cyrilzakka/clinical-trials huggingface dataset:
Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.

The primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers' diarrhea (TD) from all causes.

Travelers' diarrhea (TD) is the most common illness in travelers to the developing world, occurring in 60% or more of international travelers to high-risk areas. It can be quite debilitating for the usual 2 to 4 days of the illness and may lead to disruption of travel plans. Findings from recent studies have indicated that the chronic post-travel illness may prove to be of greater clinical and public health significance than the acute illness. Specifically, persistent diarrhea has been reported in 2% to 10% of travelers developing diarrhea. Moreover, bacterial enterocolitis, including that associated with TD, leads to post-infectious irritable bowel syndrome in 4% to 31% of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is in good health (as determined by medical history)
2. Subject is planning on traveling anywhere outside the US (except Canada) for at least 5 and no more than 14 days
3. Subject is scheduled to depart on their planned trip no later than 14 days and no earlier than 4 days after having blood drawn for clinical laboratory assessments and urine collected for a pregnancy test (females of childbearing potential only)

Exclusion Criteria:

1. Subject has hypersensitivity or allergy to rifaximin or rifampin
2. Subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment
3. Subject participated in an investigational drug or device study within the 30 days prior to enrollment
4. Subject received rifaximin in a previous clinical study
5. Subject received any systemic or gastrointestinal-specific antibiotic within 7 days of the first dose of study drug
6. Subject received antidiarrheal medication (eg, loperamide, lactobacillus, BSS, Kaopectate®) within 24 hours of the first dose of study drug
Differences in Dry Eye Symptoms Related to Geographic Location in Spain and Impact of Artificial Tears Use

This study assessed the differences in DED symptomatology measured with the OSDI questionnaire regarding climate data of the geographic location in a large population in Spain, with a special focus on the relative humidity (RH) of the place of residence and the impact of artificial tears use, to help eye care practitioners in patient management and education

This was a multicentre study enrolling patients to attend primary eye care centres of the EMO research group across 12 different Spanish locations. A comprehensive eye examination was performed in all participants. Dryness symptomatology was assessed with OSDI questionnaire. In subjects with dryness symptomatology (OSDI questionnaire score between 13 and 32) were prescribed to use high molecular weight HA-based artificial tears (DISOP Inc, Spain) along three months), instilled 3 times per day.

Additionally, the daily mean, minimum, and maximum values of the climate data for five different variables \[skin temperature (°C), wind gusts (m/s), air temperature (°C), atmospheric pressure (Pa) and RH (%)\] corresponding to the visit date were collected from the EU-funded Copernicus Climate Change Service and the 5-year average RH values published by the Spanish meteorological agency.

Eligibility Criteria:
Inclusion Criteria:

• Volunteer subjects of legal age will be included who agree to participate in the study after being informed by the researcher of each center

Exclusion Criteria:

* Hyperthyroidis
* Rheumatism
* Lupus
* Autoimmune disease
* Previous diagnosis of Dye Eye Disease
* Cicatricial conjunctivitis
* Pterygium
* Eyelid trichiasis
* History of any eye medication use in the last 3 months to treat any eye condition (glaucoma, etc.)
* Active anterior eye inflammation (such as blepharitis, conjunctivitis, keratitis, scleritis, uveitis, etc.)
* Use of contact lenses in the last 3 months
* Previous ocular trauma or surgery in the last 6 months.
The Effect of Self-Acupressure Application on Functional Composite and Quality of Life in Multiple Sclerosis Patients

It is important to consider the functional composite and quality of life of patients with multiple sclerosis (MS) and to plan interventions for these problems.

The application of Self-Acupressure helps in improving the functional composite and quality of life in Multiple Sclerosis patients.

Eligibility Criteria:
Inclusion Criteria:

* To be able to communicate adequately
* Not having psychiatric problems
* Volunteering to participate in research

Exclusion Criteria:

* None
CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF

Heart failure with preserved ejection fraction (HFpEF) causes hospitalizations, premature mortality and high health care costs. This is also due to poor understanding of HFpEF pathogenesis and, thus, lack of specific therapies. Prompted by the recent demonstration that HFpEF clusters different clinical phenotypes, the investigators propose that these phenogroups are driven by distinct myocardial abnormalities. Cardiac Magnetic Resonance (CMR) can help filling this gap in knowledge: on top of providing gold standard measurements for myocardial volume and cellular mass, recent technical advantages mean that this test can assess and quantify left ventricular extracellular volume, fibrosis and microvascular function accurately and non-invasively. In HFpEF patients, the investigators aim at assessing 1) the coronary microvascular function impairment; 2) the myocardial fibrotic burden; - seeking to understand the disease in order to improve care and cardiovascular outcomes for these patients.


Eligibility Criteria:
Inclusion Criteria:

* Age greater of or equal to 18 years at enrolment
* Able to provide written informed consent
* Diagnosis of HFpEF as defined by the 2016 ESC Guidelines (only for HFpEF group)

Exclusion Criteria:

* Pregnancy or breastfeeding
* Absolute contraindication to adenosine perfusion cardiac MRI (including uncontrolled asthma and severe chronic kidney failure, defined as glomerular filtration rate \< 30ml(min/kg)
* Atrial fibrillation
* Previous chemotherapy and/or mediastinal radiotherapy
* Known CAD
* Diabetes Mellitus
* Systemic inflammatory diseases
* Any other medical condition which, in the Investigators' opinion, could affect the study results
* Only for control group: any known cardiac, pulmonary, haematological or neoplastic known medical condition and/or any chronic therapy.
Buprenorphine Detoxification - BBDVI - 19

The purpose of this study is to examine the long-term efficacy of alternate-day dosing schedules in promoting treatment compliance in the absence of confounding behavioral contingencies.


Eligibility Criteria:
Please contact site for information.
ACZ885 in Type 1 Diabetes Mellitus

This study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 1 diabetes within 3 months of visit 1 and on a stable insulin regimen
* presence of at least one diabetes-related autoantibody
* qualifying C-peptide value in a mixed meal test at visit 1
* willing to not have vaccination with a live vaccine for 18 months, from 3 months before visit 1 until 3 months after the last dose of study drug
* body weight of at least 30 kg

Exclusion Criteria:

* women of child-bearing potential unless a highly effective method of birth control is used (such as combined oral contraceptives, intrauterine devices, etc)
* immunodeficiency
* active infections or febrile illness within 3 days before visit 1
* major dental work within 8 days before visit 1
* positive test for tuberculosis at visit 1
* use of medications other than insulin for the treatment of diabetes Other protocol-defined inclusion/exclusion criteria may apply
General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas

Objective of the study is to determine whether resection of gliomas and metastases of motor areas using awake surgery can achieve rarer motor deterioration after operation than using general anesthesia.

Awake surgery is usually used for tumor resection located in language areas. But patient's awakening during removal of mass lesions from motor areas can give additional opportunities. Besides checking of muscle contractions and integrity of motor fibers a surgeon in awake patient can assess planning of movements, praxis, visual feedback and vestibular processing of motions. Preserving of voluntary movements can be an additional proof that cortical motor centers and corticospinal tract were not damaged. At the moment there are no published results of randomized trials showing advantage of awake surgery in removal of mass lesions from motor brain areas.

Objective of the study is to determine whether resection of gliomas and metastases of motor areas using awake surgery can achieve rarer motor deterioration after operation than using general anesthesia.

Participants of the study will be randomly operated using awake surgery or general anesthesia. In both groups intraoperative neuromonitoring will be used. Dynamics of motor functions will be assessed before and after surgery by blinded neurologists.

Eligibility Criteria:
Inclusion Criteria:

* single gliomas without contrast enhancement in preoperative magnetic resonance imaging (presumed low-grade gliomas)
* single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas)
* one or several brain metastases from any cancer
* location near primary motor area or corticospinal tract
* newly diagnosed
* Karnofsky Performance Status 60-100%
* muscle strength in assessed limbs 3-5 points in Medical Research Council scale
* age 18-69 years
* body mass index 29 and less
* hemoglobin 110 and more
* platelets 100 and more
* international normalized ratio less than 2,0
* presumed blood loss no more than 8-10 percents of circulating blood volume (no more than 450-650 milliliters)

Exclusion Criteria:

* chronic obstructive pulmonary disease
* persistent smoker (smoking index 11 and more)
* major comorbidities
* implanted pacemaker
* inability to perform intraoperative tests before surgery
* severe aphasia
* psychiatric disorders
* barely controlled seizures
* contraindications to magnetic resonance imaging
* previously performed brain radiotherapy
* pregnancy
* breast feeding
Contemplative Practice for Well-being and Self-Deconstruction in Women

This randomized controlled trial aims to evaluate the effectiveness of a contemplative practice called Feeding Your Demons (FYD), based on a secular adaptation of Tibetan Buddhism, in improving psychological well-being, body image, body acceptance, compassion, and self-deconstruction in adult women. Participants will be randomly assigned to either FYD or an active control group practicing mindfulness meditation. Psychological variables will be assessed before and after the intervention, and at a six-month follow-up. Additionally, a qualitative exploration will be conducted through interviews with a subgroup of participants.

Feeding Your Demons (FYD) is a secular contemplative practice inspired by the Tibetan Buddhist tradition, integrating elements of mindfulness, compassion, and symbolic visualization. The practice offers a guided process through which individuals face internal difficulties-referred to as "demons"-and transform them through acceptance and self-compassion.

This study aims to evaluate the effectiveness of FYD compared to a mindfulness meditation intervention. It is a randomized controlled trial (RCT) with two parallel groups. A total of 122 adult women will participate. Participants will be randomly assigned to either the FYD group or the control group. Both interventions will be delivered online over eight weeks.

Variables assessed include psychological well-being, body image, body acceptance, mindfulness, compassion, and self-deconstruction. Assessments will be conducted before and after the intervention, and at a six-month follow-up.

Statistical analyses will include intra- and intergroup comparisons using repeated measures analysis of variance. Parametric or non-parametric tests will be applied depending on the assumptions met. Relationships between variables will also be analyzed through correlations. Effect sizes will be calculated to estimate the magnitude of observed changes. The significance level will be set at p \< .05, with a 95% confidence interval.

This study adopts a mixed-methods approach, combining quantitative assessments with qualitative interviews conducted with a subgroup of participants. Although the data are collected complementarily, their analysis and dissemination may be conducted separately or integratively, depending on the specific goals of each research phase.

Eligibility Criteria:
Inclusion Criteria:

* Sex assigned female at birth and self-identifies as a woman
* Aged between 30 and 60 years
* Spanish nationality, or residency in Spain for more than 5 years
* Fluent in Spanish
* At least one month of experience with meditation or mindfulness practices, with a regular practice of more than 15 minutes per session
* Provides informed consent

Exclusion Criteria:

* Indicators of eating disorders (ED) or mental health deterioration, determined by the following cut-off points: SCOFF ≥ 2 and PHQ-9 ≥ 10
* Formal diagnosis of an eating disorder or any psychiatric condition
* Substance use disorder
* History of neurological disease diagnosis
* Participant's decision to withdraw from the study at any point
"Bronchoscopic Argon Plasma Coagulation for Managing Endobronchial Carcinoid Lesions

A small tube will go through the respiratory tract and a non contact cauterization will be done to the inside tumor

fiberoptic bronchoscopy will go through the tracheobronchial tree and after localization of the tumor, argon plasma coagulation by initiation non contact electrocautery will be done to the tumor

Eligibility Criteria:
Inclusion Criteria:

1 - Cooperative patient with written informed consent. 2- Patients diagnosed with endobronchial carcinoid. 3- Patients fit for fiberoptic bronchoscopy. 4- Patients unwilling or unfit for surgery.

Exclusion Criteria:

1 -Poor karnofsky score. 2- Patients unwilling or unfit for bronchoscopy. 3- Extraluminal lesion. 4- Patients with pacemaker. 5- Forced expiratory volume 1 is less than one litre.
The Effects of Three Different Ultrasound-guided Nerve Blocks in VATS

Ultrasound-guided mid-point transverse process to pleura block, erector spinae plane block and paravertebral block are three different methods of nerve block, used for relieving postoperative pain in thoracic anesthesia. This study is to compare them on block effects, postoperative pain and analgesic consumption in video-assisted thoracic surgery.

Ultrasound-guided nerve block is an important part of multi-mode analgesia to decrease the consumption of opioids. Thoracic paravertebral block is considered as an ideal regional analgesic choice for video-assisted thoracic surgery, but it still has some side effects, such as pneumothorax, vascular injury, especially for novices. Recent years, ultrasound-guided mid-point transverse process to pleura block and erector spinae plane block are reported for thoracic surgery. The insertion depth in these two methods is more superficial than traditional paravertebral block. They could have less side effects. Therefore, we design a randomised control study to compare them on block effects, postoperative pain and analgesic consumption in video-assisted thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* selective lobetomy under VATS
* ASA classfication 1-3

Exclusion Criteria:

* history of thoracic surgery
* double lateral VATS
* allergy to local anesthetics
* coagulation disorders
* severe heart diseases, hepatic or renal insufficiency
* a history of chronic pain or chronic opioid use
* psychiatric disease or uncooperative
* BMI\>28 kg/m2
* VATS transfered to open thoractomy
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range

This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Body mass index (BMI) of
* Greater than or equal to 27.0 kg/m\^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular (CV) disease OR
* Greater than or equal to 30.0 kg/m\^2
* History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* A self-reported change in body weight greater than 5 kg (11 pound \[lbs\]) within 90 days before screening irrespective of medical records
* HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis

Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis. Cat-PAD is a novel synthetic, allergen derived peptide desensitizing vaccine currently being developed for the treatment of cat allergy.

At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at the conclusion of therapy. The aim of this study is to identify changes in potential biomarkers after peptide immunotherapy that may be subsequently developed as biomarkers that equate with clinical efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged 18-65 years
* A minimum 1-year documented history of rhinoconjunctivitis on exposure to cats.
* Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control.
* Regular exposure to a cat in their normal living or working circumstances throughout the course of the study.
* Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion Criteria:

* History of asthma
* A history of anaphylaxis to cat allergen
* A history of allergen immunotherapy in the previous 10 years, or in the previous 3 years for pre-seasonal immunotherapy treatments
* A history of any significant disease or disorder (e.g. autoimmune, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment, severe atopic dermatitis)
Randomized Study of Oral Aesculus Hippocastanum and Combinations in Hemorrhoidal Disease After 60 Days of Treatment

To demonstrate the clinical efficacy of the combination of Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, and rutin in tablets in improving local symptoms (bleeding, pain, thrombosis, perianal dermatitis, hemorrhoidal nipple prolapse) assessed using a 100mm visual scale (VAS) over 60 days among adult patients with grade 1, 2 or 3 hemorrhoidal disease.

Hemorrhoidal disease (HD) is the most common proctological condition, with an up to 86% prevalence (asymptomatic individuals underestimated). It is expected that 5% of the population might have at least one episode of HD during their lifetime, most individuals amenable to medical therapy but 10 to 20% of them requiring surgical intervention. HD has an occurrence peak between the 5th and 7th decades of life. Haemorrhoids can be defined as varicose dilatation of the submucosal anorectal veins due to persistently elevated venous pressure in the hemorrhoidal plexus, that is, they develop when the venous drainage of the anus and rectum is altered, causing dilatation of the venous plexus and connective tissue, creating an overgrowth of the anal mucosa of the rectal wall. The term HD is used when haemorrhoids cause symptoms. Aesculus hippocastanum (horse chestnut), rutin, Smilax papyracea (sarsaparilla), Polygonum acre (dotted smartweed) combination is commonly used to control chronic venous insufficiency (CVI) manifestations. Assuming pathophysiology of HD and CVI are similar, the investigators hypothesized the above combination could be also useful in the management of the former condition.

Eligibility Criteria:
Inclusion Criteria:

* Grade 1, 2 or 3 hemorrhoidal disease
* Complaints related to haemorrhoidal disease/acute hemorrhoidal crisis (defined as acute anal pain due to haemorrhoidal prolapse with or without bleeding, edema and thrombosis)
* For female patients of reproductive age, not pregnant or breastfeeding, using reliable contraception.
* Patient has read, understood, signed and dated the informed consent form

Exclusion Criteria:

* Presence of concomitant severe systemic disorders
* Treatment with venotonics within 2 months of the date of inclusion in the study
* Women of reproductive age who are pregnant or breastfeeding, or who do not wish to use contraception during the study period.
* Known allergy or hypersensitivity to any component of the study medication
* Known significant laboratory abnormality
* Anal fissure
* Inflammatory bowel disease
* Colorectal cancer
* Anal abscess or fistula
* Previous anorectal surgery and/or radiotherapy in the pelvic-perineal region
* Patient with a change in general condition that is incompatible with her participation in the study
* Patient who wishes to become pregnant within 6 months
* Inability of the patient to understand the nature of the study and follow the doctor's recommendations
Retrospective Safety Study to Compare Mortality in Intensive Care Unite (ICU) Patients Undergoing Echocardiography With or Without DEFINITY®

Retrospective analysis to observe changes in short term mortality


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* At least 18 years of age