cyrilzakka/clinical-trials huggingface dataset:
Effects of a 4-week Raw, Plant-based Diet on Anthropometric and Cardiovascular Risk Factors

This study evaluates the effects of a prescribed 4-week raw, plant-based dietary intervention in the treatment of excess body weight, hypercholesterolemia, and hypertension in the clinical setting.

Plant-based diets have emerged in the literature as effective therapeutic strategies in the reduction of body weight, serum lipids and blood pressure. In addition, raw fruit and vegetable consumption has also been associated with the reduction of these clinical indicators.

Participants were instructed to follow a prescribed, raw, plant-based dietary intervention for four weeks. All animal products, including eggs and dairy, were excluded. Cooked foods, free oils, soda, alcohol and coffee were also to be excluded. All meals and snacks were provided to the participants for the full duration of the intervention. Emphasized were raw fruits and vegetables, while seeds, avocado, raw oats, raw buckwheat, and dehydrated foods were prepared as condiments. Vitamin, herbal, and mineral supplements were to be discontinued unless otherwise clinically indicated. Participants were not advised to alter their exercise habits.

Participants came to a total of 4 follow-up visits. A laboratory panel was obtained at baseline and at 4-weeks. A 24-hour recall was also conducted at baseline and at 4-weeks. Anthropometrics, hemodynamics, and medication needs were assessed on a weekly basis.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index ≥25.0 kg/m\^2
* Serum low-density lipoprotein cholesterol concentration ≥100
* Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90

Exclusion Criteria:

* Tobacco use
* Drug abuse
* Excessive alcohol consumption (\>2 glasses of wine or alcohol equivalent per day for men or \>1 glass of wine or alcohol equivalent for woman)
* Current cancer diagnosis
* Estimated glomerular filtration rate \<60 mg/dL
* Clinically defined infection
* Mental disability
* Hospitalization \<6 months
* Previous exposure to plant-based diet
Ex-vivo Modulatory Effect of Biological Drugs for Inflammatory Bowel Disease on the Mucosa and on Peripheral Blood Mononuclear Cells

To characterize circulating DC subsets from healthy controls and IBD patients and to assess, following an ex vivo challenge, the effect of anti-TNF (infliximab, adalimumab and golimumab), anti-p40 -IL-12/IL-23- (ustekinumab) and anti-α4β7 (vedolizumab) immunomodulators on both the GI production of soluble immune mediators and the mucosal capacity to alter the recruitment capacity of circulating DC subsets. It is expected that such approach will provide further information on the action mechanisms of such therapies on IBD patients, allowing a better understanding of the pathophysiology of this disease and the identification of tissue-specific therapeutic targets, thus avoiding collateral problems associated with systemic immunomodulation.


Eligibility Criteria:
Inclusion Criteria:

Patients with active IBD, and endoscopic and histological diagnosis of CD or UC that attend a colonoscopy with sedation performed by medical criteria.

Patients without an IBD diagnosis, or other types of inflammatory, allergic, malignant or autoimmune diseases, prior to their inclusion in this project. All patients will attend a colonoscopy with sedation at medical judgment with biopsy indication for histopathological study as in cases of diarrhea but also due to changes in the bowel transit, rectal bleeding or screening for gastrointestinal diseases. Patients will be paired in age and gender with the IBD groups. All patients will have no signs of macroscopic or microscopic inflammation hence excluding the presence of microscopic colitis.

Exclusion Criteria:

1. Age less than 18 years
2. Chronic disease or any other advanced clinically significant pathology, uncontrolled by investigator judgment.
3. Should be with medication, this will be unchanged in the 3 months prior to colonoscopy.
4. Alcohol or drugs.
5. Pregnancy or lactation
6. Do not sign the informed consent form (see "Ethical Issues") In any case NO colonoscopies exclusively targeted for sampling for this project will be made
Normal Values of Brain Natriuretic Peptide in Healthy Newborn

Brain natriuretic peptide (BNP) is an important tool for diagnosis, risk stratification and prognosis in pediatric patients with heart failure1. In newborn, after delivery, the BNP plays an important role in cardiopulmonary hemodynamics by stimulating vasodilatation and diuresis. The gradual decrease in pulmonary pressure and the initiation of diuresis as expression of renal maturity could explain the subsequent decrease in serum values. This would suggest that, in healthy newborns, BNP values should be found within a given ranges. However, the evidence suggests an important variability in BNP values 2 - 4. In the other hand, in the newborn with respiratory distress BNP could have a high negative predictive value to rule out acute myocardial processes, as responsible for clinical deterioration, from infectious, metabolic or respiratory processes; with a potential of improvement in medical care. Even the increased use of this biomarker in clinical practice, until our knowledge, BNP normal values remain unknown in the healthy newborn. Therefore, the investigators performed a pioneer study to establish normal values in healthy newborn population. Multi-center, prospective and observational study was carried out. Objective: To establish normal BNP values in healthy newborn.


Eligibility Criteria:
Inclusion Criteria:

* healthy mother with pregnancy at term (38 to 42 gestational weeks) with adequate prenatal care.
* newborns with Apgar score ≥ 7 at 0 and 5 minutes respectively.

Exclusion Criteria:

* newborns of mothers with pregnancy-associated diseases.
* newborns with chromosomopathies detected during the antenatal care and newborns with signs of cardiac and/or respiratory compromise.
Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy

This prospective, randomize, controlled trial will compared cap-assisted water exchange with water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis that that cap-assisted water exchange is more efficient and causes a shorter insertion time.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing fully sedated colonoscopy performed by the investigators

Exclusion Criteria:

* obstructive lesions of the colon
* massive ascites
* history of partial colectomy
* provide written informed consent
Fimasartan and Rosuvastatin for Hypertension and Dyslipidemia Control

Fimasartan and Rosuvastatin for hypertension and dyslipidemia control


Eligibility Criteria:
Inclusion Criteria:

* Hypertension patients who are taking an anti-hypertensive agent, including Fimasartan at least 12 weeks or more.
* Dyslipidemia patients who are taking dyslipidemia drug, including Rosuvastatin at least 12 weeks or more
* Patients who has blood pressure and lipid levels (Total cholesterol, LDL-C, HDL-C, non-HDL-C, \* TG) checks 2 weeks before registration

Exclusion Criteria:

* Patients being hospitalized
* Patients who stop taking Fimasartan or Rosuvastatin within 12 weeks 14 or more consecutive days
* Patients who have more than 400mg/dl triglyceride(TG) at the registration time
Evaluation of an Early Management Strategy for Obstructive Sleep Apnea

The primary objective of this study is to evaluate the effect of more timely care for obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy at three months after treatment initiation. The secondary objectives are to determine if earlier care improves the treatment effect of PAP on patient reported sleepiness, quality of life and patient satisfaction. We will also evaluate the impact of shorter wait times on patient engagement in therapy by assessing initial acceptance of PAP therapy, patient activation and self-efficacy with respect to OSA treatment.

The study hypothesis is that the early management strategy will be superior to usual care with respect to the primary outcome of PAP adherence at three months.


Eligibility Criteria:
Inclusion Criteria:

* HSAT ODI \>= events/hr and ESS 10 - 15 OR
* HSAT ODI 15 - 30 and ESS 15 or lower

Exclusion Criteria:

* Severe nocturnal hypoxemia on HSAT (mean oxygen saturation by pulse oximetry (SpO2) ≤ 85%)
* Severe hypersomnolence (Epworth Sleepiness Scale score ≥ 16)
* Employed in safety-critical occupation
* Recent motor vehicle collision reported on screening questionnaire (within one year)
* Severe hypertension requiring ≥ three antihypertensive medications
* Recent admission to hospital due to unstable cardiopulmonary disease (within 30 days)
* Upcoming major surgery (within six months)
* Prior history of OSA treatment
* Significant co-morbid sleep disorder that would interfere with PAP acclimatization and adherence (e.g., severe insomnia, restless leg syndrome)
Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer

This research study is a way of gaining new knowledge about a drug called olaparib in women who have either: 1)never received a PARP inhibitor before to treat ovarian cancer (group 1) or 2)participants who have received a PARP inhibitor before to treat ovarian cancer, with the exception of olaparib (group 2). PARP inhibitors are drugs tht prevent cancer cells from repairing their DNA. In this research study, we are looking to see how well the drug olaparib works in women who have never received a PARP inhibitor for recurrent ovarian cancer as well as those who have received a prior PARP inhibitor and whose cancer has re-grown after receiving that PARP inhibitor.

Olaparib tablets will be taken twice daily, orally, in treatment cycles lasting 4 weeks.

On days 1, 8, 12 and 22 of the first 2 cycles and day 1 of all other cycles, subjects will have a physical exam, be asked questions about their general health, and specific questions about any problems they might be having and any medications they are taking.

Tumor will be assess by either CT or MRI scan every 2 cycles (every 2 months). Tumor biopsies will be optional in this study. Only participants that have received a PARP inhibitor in the past will be asked to have a biopsy of their tumor.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed ovarian, peritoneal or fallopian tube cancer that has recurred following a platinum-based regimen used at initial diagnosis
* Measurable disease
* Estimated life expectancy greater than 16 weeks
* Normal organ and marrow function
* Evidence of non-childbearing status for women of childbearing potential
* Able to swallow oral medication

Exclusion Criteria:

* Pregnant or breastfeeding
* Prior PARP inhibitor use for another cancer such as breast cancer
* Receiving any other study agents or any other anti-cancer treatment
* Known brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive hear failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* History of a different malignancy unless disease-free for at least 5 years
* Currently experiencing seizures or currently being treated with any anti-epileptic for seizures
* Human immunodeficiency virus (HIV) positive on combination antiretroviral therapy
* Presence of gastrointestinal disorders that, in the investigator's opinion, are likely to interfere with the absorption of olaparib, or with the patient's ability to take regular oral medication
Circumferential Pulmonary Vein Isolation Plus Transition Zone Modification in Atrial Fibrillation Patients Without Low-Voltage Areas

This study investigates two treatments for atrial fibrillation (AF) patients without low-voltage-areas (LVAs). It aims to determine whether adding transition zone modification (TZM) to the pulmonary vein isolation (PVI) improves long-term outcomes compared to PVI alone.


Eligibility Criteria:
Inclusion Criteria:

Aged 18 to 80 years AF referring for ablation No prior history of AF Absence of low-voltage areas during substrate mapping Presence of transition zone during substrate mapping Sign informed consent

Exclusion Criteria:

Presence of left atrial thrombus Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease Untreated hypothyroidism or hyperthyroidism Dialysis-dependent terminal renal failure Life expectancy \<12 months due to non-cardiovascular causes. Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study Female under pregnancy or breast-feeding Involved in other studies
Looking for Minimum Dose to Induce Sympathectomy in Infraclavicular Brachial Plexus Block

For patients who undergoing hemodialysis, it is important to have good AV fistula. One third of AV fistula usually fail during early stage. It is helpful to use nerve block to dilate the blood vessels and enhance the prognosis. But 0.2% Ropivacaine usually cause muscle weakness in present studies. The investigators hope to find the lowest concentration to provide sympathectomy without muscle weakness. Because the patients with hemodialysis usually have multiple co-morbidity, thus we choose patients with forearm fracture at the first place. With this result, the investigators can design further study for patients with hemodialysis. The investigators prefer proximal approach because brachial plexus run together in the cosctoclavicular space and show lower incidence of incomplete work.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-80 y/o, BW: 40-90 kilograms，ASA class I-III，No pre-existing neuropathy，Scheduled for upper limb surgery.

Exclusion Criteria:

1. Pre-existing neuropathy (ex: polyneuropathy)
2. History of allergy to xylocaine、ropivacaine、epinephrine
3. Emergent surgery
4. Coagulopathy
5. Patient who can not express themselves
Bupivacaine Pharmacokinetics in Ultrasound-guided Axillary Brachial Plexus Block.

Introduction: The risk of systemic toxicity when using bupivacaine is a persistent problem, making its pharmacokinetic study crucial to the safety of regional anesthesia (RA). Little evidence exists regarding the effect of different concentrations of this drug on peak plasma levels. The present study compares two bupivacaine concentrations to establish how the concentration and exchange area affect the peak plasma level of this drug during axillary brachial plexus block. Latency and postoperative analgesia periods were also compared.

Methods: 32 patients were randomly assigned to two groups. In the 0.25% group, 10 ml of 0.25% bupivacaine was injected per nerve; in the 0.5% group, 5 ml of 0.5% bupivacaine was injected per nerve. Peripheral blood samples were collected every 15 min during the first hour and every 30 min during the second hour to establish serum level dosage. High-performance liquid chromatography coupled with mass spectrometry was used for the analysis.


Eligibility Criteria:
Inclusion Criteria:

* candidates for elective surgery of the distal forearm and hand for whom brachial plexus anesthesia and analgesia were indicated.
* physical status of I or II according to American Society of Anesthesiologists (ASA) criteria
* body mass index (BMI) of less than 35 kg/m2
* Signed the free and informed consent document.

Exclusion Criteria:

* cognitive impairment
* infection at the block puncture site
* coagulopathy
* history of bupivacaine allergy
Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.


Eligibility Criteria:
Main Inclusion Criteria:

* Healthy adults who completed the primary immunization in study IC51 309
* Male and female healthy subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

• History of immunodeficiency or immunosuppressive therapy, known Human Immunodeficiency Virus (HIV), or drug addiction including alcohol dependence
Executive Function in Preterm Born Children: An Integrative Approach From Genetics to Brain Function

Hd-EEG and MRI measures are used to study the maturation of functional networks in order to identify the neural circuits underlying executive and memory processes in children born preterm. It will be determined whether children born preterm with executive function deficits will have an abnormal connectivity between basal ganglia and cortex due to WM injury. Moreover, the development of hd-EEG activity during sleep (coherence and travelling waves) and brain maturation of children and adolescents born preterm will be compared with the respective measures in healthy controls. This is of eminent importance as it helps to understand the nature of executive function and hence, it may help to develop neuroprotective strategies to prevent executive function deficits in these infants.


Eligibility Criteria:
Inclusion criteria:

* Schoolchildren between 10 and 12 or 14 and 16 (born between 1996 and 1998 or between 2000 and 2002)
* Preterm group: born \<32 weeks of gestation
* Control group: siblings or friends of preterm group in one of the two age groups

Exclusion criteria:

* Preterm Group: MDI \< 85 at 5 years of age; cerebral palsy
* Control Group: born \<37 weeks of gestation
Teva Asthma Predictive Analytics Study

This trial is being completed to determine baseline inhalation parameters and patterns of use in patients receiving treatment with TEVA digital inhalers, to develop predictive models for asthma exacerbations and response to biologics using data collected from these devices.

Enrolled participants will complete questionnaires along with other study specific procedures. Additionally, in-person and phone visits will be performed.


Eligibility Criteria:
Inclusion Criteria:

* A history of severe persistent asthma as defined by European Respiratory Society (ERS) and American Thoracic Society (ERS/ATS) criteria which includes the presence of poor asthma control on high dose inhaled corticosteroid (ICS) and a long-acting beta-agonist (CS/LABA) or the need for high dose ICS/LABA to maintain asthma control or oral steroids for maintenance therapy for more than 50% of the prior year.
* Presence of current biologic use or planned initiation of biologics following study enrollment
* Patients will be categorized on the basis of asthma control (Asthma Control Test (ACT)\< 19 will be considered poor asthma control). The study will cap the patients with good asthma control at 30% and will no longer enroll those patients once the strata have been fully enrolled.
* Willingness to switch maintenance inhalers to AirDuo® Digihaler™ and to use ProAir® Digihaler™ for rescue therapy. Use of nebulized albuterol will be discouraged but not prohibited.
* Can read and communicate in English and is familiar with and is willing to use his/her own smart device and download and use the study application
* Ability to provide informed consent.
* The patient must be willing and able to comply with study requirements and restrictions

Exclusion Criteria:

* Clinically important pulmonary disease other than asthma including Chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, or other lung disease
* Any disorder that is either not stable or could in the opinion of the investigator affect the ability of the subject to safely participate in the study or could adversely affect study results.
* History of human immunodeficiency virus or other immunodeficiency syndrome
* Malignancy other than skin cancer that has occurred within the past year and that will impact survival thus limit participation in the clinical trial
* History of chronic alcohol abuse or drug use
* Any life-threatening diseases that will impact the patient's ability to complete the 12-month study period
The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs

Through the research to confirm the effectiveness and safety of using electroacupuncture in the treatment of chemotherapy-induced peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

1. The histopathological and / or cellular pathology results prove malignancy of the tumor and the patient has received chemotherapy treatment before.
2. 15weeks after the completion of chemotherapy, the limbs are still feeling abnormal and the symptoms fulfill World Health Organization (WHO) grade 2 or more.
3. zubrod - Eastern Cooperative Oncology Group-WHO (ZPS) grade 0-2, cardiac function, liver function and renal function are not significantly abnormal, the survival period of the patient is expected to be more than 6 months.
4. Gender unrestricted, aged between 18 to 80 years old.
5. Voluntary participation in the study, will to sign informed consent, willing to comply with randomized grouping, will to follow-up.

Exclusion Criteria:

1. Patients who suffer from peripheral neuropathy due to infection, radiotherapy, HIV, chronic alcoholism, hypothyroidism, diabetes, paraneoplastic syndrome or other diseases; or are suffering from nervous system diseases.
2. Patients who are being treated with other drugs that may lead to neurotoxicity .
3. Patients with blood coagulation disorder.
4. Pregnancy and lactating women.
5. Patients with infection, scarring or defects near the acupoint sites.
6. Received intervention for the prevention and treatment of peripheral neuropathy 2 weeks before screening or has received traditional Chinese medicine (acupuncture, moxibustion, cupping, Chinese medicine therapy one month before.
Changes in Abdominal Tissues Induced by Magnetic Device - MRI Evaluation

The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and three follow-up visits, 2 months, 6 and 12 months after the final treatment.

At the baseline visit photographs of the abdomen will be taken. In addition, adipose/muscle layer thickness will be measured with the magnetic resonance imaging and the subject's weight will be recorded.

Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in.

Post-procedure evaluation (follow-up visits) will be conducted 2, 6 and 12 months after the final treatment. During those visits, magnetic resonance imaging, photographing and weight measure will be conducted. Subject Satisfaction Questionnaire will be given at every follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects of both genders with unwanted abdominal fat and expressing interest in treatment
* Age ≥ 22 years
* Voluntarily signed informed consent form
* BMI ≤ 30 kg/m2

Exclusion Criteria:

* Cardiac pacemakers
* Electronic implants
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Haemorrhagic conditions
* Anticoagulation therapy
* Heart disorders
* Malignant tumor
* Fever
* Pregnancy
* Breastfeeding
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over menstruating uterus
* Application over areas of the skin which lack normal sensation
* Scars, open lesions and wounds at the treatment area
* Unrepaired abdominal hernia