cyrilzakka/clinical-trials huggingface dataset:
Aronia Berry Consumption on Blood Pressure

Aronia berries are a native North American berry with high naturally occurring anthocyanins among other polyphenols. Based on their polyphenol composition, there is growing interest in the potential for Aronia berries to elicit health promoting cardio-metabolic effects. Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may improve blood vessel function.

Thus, the primary focus of this project is to evaluate the effects of Aronia berry polyphenols on blood pressure and other biomarkers of cardiovascular disease risk such as endothelial function, arterial stiffness and blood lipids.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged 40-70 years old
* Blood pressure comprised between: SBP 120/139 mmHg or DBP 80/89 mmHg
* Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
* Are able to understand the nature of the study
* Able and willing to give signed written informed consent
* Signed informed consent form

Exclusion Criteria:

* Manifest cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
* Grade 1 hypertensive or above, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg
* Obese participants, defined as BMI superior or equal to 30
* Diabetes mellitus and metabolic syndrome
* Acute inflammation
* Chronic and acute disease
* Terminal renal failure and other kidney abnormalities
* Malignancies
* Abnormal heart rhythm
* Allergies to berries or other significant food allergy.
* Subjects who require treatment for hypertension at any time (e.g. statins, aspirin, blood pressure lowering drugs)
* Subjects who took food supplements, dietary supplement or herbal remedies within 1 month of study start
* Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
* Subjects who reported participant in another study within 1 month before the study start
* Subjects who smoke an irregular amount of cigarettes per day
* Subjects who require chronic antimicrobial or antiviral treatment
* Subjects with unstable psychological condition
* Subjects with history of cancer, myocardial infarction, cerebrovascular incident
* Unable to swallow the capsule
* Pregnant, lactating or planning to become pregnant, as well as premenopausal women who do not have an adequate method of contraception
* Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
Brief Intervention in Primary Care for Problem Drug Use and Abuse

This study will examine the effectiveness of a brief intervention in a primary care setting to reduce drug use or abuse compared to enhanced care as usual.

A substantial body of research has established the efficacy and effectiveness of brief interventions (BI) for excessive or "hazardous" alcohol use in patients seen in medical settings. Dissemination projects of brief interventions for alcohol and drugs have recently been implemented on a widespread scale. This rapid progression of brief intervention for drugs other than alcohol has outstripped its evidence base.

The aims of the study as outlined in the grant are:

1. To examine whether BI is effective at improving outcomes (self-reported drug use and attendance in drug abuse treatment) in individuals with a wide range of problem drug use over and above enhanced care as usual. The enhanced control condition will consist of routine screening, patient notification, and referral for treatment.
2. To test whether fidelity to the BI model or lower severity of drug use is associated with better outcomes.
3. To estimate the impact of BI on several public health outcomes that are directly related to the hazardous effects of illicit drug use, including the use of acute health care services, involvement in the criminal justice system, employment, HIV risk behavior, and mortality.
4. To estimate the costs of the intervention, potential cost offsets, and its incremental cost-effectiveness versus enhanced usual care from the payer perspective based on health care service use and drug use frequency.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* receive medical care at one of the participating primary care clinics at Harborview Medical Center/University of Washington Medical Center
* will maintain care at the clinic for one year
* have a phone or easy access to phone, voicemail, or email
* used recreational drugs in the last 3 months
* used prescription medications not as prescribed in the last 3 months

Exclusion Criteria:

* participation in any formal substance abuse treatment programs in the last 30 days (excluding 12-step or self-help groups)
* terminal illness
A Study of Pain Relief in Low Back Pain

This is a study of the safety and pain-relieving ability of extended release hydrocodone and acetaminophen tablets in patients with moderate to severe low back pain


Eligibility Criteria:
Inclusion Criteria:

* Males and females, ages 21-75 years
* If female, must be of non-child bearing potential or practicing birth control
* Has a history of chronic low back pain for at least 6 months
* Requires medication for the management of the chronic low back pain
* Has sufficient pain to justify the use of around-the-clock opioids

Exclusion Criteria:

* Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study
* Is allergic or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
* Cannot discontinue pain medications, even for the short time prior to the study start
* Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery, or plans to have surgery
* Has a history of gastric bypass surgery or preexisting gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
* Has a history of malnutrition or starvation
* Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day
* Has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder
* Is a pregnant or breastfeeding woman
* Is incapacitated, bedridden, or confined to a wheelchair
* Has initiated any new therapy or medication for chronic low back pain within 1 month of screening
* Has had surgery, certain types of low back procedures, injured, or received certain medications for chronic low back pain within a certain specified time frame
* Has back pain due to or associated with certain types of conditions
* Has other conditions that may cause pain, such as rheumatoid arthritis, gout, or fibromyalgia
Sun Protection Factor Assay (SPF Assay 18677)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing.
* Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Novel Delivery Method of Transgender Voice Therapy Using a Mobile Application

The investigators hypothesize that the mobile application they developed for transgender and gender diverse individuals (TGGD) will be equivalent or better than traditional speech therapy in improving voice quality. The investigators will measure both how the participants feel about their voices and how their voice actually sounds to see if the app is effective.

The ultimate objective of this study is to use Community-Based Participatory Research (CBPR) methods to develop an effective user-friendly, health literate, inclusive and accessible mobile application (app) to improve access to gender affirming voice modification training for transgender and gender diverse (TGGD) individuals. The immediate objectives are to understand the needs of TGGD individuals in voice care,and identify barriers to creating a pilot app with evidence-based educational content for VCMT and to evaluate subjective and objective voice outcomes of TGGD participants with app use compared to standard behavioral intervention with a speech pathologist.

Eligibility Criteria:
Inclusion Criteria:

* Identify as a transgender individual
* Be 18 years or older
* Be able to read and write in English
* Have an iOS Device

Exclusion Criteria:

* Identify as cisgender
* Experience hoarseness
* Experiencing any physical pain related to voice use
Tissue Flossing and Lower Limb Neuromuscular Function

There is no study investigating different volumes, that is various sets of the configuration of tissue flossing on neuromuscular function. Previously, investigators found that 3 sets of TF impaired neuromuscular function assessed with TMG. Therefore, the aim is to compare the effects of one and two sets of TS on countermovement jump (CMJ) performance and muscle contractile properties.

The primary purpose of the study will be to examine the differences in one and two sets of applying tissue flossing to the thigh muscles on neuromuscular function using tensiomyography (TMG) and CMJ, while considering several measurement points after flossing application (i.e., +0.5min, +3min, +6min, +9min, +12min, +15min). A better understanding of the effects of flossing on acute performance enhancement as well as on individual muscle contractile properties could help practitioners to develop specific pre-conditioning activities and consequently improve athletic performance on the field. The investigators hypothesized that: (i) the application of tissue flossing will improve the contraction time of the vastus lateralis muscle as well as the maximal jumping performance, regardless of sets of configuration.

Eligibility Criteria:
Inclusion Criteria:

* healthy and physically active male subjects

Exclusion Criteria:

* Subjects who have latex allergy, hypertension, venous thrombotic disease, cardio-respiratory disease, or neurological disorders, acute and or chronic neuromuscular injuries i.e., with a history of serious lower limb injuries in 12 months period prior to study began will be excluded.
Use of Interferential Current (IFC) Therapy After Total Knee Arthroplasty

Interferential Current Therapy (IFC) is a form of electrical therapy that utilizes two simultaneous low frequency electrical stimulation which when they cross interfere with one another resulting in an interference or beat frequency. This beat frequency provides a therapeutic area of relief by blocking painful stimuli at the area of interest. IFC is different from the other electrical treatment modalities used because the cancellation effect allows for establishment of the treatment area to be in the deeper tissues of the body, whereas other electrical modalities can only be used to treat superficial body parts that lie just under the skin.

The main objective of this proposed study is to assess the post-operative short term outcomes of the patients who receive IFC treatment during their post-total knee arthroplasty (TKA) surgery hospital stay. The implications of the study would be improved patient outcome which could result in shorter hospital stay, reduced use of opioid medication, decreased need for manipulation under anesthesia and reduced re-admission rate.


Eligibility Criteria:
Inclusion Criteria:Adult patients with knee osteoarthritis who have failed conservative therapy and undergoing elected TKA.

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Exclusion Criteria:

i. \<18 years old ii. Any patient with pacemaker or any electrical stimulator device iii. Patients without capacity to consent for the study iv. Patients not able to have local nerve block or spinal anesthesia v. Patients with prior chronic opioid use vi. Patients who are categorized to have 'Severe' fear and anxiety responses to pain, according to the Pain catastrophizing scale (PCS) survey.
A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)

The purpose of this trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.


Eligibility Criteria:
Inclusion criteria:

1. Patients who consent to the study entry on their free will before starting any trial-related activities.
2. Patients who participated in Study 231 and completed the required evaluation period (10 weeks).
3. Patients who are certainly and voluntarily able to participate in this study and record their seizures by themselves or have family members or caregivers (or nurses, if hospitalized) record the seizures. Patients who wish to continue perampanel treatment and necessitate receiving the long- term administration judged by the investigator or sub-investigator.

Exclusion criteria:

1. Pregnant or lactating women, women of child-bearing potential, women willing to become pregnant.
2. Patients who are ineligible judged by the investigator or sub investigator in light of medical history or complication at enrollment in treatment period.
3. Patients who operate heavy equipment or drive should not be recruited into the study.
4. Patients who are ineligible for study entry judged by the investigator or sub-investigator.
Prophylactic Amiodarone for Shockable Cardiac Arrest

The aim of this study is to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm in patients who treated with targeted temperature management after return of spontaneous circulation from cardiac arrest which had been shockable rhythm during CPR.

Patients with cardiac arrest are in high risk of re-arrest during post cardiac arrest care due to vulnerable heart state electrically and hemodynamically. Especially if patients who had experienced shockable rhythms such as ventricular fibrillation or pulseless ventricular tachycardia during CPR, then they are at high risk of developing shockable re-arrest.

However until now there has not been any evidence of prophylactic anti arrhythmic drug effect during post cardiac arrest care.

Amiodarone is class III anti arrhythmic drug which has been used for conversion of ventricular arrhythmia during CPR.

In this study we want to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm or not.

Eligibility Criteria:
Inclusion Criteria:

* Non traumatic cardiac arrest patients who had VF or pVT during CPR in ER

Exclusion Criteria:

* age \< 18 yr
* pregnancy
* non cardiac caused arrest such as hanging
* previous amiodarone continuous infusion before radomization
* sustained ventricular arrhythmia recurrence after ROSC
* extracorporeal membrane oxygenation
* contra indication for amiodarone
* disagree with this research
Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)

This study project includes a single-arm phase 2 study and a parallel cohort study, enrolling patients with COVID-19 pneumonia.

Phase 2 study: this is a multicenter, single-arm, open-label, phase 2 study. All the patients enrolled are treated with tocilizumab. Two-week (14 days) and one-month (30 days) lethality rates are the co-primary endpoints.

The parallel cohort includes patients who are treated with tocilizumab and cannot enter the phase 2 study because:

1. emergency conditions or infrastructural or operational limits prevented registration before the administration of the experimental drug or
2. they had been intubated more than 24 hours before registration or
3. the phase 2 study has been closed due to reached sample size.

This means that, after closure of the phase 2 enrolment, patients who might be eligible for the phase 2 study will be included in the observational cohort study.

The same information planned for the phase 2 cohort is required also for the parallel cohort study whose sample size is not defined a priori, and that will close at the end of the overall project. All the patients enrolled are treated with tocilizumab.

In both study groups (phase 2 and parallel cohort), participants receive one dose of Tocilizumab 8 mg/kg (up to a maximum of 800mg per dose). A second administration (same dose) can be given after 12 hours if respiratory function has not recovered, at discretion of the Investigator.

Eligibility Criteria:
Inclusion Criteria:

1. Any gender
2. No age limit
3. Informed consent for participation in the study (consent can be oral if a written consent cannot be expressed. If the subject is incapable of giving an informed consent and an authorized representative is not available without a delay that would, in the opinion of the Investigator, compromise the potential life-saving effect of the treatment this can be administered without consent. Consent to remain in the research should be sought as soon the conditions of the patient will allow it)
4. Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
5. Hospitalized due to clinical/instrumental diagnosis of pneumonia
6. Oxygen saturation at rest in ambient air ≤93% or requiring oxygen therapy or mechanical ventilation either non invasive or invasive (intubated)
7. Patients with criteria #4 and #5 who have been already treated with tocilizumab before registration are eligible for the observational retrospective cohort

Exclusion Criteria:

1. Known hypersensitivity to tocilizumab or its excipients
2. Known active infections or other clinical condition that contraindicate tocilizumab and cannot be treated or solved according to the judgement of the clinician
3. ALT / AST\> 5 times the upper limit of the normality
4. Neutrophils \<500 / mmc
5. Platelets \<50.000 / mmc
6. Bowel diverticulitis or perforation
Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies
* ECOG Performance Status of 0 or 1
* At least one measurable lesion as defined by RECIST 1.1
* Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion

Exclusion Criteria:

* Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
* Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible
* Clinically significant cardiac disease or risk factors at screening
* A medical condition that results in increased photosensitivity Other protocol-defined inclusion/exclusion criteria may apply.
Core Training Protocol vs Traditional Abdomen Exercise Protocol

The main objective of this study is to analyse the effectiveness of core stability exercises to increase motor control, function and resistance strength of the abdominal muscles, compared to a traditional abdominal and trunk exercise program in semi-professionals soccer players

The 51 participants were semi-professional soccer player and were divided into two different groups using a computer system: the CORE-group or ABDOMINALS-group. Four weeks of training were developed. Outcome variables: Back extension test; Flexion endurance test; FMS; functional movement screen; lateral muscle test right; lateral muscle test left. Kinematic variables were recorded during the test using an accelerometer. A comparison intra-group and intergroup were developed.

Eligibility Criteria:
Inclusion Criteria:

* semi-professional soccer player

Exclusion Criteria:

* Participants who have suffered a musculoskeletal pathology in the lower limbs and/or having undergone some surgical intervention in the prior year were excluded
Effectiveness of Silver Nitrate Solution in the Treatment of Anal Fistula

Effectiveness of silver nitrate solution in treatment of anal fistula is is aimed to be investigated.

The anal fistula is a granulation tissue-lined tract, we thought of a way to ablate this granulation tissue using a chemical agent, which would eventually induce healing with fibrosis and closure of the tract without any surgical intervention. Aiming to reduce the surgery related complications; we investigated the effectiveness of silver nitrate solution as a chemical agent in the treatment of anal fistula.

Eligibility Criteria:
Inclusion Criteria:

All patients with the diagnosis of anal fistula Patients with recurrence

Exclusion Criteria:

Patients who do not sign the informed consent
Evaluation of the Dental Movements Caused by Oral Appliance in Sleep Apnea Syndrome

The DO OAM study is a mono-center, interventional, prospective study carried out in CH VALENCE.

It will estimate the prevalence of dental movements in patients treated by oral Appliance for Sleep Apnea syndrome.

The investigators will used fingerprinting technique by taking multiple photographs of the teeth that allow for the three-dimensional reconstruction of the teeth

this study will provide a better understanding of dental movement caused by oral appliance

oral appliances are indicated for the treatment of Sleep Apnea syndrome. Dentoskeletal effects of oral Appliance are imperfectly assessed.

the investigators want to study dental movements by comparing three-dimensional reconstruction of the teeth and the dental articulation in patients treated for sleep apnea syndrome in our Hospital.

The study consists of an additional acquisition of three-dimensional reconstruction of teeth.

the data previously acquired during the first digital impression according usual practise will be compared to this additional acquisition.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of sleep apnea syndrome treated by Oral appliances in CH Valence
* Availability of previous digital impressions required for Oral appliances manufacturing
* Age ≥ 18 years old
* Read, write and understand the French language

Exclusion Criteria:

* Patient under guardianship, deprived of liberty, safeguard of justice
* Refusal to participate in research