cyrilzakka/clinical-trials huggingface dataset:
Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment

This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment

This parent-to-child NMT study will test the effect of an anterior nares, or nasal, microbiota transplant (NMT) on seeding, engraftment, and diversity of the neonatal microbiome following nasal decolonization for S. aureus. Infants admitted to the Johns Hopkins Neonatal Intensive Care Unit (NICU) will be screened and parents will be approached for enrollment in the study. After consent and baseline screening of parents and infants, eligible infants will undergo an NMT.

Eligibility Criteria:
Infant:

* Inclusion criteria

  1. Infant has had a prior nasal surveillance culture grow S. aurues
  2. Infant being treated with intranasal mupirocin for S. aureus nasal colonization as part of routine clinical care
  3. Infant has anticipated hospital length of stay \>3 days after completing intranasal mupirocin treatment
  4. Infant \>25 weeks gestation
  5. At least one donor not colonized with S. aureus or another respiratory pathogen (as determined by baseline screening)
* Exclusion criteria

  1. Infant is a ward of the State
  2. Infant with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
  3. Infant cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)

Parent/adult provider:

* Inclusion criteria

  1. Donor is able to provide informed consent
* Exclusion criteria

  1. Donor had positive COVID-19 test in prior 21 days
  2. Donor with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
  3. Donor has been in close contact with someone in the last 7 days who had a respiratory viral infection (e.g., cold, flu)
  4. Donor tests positive on baseline screening test for S. aureus nasal colonization.
  5. Donor tests positive on baseline screening test for a respiratory pathogen.
  6. Donor is not able to provide written informed consent
  7. Donor is not able to be present at the bedside at the time of intervention.
  8. Donor has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
  9. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire.
  10. Donor has smoked within the last month
Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil

This study examines the efficacy and safety of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan) in patients with hypertension, who do not achieve adequate control of blood pressure with candesartane alone.

Patients meeting the entry criteria, will receive candesartan alone 16mg in the first five weeks of the study to assess blood pressure control with candesartan given alone.

Patients with an insufficient therapeutic response to candesartan alone (defined by mean seated systolic blood pressure \>/=140 mm/Hg) will enter the next part of the study, and will be randomly assigned to one of 3 treatments ( candesartan alone 16mg, combination nifedipine / candesartan 30/16 mg, combination nifedipine / candesartan 60/16 mg). Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last eight weeks.


Eligibility Criteria:
* Inclusion Criteria:
* Male and female subjects 18 years or older are eligible.
* At Visit 0, subjects not treated with antihypertensive medications are to have MSSBP (mean seated systolic blood pressure) of \>/= 160 mmHg and \< 200 mmHg, and 24 hours MASBP (mean ambulatory systolic blood pressure) \>/= 130 mmHg; those subjects treated with antihypertensive medication are to have MSSBP \>/= 150 mmHg and \< 200 mmHg as measured by a calibrated electronic BP measuring device
* At Visit 3,subject must have MSSBP \>/= 140 mmHg before randomization.
* Women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active. This applies since signing of the IC (informed consent)form until the last study drug administration.
* Exclusion Criteria:
* Mean seated systolic blood pressure (MSSBP) \>/= 200 mmHg and/or mean seated diastolic blood pressure (MSDBP) \>/= 120 mm/Hg
* Mean seated diastolic blood pressure (MSDBP) \< 60 mm/Hg
* Differences greater than 20 mmHg for systolic blood pressure (SBP) and 10 mmHg for diastolic blood pressure (DBP) are present on 3 consecutive blood pressure readings at visit 0
* Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
* Cerebrovascular ischemic event (stroke, transient ischemic attack \[TIA\]) within the previous 12 months
* History of hypertensive retinopathy - known Keith-Wagener Grade III or IV. Any history of heart failure, New York Heart Association (NYHA) classification III or IV
* Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0
* Clinically significant cardiac valvular disease
* Subjects with an aortic aneurysm that, in the opinion of the investigator, will be unsuitable to be enrolled in the study.
* Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by glycosylated hemoglobin HbA1C of greater than 9% on visit 0
Dysfunctional Renin-Angiotensin System in Septic Shock

Despite best therapy efforts, sepsis and septic shock are associated with mortality rates of up to 40%. This clinical trial will determine the benefit of exogenous Angiotensin II versus norepinephrine (conventional care) treatment in septic shock patients. This trial will determine whether there are better predictors of septic shock severity. This approach may inform more appropriate treatment regimens and improve outcomes for these patients.

This study will determine whether normalization of renin-angiotensin-aldosterone system (RAAS) signaling in sepsis occurs more rapidly with treatment with Angiotensin II compared with conventional vasopressors. Trial samples will be used to identify the best RAAS biomarker predictor of treatment response via in-depth longitudinal analysis of RAAS component and to determine the extent and mechanisms of Angiotensin II impact on innate immune function during sepsis. Successful accomplishment of our aims will provide the capability to improve endotyping of septic patients by establishing the most precise and robust measurement of renin (and RAAS dysfunction). This work will improve staging and clinical precision and will facilitate the criteria for therapeutic development of targets in septic shock.

Eligibility Criteria:
Inclusion Criteria:

* The presence of septic shock, defined by sepsis-3 criteria
* The requirement for Norepinephrine of at least 10 micrograms/minute up to 35 micrograms/minute for at least 1 hour, with or without Vasopressin, to maintain a mean arterial pressure of 65 mmHg
* Clinical suspicion or proven evidence of infection

Exclusion Criteria:

* Age \<18 years
* Prisoners
* Pregnant women
* Patients for whom urgent surgery is anticipated
* Leukocyte count \<1,000 cells/μL
* Absolute monocyte count \<200 cells/μL
* Bone marrow transplant within the past 30 days
* Patients that will be withdrawing aggressive resuscitation
Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease

This study pretends to evaluate the potential use of Hyfe Cough Tracker (Hyfe) to screen for, diagnose, and support the clinical management of patients with respiratory diseases, while enriching a dataset of disease-specific annotated coughs, for further refinement of similar systems.

This is an observational study that will take place in the two campuses of the Clínica Universidad de Navarra, located in Pamplona and Madrid (Spain).

An Artificial-Intelligence system (AI) that detects and records explosive putative cough sounds and identifies human cough based on acoustic characteristics will be used to automatically monitor cough. Potential participants either attending the outpatient clinic or hospitalised with a complaint of cough will be invited by their treating physician, or a member of the research team, and included in the study by part of the research team. A researcher will instruct participants on how to install and use Hyfe Cough Tracker in their smartphones. Participants will be monitored for 30 days (outpatients) or until discharged from the hospital (inpatients). Participants will be asked to complete a daily, online, standardised 100 mm visual analogue scale (VAS) to register changes in the subjective intensity of their cough, while using Hyfe to objectively monitor changes in its frequency.

In parallel, a dataset of annotated cough sounds will be constructed and retrospectively used to assess differences in acoustic patterns of cough, and to evaluate the performance of the system detecting them.

A first subgroup of participants will be recruited outside the clinical setting and asked to provide a series of elicited sounds, including coughs, which will then be used to determine the system's performance accurately discriminating coughs from non-cough sounds, and compared to trained human listeners.

A second subgroup of participants will be will be instructed to use Hyfe, and the related Hyfe Air wearable device continuously for a period between 6 and 24 hours, while they record themselves using a MP3 recorder connected to a lapel microphone. This group will be used to evaluate the performance of Hyfe and Hyfe Air in a real-life setting, with spontaneous coughs.

Eligibility Criteria:
Inclusion Criteria:

For participants in the main study group

* Outpatient or inpatients at the Clinical Universidad de Navarra with a complaint of cough.
* The patient or his/her legal representative, have given consent to participate in the study.

For participants in the sub-study groups:

* Being 18 years or older.
* Providing consent for the sub-study

Exclusion Criteria:

* Inability to accept the privacy policy and terms of use of Hyfe.
* Lack of access to a Wi-Fi network at the site of residence (for the main study group).
* Unwillingness to regularly use the cough-surveillance system throughout the monitoring period
Validation of PSFS in Carpal Tunnel Syndrome

Validation of the Patient Specific Functional Scale in patients with carpal tunnel syndrome


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of carpal tunnel syndrome

Exclusion Criteria:

-
A Study of Bitopertin (RO4917838) in Healthy Male Volunteers

This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male volunteers. Subjects will be randomized in cohorts to receive single oral doses of either bitopertin or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male healthy volunteer, 18 to 60 years of age inclusive
* Body mass index (BMI) 19-35 kg/m2 inclusive
* Supine blood pressure within the normal range of the center and heart rate \>/= 40 provided QTcB is \<450 ms
* Subjects must agree to use a barrier method of contraception (e.g. condom) for the duration of the study and for 30 days after study completion

Exclusion Criteria:

* History or evidence of any clinically significant disease or disorder
* Clinically significant ECG abnormalities
* Positive for hepatitis B, hepatitis C or HIV infection
* Previous treatment with iron for iron deficiency anemia
* Regular smoker (\>10 cigarettes, \>3 pipefuls or \>3 cigars per day)
* History of alcohol and/or drug abuse or addiction within the last 2 years before study start
* Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
* Participation in a clinical study with an investigational drug within the last three months prior to screening
* Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigators or their designee
Combining Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post-mastectomy Complex Regional Pain Syndrome

The aim of this study is to evaluate the efficacy of the combination of Ultra Sound (US) guided radiofrequency stellate ganglion block (SGB) and radiofrequency Thoracic Paravertebral block (TPVB) comparing to US-guided SGB or TPVB alone on the post-mastectomy pain syndrome (PMPS).

Breast cancer is the most common malignancy among females, with an incidence of about 2.1 million women each year. It is the most common cause of cancer-related deaths among women. Modified Radical Mastectomy (MRM) is one of the main surgical treatments for breast cancer. It accounts for 31% of all breast surgery cases. Nearly 40-60% of breast surgery patients experience severe acute postoperative pain, with severe pain persisting for 6-12 months in almost 20-50% of patients (post-mastectomy pain syndrome.

Complex regional pain syndrome (CRPS) is a clinical diagnosis with a highly variable presentation and prognosis. CRPS type I, previously known as reflex sympathetic dystrophy (RSD), is not associated with direct nerve injury. CRPS type II, or causalgia, is associated with direct injury of a specific nerve, often from surgical intervention or trauma. Symptoms include severe pain, sensitivity to light touch, burning, sweating, skin discoloration, edema, temperature changes, loss of motor function, and decreased range of motion of the affected limb. The mechanism of CRPS is not fully understood with central and peripheral sensitization involved.

Eligibility Criteria:
Inclusion Criteria:

* Female patients.
* Type of surgery: Modified Radical Mastectomy MRM.
* Physical status ASA II, III.
* Duration of more than 6 months and less than 2 years.
* Moderate and severe pain (visual analog scale \[VAS\] ≥ 40 mm).
* Pain described as a refractory to strong opioids (oxycodone) and adjuvant therapy such as(pregabalin) for which more invasive interventions could be tried.

Exclusion Criteria:

* Patient refusal.
* Patient with local and systemic sepsis.
* Local anatomical distortion.
* History of contralateral chest disease or pneumonectomy.
* Known sensitivity or contraindication to the drug used in the study.
* History of psychological disorders.
* Contraindication to regional anesthesia, e.g., pre-existing peripheral neuropathies and coagulopathy.
* Severe respiratory or cardiac disorders. Advanced liver or kidney disease.
* Pregnancy.
* Physical status ASA IV and Male patients.
Intramuscular Ketamine Versus Aripiprazole and Escitalopram in the Treatment of Resistant Depression

The treatment of resistant depression should be optimized aiming at complete remission of symptoms, a complex condition due to several factors. Approximately 1/3 of patients with depressive disorders do not even respond to available antidepressants. Consequently, new molecules with robust action, fast effects and sustained improvement are currently being researched worldwide. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has emerged as a promising alternative due to its involvement in neurogenesis, synaptogenesis and consequent rapid improvement of depressive and suicidal symptoms with traditional intravenous (IV) use in sub dose (0.5 mg / kg). The therapeutic response of IV use has been short and requires monitoring in a hospital setting. There are no studies evaluating response to long-term ketamine use. Recent research has focused on identifying other routes of ketamine use such as intranasal and intramuscular (IM). The use of ketamine IM, despite the fact that there are few studies and small samples, can demonstrate efficacy in acute treatment and maintenance of depression, as well as low profile of side effects, greater accessibility potential, reduced costs and risks, patient comfort and possible expansion of resistant depression treatment capabilities in different settings.

Compare the response of ketamine IM versus active control in treatment-resistant depression (TRD \[primary outcome\]) and find safety and tolerability of ketamine IM, evaluate changes in life quality, cognition and suicidal risk (secondary outcomes)

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of TRD, according to clinical evaluation and confirmed by SCID-IV (Structured Clinical Interview for the DSM);
2. Moderate to severe intensity of the disease;
3. Female patients in fertile conditions should be using a clinically accepted contraceptive method (oral contraceptive and/or condom);

   a. Blood test will be requested at the diagnostic stage and in case of clinical doubt as to the patient's gestational status,
4. Literate and able to understand the tasks requested;
5. With clinical comorbidities, however compensated;
6. Patients and/or legal representatives should understand the nature of the study and sign the Informed Consent Form.

Exclusion Criteria:

1. Imminent risk of suicide;
2. Patients with psychoactive substance dependence;
3. Intellectual deficit and psychotic symptoms;
4. Bipolar spectrum disorders and other primary psychiatric diagnoses;
5. Allergic to ketamine;
6. Glaucoma;
7. Treatment with reversible MAOI (monoamine oxidase inhibitor) in the week prior to visit 0;
8. Treatment with irreversible MAOI in two weeks prior to visit 0;
9. Fluoxetine treatment within 4 weeks prior to visit 0;
10. Treatment with others antidepressants;
11. Treatment with antipsychotics, lithium, benzodiazepines or other psychotropic drugs within 7 days prior to visit 0;

    a. Lorazepam and zolpidem may be used;
12. Patients who become pregnant will be excluded from the study and referred for obstetric care.
Metformin in Diabetic Patients Undergoing Coronary Angiography

The present study aims to evaluate the strict application of the 2018 European Society of Cardiology guidelines on myocardial revascularization, that recommends to check renal function if patients have taken metformin immediately before angiography and withhold metformin if renal function deteriorates.

The aim of this study is to assess the safety of metformin in diabetic patients undergoing coronary angiography in terms of risk of lactic acidosis and to individuate eventual predictors of augmented lactate after coronary angiography.

The study is designed as an open-label (both physician and participant know that metformin will not be discontinued before PCI and in the following 48 hours), prospective, single arm study.

In our historical cohort of diabetic patients taking metformin, we observed a mean value of lactate of 1.2+0.7 mmol/l.

A total of 150 patients will be enrolled. Patients with any deviations from the study protocol will be enrolled in a parallel observational registry.

The study consists of a screening phase, a 30-day observational phase, and an end-of-follow-up visit or phone interview. The total duration of participation in the study for each participant is approximately 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients treated with metformin undergoing coronary angiography.

Exclusion Criteria:

* Known coronary anatomy with planned complex percutaneous coronary intervention with high probability of large amount of contrast use (3.7 \* estimated glomerular filtration rate; e.g.: 167 ml in a patients with an eGFR of 45 ml/min/1.73m2).
* Moderate to severe impairment of renal function (eGFR\<45 ml/min).
* Moderate to severe impairment of liver function (Child-Pugh class B or C).
* Severely impaired left ventricular ejection fraction (LVEF \<35%).
* Patients undergoing primary percutaneous coronary intervention (i.e., patients presenting with ST elevation myocardial infarction).
* Severe to very severe chronic obstructive pulmonary disease (GOLD class 3 to 4).
* Patients scheduled for cardiac surgery in the following 5 days.
* Inability to provide informed consent.
Laboratory Diagnosis and Prognosis of Severe Dengue

A study of dengue in children presenting to outpatient departments of 5 large hospitals in Ho Chi Minh City and Tien Giang province, Viet Nam.

Different blood tests are compared at the early stages of dengue fever onset in their ability to accurately and specifically detect children whose dengue will progress to severe disease.

In a prospective study in the outpatients department of three large hospitals in Ho Chi Minh City, Viet Nam, we will determine the early diagnostic sensitivity, specificity, positive and negative predictive values of two NS1 diagnostic tests in severe dengue cases.

The study is intended to develop a prognostic algorithm for the early identification of severe dengue cases.

Routine demographic, haematological and biochemical laboratory markers will be utilized to derive a prognostic algorithm that is clinically-useful for guiding patient triage and interventions.

We hope to discover and evaluate new early biomarkers of severe dengue and will evaluate candidate host response molecules and virological markers for their prognostic value.

We further plan to understand the phylogeography of DENV in the super-urban setting of HCMC.

We will use genome scale sequencing of DENV together with geospatial information on the residential addresses of patients to better understand transmission dynamics in space and time in a high transmission super-urban district of HCMC and thereby identify opportunities for public health interventions.

Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of dengue
* Axillary temperature \>=37.5C
* Less than 72hrs of fever
* Resident in Ho Chi Minh City
* 1-15 yrs of age
* Accompanying family member or guardian has a mobile phone
* Written informed consent

Exclusion Criteria:

* Any patient who the attending physician believes is unlikely to be able to attend follow-up
* Any patient in who the attending physician believes another diagnosis is more likely.
The Effect on Knee Joint Loads of Analgesic Use Compared With Exercise in Patients With Knee Osteoarthritis - An RCT

The purpose of this study is to compare the effects of neuromuscular exercise and analgesic use on knee joint load, in patients with mild to moderate knee osteoarthritis (OA).

It is expected that the two groups will receive equipotent pain relieving effect, despite this, the investigators expect a between group difference in knee joint load, and the exercise group will have a reduction in knee joint load.


Eligibility Criteria:
Inclusion Criteria:

* Compliance with the ACR criteria
* Medial knee OA defined as "No osteoarthritis", "Doubtful narrowing of joint space and/or possible osteophytes", "Definite osteophytes and possible narrowing of joint space", "Multiple osteophytes, definite narrowing of joint space and some sclerosis and deformity of bone ends". This corresponds to the Kellgren and Lawrence (KL) grades 0, 1, 2 and 3 respectively
* Willingness to participate in exercise and use of analgesics
* A maximum of 75/100 points in the KOOS Pain subscale
* BMI of 32 or less

Exclusion Criteria:

* Medial greater than lateral joint space width
* Medial knee OA of KL grade 4
* Knee surgery or steroid injection within the past 6 months
* Already taking max dose NSAIDs or acetaminophen
* Any physician-determined condition that is a contraindication for use of acetaminophen, NSAIDs or to exercise
* Problems affecting the lower extremity overriding the problems from the knee
* Knee surgery planned in the next 6 months
* Known ACL tear within the past 6 months
* ACL reconstruction
* Diagnosis of systemic arthritis
* Difficulty complying with treatment schedule
* Inability to fill out questionnaires
* Inability to ambulate without an assistive device
* Ankle, knee or hip replacement
* Tibial/femoral osteotomy