cyrilzakka/clinical-trials huggingface dataset:
The Effect of Berry Extract on Helicobacter Pylori Eradication

Helicobacter pylori (HP) is the major risk factors of gastritis, gastric ulcers, duodenal ulcers, mucosa associated lymphoid tissue lymphoma and gastric cancer. Helicobacter pylori are found in 70-90% of the population in developing countries and in 25-50% of developed countries.

One-week of triple therapy composed of a proton pump inhibitor plus two antibiotics is currently regarded as the gold standard for HP eradication. However, the eradication rate continues to be disappointing. Poor patient compliance and bacterial resistance are the main factors contributing to treatment failure. Therefore, it is urgently necessary to develop a non-antibiotic alternative therapy to increase the eradication rates of Helicobacter pylori. Some literatures reported that cranberry may inhibit Helicobacter pylori adhesion to the human gastric mucus and may reduce Helicobacter pylori infection in adults. The aims of his experiment were to explore the impact of berry extract on triple therapy for Helicobacter pylori eradication.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18

Exclusion Criteria:

* Pregnancy or breastfeeding
* Use of antibiotics 2 weeks prior to inclusion
* Previous eradication treatment
Personalised Dose Optimisation of Zestril Supported by the Digital Blood Pressure Diary in a Primary Care Environment in England: Pragmatic Observational Pilot Study for Remote Hypertension Treatment

A pragmatic observational proof-of-concept study which aims to determine the feasibility of a remote titration clinic, assisted by home blood pressure monitoring and digital solutions, and assess its impact on real-world outcomes. By incorporating home blood pressure monitoring, the study seeks to offer a promising solution for personalised drug titration and self-management, potentially enhancing patient outcomes while optimising Zestril utilisation


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 years and older.
2. Patients diagnosed with uncomplicated essential (primary) hypertension eligible for Zestril per SmPC for hypertension management.
3. Participants must provide written informed consent to participate in the study, including agreeing to adhere to the study procedures.
4. Have access to and be able to use a suitable smartphone independently, running either iOS version 15 or later or Android version 10 or later.

Exclusion Criteria:

1. Clinically significant abnormal blood results as judged by the investigator (exclude patients with known renal impairment).
2. History of clinically important medical conditions that would compromise a patient's ability to participate safely (including an allergic reaction to Zestril/lisinopril or any other medicine and/or other contraindications and interactions listed in Zestril's SmPC).
3. Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and /or volume depletion, cardiac decompensation, or severe hypertension) as per SmPC
4. Participants who are unwilling or unable to participate in remote study procedures, including home BP monitoring, remote consultations, and data submission as judged by the investigator.
5. Any condition associated with poor compliance including alcoholism or drug dependence.
6. Participants with cognitive impairments or language barriers that hinder their ability to understand and comply with study instructions and e-questionnaires.
7. Failure to satisfy the investigator of fitness to participate for any other reason.
Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)

The purpose of this study is to determine whether XPF-001 is safe and effective in the treatment of pain caused by Inherited Erythromelalgia (IEM).


Eligibility Criteria:
Inclusion Criteria:

The study requires you to:

* Be18-75 years old
* Have inherited erythromelalgia
* Be experiencing pain caused by erythromelalgia (Moderate pain score 4/10)
* Be generally healthy (apart from your pain)
* Stop taking your usual pain medications for 9 days
* Not be pregnant or breast-feeding

Your role in the study includes:

* An out-patient screening visit
* 9-days/8 nights-in-patient treatment visit at Nijmegen Medical Center (where you will be closely monitored)
* A follow up phone call (after your return home)
* Taking the investigational medication daily
* Recording your pain levels daily during stay at the Medical Center.

Exclusion Criteria:

* Coexistent source of pain from other conditions
* Receiving professional psychological support for dealing with IEM
* Treatment for significant depression within 6 months of screening
* Active HIV, Hepatitis B or C
* Use of prescription or OTC medication between check-in and discharge
* Women who are pregnant, or lactating
* Not currently using adequate contraception
* Alcoholism or alcohol or substance abuse
* Presence or history of major psychiatric disturbance
* Unwilling or unable to comply with all dietary and activity restrictions
* Any other condition or finding that may pose undue risk for participation
* Use of any other investigational drug in the 60 days prior to dosing
Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification.

This is a two-arm, parallel group, open-label, randomized controlled trial to compare the visual acuity, visual quality, operative complications and the satisfaction of patients between primary posterior capsulorhexis group and laser capsulotomy group of cataract patients combined with primary posterior capsular opacification (PPCO).

Primary posterior capsular opacification (PPCO) refers to the posterior capsule opacification which cannot be removed by polishing or vacuuming during cataract surgery. The surgeon may have to decide on primary posterior capsulorhexis or early neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy in these cases. The aim of this study is to compare the visual acuity, visual quality, operative complications and the satisfaction of patients between primary posterior capsulorhexis group and laser capsulotomy group of cataract patients combined with primary posterior capsular opacification (PPCO).

Eligibility Criteria:
Inclusion Criteria:

1. Cataract patients with primary posterior capsular opacification, which involves the central posterior capsular and interferes with visual axis;
2. Aged 18 years or over;
3. With best corrected visual acuity (BCVA) less than 0.3.

Exclusion Criteria:

1. History of other eye disease that contributes to visual impairment, including keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery.
2. Cases with operative complications, including anterior or posterior capsular rupture, lens suspensory ligament rupture, the falling of lens nucleus into vitreous cavity.
3. Unwillingness to participate in the study.
A Study to Assess Relative Bioavailability and Food Effect of ABBV-668 Extended-Release Formulations in Adult Participants

The objectives of this study are to assess safety and tolerability of the new ABBV-668 ER tablets, to assess the oral bioavailability of the ABBV-668 ER tablets relative to the ABBV-668 IR capsules, and to assess the pharmacokinetics of the ER tablets under fasting and fed conditions in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* BMI is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at screening.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

* History of any clinically significant sensitivity or allergy to any medication or food.
* History of any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* Participant using any medication, vitamins and/or herbal supplements (including traditional Chinese medicine), with the exception of hormonal replacement therapies for females, on a regular basis.
* Any use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation

The purpose of Part 1 of this study is to determine the maximally tolerated dose of OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF).

The purpose of Part 2 of this study is to determine potential efficacy of dose(s) of OPC-108459 for the treatment of paroxysmal and persistent atrial fibrillation.

This trial will test the pharmacokinetic and pharmacodynamic characteristics of ascending doses of OPC-108459 in separate populations of paroxysmal and persistent AF subjects.

The trial will consist of two parts. Each part will evaluate two populations of subjects presenting for cardioversion in a hospital setting.

Cohorts of paroxysmal and persistent subjects may have their dose increased independently.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with paroxysmal atrial fibrillation (AF) (recent or new onset) or subjects with persistent AF at the time of randomization
* Subjects who are hemodynamically stable
* Subjects with a low risk of thromboembolic potential
* Subjects who are willing to comply with the reproductive precautions

Exclusion Criteria:

Subjects with:

* History of long QT syndrome, Torsade de Pointes or an uncorrected QT interval of \> 450 ms
* History of myocardial infarction within 6 months of screening
* Acute coronary syndrome, angina or active myocardial ischemia diagnosed by ECG, or other imaging within 6 months of screening
* History of ventricular tachycardia, fibrillation, or resuscitated cardiac arrest
* History of clinically significant congenital heart disease
* Presence of severe aortic or mitral stenosis, aortic or mitral regurgitation, atrial septal defect, or other conditions leading to AF
* Diagnosis of heart failure NYHA Class II-IV or with an ejection fraction \<40% (Part 1 only)
* Diagnosis of heart failure NYHA Class IV or NYHA I, II, or III with an ejection fraction \<35% (Part 2 only)
* Concomitant treatment with class I or III anti-arrhythmics agents unless the medication was discontinued more than 5 half-lives before dosing
* History of seizures
* Diagnosis of atrial flutter
* Diagnosis of stroke, TIA (transient ischemic attack), or any transient neurological deficit within 1 year of screening or known carotid artery stenosis of \>50%
* Cardiac surgery within 3 months of screening
* Bradycardia (\< 50 bpm) or sick sinus syndrome, unless controlled by a pacemaker
* Current reversible cause of AF
* Wolff-Parkinson-White syndrome
* Any congenital abnormality, severe valve disease
* Subjects who have taken another investigational product within 30 days of dosing
Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal Syndrome

The purpose of this multiple-centered, randomized, controlled study is to investigate the efficacy and safety of a combination using herbs prescription and traditional Chinese medicine (TCM) emotion treatment in women with menopausal syndrome.

Menopausal syndrome is a high incident disease which is associated with great influence in women's health and quality of life. It involves physical discomforts and emotional symptoms. Traditional Chinese medicine (TCM) theory emphasizes treating physical and emotional symptoms simultaneously viewing one person as an entirety. Herbs prescription and TCM emotion treatment is effective and safe to treat women with menopausal syndrome in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Aged 41-60;
* Amenorrhea for at least 6 months;
* Menstruation dysfunction or cessation because of age or bilateral ovariectomy;
* Hot flushes and night sweats symptoms;
* Vaginal secretion decreased with or without dyspareunia;
* Kupperman Index (KI) score ≥ 15;
* Self-rating Anxiety Scale or Self-rating Depression Scale standard score \>50,but \<72(standard score= scale score ×1.25);
* FSH ≥ 20 IU/L;
* Thickness of endometrium ≤0.5cm if Amenorrhea for at least 12 months;or ≤1.5cm if Amenorrhea for 6 months to 12 months;
* Meet the diagnosis criteria of TCM syndrome of liver stagnation and kidney deficiency.

Exclusion Criteria:

* With malignant tumor in reproductive system;
* With benign tumor in reproductive system and need surgery;
* Malignant tumor in mammary gland;
* Irregular vaginal bleeding for unknown reasons;
* Thickness of endometrium ≥1.5cm by ultrasound examination;
* Have used Sex hormone medicine or joined other clinical trials 3 months before;
* Allergy;
* Severe diseases (eg., of the cardiovascular, liver, kidney) or uncontrolled endocrine diseases (eg., diabetes mellitus, hyperthyreosis )
* Severe psychiatric disease diagnosed by psychiatric physician;
* Refuse informed consent.
Secondary Prevention and Health Promotion After Stroke

The aim of this study was to examine to what extent a one year population of stroke patients at a university hospital had well regulated risk factors and health problems one year after stroke, and if a structured nurse-led previous follow-up in the intervention group including referrals if needed could influence health outcome and risk factors one year after stroke.

The follow-up protocol was categorized into Risk factors, Patients' self-reports, and Other health problems. Referral was sent to a physician if medical interventions were needed regarding risk factors measured above the limits as stated in the follow-up protocol in accordance with guidelines,and/or if any self-reported health problems were stated by the patients, or had been detected by the Specialist Nurse. Primary outcome was comparison between the intervention group and control group at one year after stroke regarding proportion of regulated risk factors, and self-reports on health outcome. Results of the two follow-ups of the intervention group were also compared.

Eligibility Criteria:
Inclusion Criteria:

WHO criteria for definition of stroke Signed consent

Exclusion Criteria:

Other diagnosis causing neurological symptoms
Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine)

To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)

Subjects will participate in a two-period, single-sequence study to assess the effects of administration of a nasal corticosteroid, Nasonex (mometasone furoate), on the pharmacokinetics, safety and tolerability of PMI-150 (intranasal ketamine HCl) in healthy adult volunteers.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults
* nonsmoker
* no drug use

Exclusion Criteria:

* nasal abnormalities
* airway abnormalities
Effects of the COVID-19 Health Emergency on Biopsychosocial Health

There is a critical need to determine the impact of the COVID-19 emergency on the comprehensive well-being of people as they are living through the emergency and sequelae of the emergency period. The research team is requesting National Institutes of Health funding with the goal to investigate rural vs. urban living people's response to the crisis and its impact using mixed methods research.

The state of New Mexico and the entire nation have entered an unprecedented health emergency created by the COVID-19 virus; affecting the lives of all people, many of whom were significantly unprepared for the disruptions the emergency created in daily life. Rural residents are at increased risk from effects of the emergency due to numerous disadvantages as compared to urban living people (i.e. critical care access, food insecurity, social isolation). Very little is known about how people are living through a national emergency event affecting all people of the nation. Therefore, a significant gap in knowledge exists: 1. How are rural-living vs. urban-living people responding physically and mentally to the crisis? 2. What strategies of resilience are employed by people living in rural vs. urban counties? 3. What are perceptions of access to critical supplies and services in urban vs. rural counties; 4. How is the availability and use of technology used for news, reliable information, and communication? and 5. Use of time: what alterations in daily life self-care, care of others, commerce, and valued routines in urban vs. rural counties are occurring?

Eligibility Criteria:
Inclusion Criteria:

* Urban and rural living residents of New Mexico, any gender, gender identity, any ethnic origin, any health status (healthy, chronic, disabled), and adult age from 18-85

Exclusion Criteria:

* Non-New Mexico residents, adults unable to give consent due to cognition or incarceration status
Mapping Epileptic Networks Using Multimodal Imaging

Currently, mapping the epileptogenic zone is based on a comprehensive preoperative assessment involving clinical, imaging and electrophysiological examinations.

To reduce the need for invasive stereoelectroencephalography (SEEG) explorations, electrophysiological and imaging methods have been developed, such as resting-state functional MRI (fMRI) coupled with electroencephalogram and arterial spin-labeling perfusion MRI (ASL-MRI).

It has been published that these new methods enable precise delineation of the epileptogenic zone and better preparation for surgery.

The aim is to determine whether, in children with focal lesional epilepsy, the combination of ASL-MRI-EEG and resting-state fMRI-EEG enables precise identification of the epileptogenic zone to be defined by SEEG, the current reference examination.


Eligibility Criteria:
Inclusion Criteria:

* Be under 18 years of age on the day of inclusion.
* Present with one of the following forms of epilepsy:

  * refractory focal lesional epilepsy
  * rare non-lesional epilepsy
* Present abnormalities (spikes) on the intercritical EEG
* Have been selected by the "Epilepsy" multidisciplinary staff.
* In the case of refractory lesional epilepsy, be required to perform an EEG-video recording using intracranial electrodes (SEEG) as part of the pre-surgical workup.
* Be affiliated to a health insurance scheme.

Exclusion Criteria:

* Requiring general anesthesia for MRI
* Require sedation specifically for research
* Have generalized epilepsy
* Be deprived of liberty or under guardianship.
Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension

The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Men or women of African American background; self identified
* Patients with stage 2 hypertension defined as MSSBP ≥ 160 mmHg and \< 200 mmHg at Visit 5 (randomization

Exclusion Criteria:

* Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg)
* Patients on 4 or more antihypertensive medications.
* Patients with uncontrolled hypertension (MSSBP \>180 mmHg) taking more than 1 antihypertensive medication at Visit 1
* Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
* Evidence of a secondary form of hypertension, including but not limited to any of the following:

  * coarctation of the aorta
  * hyperaldosteronism
  * unilateral or bilateral renal artery stenosis
  * Cushing's disease
  * polycystic kidney disease
  * pheochromocytoma
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of angioedema due to usage of an ARB or ACE inhibitor.
* History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, heart failure (NYHA Class II-IV), coronary bypass graft surgery (CABG), percutaneous coronary intervention (PCI), unstable angina pectoris, or myocardial infarction in the last 12 months

Other protocol defined inclusion/exclusion criteria applied
Dry Needling and Patients Treatment Expectations

Objectives The aim of this study is to compare the effects of inducing positive expectations against negative or neutral induced expectations on the activation of the Autonomic Nervous System and the analgesic response, after a dry needling technique in upper trapezius fibers in patients with unspecific neck pain.

Summary Theoretical framework: Dry needling has proven its efficacy for the treatment of myofascial trigger points. Moreover, it has proven its effects over the Central Nervous System and the Autonomic Nervous System (ANS). Despite that previous studies have researched the role of patient's expectations and their relationship with the results of treatment, there is insufficient information concerning the effects of inducing expectations and the activation of the ANS during the application of widely used therapies, such as dry needling.

The aim of this study will be to research the effects of induced expectations combined with a dry needling technique on the activation of the ANS and on the results of the treatment.

Hypothesis: The induction of a positive expectation shall cause a greater analgesic response associated with a response in the ANS compared to the induction of neutral or negative expectations.

Methods: Patients with neck pain will participated in this randomized clinical trial, which will be randomly assigned into 3 groups in order to receive positive, neutral or negative expectations concerning the treatment, by means of an individual informative talk. All subjects will received treatment using dry needling in the upper trapezius fibers. The main variables measured will be the following: Analogic Visual Scale, Pressure Pain Threshold using a mechanical Force Gage (before and after) and the activation of the ANS measuring the skin conductance, skin temperature, heart rate and breathing rate (monitored for 5 minutes before the intervention, during and 20 minutes afterwards).

Eligibility Criteria:
Inclusion Criteria:

* Neck pain.
* Hiperalgesic point in Upper trapezius muscle.

Exclusion Criteria:

* Pain Irradiation toward upper limb
* Psychological disorders
* Whiplash.
* Neuropathic symptoms
* Cervical and / or Shoulder Spine Surgery
Effect of High-intensity Training on the Level of Physical Activity After Thoracoscopy Surgery: a Pilot Study

Goal of this study is to evaluate management with high intensity re-entrainment during the postoperative hospital phase.

This type of early treatment with as little intervention time has so far never been done. The investigators therefore want to carry out this feasibility study in order to collect the data needed to calculate the number of randomized control trial. Investigators will also evaluate the feasibility of this project concerning recruitment, intervention in the hospital phase and data collection once the return home. The evaluation of the activity will be done one month after the return to home by means of a actigraphy of one week.


Eligibility Criteria:
Inclusion Criteria:

* Indication of thoracoscopic surgery
* Autonomous mobilization (with or without auxiliary device)

Exclusion Criteria:

* Patient dependent on oxygen before the procedure
* chronic obstructive pulmonary disease patient with forced expiratory volume at one second \<50% predicted