cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium+Imipenem+Cilastatin in Imipenem-Resistant Bacterial Infection (MK-7655A-013)

The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (MK-7655A) versus colistimethate sodium+imipenem+cilastatin in the treatment of imipenem-resistant bacterial infections. Infections evaluated in the study will be hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), and complicated urinary tract infection (cUTI).


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization that requires treatment with IV antibiotic therapy for a new, persistent or progressing bacterial infection involving at least 1 of 3 primary infection types (HABP, VABP, cIAI, or cUTI)
* Positive culture data from the primary infection-site specimen collected within 1 week of study entry. At least one of the suspected causative pathogens from the specimen meets all of the following: 1) identified as a Gram-negative bacterium, 2) culture-confirmed imipenem resistance (and colistin resistance for Group 3 only), 3) culture-confirmed susceptibility to imipenem/relebactam and to colistin (for Groups 1 and 2 only)
* Not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner by complying with one of the following: 1) practice abstinence, or 2) use of acceptable contraception during heterosexual activity

Exclusion Criteria:

* Concurrent infection (endocarditis, osteomyelitis, meningitis, prosthetic joint infection, disseminated fungal infection, or active pulmonary tuberculosis) that would interfere with evaluation of the response to the study antibiotics
* Received treatment with any form of systemic colistin for \>24 hours within 72 hours before initiation of study drug (for Groups 1 and 2 only)
* HABP or VABP caused by an obstructive process
* cUTI which meets any of the following: 1) complete obstruction of any portion of the urinary tract, 2) known ileal loop, 3) intractable vesico-ureteral reflux, 4) presence of an indwelling urinary catheter which cannot be removed at study entry
* History of serious allergy, hypersensitivity, or any serious reaction to listed antibiotics (per-protocol)
* Female who is pregnant or is expecting to conceive (or a male partner of a female who is expecting to conceive), is breastfeeding, or plans to breastfeed before completion of the study
* Anticipated treatment with any of the following during the study: valproic acid or divalproex sodium, or concomitant systemic (e.g. IV, oral or inhaled) antimicrobial agents with known Gram-negative bacterial coverage
* Currently undergoing hemodialysis or peritoneal dialysis
* Participated or anticipates participating in any other clinical study involving administration of investigational medication up to 30 days before screening or during the course of the trial
Is it Possible to Treat Cyanide Poisoning With HBO?

People who has been in a fire accident have been shown often to be cyanide poisoned as well as poisoned with carbon monoxide(CO). According to recommendations from the Danish Health Agency people who are CO poisoned must be treated with hyperbaric oxygen (HBO). We want to see if HBO treatment can also treat cyanide poisoning.

The hypothesis is that as cyanide binds the same place in the mitochondria as CO cyanide will be detached from the mitochondria like CO and diffuse back to the blood.This way it will be easier to treat with hydroxycobalamin.


Eligibility Criteria:
Inclusion Criteria:

* Going to receive HBO treatment for carbon monoxide poisoning from fire accidents

Exclusion Criteria:

* Under 18 years
Risk Factors and Machine Learning Model for Diuretics Related Acute Kidney Injury

Acute kidney injury (AKI) is a series of clinical syndromes in which serum creatinine (Scr) concentrations increase over a short period of time, or urine output decreases. It has become an increasing global concern.Drug-induced acute kidney injury (D-AKI) refers to kidney injury caused by drugs or their metabolites within 7 days after the use of one or more drugs. The kidneys are rich in blood flow and have the function of acidifying the urine, making them an easy target for drug toxicity. Besides, there are enzymes in the kidney that metabolize some drugs, and if these drugs are metabolized abnormally in the kidney, substances toxic to the kidney may be produced.It was found that about 20% of AKI in hospitalized patients was caused by medications.Diuretics are one of the well-known nephrotoxic drugs, since they can directly or indirectly cause a significant decrease in renal blood perfusion and glomerular filtration rate through the mechanism of affecting tubulobulb feedback, which leads to kidney ischemia and hypoxia.However, there are few real-world studies on the incidence of AKI in hospitalized patients received diuretics. In this study, we aimed to explore the incidence and risk factors analysis of AKI in hospitalized patients received diuretics and develop the machine learning model for diuretics related AKI based on electronic medical record data. With the individual characteristics of patients, the risk of AKI can be evaluated before receiving diuretics, which may provide useful information for clinical decision making to better prevent D-AKI.


Eligibility Criteria:
Inclusion Criteria:

All inpatients who used diuretics during hospitalization Hospital stay ≥ 48h Age ≥ 18 years There were two or more blood creatinine tests during hospitalization

Exclusion Criteria:

Hospital stay \< 48h Age \< 18 years GFR \< 30ml/min/1.73m2 within 48 hours after admission AKI was diagnosed on admission Less than two Scr test results during hospitalization The Scr values were always lower than 40 μmol/L during hospitalization Cases with incomplete medical history information
Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer

The objective of this study is to establish the performance characteristics of an assay that detects the recurrence of bladder cancer in patients previously diagnosed with bladder cancer. The study is conducted at locations within and outside of the United States. Testing is performed on urine specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 40 years of age
* Subject has provided documented informed consent as required by the reviewing IRB or EC. Experimental Bill of Rights will be documented for all subjects enrolled in applicable states.
* Subject is considered disease positive within 12 months (365 days) of enrollment.
* At the time of the enrollment visit, the subject is scheduled for a standard of care cystoscopy which will be completed within 3 days of providing a urine specimen.
* Subject has agreed to provide at least 60 mL of voided urine for study purposes at the enrollment visit.
* Subject has agreed to provide at least 60 mL of voided urine for study purposes at each subsequent standard of care cystoscopy visit for at least 12 months (365 days) following enrollment if the subject will enter the Longitudinal cohort.
* Any subject considered anticipatory positive at the initial visit shall be enrolled into the longitudinal cohort. For each anticipatory positive enrolled into the longitudinal cohort a random disease negative subject shall be enrolled.

Exclusion

* Subject has been previously enrolled into the study.
* Urine specimen to be used for study purposes is from the first morning void.
* Subject has had an excision procedure within six weeks (42 days) of enrollment.
* The subject is not scheduled for a standard of care cystoscopy visit within 12 months (365 days) following enrollment.
The Acute T-Rex (Timing of Resistance Exercise) Study

The primary aim of this study is to evaluate if a single bout of AM vs PM resistance exercise has different effects on insulin sensitivity and sleep. A randomized cross-over trial be used to compare resistance exercise at two different times of the day. Each condition will take place in a laboratory setting. Each condition will consist of exercise, overnight sleep, and oral glucose tolerance tests the following day. The AM exercise will occur \~1.5 hours after habitual wake, and PM exercise will occur \~11 hours after habitual wake. After a 2-6 week washout, participants will complete the other condition. The hypothesis is that PM exercise will be more beneficial than AM exercise in improving insulin sensitivity. This study could identify if there is a better time of day to perform resistance exercise to decrease risk of developing Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, all ethnicities, aged 50-74 years
* BMI ≥25 kg/m² and \<45 kg/m²
* Weight stable (less than 5% change in the past 6 months)
* Generally healthy individuals
* Not meeting recommended activity guidelines for aerobic or resistance exercise

Exclusion Criteria:

* Uncontrolled cardiovascular, metabolic, renal, or pulmonary disease
* Cancer treatment in the past 5 years
* Untreated thyroid disease or other medical conditions affecting weight or energy metabolism
* Current use of weight loss medication or other medications likely to impact energy balance
* Bariatric surgery or extensive bowel resection in the past 2 years
* Current or recent history (past 2 years) of eating disorder
* Diagnosis of insomnia, sleep apnea, or other sleep and circadian disorders
* Non-English speaking
* HbA1c \>6.5%
Pharmacodynamic Evaluation of Intranasal Nalmefene

This study is to determine the pharmacodynamics (the effects of the drug and mechanisms of their action within the body) of Nalmefene when given intranasally (IN; into the nose) compared to intranasal naloxone when given to healthy volunteers under steady state opioid agonism.

Open-label, 2-part study. Part 1 is a pilot study to determine the relationship between opioid agonism and suppression of carbon dioxide induced increases in minute ventilation prior to opioid exposure. Part 2 will be a randomized, 2 period, 2 treatment, crossover study to evaluate the pharmacodynamic effects of intranasal (IN) nalmefene compared to IN naloxone to reverse opioid-induced suppression of carbon dioxide induced increases in minute ventilation, in healthy volunteers with prior opioid exposure.

Both Part 1 and Part 2 of the study will consist of an outpatient Screening Visit taking place 28 days prior to admission, an in-clinic Treatment Phase consisting of a 6 or 7 day inpatient stay, and a Follow-Up Phone Call conducted 3 to 7 days after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 to 55 years inclusive
* BMI ranging from 18 to 32 kg/m2, inclusive
* Adequate venous access
* Healthy subjects and non-dependent who are non dependent opioid experienced users, opioid experience defined as exposure to an opioid on at least 1 occasion prior to screening

Exclusion Criteria:

* History of clinically significant disease
* Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
* Subject who has a difficult airway for intubation.
* Following an abnormal diet 4 weeks prior to screening
* Use of over-the-counter medications, dietary supplements, herbal products, vitamins or opioid analgesics 14 days before intervention
* Use of enzyme altering drugs 30 days before intervention
* Use of nasal products 28 days before intervention and throughout the study
* Previous or current opioid, alcohol, or other drug dependence
* Donated or received blood 30 days before intervention
* Women who are pregnant or breastfeeding at screening
* Women of childbearing potential unless surgically sterile or use effective contraception
* Current or recent upper respiratory tract infection
* Allergic to nalmefene or naloxone or known hypersensitivity reaction to plastics.
the Association Between Obesity and Early Puberty

childhood obesity and early puberty are closely related, but existing reports usually focus on their relationship from the perspective of phenotype. This study was designed to investigate the association between obesity-related genic polymorphisms and the risk of early puberty in Chinese Han girls.

the genotypes of obesity-related SNPs were determined and the unstimulated luteinizing hormone, follicle stimulating hormone and estradiol levels were also detected.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of central precocious puberty or early and fast puberty.

Exclusion Criteria:

* The participants who were not the first visit to the hospital and had been treated before.
* The participants who were with endocrine disorders.
Product Performance of a Toric Contact Lens

Product performance of a Bausch \& Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens


Eligibility Criteria:
Inclusion Criteria:

* Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater
* Visual acuity (VA) correctable to 0.3 logMar or better (driving vision)
* Clear central cornea

Exclusion Criteria:

* Systemic disease affecting ocular health
* Using systemic or topical medications
* Wears monovision or multifocal contact lenses
* Any grade 2 or greater slit lamp findings
* Adapted wearer of Ciba Focus Dailies Toric lens upon study entry
MIME THERAPY vs MOTOR IMAGERY TECHNIQUE in Bell's Palsy

Bell's palsy, characterized by unilateral paralysis/paresis of facial muscles, is a condition with a significant impact on individuals' lives. It was first identified by scientist Sir Charles Bell, and its sudden onset can lead to social, psychological, and emotional distress. Left untreated, Bell's palsy can have long-lasting effects on a patient's quality of life, including loss of facial muscle control, emotional stress, and communication difficulties. Rehabilitation protocols encompass various physical therapy techniques, among which Mime therapy and Motor imagery technique have shown promise.

While rehabilitation protocols have shown promise in enhancing facial muscle control, reducing disability, and preventing long-term complications, there remains a critical gap in the literature regarding the comparative effectiveness of various rehabilitation techniques. Currently, there is limited empirical evidence to guide healthcare professionals in selecting the most suitable rehabilitation approach for individual patients. The purpose of this study is to address this gap in knowledge by comparing two specific rehabilitation techniques: Mime therapy and Motor imagery technique. Understanding which of these rehabilitation techniques is more effective can significantly influence clinical practice and patient care. By conducting a systematic comparison, this study aims to provide evidence-based recommendations to healthcare professionals in selection of appropriate rehabilitation protocol for Bell's palsy patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-40 years
* Both male and female
* Patients diagnosed with Bell's Palsy
* Paralysis/paresis of all muscle groups of one side of face

Exclusion Criteria:

* Patients diagnosed with facial palsy
* Patients with impaired cognition
* Patients diagnosed with other neurological diseases
The Effect of Punctal Plugs on Tear Volume and Osmolality

The purpose of this study is to evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity.

50% of contact lens wearers have dryness/discomfort during contact lens wear. Significant decreases in lipid layer and tear film break up time during contact lens wear have been reported, leading to excessive evaporation, reduced tear volume and an increase in osmolality.

Similar tear film changes occur with Dry Eye Disease. A commonly used therapy in treating dry eye is the insertion of punctal plugs to increase tear volume and ease dry eye symptoms. Punctal plugs block the tear drainage system, and often increase tear stability, and improve ocular surface health.

This study will evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity. Collagen punctal plugs will be used for this study, as these allow a temporary (3-14 days) occlusion of the ocular drainage system, are easily removed if necessary and are inserted with minimal risk.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age

Exclusion Criteria:

* Corneal refractive surgery
* Contraindications to contact lens wear
* Latex allergy
* Corneal hypoesthesia
* Active corneal infection
* Acute or sub-acute inflammation or infection of the anterior chamber of the eye
Augmentation Study of A Computerized Treatment for Social Anxiety Disorder

The purpose of this study is to determine whether briefly reactivating a fear memory 10 minutes prior to administering a social anxiety treatment will enhance the durability of treatment effects.

This study examines whether cognitive bias modification of interpretation (CBM-I) for socially anxious individuals can be augmented with the inclusion of a fear memory reactivation prior to administration of CBM. To date, CBM-I generally involves presenting participants with short vignettes that have ambiguous meaning. The ambiguity is resolved by having the subject complete a word stem at the conclusion of the paragraph, resolving the ambiguity in a positive/negative/neutral fashion. CBM attempts to retrain the tendency for socially phobic individuals to adopt negative interpretations of ambiguous events by repeatedly presenting trials resolving in a positive fashion. An inert control can be administered by having the majority of CBM trials resolve in a neutral fashion, without having the vignette end in either a positive or negative fashion.

Reactivating a fear memory, followed by a short break, purportedly opens a window of several hours during which the fear memory is rendered labile, and so CBM given during this time should show greater durability of effects. However, manipulations given outside of this timeframe will presumably have no increased effects. Individuals exhibiting clinical levels of social anxiety, as measured with the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, will be randomly assigned to one of three conditions: (1) fear reactivation administered 10 minutes prior to CBM, (2) fear reactivation administered 12-36 hours prior to CBM, and (3) fear reactivation administered 12-36 hours prior to an inert form of CBM. A variety of measures measuring anxiety, interpretation bias, and cognitions will be repeatedly assessed across the study, including at pretreatment, post treatment, and at one and two week follow up. Additionally, several potential moderators of treatment outcome will be assessed prior to engaging in treatment. At two week follow up, participants will also be given a speech stressor task to determine its effect on subsequent interpretation bias.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65
* Score of 30 or above on LSAS
* Score of 1.4 or greater on ASSIQ

Exclusion Criteria:

* Receiving any form of anxiety medication or psychotherapy for anxiety during the past 3 months
* Scoring above a "1" on item 9 of the BDI-II (presence of serious suicidal ideation)
An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia

Accumulating evidence suggests a role of oxidative stress in the pathophysiology of schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as the electrophilic responsive element or antioxidant responsive element. Recently, we reported that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia for DSM-IV TR criteria
* Patients are treated with an antipsychotic drug (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone).
* Patients are stable for 4-weeks for antipsychotic medication.

Exclusion Criteria:

* Patients treated with clozapine
* Patients treated with two or more antipsychotic drugs
* Pregnant or breast-feeding women
* Patients treated with sulforaphane for more than 8-weeks in the past.
A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage

The purpose of this study is to determine if usage of early lumbar drainage leads to less shunt surgery and less catheter associated complications in patients with communicating hydrocephalus after intracerebral hemorrhage with severe ventricular involvement.

All patients requiring external ventricular drain (EVD) for treatment of acute obstructive hydrocephalus receive intraventricular fibrinolysis with rt-PA via the ventricular catheter. Lumbar drainage (LD) is inserted at a timepoint, when communication between the internal and the external CSF-spaces is recognizable on CT ("opening" of third and fourth ventricle and aqueduct).

Eligibility Criteria:
Inclusion Criteria:

* supratentorial intracerebral hemorrhage \<60ml
* intraventricular hemorrhage with casting of the third and fourth ventricles
* obstructive hydrocephalus with need of external ventricular drainage
* GCS \<9 on admission or within 48h of symptom onset
* admission within 48h of symptom onset
* preceding modified Rankin scale ≤3
* age 18-85 years

Exclusion Criteria:

* ICH related to oral anticoagulation, trauma, tumor, arteriovenous malformation, aneurysm, systemic thrombolysis or sinus thrombosis
* infratentorial hemorrhage
* pregnancy
* admission 48h after symptom onset
* preceding modified Rankin scale \>3
Study of the Effect of Cardioversion on Cardiac Volume in Patients With Persistent Atrial Fibrillation

The main objectives in this study were to examine the cardiac structural and functional changes in patients with persistent and permanent AF, with the aim of improving our understanding of the underlying pathophysiological mechanisms. In addition we aimed to identify variables predictive of recurrent AF.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* severe pulmonary or renal disease
* contraindications to magnetic resonance imaging
* valvular disease
* previous cardiac surgery