cyrilzakka/clinical-trials huggingface dataset:
Comparison of Clinical Outcomes of IVUS -Guided and Angiography-guided PCI in Patients With Acute STEMI

To compare the long-term clinical outcomes of IVUS-guided vs angiography-guided PCI in patients with acute STEMI

This study is a prospective, multicenter, randomized controlled trial, led by the second hospital affiliated to zhejiang university school of medicine, A total of 10 hospitals in zhejiang province interventional cardiovascular center to participate in, plan to recruit 200 STEMI patients.

Subjects according to the proportion of 1:1 were randomly allocated to two treatment groups.(Experimental group (IVUS) steering group or control group (imaging) steering group.) Plan 10 centers in 200 men and women aged 18 and older patients, according to the American heart association and the United States The college of cardiology interventional treatment guidelines for the participants.

Each center recruiting number does not exceed 40% of the total plan recruitment.

Eligibility Criteria:
Inclusion Criteria:

-Clinical Inclusion (CI) Criteria: CI. Age \> 18 years C2. Onset of STEMI \> 30 minutes, but \< 12 hours C3. ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG C4. Willing and able to provide informed consent

* Angiographic Inclusion (AI) Criteria (visual estimate) AI1. Having at least one infarct-related coronary artery of which
* the Culprit lesion is suitable for stenting
* the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm
* the TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing AI2. No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation

Exclusion Criteria:

* Clinical Exclusion (CE) Criteria CE1. Contraindicating to any concomitant study medications CE2. Having cardiogenic shock with hemodynamic instability CE3. A history of bleeding diathesis or known coagulopathy CE4. A history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months; or a history of intracranial tumor, aneurysm or arteriovenous malformations; or a history of active peptic ulcer or active gastrointestinal (GI) bleeding within the past 2 months; or planned major procedure within 6 weeks; or known platelet count \< 100,000 /mm3 or Hb \< 10 g/dL CE5. Planned surgery which may cause discontinuation of ADP-receptor antagonist CE6. Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year CE7. Repeated MI within 7 days of hospitalization for acute MI
* Angiographic Exclusion (AE) Criteria (visual estimate) AE1. Bifurcated lesion unable to identify the culprit lesion AE2. The culprit lesion is located in the left main artery. AE3. Diffusive lesions without distinguishable culprit lesion AE4. Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis AE5. Likely CABG procedure within 30 days
Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg

The objective of this study was to investigate the bioequivalence of Mylan nitrofurantoin monohydrate/macrocrystals capsules to Procter \& Gamble Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study
Study Evaluating Venlafaxine ER in Children and Adolescents With Social Anxiety Disorder

To determine the anxiolytic efficacy, safety, and tolerability of a flexible-dose of venlafaxine extended release (ER) administered for 16 weeks in the treatment of children and adolescent outpatients with social anxiety disorder (generalized) in a placebo-controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatient
* 8-17 year old
* diagnosis of Social Anxiety Disorder

Exclusion Criteria:

* concomitant psychiatric or medical disorders which interfere with safety or assessment
Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema

To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema


Eligibility Criteria:
Inclusion criteria:

* Type 1 or type 2 diabetes
* Diabetic macular edema

Exclusion criteria:

* Recent intra-ocular surgery in the study eye (e.g., cataract surgery in the last 6 months)
* Recent laser photocoagulation in the study eye
* Recent treatment with Avastin, Lucentis, or intravitreal corticosteroids in the study eye

Other protocol-defined inclusion/exclusion criteria applied
Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)

The primary objective of this trial was to assess the presence of susceptibility to tipranavir and other ARVs of the HIV-1 isolates in treatment experienced patients. The secondary objective was to examine clinicians' use of HIV drug resistance testing in treatment experienced patients currently failing a PI based HAART regimen.


Eligibility Criteria:
Inclusion criteria

Patients that meet the following inclusion criteria will be eligible for participation in this study:

1. Signed patient informed consent prior to study participation.
2. HIV-1 infected male or female ?18 years of age.
3. Have confirmed (2 consecutive) HIV RNA ?1000 copies/mL (one of the results must be within 3 months of enrollment into the study).
4. Current HAART regimen contains a protease inhibitor for ?3 months.
5. Physicians considering a change in the patient?s HAART regimen. f.) History of treatment with 2 or more protease inhibitors (including the current PI). Low dose ritonavir (i.e.\< 400 mg. bid) is not counted as one of the PIs.

Exclusion criteria

A patient with any of the following criteria will be excluded from participation in the study:

1. ARV medication naive.
2. Active opportunistic infection. c.) Known or suspected non-adherence to current HAART regimen as assessed by the investigator.
Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery

To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.

Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We hypothesized that limb remote ischemic preconditioning (RIPC) would safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.The primary outcomes included the incidence of delirium in the first 7 days after surgery using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.The quality of recovery over a 6-month period was evaluated as well.Secondary endpoints included length of stay in the hospital after surgery (from day of surgery to hospital discharge), occurrence of non-delirium postoperative complications, and all-cause 6-month mortality.

Eligibility Criteria:
Inclusion Criteria:

* elderly patients received elective non-cardiac surgery with general anesthesia
* anticipated surgery time \> 2 hours

Exclusion Criteria:

* age \< 65 years old
* Acute coronary syndrome or myocardial infraction within 3 months
* Chronic obstructive pulmonary emphysema
* Serious hepatic dysfunction (Child-Pugh class C)
* serious renal dysfunction (undergoing dialysis before surgery)
* Ejection fraction less than 40%
* Poor pulmonary function (PaO2 \<60mmHg)
* Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis
* Inability to communicate in the preoperative period (coma, profound dementia, or language barrier)
* Brain injury or neurosurgery
A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer

To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.

Hematuria is the most common presentation of BCa with 22% of patients with gross hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable.

Because of this severe limitation, patients with hematuria (microscopic or gross) will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose to improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Have documented or reported gross hematuria within 3 month of study enrollment
* Willing and able to give written informed consent

Exclusion Criteria (patients must not):

* Have history of BCa
* History of previous cancer (excluding basal and squamous cell skin cancer) within the past 3 years
* Have a known active urinary tract infection or urinary retention
* Have active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) Serum creatinine value can be up to 60 days before consent, otherwise repeat
* Have ureteral stents, nephrostomy tubes or bowel interposition
* Have recent genitourinary instrumentation (within 10 days prior to signing consent)
* Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)
Evaluation of the Clinical Success of Direct Restorations of Endodontically Treated Posterior Teeth in the Presence of Parafunction: A Pilot Study

The aim of this prospective, randomized, parallel-group clinical study is to compare the 6- and 12-month clinical performances of direct composite restorations applied to endodontically treated posterior teeth with or without the use of fiber-reinforced composite material in individuals with parafunctional habits.

Bruxism is a repetitive jaw-muscle activity characterized by clenching and/or grinding of teeth. The possible outcomes of bruxism include wear and/or fractures in the teeth and restorations. Therefore, the choice of restorative methods and materials for restorations in bruxist individuals is of great importance. Direct adhesive restorations are the first treatment option for endodontically treated teeth with no excessive material loss and/or those that have lost vitality due to trauma. Over the past decade, the use of fiber-reinforced materials has been recommended to prevent catastrophic fractures. Fiber-reinforced materials have been developed and introduced to the market based on the idea that a restorative material that distributes or absorbs stress in high-stress areas will protect the underlying tooth structure.

Although there are numerous studies on the mechanical durability of restorative treatments for endodontically treated teeth in cases with parafunctional habits, there are limited clinical studies regarding the clinical performance of these methods.

The study included 32 premolar or molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were divided into two groups (n=16): Group 1: fiber-reinforced composite restoration (EverX flow, GC) (FRCR), Group 2: composite restoration (Gneal Posterior, GC) (CR). The restorations were evaluated at 6 and 12 months using the FDI criteria.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers aged 18 and above Cases where restoration was performed immediately after the completion of root canal treatment on posterior teeth Endodontically treated posterior teeth that required replacement of the old restoration due to secondary caries or fractures Cases without pulpal symptoms Posterior teeth classified as Class 1 and Class 2 according to cavity classification Teeth with a remaining wall thickness of at least 3 mm Presence of parafunction Teeth with a natural tooth in the opposing arch and adjacent teeth on both proximal sides

Exclusion Criteria:

* Individuals who are not volunteers
* Cases with ongoing pulpal symptoms
* Posterior teeth with cusp loss
* Teeth with root canal filling that is at least 2 mm shorter than the radiographic apex
* Individuals unable to attend periodic follow-up visits
* Individuals with a Gingival Index score greater than 1
* Severe periodontal disease
* Presence of systemic diseases
* Individuals with allergic reactions to any of the materials to be used
* Pregnant or breastfeeding women
Patient Centered Outcomes Study

Several questions exist when looking at ventral hernias:

1. what is the baseline quality of life and abdominal wall function among patients with or without a ventral hernia?
2. what is the clinical significance of a ventral hernia seen on radiography but not on clinical examination (e.g. occult hernia)?
3. what is the natural history of quality of life of patients with and without a ventral hernia?
4. what is the impact of disclosure of presence or absence of a ventral hernia on quality of life?

Answering these questions can provide valuable information on the impact of surgery with or without subsequent ventral hernia on a patient's abdominal wall function and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years or older
* Patients at LBJ Hospital
* Patients who received a CT of the abdomen

Exclusion Criteria:

* Children (under age 18 years old)
* Any patient in any vulnerable population (e.g pregnant women, prisoners, etc.)
Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients

The goal of this clinical trial is to evaluate the effectiveness of mastectomy flap fixation in breast cancer patients. The main questions it aims to answer are:

- To compare seroma formation after mastectomy flap fixation with conventional surgery in breast cancer patients Participants will be randomly divided into 2 groups,

1. Mastectomy flap fixation
2. Conventional surgery with non flap fixation. Researchers will record the amount and color of drainage fluid, patient and tumor characteristics, and operative related factor after surgery.

Researchers will compare with conventional surgery to see if seroma formation, and wound infection.

Seroma is collection of blood plasma or lymphatic fluid under skin flap or axillary dead space. It occurred after modified radical mastectomy. Patient will have subcutaneous swelling or edema which be confirmed by physical examination or bedside ultrasound. It categorized by common terminology criteria for adverse events version 5.0 for 3 grades.

1. asymptomatic
2. symptomatic with medical intervention or simple aspiration
3. symptomatic with required interventional radiology or operative intervention.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer (CA Breast) patients plan to modified radical mastectomy
* Operable case, or Resectable case

Exclusion Criteria:

* Having medical bleeding tendency e.g., Idiopathic Thrombocytopenia (ITP), leukemia, other bleeding disorder
* Immunocompromised e.g., HIV, Systemic Lupus Erythematosus (SLE), liver cirrhosis, immunosuppressive drug
* Other modified radical mastectomy whom required reconstruction, flap coverage e.g., Transverse Rectus Abdominis Musculocutaneous (TRAM) flap, Latissimus Dorsi (LD) flap
* Past history of mammoplasty, augmentation
* Past history of axillary lymphatic system operation
* Pregnant women
Behavioral Parenting Skills As A Novel Target for Improving Pediatric Medication Adherence

This study observes behavioral parenting skills to see whether it could be a novel target for improving pediatric medication adherence. This study may help researchers better understand the challenges parents face when giving their young child with an illness medicine at home and learn about various factors related to medication compliance in young children

PRIMARY OBJECTIVES:

I. Use direct observation of medication administration in the home to understand common episode-level barriers and identify the most impactful behavioral parenting skills for intervention.

II. Use daily diary methods to identify contextual barriers to adherence and identify intervention components to help parents anticipate barriers and plan strategies to promote successful adherence.

OUTLINE:

Participants complete a survey over 15-20 minutes at baseline. Family behaviors before, during and after the administration of medication to the child are video-recorded over 40-45 minutes. Participants receive MEMS electronic pill bottle to use for 2 weeks and complete daily survey over 5 minutes for 14 days.

Eligibility Criteria:
INCLUSION:

* Parent of a child diagnosed within the past month with acute lymphoblastic leukemia (ALL)
* Pediatric patient's age 3 - 9.

  \* If present during the home visit, any other child, ages 0-18
* Child on therapy that includes oral mercaptopurine (6-MP) administration
* Parent age 18 - NA (No Limit)
* Parent should have verbal English fluency
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
* The following special populations may be included in this study:

  * Pregnant women: due to the design of this behavioral research, pregnant and fetuses should incur no elevated risk from participation.

Children under age 18 will participate in one aspect of the study, the video recording of medication administration.

\* Other children (not the pediatric patient) under age 18 that are present during the time of the home visit

Exclusion:

* Pediatric patient is on therapy that does not include oral 6-MP administration
* Cognitively impaired adults/adults with impaired decision-making capacity
* Pediatric patients who are not yet adults (infants under the age of 3, children over 9 years, teenagers)
* Prisoners
Ketum and Pain Tolerence

The study aim is to evaluate potential analgesic properties of ketum using the cold pressor task.

Participants in the proposed study will be individuals who report consuming ketum more than once a day, daily for the past 12 months. The study is a placebo-controlled, double-blind within-subject repeated mesaures design. Participants will ingest a sequence of ketum and placebo drinks prepared by pharmacologists at USM Centre for Drug Research and their pain tolerance will be measured by the cold pressor task after ingesting ketum or placebo.

Eligibility Criteria:
Inclusion Criteria: Individuals who report drinking ketum decoction more than once a day, daily for the past 12 months.

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Exclusion Criteria: (1) tested positive for illicit drug use including morphine, cannabis, methamphetamine, amphetamine, methadone, benzodiazepine and ketamine; (2) have current or previous history of psychological or neurological problems (self-report); (3) have current or previous alcohol use history (self-report); (4) HIV infections; (5) history of chronic liver disease (e.g. cirrhosis, hepatitis A, B, C, etc.) 6) non-alcoholic fatty liver disease; (7) history of coronary heart disease and diabetes; (8) existing chronic pain condition and (9) history of psychiatric disorders. Exclusion criteria for female particiapns: (1) pregnancy, (2) nursing.

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Multistability: Perception is Inspired by Noise

Some stimuli, such as sinusoidal networks in motion, or the best known, Necker's cube, are simple visual stimulations generating interpretations of unstable and oscillatory shapes or movements, mutually exclusive. Currently, the explanatory models of these perception phenomena are based on adaptation and learning mechanisms as well as the importance of noise in the perceptual and decision-making system. Often noise is a harmful component, but it can also be a facilitator in perceptual systems: the investigator's eye is always in motion, it is the micro-movements during eye fixation (phase of eye stability). In particular, the role of micro-eye movements has been identified in perceptual systems, and it will be necessary here to relate these micro-movements to the perceptive tilts facing multisable stimuli. However, how to access the perceptive states is a real question, since it has been shown that the participant's transfer of his perceptual state by means of a motor response can alter the very state of the percept. This is why the EEG activity will be analyzed to learn to discriminate the different percepts over time, without disruption of the participant's perceptual exploration endogenous activity.

Each participant will benefit from a medical interview before inclusion to eliminate the contraindications to this study. The maximum duration of the individual participation of each subject in this study is 5 hours in two sessions. Each session lasts 2h30. Both sessions are spaced a maximum of 14 days apart. Each session includes EEG headset placement and oculometer calibration (20 min), followed by recording EEG and eye tracking activity during a visual cognitive task where the participant will be presented with multi-stable visual stimuli to watch. for one or two minutes after the tests. By repeating the essays and the conditions of presentation, each session will be organized in six blocks of 20 minutes each, interspersed with a break.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Medical examination carried out before the participation in the research
* Age between 18 and 55 years
* Minimum level of studies
* Obligation to join the social security system
* normal or corrected vision normal

Exclusion Criteria:

* Subject included in another clinical and / or therapeutic experimentation in progress
* Major vision disorder
* Past or current neurological or neuropsychiatric pathologies
* History of cranial trauma with loss of consciousness.
* Medication treatments likely to modulate brain activity: benzodiazepine, antidepressants, neuroleptics, lithium, etc.
* Diabetes, cardiac pathology, immunodeficiency.
* Medication treatments likely to modulate the activity of the cardiovascular system.
* History of abuse or recent ingestion of alcohol, hard drugs or doping products.
* Consumption of more than 15 cigarettes per day
* Subject deprived of liberty by a judicial or administrative decision (L1121-6 CSP)
* Major subject subject to a legal protection measure or unable to express their consent (L1121-8 CSP)
* Pregnant, parturient and nursing mothers (L1121-5)
The Role of Breastmilk and Serum Exosomes in Neonatal Jaundice Due to ABO Incompatibility

Neonatal jaundice is a major global health issue that can lead to serious complications and even death if not promptly treated. ABO incompatibility is a common cause of pathological neonatal jaundice, but there are currently no specific tests to predict its severity or progression. This project aims to study the role of exosomes in the diagnosis and treatment of newborn jaundice, focusing on their impact on infants with ABO incompatibility. The study will take place at a reference neonatal intensive care unit, involving 45 infants. Serum and breast milk samples will be collected and analyzed to determine any relationships and possible correlations.


Eligibility Criteria:
Inclusion Criteria:

* Newborns who are needed treatment for neonatal jaundice due to ABO incompatibility
* Newborns who are admitted to the study center due to ABO hemolytic disease
* Newborns with ABO incompatibility
* Healthy newborns
* Healthy mothers

Exclusion Criteria:

* Lack of informed consent
* Congenital abnormalities
* Maternal Liver diseases
* Neonatal liver diseases
* Sepsis
* Neonatal jaundice due to the causes other than ABO incompatibility
* Acute or chronic disease state in newborn
* Maternal acute or chronic disease
* Medication or substance use effecting liver functions