cyrilzakka/clinical-trials huggingface dataset:
Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection

This study intends to assess the possible effectiveness and safety of Diosmin and Hesperidin combination in patients with Helicobacter pylori Infection through evaluating its effect on stool antigen test and serum levels of inflammatory biomarkers as(TNF-A and MDA).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed H. pylori infection through stool antigen test.

  * Patients did not receive prior eradication therapy.
  * Male and female.
  * Age of 18-75 years old.
  * Good mental well-being to clearly understand the study's objectives, advantages and procedures.

Exclusion Criteria:

* Age less than 18 years.

  * Patients with previous H. pylori eradication therapy.
  * Patients with hypersensitivity/allergy to the study medications.
  * Patients with history of using proton pump inhibitor, H2-blocker, antibiotics that affect H.

pylori in the last month.

* Patients with history of using diosmin and/or hesperidin in the last month.
* Patients with history of gastric tumor or gastrointestinal (GI) surgery.
* Patients with concomitant severe disorders; cardiovascular, pulmonary, renal or hepatic, or active malignancy.
* Pregnancy or breastfeeding.
* History of drug misuse or recent alcohol consumption.
* Patients with gall bladder disorders.
* Patients on blood thinning agents (warfarin, clopidogril, aspirin, etc), anticonvulsants (carbamazepine and phenytoin), muscle relaxants (chlorzoxazone) and NSAID (diclofenac) in order to avoid potential pharmacodynamic and pharmacokinetic drug interactions with diosmin.
* Patients on anti-inflammatory drugs and antioxidant drugs.
* Patients with inflammatory conditions (ulcerative colitis, rheumatoid arthritis, etc.).
* Patients with conditions associated with oxidative stress (smoking, COPD, etc.).
Adhesive Strips Vs Sutures in Skin Closure for Lumbar Spinal Fusion

Comparison between two methods for skin closure in lumbar spinal fusion surgery, a non-inferiority approach between sutures and adhesive strips and its effect on surgical site infections.

Surgical site infections (SSIs) are among the most common complications in spine surgery, the average rate of infection in spine surgery has been estimated to be around 2.1-3.1%, being the lumbar region the most prone to infection with a reported incidence of 3.7-6.9%. Wound management and the choice of materials used for skin closure can influence the rate of wound-related complications.

This work is a retrospective, mono-centric analysis of data collected for surgical site infections (SSIs) surveillance in patients with lumbar spinal fusion surgery, the primary outcome is surgical site infections rate in the cohort and its relation to the wound closure method (Adhesive strips vs sutures). Using a propensity score matching and a non-inferiority analysis the objective was to determined if adhesive strips is not inferior to sutures regarding SSIs.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing spinal fusion surgery.
* Open posterior approach.
* Surgery involving one or two spinal segments.
* Patients aged 18 years or older.
* Skin closure performed using either sutures or adhesive strips.

Exclusion Criteria:

* History of previous surgical site infections.
* Diagnosis of spondylodiscitis.
* Postoperative complications unrelated to surgical site infections.
* Deep surgical site infections (A3 classification).
* Patients undergoing surgeries other than lumbar spinal fusion.
Ticin Pilot Study: Sirolimus-Eluting Balloon for Stabilization and Regression of Non-Obstructive Coronary Plaques.

The goal of this pilot clinical trial is to evaluate the use of the Selution SLR sirolimus-eluting balloon, in addition to guideline-directed medical therapy (GDMT), for the preventive treatment of non-flow-limiting vulnerable coronary lesions, compared to GDMT alone, in adult patients with multivessel coronary artery disease and a recent acute coronary syndrome (within 90 days).

The main research question is:

Does the use of the Selution SLR sirolimus-eluting balloon in combination with GDMT reduce the progression and vulnerability of non-flow-limiting vulnerable coronary plaques?

Participants will undergo

* PCI procedure with baseline IVUS-NIRS assessment
* Follow-up coronary angiography at 6 months with IVUS-NIRS assessment
* Clinical follow-up at 3, 6, and 24 months after study enrollment


Eligibility Criteria:
Inclusion Criteria:

Potential subjects must fulfill all following inclusion criteria:

1. Multivessel coronary artery disease with ACS within 90 days prior to inclusion and successful interventional treatment of the culprit lesion
2. Presence of ≥ 2 de novo non-culprit lesion without hemodynamic relevance in two different coronary vessels (demonstrated either by wire-based or angiography-based coronary physiology) and with MaxLCBI4mm ≥ 325 at baseline IVUS-NIRS
3. Age ≥ 18 years
4. Written informed consent

Exclusion Criteria:

Patients are not eligible if any of the following applies:

1. Non culprit lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery;
2. Non-culprit lesion in a previously stented segment (i.e. within 15 mm from the previously implanted stent);
3. Non-culprit lesion involving small vessel (\<3.0 mm) deemed not suitable to PCI,
4. Non-culprit lesion located in a bypass graft or in a grafted vessel;
5. Severe renal impairment (eGFR\<15ml/min/1.73m2) or patient on dialysis treatment;
6. Known pregnancy r breast-feeding patients;
7. Life expectancy \<2 year due to other severe non-cardiac disease;
8. Legally incompetent to provide informed consent;
9. Partecipation in another clinical study with an investigational product
Model-based Cueing-as-needed for Walking in Parkinson's Disease

Correcting of the lack of regularity in steps is a key component of gait rehabilitation in Parkinson's disease. The proposal is to introduce adaptive spatial auditory cueing (ASAC) based on verbal instruction "lengthen the step" automatically delivered when the stride length decreased below a predetermined threshold. The present study compared the effect of usual rhythmic auditory cueing versus ASAC used during a walking training in Parkinson's disease.

Correcting of the lack of regularity in steps is a key component of gait rehabilitation in Parkinson's disease. The proposal is to introduce adaptive spatial auditory cueing (ASAC) based on verbal instruction "lengthen the step" automatically delivered when the stride length decreased below a predetermined threshold. The present study compared the effect of usual rhythmic auditory cueing versus ASAC used during a walking training in Parkinson's disease. Fifteen patients with Parkinson's disease performed both interventions in randomized order, one week apart: a 20-minute walking training with rhythmic auditory cueing, in form of a metronome adjusted on 110% of the patient's own cadence, or ASAC delivered when the stride length is less than 110% of the patient's own stride length. Assessment criteria were walking distance covered during the intervention, speed, step length, cadence, coefficients of variation of step length and step duration, and indexes of spatial and temporal asymmetry during a walking test before and just after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* the diagnosis of idiopathic PD based on the United Kingdom-Parkinson's Disease Society Brain Bank criteria;
* stage 2 or 3 on the Hoehn and Yahr scale;
* comfortable walking speed over 10 meters ≤ 1 m/s;
* ability to walk over 20 minutes without aids or antiparkinsonian medications;
* a stable antiparkinsonian medication regime;
* cognitive abilities to understand the verbal instructions for a walking test according to the investigator's judgment;
* written consent for the participation.

Exclusion Criteria:

* intercurrent disease other than PD, affecting gait;
* any intercurrent medical condition preventing them from participating in two consecutive gait training one week apart;
* medical diagnosis of hearing loss;
* non-affiliation to the social security regime.
Genetic Basis of Immunodeficiency

This study will examine the role of hereditary factors in different forms of severe combined immunodeficiency (SCID).

Patients with immunodeficiencies may be eligible for this study. Candidates include:

* Patients with diminished numbers of T cells or NK cells or both, or
* Patients with normal T cell and NK cell numbers but diminished T cell, B cell, or NK cell function.

Relatives of patients will also be studied.

Participants will have blood samples collected for genetic analysis in studies related to SCID at the National Institutes of Health and other institutions.

...

The goal of this project is to identify the genetic basis of new forms of inherited immunodeficiency. The particular focus relates to cytokines such as IL-2, IL-4, IL-7, IL-9, IL-15, and IL-21 that share the common cytokine receptor (Gamma) chain, (Gamma c), and to molecules that are important for signaling or gene regulation in response to these cytokines, although other causes of inherited immunodeficiency are also encompassed.

Eligibility Criteria:
* INCLUSION CRITERIA:

Index cases to be included are those with diminished numbers of T cells and/or NK cells and/or B cells or other immune cells or those who have normal numbers of T cell, B cells, NK cells and other immune cells but diminished function of one or more immune cells. Relatives of affected individuals may also be studied

* Patients (index cases): 6 months of age and older
* Siblings: 6 months of age and older
* Non-sibling relatives (biological parent, aunt, uncle or grandparent): 18 years or older

EXCLUSION CRITERIA:

* Patients with a known diagnosis
* Patients with a particular immunological phenotype that is not of interest to the research conducted under this study.
* Pregnancy or lactation
* Adults with current decisional impairment
Drug Metabolism, Excretion, and Human Body Composition of Aximus Capsules

This project will be based on the bioequivalence test of Aximus capsules, measuring the body composition indicators of healthy subjects before and after medication, and collecting urine samples from subjects at different time periods after medication, measuring urine drug concentration, calculating urine excretion, analyzing the individualized differences in metabolism and excretion of Aximus capsules under different health states of human components, and providing guidance for clinical precision medication.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult men and non-pregnant non-lactating women who successfully participated in the bioequivalence test of acylimus capsules；
2. Signed the informed consent form, and fully understood the content, process and risks of this research, and be able to communicate well with the researchers.

Exclusion Criteria:

1. Female subjects who are menstruating (which may affect urine sample collection);
2. The subjects may not be able to complete this study for other reasons or may not be suitable to participate in this study.
Acupuncture and Auditory Evoked Potentials

To investigate whether body acupuncture of acupuncture points specific for hearing influences the auditory avoked potentials in comparison to puncture of non-specific acupuncture points


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers aged 20-40 years
2. Physical status I according to American Society of Anesthesiologists (ASA) classification
3. No history of nervous or psychiatric disease
4. Normal audiogram before the study
5. No chronic consume of analgesics, anticoagulants and/or antiplatelet agents, sedatives or alcohol
6. No local infection at the site of acupuncture
7. Volunteers who have given informed consent

Exclusion Criteria:

1. Pregnant or nursing females.
2. History of peripheral neuropathy
3. Abnormal skin conditions (infection, scars, psoriasis, eczema)
4. Inflamed site of acupuncture within 1 week
Body Composition in Older Adults

The primary aim of the study is to explore body composition in older adults (aged 70 years and over) with cancer, undergoing systemic anticancer treatment. Additional aims include to explore the extent of body composition changes and whether changes are tumour specific, the incidence for cancer-related cachexia and sarcopenia and finally, how body composition can inform nutritional management of older adults with cancer.

To do this, the investigators applied for and were awarded funding from a company called Nutricia to pay for a band 4 (0.6 WTE for 7 months) to take monthly body composition measures on the patients who are eligible, accepting of assessment by the Senior Adult Oncology Programme (SAOP) and consent to these measures. Measurements will include an analysis from the Bioelectrical Impedance Analysis (BIA) machine which will quantify fat, lean muscle, and water content; waist to hip ratio; handgrip strength; calf circumferences. Socio-demographic data will also be collected.

Descriptive data analysis will take place to explore possible trends and associations which may inform future research and drive even further personalised care for this growing and typically underrepresented in research, population.


Eligibility Criteria:
Inclusion Criteria:

* Adults eligible and accepting of assessment in the SAOP.

  1. adults aged 70 years and over
  2. a cancer diagnosis
  3. just starting SACT
  4. able to provide at least 2 data sets during the study period (baseline + at least 1 research clinic visit)
  5. willing and able to provide written informed consent

Exclusion Criteria:

* No further exclusions
Intraventricular Stasis in Non Ischemic Dilated Myocardiopathy

This study is designed to quantify the ventricular stasis in patients with non-ischemic dilated cardiomyopathy by post-processing of 2D color Doppler echocardiography images in order to establish the relationship between quantitative variables of intraventricular stasis and the prevalence of silent embolic events and/or intraventricular mural thrombosis determined by magnetic resonance.

In patients with left ventricular dysfunction, intraventricular mural thrombosis is a recognized risk factor for cardioembolic events. The flow stasis accompanying ventricular remodeling and myocardial dysfunction could favor the formation of small intracavitary thrombi between LV trabeculae, small enough not be detected by conventional imaging techniques. Computational post-processing techniques allow a robust and complete characterization of numerous aspects of fluid dynamics within the heart using the flow field obtained by Echo or MRI imaging, and it is possible to quantify the stasis and washing of blood in the left ventricular cavity.

A cross-sectional study in 80 patients with non-ischemic DCM in sinus rhythm is proposed in which an echocardiogram, cardiac and cerebral MRI will be performed. Our objective is to quantify the ventricular stasis by post-processing of 2D color Doppler echocardiography images in order to establish the relationship between quantifiable intraventricular stasis variables and the prevalence of silent and embolic events and intracavitary thrombosis determined by magnetic resonance (MRI).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of nonischemic dilated cardiomyopathy.
* Sinus rhythm.
* LV ejection fraction (EF) less than 45%.
* Signature of informed consent for the study.

Exclusion Criteria:

* Implantable defibrillation or stimulation devices not compatible with MRI.
* Hemodynamically significant primary valvular disease or cardiac valve prosthesis.
* Claustrophobia.
* Documented history of paroxysmal or persistent atrial fibrillation (AF).
* Previous carotid disease diagnosed with stenosis greater than 50%.
* Complete oral anticoagulation prior to inclusion in the study or indication of anticoagulation.
* Known prothrombotic states (active oncological pathology, alteration of the coagulation cascade).
Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement

The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for beard enhancement.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male

Exclusion Criteria:

* serious underlying diseases.
* history of beard/ hair treatment before 6 months
* history of surgery or trauma on beard area.
* history of minoxidil allergy
Adipose Secretory Function in Patients Before & After Laparoscopic Surgery

The central hypothesis of our study is that metabolic and hemodynamic improvements following gastric bypass surgery are mediated by downregulation of inflammation-related adipokines produced by the intra-abdominal adipose tissue such as Visfatin.

Central obesity represents a major risk for the development of type 2 diabetes and cardiovascular complications. Obesity is often associated with insulin resistance and abnormal production of inflammatory cytokines. Adipose tissue and especially omentum (adipocytes and resident macrophages) release several cytokines. Visfatin corresponds to a protein identified previously as pre-B cell colony-enhancing factor (PBEF), a 52-kilodalton cytokine expressed in lymphocytes. \[1\] Visfatin exerted insulin-mimetic effects in cultured cells and lowered plasma glucose levels in mice. Mice heterozygous for a targeted mutation in the visfatin gene had modestly higher levels of plasma glucose relative to wild-type littermates. Surprisingly, visfatin binds to and activates the insulin receptor.

Adipose tissue protein and mRNA expression of Visfatin (PBEF) has not been investigated in a single study design with regard to the relationship to fat distribution, insulin resistance and other metabolic risk factors, especially in morbidly obese individual undergoing weight loss surgery. Therefore, we propose the following specific aims: Investigate the protein and mRNA expression of Visfatin (PBEF) in the peripheral (subcutaneous) and visceral (omentum) adipose tissues of morbidly obese subjects and their relationships to the changes in body composition, fat distribution, insulin sensitivity and time-dependent reversal of co-morbidities following gastric bypass surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a BMI \< 35undergoing laparoscopic surgery;
* Patients undergoing bariatric surgery with a BMI \>35kg/m2; and
* Those patients who have had gastric by-pass that require additional surgical procedures are eligible for this research protocol.

Exclusion Criteria:

* Unwilling to consent.
Revealing Engagement Dynamics Among Semantic Dementia Patients

The study intends to investigate the personal experiences of semantic dementia patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.

The data collected from this study will help improve future outcomes for all semantic dementia as well as those in under-represented demographic groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with semantic dementia
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

Exclusion Criteria:

* Refusal of consent
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
* Any serious and/or unstable pre-existing medical disorders
Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis

Although stress ulcer is a complication that can cause significant mortality and morbidity in critical patients with risk factors, there is still lack of consensus about its prophylaxis. There are also few data available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less association with nosocomial pneumonia. Recently, proton pump inhibitors were shown to have good prophylactic effects for stress ulcer. Pantoprazole (iv) is the first intravenous form of proton pump inhibitor that was approved by FDA. There are some reports about its application for treatment of peptic ulcer bleeding. It also has good acid suppression effect in patients under critical care. We expect that intravenous pantoprazole will have a role in stress ulcer prophylaxis.

We will enroll those patients that have received major abdominal surgery and admitted to surgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7 days within 24 hours. They are randomly allocated to 2 groups. Group I: pantoprazole 40 mg iv bolus stat and then qd ; Group II: famotidine 20 mg iv bolus stat and then q12h. We will monitor the following data: operation type \& time, APACHE II score, CBC, CXR, stool character and OB test, NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopic examination will be performed. We define the end point as overt bleeding, death or transfer out of ICU. We will compare the prevalence of UGI bleeding and ventilator associated pneumonia in these 2 groups

Patient selection: those receive major abdominal operation (estimated postopeartive ICU stay more than 7 days); agree and give their consent(by their surrogate)within 24 hours after admissionto SICU; those are less than 18 y/o, pregnant, history of allergy to esomeprazole or famotidine, already have GI bleding are excluded Randomized to 2 groups: (1) 1st group to receuve pantoprazole 40 mg iv bolus stat and then qd, (2)2nd group to receive famotidine 20 mg iv bolus stat and then q12h;prophylactically used for 7 days; estimated enrollment of 60 patients for each group Monitoring items: recording opeartion procedure and time; APACHE II score at baseline, CBC、CXR at basleine and qod, stool OB at baseline; NG drainage、sputum、stool character, ICU routine （TPR, BP）;ICU stay，mortality rate at 30 days; EGD perfomed according to decision of attending physician End points: apparant UGI bleeding（tarry stool, meatemesus, large amount(more than 60 ml) of coffee ground from NG、decrease of Hb more than 2g/dl and endoscopically proved lesion）, mortality; ventilator associated pneumonia: new and persistent hazziness in CXR \& examination of tracheal aspirate, judged by chest specialist

Eligibility Criteria:
Inclusion Criteria:

* those recieved major abdominal surgery (estimated admission to sirgical ICU more than 7 days); give written consent and was randomized within 24 hours of admission

Exclusion Criteria:

* age less than 18 y/o; pregnant; allergy to famotidine or pantoprazole; have had GI bleeding
Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material

The purpose of this study is to see if implanting MatriStem will lower the risk of one of the more common complications after stomach or esophagus surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older
* Pathologically confirmed Gastric, Gastroesophageal Junction (GEJ) or Esophageal, adenocarcinoma at either MSKCC or a participating site (biopsy may be performed at other institutions but slides must be confirmed at MSKCC or a participating site, as is routine care at our institution)
* Patient undergoing any resection requiring an anastomosis to the esophagus for curative intent. Including but not limited to esophagectomy or total gastrectomy.
* Subject is willing to provide written informed consent
* Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

* Pregnant or lactating women
* Intraoperative evidence of metastatic or locally-unresectable disease
* Patients with known sensitivity or allergy to porcine materials.
* Patients undergoing any resection requiring an anastomosis to the esophagus for palliative intent.