cyrilzakka/clinical-trials huggingface dataset:
Study of Radiofrequency Device for Use in Non-Invasive Cosmetic Procedures

The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device used to treat and improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 21 to 70 years old,
* For females, at least 9 months post-partum,
* Clinically appreciable skin laxity on the abdomen, thigh, upper arms or neck as determined by the study investigator,
* For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
* Apparently healthy,
* Informed consent signed by the subject.

Exclusion Criteria:

* History of skin hypersensitivity,
* Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex),
* Use of non-steroidal anti-inflammatory drugs within past 2 weeks,
* Suffering from hormonal imbalance which may affect weight or cellulite,
* Subjects with pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
* Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
* The current or recent use (within the past 12 months) of isotretinoin,
* Pregnancy or breast feeding,
* Infectious diseases (such as HIV) present,
* Are a tobacco smoker,
* Insulin dependent diabetic subjects,
* Oxygen dependent subjects,
* Subjects with severe chronic illness, scleroderma, or lupus,
* Subjects with open sores or scars in the treatment region, or
* Subjects with ischemia in the treatment region.
Effects of Fixed and Removable Space Maintainers on Periodontal Health and DMFT/Dft Values

Space maintainers are appliances that applied when primary teeth were lost prematurely because of many reasons such as tooth decay, trauma, lack of germ of permanent tooth.4 Space problems play an important role in practice of dentistry and also understanding of the dental development in the primary and mixed dentitions could help to intercept the malocclusion.The aim of this study is to evaluate the effects of applied space maintainers on periodontal health and dental status after teeth missing in pediatric dentistry clinic.

The study was approved by the Ethics Committee of the Istanbul University Faculty of Dentistry (No:2014/8) and was carried out in agreement with the Declaration of Helsinki principles. This study conducted 104 patient whose age between the range of 4-15 years were chosen to applied fixed (band and loop, palatal arch, lingual arch) or removable space maintainers in Istanbul University Faculty of Dentistry Department of Pediatric Dentistry were followed between years of 2013-2014. Totally, four of the patients excluded due to systemically and genetically disorder.

In primary and mixed dentition, dft index was used and in permanent dentition DMFT index was used. Longevity time in the mouth, the number of developing new caries were evaluated and DMFT/dft and plaque index were compared.

Eligibility Criteria:
Inclusion Criteria:

* healthy and applied space maintainer patients

Exclusion Criteria:

* unhealthy and non-applied space maintainer patients
Quantification With Lutetium-177 on Cadmium-Zinc-Telluride Camera 3D

The main of this study is to demonstrate the feasibility of carrying out quantitative acquisitions regardless of the energy peak considered (113 keV (kiloelectronVolts) or 208 keV or a combination of the 2 energy peaks). A study on phantom will optimise the reconstruction parameters. These parameters will then be applied to a population of patients who have already benefited from a recording on a 3D CZT camera (retrospective data).

Lutetium 177 is a beta emitter - and is used in therapy. It also emits during its radioactive decay, two gamma photons of energy 113 and 208 keV allowing to produce images. The dosimetry committee of the European Association for Nuclear Medicine (EANM) recommends using only the peak at 208 keV to obtain so-called quantitative images using a conventional camera also called an Anger camera.

For several years, new semiconductor cameras (CZT cameras) have been available in nuclear medicine departments. They offer better performances particularly in terms of detection sensitivity and energy resolution. The nuclear medicine team has already carried out studies with Lutetium-177 with these semiconductor cameras on phantoms as well as dosimetry studies after treatment using Lutetium-177.

This study should demonstrate the feasibility of carrying out quantitative acquisitions regardless of the energy peak considered (113 keV or 208 keV or a combination of the 2 energy peaks). A study on phantom will optimise the reconstruction parameters. These parameters will then be applied to a population of patients who have already benefited from a recording on a 3D CZT camera (Retrospective data).

Eligibility Criteria:
It is a retrospective study and the criteria to collect the imaging are:

Inclusion Criteria:

Patients treated by at least one cure of lutetium vipivotide tetraxetan with imaging

Exclusion Criteria:

Patient having sent an objection to the use of their data
Overview of Self-medication Among French Navy Personnel

The goal of this cross-sectional descriptive observational study is to assess the extent of self-medication among the crews of surface ships at the Toulon naval base. This study could include healthy volunteers, or participants with well-controlled chronic pathologies enabling them to be fit for embarkation, who are currently being deployed for at least 4 weeks on a surface ship at the naval base.

Participants will tick and complete a questionnaire (between 15 and 30 minutes) after 4 consecutive weeks on the ship.


Eligibility Criteria:
Inclusion Criteria:

* French military personnel;
* age \> 18;
* embarked on a French navy vessel from the naval base;
* for a minimum 4-week mission;
* covered by social security.

Exclusion Criteria:

* Refusal to participate,
* Legionnaire
* Military Health Services member
Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors

This study will assess whether alternative, high phytoestrogen dietary interventions result in favorable effects on biological parameters that have been associated with hormone-dependent cancers, cardiovascular disease, and osteoporosis.

Broad health effects of endogenous and exogenous estrogens on diseases of aging, including hormone-dependent cancers, cardiovascular disease, and osteoporosis, are generally recognized. For example, estrogen replacement therapy (ERT) may increase the risk of subsequent breast and endometrial cancer, but also decreases the risk of coronary disease and fractures. Because of the increased cancer risk, many women seek out alternatives to ERT. Phytoestrogens, plant compounds that have estrogenic effects, have been a focus of interest as an alternative to ERT. The isoflavones and lignans are two major classes of phytoestrogens that occur in the food supply. Among the former, soy foods have attracted much interest, while among the latter, whole grains and seeds are sources in a typical diet. More specifically, women consuming a macrobiotic diet have been observed to have extremely high levels of phytoestrogen metabolites in their urine, perhaps 10 to 20 times that seen in women consuming an omnivorous diet. Proponents of a macrobiotic diet have proposed that it is beneficial in the context of cancer therapy, as well as for the prevention and treatment of cardiovascular disease.

This study will investigate, in a randomized, three-arm study, the effects of two interventions that are high in phytoestrogens on various parameters related to estrogen metabolism and fibrinolysis. Approximately 120 women will be randomized to receive an American Heart Association (AHA) Step 1 diet, an AHA Step 2 diet + 10 g/day flax seed, or a macrobiotic dietary intervention. Blood and urine samples will be drawn at baseline, and at three, six, nine, and twelve months, to examine both short and long-term effects of these interventions. Outcomes include blood and urine levels of total estrogens and estradiol, and related metabolites; antigens to plasminogen activator inhibitor-1 (PAI-1) and tissue plasminogen activator (t-PA), fibrin D-dimer, and von Willebrand Factor; and endothelial function as measured by high-resolution ultrasound. Blood levels of antioxidant vitamins and retinoids will also be examined.

This study should provide information on whether these alternative, high phytoestrogen dietary interventions result in favorable effects on these biological parameters that are related to risk of major diseases of aging.

Eligibility Criteria:
Inclusion Criteria:

THIS TRIAL IS RECRUITING IN THE NEW YORK METRO AREA ONLY

* Postmenopausal
* Weight within 90% to 120% of ideal body weight
Studying Mechanisms of Radiation Therapy Resistance in Samples From Younger Patients With Rhabdomyosarcoma

This laboratory study is looking into mechanisms of radiation therapy resistance in samples from younger patients with rhabdomyosarcoma. Studying samples of tissue 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 find better ways to treat cancer

Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples with DNA Biospecimen Description: Tissue Study Population Description: Primary care clinic Sampling Method: Non-probability sample

OBJECTIVES:

I. Determine the molecular response/resistance signatures with radiotherapy and standard chemoradiation treatments using the xenograft model of the Pediatric Preclinical Testing Program (PPTP).

II. Validate these novel pathways/biomarkers by their detection within clinically annotated patient tumor tissue samples and testing their associations with clinical response, local control rates, and overall survival rates.

OUTLINE: Archived tissue samples of matched primary-relapsed and non-matched primary are analyzed for genomic DNA, DNA methylation profiles, RNA sequencing, differences between alveolar rhabdomyosarcoma (ARMS) and embryonal rhabdomyosarcoma (ERMS), gene expression profiles, target-of-rapamycin complex 1 (TORC1) and TORC2 pathway intermediates, and paired box 3 (PAX3)/forkhead box O1 (FOXO1) translocation by microarray, immunohistochemical staining, and fluorescence in situ hybridization (FISH).

Eligibility Criteria:
Inclusion Criteria:

* Tissues requested from the Children Oncology Group (COG) sarcoma banking protocol COG-D9902
* All subtypes of rhabdomyosarcoma specimens

  * Matched primary-relapsed specimens (from same patient, separated by time):

    * Frozen tissue if available
    * Scrolls of formalin-fixed paraffin-embedded tissue (if frozen not available)
    * 10 unstained formalin-fixed paraffin-embedded thin sections
  * All other general (primary or relapsed) cases

    * 10 unstained formalin-fixed paraffin-embedded thin sections
Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

The purpose of this study is to determine if Toric intraocular lens implantation in cataract surgery is a more efficient and cost-effective treatment of astigmatism than Monofocal intraocular lens implantation.

A recent innovation in cataract surgery consists of the introduction of toric intraocular lenses (IOLs) that can correct corneal astigmatism. It offers the opportunity for patients with substantial astigmatism to achieve optimal distance vision without using spectacles. Good near vision may subsequently be achieved with low-cost reading glasses. The current practice of non-toric IOL implantation in astigmatic patients warrants the use of expensive bifocal or multifocal spectacles with cylinder correction to achieve good distance and near vision.

Objective: The primary objective of this study is to compare spectacle independence for distance vision following toric IOL implantation and monofocal intraocular lens (IOL) implantation. The secondary objectives are to compare uncorrected distance vision, residual refractive astigmatism, quality of vision, wavefront aberrations, contrast sensitivity, complication profile, costs of postoperative spectacles and cost-effectiveness.

Study design: Multi-centre randomised clinical trial. Study population: 160 patients with regular corneal astigmatism of at least 1.25 diopters in both eyes who require bilateral cataract surgery.

Intervention: Cataract surgery with implantation of a toric IOL (AcrySof model SN60TT) or an monofocal IOL (AcrySof model SN60AT).

Eligibility Criteria:
Inclusion Criteria:

* Bilateral cataract
* Bilateral corneal astigmatism (at least 1.25D)
* Predicted residual astigmatism less than 0.5D

Exclusion Criteria:

* Irregular corneal astigmatism or keratoconus
* Fuchs endothelial dystrophy (stage 2)
* Expected postoperative best-corrected visual acuity worse than logMAR +0.3
Factors Issued From Functional Exploration Associated to SAHOS in Asthmatic Children

There is an increase in the prevalence of obstructive apnea-hypopnea syndrome (OSA) in children for which the pathophysiological explanation is unknown. The main objective is to compare pharyngeal collapsibility in asthmatic children with SHS score \> 2.75 or ≤ 2.75 (OSA prediction score validated in French). Secondary objectives: Compare pharyngeal size, tracheal size, loop gain and its components (controller, plant), lung volumes and expired and nasal NO in asthmatic children with SHS score \> 2.75 or ≤ 2.75. The bias due to the possible existence of an alveolar hyperventilation syndrome associated with asthma will be taken into account.

Detailed measurements and questionnaires: Measurement of pharyngeal volume by acoustic pharyngometry in sitting and lying position with calculation of pharyngeal compliance. Measurement of ventilation (15 minutes) and transcutaneous PCO2 measurement, three apnea tests at the end of the test, hyperventilation test. PFT with spirometry and static volume measurement. Multiple flow measurement of exhaled NO with calculation of bronchial flow and alveolar fraction of NO. Nasal NO measurement. Questionnaires for OSA: the Pediatric Sleep Questionnaire (PSQ) and the SCR (Sleep Clinical Record). Questionnaires for functional respiratory disorder: French hyperventilation questionnaire SHAPE and the Nijmegen score

Eligibility Criteria:
Inclusion Criteria:

* Confirmed asthma established on the notion of typical respiratory functional signs and the notion of reversibility of a bronchial obstruction on previous PFT and/or asthma exacerbation diagnosed by the physician in an emergency room. Ongoing asthma treatment (including SABA on demand)

Exclusion Criteria:

* not asthmatic children
Moving On - An RCT to Test Physical Therapy Education

The purpose of this study is to test the acceptability, feasibility and explore the possible effects of an early physical therapy education intervention for breast cancer survivors.

This study uses a randomized controlled and longitudinal study design. We will compare two groups - an intervention group and a control group - to test the effects of an early physical therapy education intervention for breast cancer survivors who are candidates for breast cancer surgery. Because of the nature of the intervention (patient early education with 1:1 discussion of educational materials) we will be unable to introduce blinding of the participant as well as the staff.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with unilateral breast cancer
* Candidate for breast cancer surgery as first line of cancer treatment
* Undergo breast cancer surgery at Brigham and Woman's Hospital, Boston, Massachusetts
* Female
* English speaking
* Greater than or equal to 21 years old

Exclusion Criteria:

* Previous history of breast cancer and/or recurrent/metastatic disease
* Receiving neoadjuvant chemotherapy treatment
* Bilateral breast cancer
* History of shoulder impairments or severe upper quarter scarring
* Pregnancy
* Central nervous system damage
* Dementia
* History of other previous cancers (except non-melanoma skin)
* Systemic medical conditions (e.g.: fibromyalgia, rheumatoid arthritis, etc.)
* Amputation of either upper extremity
Effects of Acupuncture in Spontaneous Rapture of Membranes: Applicability and Effectiveness

The aim of the study is to investigate the effects of acupuncture in women presenting with spontaneous rapture of membranes (PROM) at term and negative swab for Streptococcus Agalactie to promote a spontaneous onset of labour and avoid labour induction after 24 hours, accordingly to our policy. Secondary outcomes were considered the duration of first and second stage of labour, the time elapsed between PROM and delivery.


Eligibility Criteria:
Inclusion Criteria:

* PROM after 37 weeks of gestation
* absence of maternal and fetal complications
* negative swab of Streptococcus Agalactiae
* limpid amniotic fluid
* absence of uterine contractions after 6 hours of observation
* single pregnancy

Exclusion Criteria:

* PROM before 37 weeks of gestation
* presence of maternal and fetal complications
* positive swab of GBS
* M1 - M3 amniotic fluid
* regular uterine contractions during the first 6 hours of observation
* twin pregnancy
Ultrasonic Treatment of Food Addiction

This study will evaluate a new form of non-invasive deep brain therapy for food addiction. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled trial. The trial will evaluate brain target engagement using magnetic resonance imaging, Food Cravings Questionnaire-State, and changes in subject's weight over the course of the study.


Eligibility Criteria:
Inclusion Criteria:

* History of at least one self-reported unsuccessful dietary effort to lose body weight
* Body mass index more than or equal to 30 kg/m\^2 or more than or equal to 25 kg/m\^2 with the presence of at least one of the following weight-related comorbidities: hypertension, dyslipidaemia, obstructive sleep apnoea, or cardiovascular disease.

Exclusion Criteria:

* Lifetime history of a serious suicide attempt
* MRI intolerance or contraindication
* Pregnant or breast feeding
* Diabetic (HbA1c more than 48 mmol/mol or 6.5%)
* A self-reported change in body weight more than 10 lbs within 60 days before screening
* Clinically inappropriate for participation in the study as determined by the study team
Effects of Radio-frequency in Patients With Myofascial Chronic Neck Pain

The aim of this study was to evaluate the potential clinical benefits of Monopolar Capacitive Resistive Radio-frequency (448 kHz) (MCRR)F for the treatment of myofascial chronic neck pain.

A randomized, double-blind, placebo-controlled trial. Setting: University community.

Patients with myofascial chronic neck pain with active MTrP in one upper trapezius muscle were involved. The patients were randomly divided into two groups: a radiofrequency group (RFG), who (14 patients) received 8 sessions of a monopolar capacitive resistive radiofrequency (MCRRF) application over the upper trapezius muscle and ten patients received 8 sessions of placebo radiofrequency (PG) over the same muscle. Main outcome measures: Visual analog scale (VAS), neck disability index (NDI) and cervical range of motion (pre-treatment, immediately post-first session treatment and post-treatment.

Eligibility Criteria:
Inclusion Criteria:

-Patients aged between 18 and 60 years with myofascial chronic neck pain. The area of neck pain was defined as the cervical region, possibly with referred or radiating pain into the occiput, nuchal muscles, shoulders and upper limbs. Symptoms had to have been present for at least six months before. At least one active MTrP in one upper trapezius muscle had to be present. For bilateral neck pain, the most painful side was designated for treatment.

Exclusion Criteria:

* Severe disorders of the cervical spine, such as spinal stenosis, disk prolapse, postoperative conditions of the neck and shoulder areas, history of severe trauma, whiplash, spasmodic torticollis, instability, migraine, peripheral nerve entrapment, fibromyalgia, shoulder diseases, inflammatory rheumatic diseases, severe psychiatric illness and pregnancy.
Study for the Assessment of the Quality of Echocardiographic Clips.

This study main objective is to evaluate the safety and efficacy of the UltraSight AI Guidance software. The investigational product is a software that guides the user to capture a high quality ultrasound image. The study will include healthcare professionals, not specialized in echocardiography, who will perform echocardiography by using UltraSight AI Guidance software, on subjects in the medical centers cardiac units.

This pivotal study is a multi-center, multi-reader multi-case (MRMC) study, designed to assess the quality of the clips obtained by novice users when using the UltraSight AI Guidance software. Prior to the study start, there will be a pre-study training phase for training the novice users.

During the study, eligible subject will undergo the echocardiography examination twice on a single study visit (same day): once by one of the novice users when using the UltraSight AI Guidance software, and once by an expert sonographer without the aid of the software.

Each novice user will perform the examination on at least 20 subjects (with the aim that the number of examinations by each novice will be similar). All examinations will be sent to multiple Board certified cardiologists for their quality evaluations.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and older
2. Subjects willing and able to give written informed consent.

Exclusion Criteria:

1. Emergency (non-elective) admission within 24 h prior to participating in the study
2. Female subjects who are pregnant (women of childbearing potential will perform a urine pregnancy test)
3. Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
4. Subjects who currently participate a clinical trial, involving interventional cardiac devices.
5. Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report
6. Subjects with BMI above 40
7. Subjects experiencing a known or suspected acute cardiac event
8. Subjects with severe chest wall deformity as per previous medical records and physical examination
9. Subjects who have undergone pneumonectomy
10. Subjects whose anatomy does not lend itself to yield diagnosable standard echocardiography clips (i.e. situs inversus with dextrocardia, single ventricle anatomy due to congenital heart disease, etc.).

    * A woman is of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis.).