cyrilzakka/clinical-trials huggingface dataset:
The Effects of Manual Lymphatic Drainage and Transcutaneous Electrical Nerve Stimulation in Premenstrual Syndrome

The aim of this study is to (a) investigate the effects of manual lymphatic drainage and transcutaneous electrical nerve stimulation on the severity of syndrome symptoms, pain, heart rate variability, and quality of life in women with premenstrual syndrome, and (b) compare the effectiveness of these two methods. Female participants who met the inclusion criteria and volunteered to participate in the study will be called approximately one week before menstruation. After the participants are randomly divided into 3 groups, their baseline assessments will be made. Then, the participants will be treated according to the group they are assigned to. Treatments will be applied for 5 days and once a day. No treatment will be applied to the control group. The assessments will be repeated after the treatment, on 1st day of menstruation, two days before the next menstruation, and on the first day of the next menstruation. The hypothesis of this study is that manual lymphatic drainage and transcutaneous electrical nerve stimulation have positive effects on the severity of premenstrual syndrome symptoms, pain, heart rate variability, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* women aged between18-45 years-old
* regular menstrual cycles (cycles of 21-35 days with a bleeding time of 3-10 days)
* premenstrual syndrome (according to the premenstrual syndrome scale, be above 110 points)

Exclusion Criteria:

* pregnancy
* premenstrual dysphoric disorder
* menopause
* chronic disease
* continuous use of medication
* under hormonal therapy
* infection
* using any method to cope with premenstrual syndrome
The Effect of Olive Leaf Extract Administration on Cardiovascular Health

The purpose of this study is to investigate the effects of daily supplementation of OLECOL for a period of 8 weeks on cardiovascular risk markers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Age between 18 and 70 years
* Total cholesterol levels ≥ 5.0 mmol/L
* BMI 25-35 kg/m2

Exclusion Criteria:

* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat). Dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and /or laboratory assessments that might limit participation in or completion of the study protocol.
* Diabetes
* Use of medication that might have influence on endpoints (e.g. cholesterol lowering medication, hypertension medication)
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to the study
* Use of antibiotics in the 30 days prior to the start of the study
* Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
* Pregnancy, lactation
* Abuse of products (\> 20 alcoholic consumptions per week and drugs)
* Smoking
* Weight gain or loss (\> 3 kg in previous 3 months)
* High physical activity (\>4.5 hours of running/week)
* History of any side effects towards intake of olives
Body Awareness and Perception Across Menstrual Phases:

The study explores the dynamic interplay between body awareness and body perception across the menstrual cycle's phases, emphasizing hormonal influences on these dimensions. Conducted with 43 female participants aged 18-35, this research highlights significant variability in body-related experiences tied to hormonal fluctuations.

The study aims to address the gap in understanding how menstrual cycle phases impact women's body awareness-sensitivity to physiological states-and body perception, encompassing self-image and physical self-evaluation.

Methods: Participants were divided based on menstrual phases: follicular, ovulatory, and luteal. Hormonal fluctuations were tracked through menstrual calendars and ovulation kits. Tools such as the Body Awareness Questionnaire (BAQ) and Multidimensional Body-Self Relations Questionnaire (MBSRQ) assessed participants' awareness and perception. Other assessments included the Premenstrual Syndrome Scale (PMS), Menstruation Attitude Scale (MAS), and physical activity tracking through the IPAQ-SF questionnaire.

Limitations The reliance on self-reported data and single-cycle assessments are noted as constraints, suggesting the need for longitudinal studies for greater robustness.

Eligibility Criteria:
Inclusion Criteria:

* female volunteers
* aged 18-35 years
* regular menstrual cycles

Exclusion Criteria:

* not using hormonal contraceptives in the preceding six months
* having no history of gynecological disorders
* having no chronic diseases
Diabetes Inspired Culinary Education

The aim of this study is to assess the feasibility and efficacy of a community-based culinary nutrition education program (Diabetes Inspired Culinary Education, DICE) on improving the diabetes management and dietary intake of 6-14 year old children with type I diabetes mellitus (TIDM).


Eligibility Criteria:
Inclusion Criteria:

* Children: 6-14 years old; diagnosed with type I diabetes within the past 5 years; English speaking
* Adults: primary caregiver of a 6-14 year old child diagnosed with type I diabetes within the past 5 years; English speaking

Exclusion Criteria:

-
Study Evaluating Anxiety and Depression in Patients With Psoriatic Arthritis

This is an epidemiological non-interventional study assessing the prevalence of anxiety and/or depression disorders in patients suffering from Psoriatic Arthritis (PsA) in Spain.


Eligibility Criteria:
Inclusion criteria:

* Patients both genders over 18 years old
* Patients with PsA diagnosis

Exclusion criteria:

* Patients with PsA that suffer from other rheumatologic diseases or non-concomitant rheumatologic diseases that the investigator considers not to be appropriate for the study.
* Patients with any medical or physical condition (cognitive damage or difficulties for understanding) that create difficulties for reading and completing the questionnaires described in the protocol.
* Patients that in the study period are taking part in another clinical trial.
SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER

This post-marketing study is a multicenter cohort study in individuals aged 60 years or older vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in individuals aged 60 years or older under actual clinical practice in Japan.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 60 years or older who have been vaccinated with Abrysvo for the first time after Abrysvo is launched. Those who have previously participated in the clinical trials of this product will be excluded.
2. Vaccinated participants (or his/her legally acceptable representative) who understand the information on this study and have provided written consent regarding their participation in the study.

Exclusion Criteria:

-There are no exclusion criteria for this study.
Feasibility of Ambulatory Hysterectomy

Hysterectomy is one of the most performed surgery in women. Public authorities wish that one-day surgery become a majority and hysterectomy could be part of it in the future. The aim of this study is to determine the feasibility of ambulatory hysterectomy.

Patients and methods: Investigators will realize an observational descriptive survey based on questionnaires in two surgical gynecology units. Women under 70 years old, who undergo hysterectomy will be included.


Eligibility Criteria:
Inclusion Criteria:

* women, undergo surgery for hysterectomy by laparoscopy or vaginal procedure

Exclusion Criteria:

* comorbidities included: heart disease, anti-coagulant treatment, anti-aggregant treatment; sleep apnea syndrome, laparotomy laparoconversion if hysterectomy associated with appendectomy and/or, omentectomy and/or, lymph nodes dissection
Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure

The ENGAGE-HF mobile application tracks three key features over time: (1) heart failure health status, (2) vital signs (e.g., blood pressure, heart rate) and weight, and (3) the quality of heart failure medication therapy. Helping patients understand how these characteristics interact and change over time may improve their ability to understand and manage heart failure.

In this study, the investigators aim to evaluate whether the ENGAGE-HF mobile application, by facilitating the behavior change strategies of self-monitoring and feedback, and a clinician-facing dashboard, improves the optimization of heart failure guideline-directed medical therapies (GDMT) and quality of life.

An optional sub-study of cognitive function will invite all eligible participants enrolled in the main study to participate.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of heart failure
* Last left ventricular ejection fraction within 2 years \< 50% based on echocardiogram, MRI, CT, or nuclear perfusion and, if no ejection fraction documented, then clinical documentation of heart failure with reduced ejection fraction
* Currently admitted with upcoming discharge or discharged from hospital within the prior 4 weeks
* At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or at \< 50% of target dose at time of enrollment

Exclusion Criteria:

* Receives dialysis
* Inotropic therapy after hospitalization
* History of a prior solid organ transplant or actively listed on heart transplant waiting list
* History of left ventricular assist device implantation
* Cardiac amyloidosis
* Currently pregnant or intends to become pregnant during the study period
* Life expectancy estimated less than 6 months related to cardiac or non-cardiac comorbidities as per investigator's judgment
* Actively enrolled in hospice or comfort care
* Currently participating in an investigational device or drug study or having participated in such a study 30 days prior to screening
* Subject without a compatible smartphone
* Subject not proficient with written and spoken English
* Any other disorder or condition that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
* Participant has diminished decision-making capacity
* Admitted to or planned discharge to a skilled nursing facility or rehabilitation facility (acute or subacute)
ShotBlocker During Intramuscular Injection Randomized Control Trial

The objective of this trial is to evaluate the effect of Bionix ShotBlocker on pain of injection of the first Hepatitis B vaccine in healthy newborns. ShotBlocker is a pain reducing tool used in babies, children, and adults for injections. Swaddling during the injection and administration of oral sucrose prior to the injection are established standards of care for painful procedures in neonates. The investigators hypothesize that the use of ShotBlocker in addition to swaddling and oral sucrose administration will lessen the pain response.


Eligibility Criteria:
Inclusion Criteria:

* Infants born at UMass Memorial Medical Center (UMMMC) via vaginal delivery or cesarean delivery and under the care of the nursery team
* Term infants (37 to 42 weeks gestational age)
* No acute illness that causes pain
* Apgar score above 7 at 5 minutes
* Have successfully attempted at least one oral feeding
* No circumcision in the last 6 hours
* Parental consent for Hepatitis B vaccine

Exclusion Criteria:

* Swallow dysfunction
* Congenital or genetic abnormalities
* Infants who were exposed to sedatives within the last 12 hours
* Infants with skin on thigh, hand, or foot that is not intact
* Diagnosis of Neonatal Abstinence Syndrome (NAS)
* Infants who are simultaneously receiving Hepatitis B Immunoglobulin or Nirsevimab (RSV vaccine)
* Department of Children and Families (DCF) custody
The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)

to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the safety and tolerability of Sitagliptin.


Eligibility Criteria:
Inclusion Criteria:

* Patients Who Are 18 Years Of Age With Type 2 Diabetes Mellitus Who Are Either:

  * Not On Antihyperglycemic (AHa) Medication (Off For At Least 2 Months)
  * Or On A Single AHa
Use of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease

The Balloon Analogue Risk Task \[BART\] is an experimental task modelizing risky behaviors. In Parkinson disease, the correlation between BART and modifications of cerebral activity in ventral striatum has been shown. BART thus seems to be particularly adapted for modelization of HYPERdopaminergic behavioral disorders \[TYPER\] into Parkinsonian patients. Previously, a version of the BART performed with EEG has been specifically developped by the Centre d'Investigation Clinique of Besançon University Hospital, in collaboration with the Clinical and integrative neurosciences laboratory. Preliminary data suggest that the analysis of evoked potentials including Feedback-related Negativity \[FRN\], P300 wave, and Reward Positivity \[RewP\], could help assessing the motivational and attentional attributes of decision making and the delayed treatment of any reward.

The hypothesis of the study that the EEG version of the BART could help predicting the risk to develop TYPER into Parkinsonian patients treated by dopaminergic in routine care.


Eligibility Criteria:
Inclusion Criteria:

* Probable Diagnosis of Parkinson's disease according to the Movement Disorder Society criteria
* Parkinson disease appeared ≤ 60 years old
* Disease evolving since ≥ 5 years
* Daily dose for du dopaminergic treatment ≥ 200mg/day DOPA equivalent
* Patients requiring in routine care the introduction or increase of dopaminergic agonists treatment because of:

  1. HYPOdopaminergic behavioral syndrome \[TYPO\] including apathy, anxiety, depression and/or
  2. motor syndrome insufficiently controlled by dopaminergic treatment (akinesia, rigidity, tremor)

Exclusion Criteria:

* Cognitive disorders (Montreal Cognitive Assessment \[MoCA\] \< 25/30)
* Parkinson disease psychosis
* HYPERdopaminergic behavioral disorders \[TYPER\] defined by a score ≥ 2 at at least 1 item of HYPERdopaminergic behavioral spectrum of Parkinson disease
* Contraindications for dopaminergic agonists
* Patient treated with deep brain stimulation
* Serious psychiatric comorbidity (major depressive episode according to Diagnostic and Statistical Manual of Mental Disorders \[DSM\] V criteria, suicidal patient, other active psychosis, etc.)
* Unstabilized psychotropic treatment
* Pregnant or breastfeeding women
Approaches and Metrics in Fraily Patients During COVID-19 Era

The COVID-19 pandemic started in December 2019 in Wuhan, the Chinese province of Hubei. Compared to the period of the first epidemic wave (March to May 2020), in the period of the second epidemic wave (October 2020 to July 2021), deceased people have a more significant clinical complexit, as demonstrated by the higher number of comorbidities.The need to allocate significant amounts of healthcare resources to the COVID-19 emergency, deferral of routine healthcare visits, and invitation to avoid medical controls, if not strictly necessary, may have led to interruptions of disease management undersupply of chronic treatments. Consequently, the health status of patients with chronic pathologic conditions have worsened during and beyond the crisis. Patients with cancer, autoimmune disease, and immune deficiencies represented populations with varying immunocompetence, which made translate into higher susceptibility to SARS-CoV-2 and, for this reason, we defined them as frail populations.The main goal of the study was to propel the field of COVID-19 impact on particularly vulnerable categories of patients. The findings of this study could aid in determining the conditions under which healthcare organizations must operate in the event of a pandemic in order to protect patient's rights to care.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent for participation in the study
* In the period between April 1, 2021, and September 31, 2022, all COVID-19 positive frail patients identified by molecular swabs taken at participating institutions were included in the study; ii) on a quarterly basis, a cohort of equal numbers of COVID-19 negative frail patients wre identified and paired by disease , gender, and age.

Exclusion Criteria:

* No exclusion criteria were identified
TweeSteden Mild Stenosis Study

Psychosocial factors have been found to be associated with an increased risk for coronary artery disease incidence, progression and worse clinical outcomes.

Patients with non-significant coronary artery disease (confirmed vascular irregularities, but \<60% coronary occlusion) often present with complaints such as chest pain, which warrant screening by coronary angiography (CAG) or computed tomography (CT scan). The prognosis of this group of patients with mild stenosis remains to be investigated in more detail, and we propose that psychosocial factors play a role in the clinical prognosis and patient reported outcomes in this group.

A special focus lies within examining personality characteristics, of which Type D personality is a primary predictor variable for prognosis. Type D personality is characterised by high negative affect and high social inhibition. In addition to psychosocial factors (personality, mood state, social support, SES), biomarkers(inflammation, clotting, DNA) as well as standard clinical risk factors (metabolic syndrome, activity level, smoking, medication use, disease severity) will be investigated.

The goal of the proposed study is to investigate a preexisting psycho-biochemical risk profile for major adverse cardiovascular events (MACE) and patient perceived symptoms in a group with angiographically or CT-scan confirmed, non-significant coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Based on quantitative coronary angiography (CAG): visible, but non-significant (\<60% coronary occlusion) vascular irregularities and mild coronary stenosis.
* Based on 64-slice CT-scan (CT-scan): detected non-significant stenosis (calcium score \>= lowest 10th percentile), and not eligible for CAG.

Exclusion Criteria:

* Normal coronary arteries (based on CAG or CT scan)
* Significant occlusion of coronary arteries (\>=60% stenosis)
* Eligible for coronary intervention such as PCI or CABG
* History of coronary events (being either MI,PCI, CABG, heart failure)
* For the CT-screened group: eligible for CAG based on the CT-scan
* Serious comorbid conditions such as chronic kidney failure, or receiving chemotherapy
* Insufficient knowledge of the Dutch language
Bactericidal Permeability Protein Inhibitor and Interleukin-1beta Levels After Non-surgical Periodontal Treatment

The aim of this study was to examine the relationship between healing response after non-surgical periodontal treatment and baseline gingival crevicular fluid (GCF) levels of bactericidal/permeability-increasing protein (BPI) and interleukin-1beta (IL-1ß).

Bactericidal/permeability-increasing proteins (BPI) specific and powerful effect against Gram negative bacteria and their LPSs is completely observable in biological fluids such as plasma, serum, and whole blood.

Objective: It is the evaluation of periodontal disease effect of BPI and interleukin-1 beta (IL-1 β) levels in gingival fluid before and after non-surgical periodontal treatment (NSPT)in patients with periodontal disease.

Method: Thirty systemically healthy and non-smoking individuals with periodontitis were included in the study. Before NSPT, the clinical parameters of plaque index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAS), bleeding on probing (BOP) were measured. The gingival fluid samples were taken using the paper strip method. The same procedures were repeated at 6 weeks and 6 months after non-surgical periodontal treatment. ELISA method was used for the analysis of the samples

Eligibility Criteria:
Inclusion Criteria

Systemically healthy,

* Stage II or III, Grade A periodontitis
* Having at least 20 permanent teeth (excluding third molars and any tooth loss induced by -non-periodontal causes).

Exclusion Criteria:

Smoking,

* use of alcohol; pregnancy or lactation; intake ofantibiotics, steroidal or non-steroidal anti-inflammatory drugs within the last 6 months
* having received periodontal treatment within the last 6 months
Safety and Efficacy Study of Pilocarpine HCl Ophthalmic Solution in Participants With Presbyopia

A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine HCl ophthalmic solution when administered bilaterally, once daily for 30 days in participants with presbyopia.


Eligibility Criteria:
Inclusion Criteria:

* 1 Participant must be 40 to 65 years of age inclusive, at the time of the screening visit;
* 2 Emmetropes or non-emmetropes with best distance correction in the range of spherical -4.00 D to +2.00 D inclusively and cylinder ±2.00 D with photopic, high contrast CDVA of 20/25 or better in each eye at the screening and baseline visits;
* 3 Mesopic, high contrast DCNVA of 20/40 to 20/100 in each eye at the screening and baseline visits;
* 4 Photopic, high contrast, near visual acuity correctable to 20/40 or better in each eye at the screening and baseline visits;
* 5 Dark adaptation pupil diameter between 4.0 mm and 8.0 mm in both eyes at the screening visit;
* 6 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria:

* 1 Clinically significant disease state, in the opinion of the examining investigator or designee, in any body system;
* 2 Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications;
* 3 Any active ocular inflammation within 30 days prior to the first use of the investigational drug;
* 4 Current enrollment in an study or participation in such a study within 30 days prior to the first use of the investigational drug;
* 5 Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion;
* 6 History of cataract surgery, phakic intraocular lens surgery, corneal refractive surgery, radial keratotomy, or any intraocular surgery;
* 7 Presence of any ocular condition that, in the opinion of the investigator, could affect the safety of the participant or interpretation of efficacy parameters;
* 8 Moderate to severe dry eye disease at the screening visit;
* 9 Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis at the screening visit;
* 10 Diagnosis of any type of glaucoma or ocular hypertension;
* 11 Female who have a positive pregnancy test during the screening period, lactating, or planning a pregnancy during the study.
Maximizing Language Development in Children With Hearing Loss

The purpose of this study is to evaluate the effects of early intervention on language skills for children with hearing loss.


Eligibility Criteria:
Inclusion Criteria:

* 6 to 18 months of age
* bilateral, moderate to profound congenital hearing loss

Exclusion Criteria:

* auditory neuropathy
* no known additional disabilities (e.g., cerebral palsy, Down syndrome)
* both parents have a severe to profound hearing loss