cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Tart Cherry Juice to Reduce Pain and Inflammation Among Patients With Inflammatory Osteoarthritis

The purpose of this study is to assess the effects of tart cherry juice to reduce pain and inflammation among individuals with arthritis.

Numerous antioxidant and anti-inflammatory agents have been identified in tart cherries, and a study among healthy, non-exercising individuals demonstrated that cherry consumption decreased serum inflammatory biomarkers after 14 days. Osteoarthritis (OA) is a common syndrome affecting 65 million Americans characterized by pain, inflammation, and disability. Such natural anti-inflammatory effects of cherry consumption may be beneficial for the management and treatment of osteoarthritis and inflammatory diseases. The purpose of this randomized, double-blind, placebo controlled study is to examine individuals with inflammatory OA and assess the analgesic and anti-inflammatory effects of tart cherry juice as compared to a placebo drink among twenty 30-70 y/o OA subjects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with inflammatory osteoarthritis
* In good general health
* Stable pattern of anti-inflammatory or pain relieving drug use for 3 months prior to study
* Ability and willingness to maintain consistent pattern of anti-inflammatory or pain relieving drug use during the course of the study, and to not seek any other treatment during the study
* Ability and willingness to consume juice or placebo drink for 21 consecutive days, and to participate in screening measures, including a blood draw, before and after the intervention period

Exclusion Criteria:

* Pregnancy
* Serious medical conditions such as recent heart attack or stroke, cancer, diabetes (type 1 and type 2), or gastrointestinal ulcers
* Individuals who have not been on a stable dose of pain medications or pain modalities for at least 3 months, including muscle relaxants, tender point anesthetic injections, systemic or intrabursal or intraarticular steroids, or any investigational drug/device in the prior 90 days
* Individuals who have used nonpharmacologic pain therapies including acupuncture, ultrasound, or transcutaneous electrical nerve stimulation within the past 30 days
A Study to Describe the Efficacy of Diphereline Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months

The purpose of this study is to describe changes in the intensity of specific endometriosis symptoms from baseline pre-surgery to after surgery and subsequent continuous Diphereline (Triptorelin Acetate) treatment for up to 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with DIE and having received surgery treatment within one month before inclusion
* Premenopausal women aged \>=18 years old.
* Written ICF has been obtained prior to any study-related procedures
* Patient for whom the treating physician already made the decision to treat by Diphereline.
* Patient should be mentally and physically able to express her symptom complaints and answer questions.

Exclusion Criteria:

* Pregnancy or lactation.
* Patients currently on treatment or who have been on therapy with a GnRHa in the last 6 months.
* Premenopausal women who may reach menopause within the 3 years post randomisation.
* Hypersensitivity to Triptorelin or one of the excipients of Triptorelin 3.75mg
* Treatment with another research drug over the last 3 months before the study
* Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
Feasibility of Constraint-induced Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke

The aim of this study is to test the feasibility of a constraint intervention combined with visual-spatial cueing strategy in patients with acute stroke to improve their daily life activities.

As part of treatment in acute stroke (from D0 to D14), the investigators were able to observe that despite motor recovery during physiotherapy sessions, it remained difficult for some patients to use their affected arm (AA) during activities of daily life (ADL). This mechanism of "learned non-use" would be due to a cognitive process decreasing the use of the AA and could partly explain that 75% of patients maintain an upper limb deficit at 3-6 month post-stroke.

In order to combat this phenomenon, a bottom up method (sensorimotor action on the deficit) of constraint-induced movement therapy (CIMT) has been developed and consists in immobilizing the unaffected arm to force the use of the AA.

This technique has proved its effectiveness in the chronic phase and has also recently been proven to improve motor performance in the acute phase. Transposing progress on ADL, however, remains difficult because CIMT does not contain adequate behavioral strategies.

To help the patient mobilize these strategies, coupling of CIMT with a top-down method (conscious action on motor skills) has been successfully tested as an intervention of an occupational therapist with the patient at least 1h / day. This intervention remains not compatible with the investigators care organization because the caregiver can not spend that amount of time with each patient.

Investigators therefore propose to associate CIMT with another top down technique: visual-spatial cueing (use of panels and/or visual messages to encourage the conscious use of the AA) and investigators want to evaluate the effectiveness of this treatment on learning transfer to ADL.

The objective of our study will be to test the feasibility of setting up such an intervention.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patient in neurovascular unit for stroke
* Time since stroke between 2 and 4 days
* Movement capacity of the upper arm (against gravity) :
* Ability to extend actively the metacarpophalangeal and interphalangeal joints at least 10°, and the wrist 20°
* Ability to bend actively the elbow at least 45°
* Ability to bend and abduct actively the shoulder at least ≥ 45°
* Age ≥ 18 years old
* Patient agreement to join the study
* Patient covered by french social security

Exclusion Criteria:

* Excessive spasticity : score \> 2 on the modified Ashworth scale
* Excessive pain in the affected arm : score ≥ 4 on the visual analogue scale
* Joint limitation on the affected arm
* Patient under guardianship or curatorship
* Pregnant or breastfeeding woman
Physical Activity and Acceptance and Commitment Therapy as Treatment for Long Term Pain

Only to a limited extent has been compared the effectiveness of physical exercise and psychological interventions in subjects with chronic pain. Knowledge about this is necessary in order to compose optimal multimodal rehabilitation programs at different health care levels. Moreover, assuming that both types of interventions have effects, these effects may necessarily not concern the same outcome variables. Therefore it may be important to understand to what extent the effects overlap and the extent to which the effects are isolated to an intervention.

The overall strategic purpose of the present study is to develop effective multimodal rehabilitation programs. In this study the effectiveness of following three interventions are compared.

* Group-based rehabilitation according to a concept based on an Acceptance and Commitment Training -Stress Management Intervention (ACT-SMI)
* Group-based rehabilitation compromised of physical exercise (Exercise).
* Group-based discussion concerning pain and its consequences (i.e., the control group, CON) The effectiveness is investigated with respect to long-term effects on pain and its consequences, including perceived health and return to work / sick leave.

The overall hypothesis is that the former intervention means better long-term results because it clearly helps the individual to process the psychological aspects of itself likely to have long lasting effects.


Eligibility Criteria:
Inclusion Criteria:

* chronic pain in the neck and/or back with or without pain in one or more quadrants of the body

Exclusion Criteria:

* Inflammatory and neurological diseases, severe social and/or psychological problems, patients that already have taken part in multidisciplinary rehabilitation programs
TTVR Early Feasibility Study

The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

Multi-center, prospective, non-randomized, investigational, and pre-market.

Eligibility Criteria:
Inclusion Criteria:

* Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement
* Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
* Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)
* New York Heart Association (NYHA) Function Class II or greater
* Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access
* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements

Exclusion Criteria:

* Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
* Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
* Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
* Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system
* Echocardiographic evidence of severe right ventricular dysfunction
* Left ventricular ejection fraction (LVEF) \<30 as measured by resting echocardiogram within 30 days of the Index Procedure
* Need for emergent or urgent surgery
* Untreated clinically significant coronary artery disease requiring revascularization
* Carcinoid tricuspid regurgitation
Hyaluronic Acid and Articular Pain

This is a prospective longitudinal single-center clinical study on OA patients treated with HA . Patients will be enrolled at baseline (T0) and then monitored at 90 days (T1), 180 days (T2; ), and 360 days (T3). The first efficacy end-point will be the statistically significant difference (P\<0.05) in VAS scale between T2 and T0 and between T3 and T2

This is a prospective longitudinal single-center clinical study on OA patients treated with HA at the Pain Medicine Room of the Clinical Pharmacology and Pharmacovigilance Operative Unit of the "Renato Dulbecco" University Hospital of Catanzaro from January 2023 to December 2024. Patients will be enrolled at baseline (T0) and then monitored at 90 days (T1), 180 days (T2), and 360 days (T3). At the beginning of the study, all enrolled patients signed the informed consent. After the enrollment (T0) and during the follow ups (T1-T3), clinical and laboratory data will be collected directly by the medical staff involved in the study and Zung SAS, Zung SDS and SF-36 questionnaires will be administered. The dedicated database evaluated and recorded any systemic or local side effects. HA will be administered at the beginning of the study (T0) in agreement with the leaflet.

The first efficacy end-point will be:

the statistically significant difference (P\<0.05) in VAS scale between T2 and T0 and between T3 and T2 the statistically significant difference (P\<0.05) in functional mobility and walking ability (six minutes walking test) between T2 and T0 and between T3 and T2 the statistically significant difference (P\<0.05) in mood disorders (Zung SAS and Zung SDS) between T2 and T0 and between T3 and T2

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes between 18 and 65 years old, with a Body Mass Index \< 29 kg/m2.
2. Patients with second- or third-degree of OA
3. Patients with VAS (Visual Analogue Scale) intensities higher than 5/10 who did not respond to systemic medication therapy.
4. Patients who can comprehend the study's objectives and (adhere to the orthopedist's instructions, return for follow-up, and complete the evaluation questionnaires).
5. Patients able to provide their written informed consent to participate to the study and to use their data anonymously for scientific purposes

Exclusion Criteria:

1. presence of active malignancy of any type or history of malignancy
2. Local or systemic infection.
3. Uncooperative patient or suffering from neurological disorders, therefore unable to follow the orthopedist's instructions or unable to provide informed consent for participation in the study or who have not provided written consent.
4. Any case not described in the inclusion criteria.
Phosphoproteomic Profile of Children With Down Syndrome

One of the major causes of cognitive disorders limiting the learning abilities of children with Down's syndrome is excess activity of the DYRK1A protein kinase, whose gene is located on chromosome 21. Consequently, variations in the level of phosphorylation, and hence activity, of DYRK1A target proteins involved in synaptic transmission, could identify mechanisms underlying these cognitive disorders.

Several studies have shown that plasma proteins can reflect a pathophysiological brain state. The investigators plan to carry out a phosphoproteomic study to determine the phosphorylation profile of plasma proteins in children with Down's syndrome, and identify potential DYRK1A-dependent pathophysiological mechanisms and biomarkers involved in the natural course of cognition in children with Down's syndrome.

During a consultation in their usual care department, dedicated to the care of children with trisomy 21, the children with trisomy 21 and their parents present will be informed about the study. An additional 2 mL of blood (from a blood sample taken as part of the consultation) will be drawn for the study by experienced nurses as part of their usual care.

Plasma from this remaining volume will be fixed and analyzed to determine a phosphoproteomic profile.

Multidimensional liquid chromatography with ultra-high resolution mass spectrometry will be used to analyze the native proteome and to obtain expression and phosphorylation levels of plasma proteins.

Similar procedure will be performed on remaining blood samples of boys without genetic abnormality having blood analysis.

Phosphoproteomic profiles of children with Down Syndrome and children without genetic abnormality will be compared to identify specific biomarkers of Down Syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of free and homogeneous trisomy 21,
* Body mass index (BMI): 15-25,
* Able to understand the study based on the pictorial information leaflet and give agreement/assent to participate,
* Parent present on the day of the visit to validate their child's consent/assent, if applicable.

Exclusion Criteria:

* Celiac disease,
* Autoimmune dysthyroidism,
* Type I autoimmune diabetes,
* Alopecia,
* Other autoimmune diseases,
* Current infectious pathology,
* History of infantile spasms,
* Autism spectrum disorders,
* Epilepsy,
* Central nervous system infections,
* Leukemia not in remission,
* Anti-inflammatory treatments (NSAIDs, local or systemic corticosteroids).
Comparison of Concentric or Eccentric Virtual Reality Training Program in Subacute-stroke Patients With Hemispatial Neglect

The purpose of this study is to compare and analyze how the visual gaze training in the afferent direction and the visual gaze training in the efferent direction using virtual reality affects the improvement of the neglect phenomenon in patients with subacute stroke with unilateral neglect.

Based on the behavioral intention test (BIT) test and the Mini-Mental Screening Examination test (MMSE) test for the group of unilateral neglected patients with stroke findings among all eligible patients for this experiment.

Appropriate subjects are selected and randomly divided into two groups. One group uses an afferent virtual reality program, and the other uses an efferent virtual reality program to train five times a week for a total of 4 weeks.

Before training, a computer experience scale 21 was additionally performed, and to find out the degree of unilateral negligence, evaluation was performed using the Behavioral Inattention Test (BIT) and Catherine Bergego Scale (CBS)22, and the angle of deflection (deviation angle), out-of-focus time, gaze time, failure rate, and head rotation trajectory were evaluated. In addition, reaction time, failure rate, and head rotation trajectory were evaluated using a virtual reality program (Assessment program-V2) to evaluate the degree of unilateral negligence. After that, BIT, CBS, and Assessment program-V2 tests are performed to determine the degree of improvement in visual ignorance due to each program.


Eligibility Criteria:
Inclusion Criteria:

1. A person with left hemiplegia who was found to have a stroke by MRI or CT.
2. A person who has been confirmed to have unilateral neglect (BIT 196 or less, or each subtest cut off or less)
3. A person who has enough cognitive ability to receive virtual reality training. (In case of more than 20 points in MMSE)
4. Those within 3 months of onset.

Exclusion Criteria:

1. Those with a history of recurring brain damage
2. hemianopsia
3. When there is a disorder in the movement of the neck due to orthopedic problems
4. Someone has vision and hearing problems during evaluation and treatment
5. difficult to maintain a sitting position in a chair with back and armrests
6. other diseases that may affect your general cognitive decline
7. who disagree with this study
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses AZD8848 in Healthy Subjects

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AZD8848 in healthy subjects.

A Phase 1, Single Centre, Double-blind, Randomised, Placebo-controlled, Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics after Administration of Multiple Ascending (MAD) Once Weekly Inhaled Doses of AZD8848 in Healthy Subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture
* Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive for at least 3 months prior to Screening and be willing to continue on the chosen contraceptive with additonal use of condom until 3 months postdose
* Male subjects should be willing to use barrier contraception ie, condoms, from the first day of investigational product administration until 3 months after the last administration of investigational product
* Have a body mass index (BMI) between 18 and 32 kg/m2 and weigh at least 50 kg and no more than 110 kg
* Women must have a negative pregnancy test at screening and on admission to the study centre, must have a date of last menstruation, must not be lactating or must be of non-childbearing potential

Exclusion Criteria:

* Abnormal vital signs, after 10 minutes supine rest, defined as any of the following: SBP \>140 mmHg, Diastolic blood pressure (DBP) \>90 mmHg, Heart rate \<40 or \>85 beats per minute
* History of asthma or allergic rhinitis
* Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class as AZD8848 - Any clinically significant abnormalities in clinical chemistry.
Evaluation of a Multicomponent Nature-based Intervention for Well-being and Relationship With Nature

Randomized clinical trial to evaluate the efficacy of a multi-component nature-based intervention on clinical outcomes for visitors from different natural areas in Brazil.

There is a growing scientific literature that indicates a series of benefits of contact/connection with nature for health and well-being, such as the mental health improvement, hypertension improvement, restoration of attention and memory and immune system improvement. It is already known, among other findings, that contact with nature, even indirectly, through videos and photos, can promote a greater sense of relaxation, decrease stress levels and can promote positive emotions. The adoption of nature-based interventions has been expanded, both for the prevention of chronic health conditions and the promotion of general well-being, as well as for the treatment of physical, mental and social health.

This clinical trial aims to assess the mean change in the World Health Organization well-being index, changes in self-perception of happiness, vitality, connection and engagement with nature in the pre-intervention, post-intervention and 30-day follow-up moments, in the control and intervention groups, in six different natural areas. In the multicomponent intervention, in addition to including walking in nature with attention to the senses, which will be carried out by the control group, the investigators associate other elements of a cognitive-behavioral nature, aiming human and non-human well-being. Therefore, in this health nature-based intervention, activities related to four types of experience are proposed (1- knowledge; 2- aesthetic/emotional; 3- integrated multisensory, 4- active experience). The study hypothesis is that Well-being, happiness and vitality outcomes will be more positive in the intervention group, and the connection with nature and engagement with conservation at 30 days post-intervention will be greater in the intervention group as well, due to adherence to nature-related activities that will be monitored and knowledge offered

Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation;
* Signed in the Informed Consent Form (able to understand and agree to participate in the study)
* Have conditions of digital access to the link of the study questionnaires, which will be provided by the team.

Exclusion Criteria:

* Display walking difficulties;
* Participants with phobia related to elements of nature;
* History of allergies when in contact with nature.
3D Maternal Fetal Attachment and Smoking

To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal attachment and aid in smoking cessation. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby


Eligibility Criteria:
Inclusion Criteria:

* Age - Female 19-45 years of age
* Fluent in English
* Currently smoking cigarettes
* Currently pregnant (between 21- and 36-weeks' gestation)
* Have normal 20-week ultrasound

Exclusion Criteria:

* Having received more than 3 ultrasounds prior to study
* Medical need for additional ultrasounds
* Multiple fetuses
* \> 31 weeks gestation
* Does not smoke cigarettes
* Is not fluent in English