiving pitavastatin
* Patients with severe hypertension
* Patients with renal disorders or undergoing dialysis
* Patients with hepatobiliary disorders
* Patients with hepatobiliary disorders
* Patients with family history of hypothyroidism or muscular dystrophy
* Patients with history of drug-induced hepatic disorder
* Drug abuser or dipsomaniac
* Patients with cardiogenic shock.
* Patients who hopes for pregnancy during this study
* Contraindications, Relative Contraindications, Absolute Contraindications for Coadministration and Relative Contraindications for Coadministration for pitavastatin or atorvastatin
* Patients who are ineligible in the opinion of the investigator
2D Perfusion DSA for the Quantification of Infrapopliteal Angioplasty

A custom-made, 2D-perfusion digital subtraction angiography (PDSA) algorithm has been designed and implemented towards foot perfusion quantification following endovascular treatment of critical limb ischemia (CLI), in order to assist intra-procedural decision-making and enhance clinical outcomes.

This is a prospective, single-center, study investigating the feasibility of 2D-PDSA using newly-developed, non-commercially available, color-coded software for the quantification of foot perfusion following infrapopliteal angioplasty for the treatment of CLI. In total, 7 consecutive patients scheduled to undergo infrapopliteal endovascular treatment of CLI were enrolled. Perfusion Blood Volume (PBV), Mean Transit Time (MTT), and Perfusion Blood Flow (PBF) maps were extracted by analyzing Time-Intensity Curves and signal intensity on the perfused vessel mask. Mean values calculated from user-specified ROIs on perfusion maps were employed to evaluate the patient's pre- and post- endovascular treatment condition.

Eligibility Criteria:
Inclusion Criteria:

* Patients prescheduled for infrapopliteal angioplasty due to chronic limb-threatening ischemia.
* Written informed consent obtained

Exclusion Criteria:

* Image post-processing not feasible due to significant motion artifacts produced during DSA
Significance of the High-risk Hpv Viral Load

The aim of this study is to evaluate the significance of an elevated high-risk HPV (HR-HPV) viral load.

We will particularly evaluate if the HR-HPV viral load:

* Is correlated to the transcription of the genes of the oncoproteins E6 and E7
* Is predictive of the integration of the virus in infected cells
* Is predictive of the presence of HPV in patients' blood
* Influences the local and systemic immunologic response

Eligibility Criteria:
Inclusion Criteria:

* The women consulting for the therapeutic care (by hysterectomy or conization) of a LIEHG or a cervical cancer (carcinoma epidermoid or adenocarcinoma) confirmed by the anatomopathologique analysis of a preoperative cervical biopsy.
* The women having a normal cervix consulting for the surgical care by hysterectomy of a good-hearted pathology of the womb. The normality of the cervix will be confirmed by the anatomopathologique analysis of the detail of hysterectomy
* The patients participating in this study will have to be of more than 18 years old. All the subjects will be profitable of a regime of Social Security.

Exclusion Criteria:

* The patients having a LIEBG
* The patients incapable to receive the information enlightened on the progress and the objectives of the study
* The patients not having signed enlightened assent