cyrilzakka/clinical-trials huggingface dataset:
ProSALUTE: Community Program for Cardiovascular Health

The purpose of this study is to determine the efficacy and cost/effectiveness (change in CV risk factors and lifestyle vs costs) of ProSALUTE as a new organizational model of primary CV prevention.

Primary Cardiovascular (CV) prevention programs in the healthcare place and community-based interventions have a variable impact on health at the population level. The largest benefit may be obtained by addressing high-risk, disadvantaged and traditionally hard-to-reach groups.

Effective actions include health promotion, timely screening of modifiable risk factors, application of evidence-based targets and interventions, broad access to heart-friendly environments/facilities and dissemination of favorable social norms. Thus, community prevention is a multifaceted task that requires multidisciplinary collaboration. A suitable program should be tailored to the specific social context and make the most of local resources to improve access, adherence and continuity, as well as sustainability.

ProSALUTE is a new model of primary CV prevention for the prevalently low-income and multiethnic community of Ponte Lambro (n=3600 adults), the neighborhood where the coordinating hospital (Centro Cardiologico Monzino, Milan, Italy) is located.

Under the coordination of a Case Manager (a Nursing Researcher) the citizens are involved in a prevention program, which is personalized (content and intensity) according to the individual global risk and specific risk factors. The citizens follow an individualized schedule of short-term specialist care. Besides, the participants are "gently nudged" to make use of local resources that may contribute to sustain a healthy life-style (e.g. parks, gyms, social services, etc). Moreover, public preventive events for the community are devised (e.g. healthy-cooking course, walking groups, etc) through a collaborative network with representatives of the neighborhood.

Eligibility Criteria:
Inclusion Criteria:

* Live in Milan at neighborhood of Ponte Lambro

Exclusion Criteria:

* Patients with known atherosclerotic disease (secondary prevention)
* Severe diseases or disabilities that hinder the participation in the program
Hybrid Imaging Modalities for the Evaluation of Infection

The synergistic value of the fusion of physiologic and anatomical data has been described using several co-registration techniques for various nuclear medicine procedures and morphologic imaging modalities (single photon emission computed tomography-computed tomography \[SPECT-CT\], SPECT-magnetic resonance imaging \[MRI\], camera-based positron emission tomography \[PET\]-CT and PET-CT). The researchers hypothesize that fusion of nuclear medicine (NM) and CT data acquired sequentially in a single imaging session on one device is clinically superior to side-by-side evaluation of separately performed imaging tests. They hypothesize that more accurate localization of increased radiotracer activity on NM procedures will improve the diagnostic accuracy for detection of infection and will subsequently have a significant impact on patient management.

The purpose of the present study is to assess the clinical value of this new technology of fused imaging in patients undergoing diagnostic nuclear medicine evaluation for suspicion of an infection process.

The researchers hypothesize that fusion of nuclear medicine (NM) and CT data acquired sequentially in a single imaging session on one device is clinically superior to side-by-side evaluation of separately performed imaging tests. They hypothesize that more accurate localization of increased radiotracer activity on NM procedures will improve the diagnostic accuracy for detection of infection and will subsequently have a significant impact on patient management.

The purpose of the present study is to assess the clinical value of this new technology of fused imaging in patients undergoing diagnostic nuclear medicine evaluation for suspicion of an infection process.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for NM imaging procedures to assess the presence of infectious processes.
* Patients signed informed consent

Exclusion Criteria:

* The study will not be performed in pregnant or lactating women.
* Patients unable or unwilling to tolerate the scan until its completion
Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular Atrophy

The primary objective of the study is to evaluate anxiety level during intrathecal administration (IT) under standard of care (SOC) and virtual reality (VR) conditions using a reliable self-rating scale.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants aged 7 years and greater
* Genetically documented spinal muscular atrophy linked to chromosome 5q (5q-SMA)
* Loading nusinersen dose period is completed, and ongoing treatment with nusinersen
* Ability of the candidate and/or their legally authorized representatives (e.g., parent, spouse, or legal guardian), as appropriate and applicable, to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations
* Signed written informed consent from adult participants, or from legal authorized representatives for minors

Key Exclusion Criteria:

* History of any clinically significant abnormalities that would render the candidate unsuitable for VR (e.g., visual or hearing impairment, presence of eye, face or sclap injuries) or for inclusion (e.g. cognitive impairment), as determined by the Investigator
* Conditions that could be exacerbated by the VR environment, such as: (i) current symptomatic nausea, vomiting, dizziness, migraine; (ii) history of psychosis, hallucinations, epilepsy
* Ongoing medical conditions or treatments that according to the Investigator would interfere with the conduct and assessments of the study (e.g. general anesthesia)
* Participants wearing a pacemaker and pregnant woman

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage

Hemopatch is an alternative to reduce morbidity associated with axillary lymphadenectomy surgery, possibly contributing to improved patient management, clinical outcomes, and hospital costs. We propose a multicenter, controlled, and randomized trial to study the efficacy of Hemopatch in reducing serous wound drainage.


Eligibility Criteria:
INCLUSION CRITERIA

Preoperative:

* Female gender
* Age ≥ 18 years
* Breast cancer N+
* Conservative Surgery: Lumpectomy or Quadrantectomy
* Berg levels 1-2 axillary lymphadenectomy

Intraoperative:

* Axillary incision separated from the incision for the breast lesion
* Placement of a closed low pressure suction drain in the axillary fossa
* Hemostasis and lymphostasis using clips, electrocautery, electric scalpel or bipolar coagulation

Postoperative:

- Patients with ≥ 10 axillary nodes removed

EXCLUSION CRITERIA

Preoperative:

* Mastectomy
* Previous radiation therapy
* Previous axillary emptying
* Liver pathology
* Diabetic decompensation: defined as any episode that has required medical attention in an emergency service or hospital admission; and also that which has required a modification of the patient's drugs, or an increase of more than 20% of the total daily dose.
* Known allergies to any component of Hemopatch (proteins of bovine origin or PEG)
* Psychiatric disorder that conditions the non-understanding of the questionnaire, or incapacitation of the patient to understand it
* Simultaneous participation in another clinical study
* PCR positive for SARS-CoV-2

Intraoperative:

* Level 3 axillary dissection (severe axillary involvement)
* Unexpected surgical contraindication
* Hemostasis and lymphostasis: ultrasonic techniques or other advanced energy techniques are excluded.
* Use of fibrin sealants (eg: Tisseel, Artiss, Tachosil), cyanoacrylate type adhesives (eg: Glubran-2) or other types of products (oxidized cellulose format, powders or gelatin sheets or collagen).
Pilot Study on Sleep Management for US Veterans

The aim of the proposed pilot study is to scientifically evaluate the use of Mind-Body Bridging Program (MBBP) as an effective intervention for improving health outcomes in veterans exhibiting sleep disturbance in the Primary Care Clinic at the Veterans Administration Salt Lake City Health Care System (VASLCHCS).

Participants will be randomly assigned to either MBBP or a treatment as usual sleep hygiene (SH) group. The interventions will last two weeks in which participants will attend 2 classes 1-1.5 hr each over two consecutive weeks. Assessment of the effects of the treatments will be based on self-report outcome measures; participants will complete five questionnaires approximately one week prior to the start of the interventions (pre-treatment) and one week after the second session (post-treatment). The sleep quality assessment questionnaire will be additionally completed after the first session (Week 1).

Eligibility Criteria:
Inclusion Criteria:

1. Selection of subjects will be based on the patients exhibiting sleep disturbance as assessed by a standardized sleep questionnaire. Because we are also interested in the effects of MBBP on co-morbid illnesses besides insomnia, we will include subjects that are being treated for depression, pain, and general medical conditions, except as defined as exclusion criteria. Subjects using anti-depressants, sleep and pain medications, and other medications for any condition that is not under exclusion criteria will be admitted to the study. Thus our inclusion criteria will be broader than those based on DSM-IV for primary insomnia.
2. On the day of the study session, patients must arrive before the session for intervention assignment and to turn in their packets, and thereafter on the same day they must be able to attend a mind-body bridging program or sleep hygiene class (see Study Procedure). In addition, they must also be able to attend the second session the following week.

Exclusion Criteria:

1. The patient presents with significant mental health issues, such as severe psychosis or major depression (as verified by the primary care provider) or the patient is under intensive mental health case management.
Cannabis Effects as a Function of Sex (CanSex)

The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-related effects between men and women

The proposed study will compare smoked cannabis's dose-dependent, analgesic and abuse-related effects between men and women and variables that underlie these sex-dependent differences, including pharmacokinetics of THC.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female aged 21-55 years
* Report use of cannabis an average of 1-7 days per week
* Not currently seeking treatment for their cannabis use
* Urine test positive for recent cannabis use for heavy users
* No reported adverse effects with cannabis smoking in light users
* Have a Body Mass Index from 18.5 - 34kg/m2.
* Able to perform all study procedures
* FEMALES: Currently practicing a non-hormonal effective form of birth control
* FEMALES: Must be regularly cycling

Exclusion Criteria:

* Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine, or cannabis use disorder
* Report using other illicit drugs in the prior 4 weeks
* History or current evidence of severe psychiatric illness or medical condition judged by the study physician and PI to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.
* Current use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes
* Current pain
* Insensitivity to the cold water stimulus of the Cold Pressor Test
* FEMALES: using a hormonal contraceptive
The Effect of Thyroid Hormon Levels on the Corneal Measures

In this cross-sectional comparative study, it is aimed to investigate the topographic measurements,aberrometrics and densitometrics values of corneas in hypothyroid and hyperthyroid patients compared to healthy individuals. A number of 20 hypothyroid patients (group I), 20 hyperthyroid patients (group II), and 20 age-matched healthy controls (group III) have been recruited. The Pentacam high resolution imaging system is used to determine corneal topographic measurements,aberrometry and densitometry.

Thyroid hormone diseases can cause different symptoms and signs in the body according to the hormone levels, particularly in the eyes. Corneal tissue can be affected by many biochemical and hormonal factors, and many ocular surface and systemic diseases can affect the cornea.Hyperthyroidism has been shown to cause symptoms such as conjunctival chemosis, proptosis, increased intraocular pressure, limitation to globe movements due to the restriction of extraocular muscles, increased orbital volume, increased risk of glaucoma with inflammation in the trabecular meshwork and exposure keratopathy, especially in Graves' disease. In the case of hypothyroidism, studies have shown fluid retention and edema in all body tissues, thereby resulting in increased thickness in the cornea, as well as a decrease in corneal hysteresis, which increases the risk of glaucoma. In this study, it is aimed to assess whether thyroid hormone changes affect those parameters by objectively measuring corneal changes via corneal topography, corneal densitometry and corneal aberrometry.

Eligibility Criteria:
Inclusion Criteria:

* Thyroid hormone disorder patients with a novel diagnosis
* Age-matched healthy individuals without any systemic disorder (e.g., diabetes mellitus, hypertension, rhematoid artritis, asthma etc.)

Exclusion Criteria:

* Having a spherical or cylindrical refractive error of \>1.0 degrees,
* Congenital corneal dystrophies, corneal ectasia, corneal ulcers or scars, keratitis, ocular surface infections, keratoconus,
* A history of ocular trauma,
* Uveitis,
* Glaucoma,
* A history of contact lens wear,
* A history of ocular surgery,
* Dry eye diseases
The Effect of Feeding Infant Formula With Enriched Protein Fractions in the US

This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.


Eligibility Criteria:
Inclusion Criteria:

* Singleton, 0-90 days of age at randomization
* Term infant with birth weight of a minimum of 2500 grams
* Receiving at least 75% of the recommended caloric intake from cow's milk-based infant formula
* Parent or legally authorized representative attending study visits reads, understands, and speaks English
* Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria:

* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
* Feeding difficulties or formula intolerance
* Infant born small for gestational age
* Infant born from a mother who was diabetic at childbirth
* History of seizures or neurological disorders or infant with known head/brain disease/injury
A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.

This study did not have a fixed duration, and the duration of individual subject participation was determined based on investigator assessment of subject tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no subjects, therefore, were considered to have "completed" the study.

Eligibility Criteria:
Inclusion Criteria:

* Subject has completed the treatment period of a previous blinded study of pimavanserin
* The subject is willing and able to provide consent
* Caregiver is willing and able to accompany the subject to all visits

Exclusion Criteria:

* Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
* Subject is judged by the Investigator to be inappropriate for the study
Renal Denervation in Patients After Acute Coronary Syndrome

This study is aimed to evaluate the effect of renal denervation to decreasing blood pressure and left ventricle remodeling progression in patients after acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

* acute Q negative myocardium infarction (during first 14 days)
* non stable angina
* significant stenosis
* BP \> 140/90 torr. during more than 1 year

Exclusion Criteria:

* absence of arterial hypertension
* Thrombolysis during previous 24 hours
* indications for CABG
Validation Study of a Watch for the Detection of Atrial Fibrillation

The proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF).


Eligibility Criteria:
Inclusion Criteria:

* adults, men or women, at least 18 years old
* person having signed the informed consent form
* person affiliated to a social security system

Exclusion Criteria:

* vulnerable subject according to current regulation:

  * pregnant woman, parturient or breastfeeding
  * subject deprived of freedom by judicial, medical or administrative decision
  * subject legally protected or unable to express his consent
  * subject non-beneficiary of healthcare
  * subject falling into more than one of the above categories
* subject who refused to participate in the study
* subject in linguistic or psychic incapacity to sign a written informed consent form
* subject in physical incapacity to wear a watch on their wrist
* subject with electrical stimulation by pacemaker
Neoadjuvant Database

The NEOADJ Database base contains data collected during the regular clinical patient management (sociodemographic, clinical, pathological, radiological, biological, disease evolution...). This database allows easy access to information in a centralized and structured way.

This cohort is used to gather insights for research purposes. All data collected come from medical files of patients managed at Centre Georges Francois Leclerc, Dijon, France.


Eligibility Criteria:
Inclusion Criteria:

* Women followed for breast cancer in Georges Francois Leclerc Center
* Neoadjuvant chemotherapy
* Age \>= 18

Exclusion Criteria:

* Males
* Metastatic breast cancer
Chiropractic and Acupressure for Headaches

This study will investigate the effect of chiropractic treatment with and without the use of an acupressure pillow for cervical headaches. Subjects will be randomly allocated to groups with and without the pillow and will be followed for five weeks. The primary outcome measure will be headache frequency. The investigators predict that the group using the pillow on a daily basis will demonstrate significantly greater decrease in headache frequency over a 5-week interval.


Eligibility Criteria:
Inclusion Criteria:

* males and females
* ages 21-60
* recurrent headaches
* sub-occipital tenderness
* a minimum of 4 headaches per month

Exclusion Criteria:

* migraine with aura
* sinus headache
* any other organic pathology
* any contraindications to cervical manipulation
Micronutrients and Health in Adult Chinese

Adult subjects were recruited from a health examination center. Their fasting blood samples were collected for laboratory analyses of multiple measures including mineral, glucose, lipids, etc.


Eligibility Criteria:
Inclusion Criteria:

* adult volunteer
* Han population
* living in Shenzhen City for \> 2 y

Exclusion Criteria:

* caught by organic diseases
* in pregnancy
Type III Dysbetalipoproteinemia

Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in subjects with dysbetalipoproteinemia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dysbetalipoproteinemia defined as VLDL-C/VLDL-TG mass ratio \>0.35 at Visit 2 or the concurrence of mixed hyperlipidemia (fasting TC ≥ 200mg/dL, fasting TG ≥ 200mg/dL at Visits 2 and 3) and a genotype of ApoE published to be associated with dysbetalipoproteinemia

Exclusion Criteria:

* Use of cholesterol-lowering drugs, lipid lowering dietary supplements or food additives after Visit 1 except in accordance with the protocol as co-administered therapy (i.e., a fenofibrate) with rosuvastatin 40mg at Weeks 30 to 36; current active liver disease or hepatic dysfunction, serum CK ≥ 3 times ULN (unless explained by exercise) anytime during dietary period, serum creatinine \> 2.0 mg/dL or a history of renal transplantation before the treatment phase, fasting triglyceride \> 1000 mg/dL at any time during the dietary lead-in or a history of pancreatitis while on treatment for dysbetalipoproteinemia.
A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease

We investigate the impact of a 4-week virtual reality-based upper limb training in Parkinson's disease. The benefits on dexterity of this training program will be evaluated.

For these purposes, a randomised, two arm, single assessor blind, parallel design with a monocentric, study setup will be performed.

Patients with Parkinson's disease (PD) suffer from significantly decreased coordination and have difficulties with precise hand/finger movements during the performance of both basic activities of daily living (ADL), such as dressing, grooming as well as higher ADL, such as cooking, shopping and regular medication intake. These difficulties further add to the burden of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly growing aspect of training in PD neurorehabilitation offers virtual reality (VR). We explore the effects of a VR-based upper limb hand training compared to a VR control training, which is less specific for dexterity. Moreover, we examine the effetcs of the trainings on upper limb related ADL, and therefore the impact on QoL in patients with PD.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed PD, according to UK Brain bank Criteria
* Hoehn \& Yahr Stadium I to IV
* Age 40 to 99 years
* written and signed informed consent
* self-reported dexterous difficulties

Exclusion Criteria:

* MoCA \<21/30
* psychiatric disease
* participation on other interventional trials
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
* severe visual impairment
Plantar Cutaneous Sensory Stimulation in Patients With Diabetic Neuropathy

To determine the effects of plantar cutaneous sensory stimulation on foot tactile sensitivity, postural control, and spatiotemporal gait parameters in patients with diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Age ranged between 45-67 years.
* Both male and female genders are included.
* DM for the past 7 years.
* Scored \> 2/13 on the Michigan Neuropathy Screening Instrument (MNSI) questionnaire including at least two DPN symptoms.
* Scored \>1/10 on MNSI physical assessment including impaired vibration perception

Exclusion Criteria:

* Loss of protective foot sensation (defined as a lack of response to the monofilament of the sensory evaluation instrument).
* Comorbidities include visual impairment, cerebrovascular accident, orthopedic trauma, labyrinthitis, peripheral vascular disease, and heart failure.
* Foot ulcers, orthopedic or surgical problems in a lower limb, other neurological impairment.
* Use of assistive devices for ambulation.
* Inability to walk independently with or without an assistive device.
* Receiving any structured supervised physiotherapy intervention