cyrilzakka/clinical-trials huggingface dataset:
The Effects of RVX000222 on Glucose Metabolism in Individuals With Pre-diabetes

This study builds on data that high-density lipoprotein (HDL) has a number of potentially beneficial effects including directly modulating glucose metabolism through multiple mechanisms. The primary objective of this study is to determine the effects of RVX000222 on postprandial plasma glucose in male individuals with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), during a frequently sampled oral glucose tolerance test (OGTT).


Eligibility Criteria:
Inclusion Criteria:

* Males aged 18-70 years, inclusive
* Body mass index (BMI): 25-40 kg/m2
* HDL cholesterol plasma levels: ≤1.4 mmol/L
* Pre-diabetes: Either impaired fasting glucose (IFG; 6.1-6.9mmol/L) or impaired glucose tolerance (IGT; 2 hour OGTT glucose 7.8-11.0mmol/L, WHO classification) as measured at Visit 1
* No current use or need for prescription or over-the-counter medication within four days of Visit 1
* Have given signed informed consent to participate in the study

Exclusion Criteria:

* Identification of any other medical condition requiring immediate therapeutic intervention
* Has received any over-the-counter medication including vitamins, herbal, or dietary supplements within four days of Visit 1 unless prior approval from the Investigator
* Tobacco use within six months of Visit 1 (including cigarettes, pipes, chewing tobacco)
* Elective surgery requiring general anaesthesia during the course of the study
* Clinically significant heart disease at Visit 1
* Clinically significant abnormal ECG at Visit 1
* Evidence of renal impairment defined as serum creatinine \>1.5 mg/dL (133 μmol/L) or creatinine clearance of \<60 mL/min
* History of hypertension or supine SBP \>160mmHg or DBP \>95mmHg as measured at Visit 1
* Evidence of type 2 diabetes (fasting plasma glucose ≥7.0mmol/L; 2 hour OGTT glucose ≥11.1mmol/L)
* Evidence of liver disease defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin \>1.5 x upper limit of normal (ULN) at Visit 1
* History of malignancy within past 5 years
* History or evidence of drug or alcohol abuse within 12 months of Visit 1
* Use of other investigational drugs and/or devices at the time of enrolment, or within 30 days of Visit 1
* History of non-compliance to medical regimens or unwillingness to comply with the study protocol
* Any condition that in the opinion of the Investigators would confound the evaluation and interpretation of the data
* Persons directly involved in the execution of the protocol
Different Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery

The investigators want to assess the effect of intraoperative low tidal volume vs intermediate tidal volume on respiratory mechanics, oxygenation and pulmonary complications in older patients undergoing Trendelenburg pneumoperitoneum surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III class;
* Colorectal cancer patients;
* Elective laparoscopic colorectal surgery;
* expected duration of surgery greater than 2 hours.

Exclusion Criteria:

* serious complications associated with other systems;
* severe cardiac insufficiency;
* renal failure;
* body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2;
* the use of low tidal volume and consequent hypercapnia can induce harm;
* refusal to participate in the study.
FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients

This study has been designed to help us determine if FACBC PET or PEM can accurately evaluate how far the breast cancer has spread in the breast. Also, to help determine if FACBC PET or PEM can accurately measure your response to chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Women presenting for evaluation at MSKCC with biopsy proven primary IDC or ILC
* No prior therapy for IDC or ILC
* Clinical need for local disease staging with breast MR (Group A only)
* Clinical need for neoadjuvant chemotherapy (Group B only)
* Patients must provide written informed consent

Exclusion Criteria:

* Age \<21 years
* Men
* Pregnancy or lactation
* Patients who have already started treatment for the current malignancy
* Patients who cannot undergo PET scanning (i.e. because of weight limits)
* Patients who are known to have contraindication for MRI (e.g. metal implants)
* Patients may only participate in group #1 or group #2, but not both
The Edi Level and Cardiopulmonary Function Between HHHFNC and Unheated Humidified High-Flow Oxygen Mask in COPD

Patients with COPD exacerbation usually need respiratory support after extubation. Recently, HHHFNC has been used in both adult and neonates with post-extubation respiratory support. Studies indicate that HHHFNC has seminar efficacy compared to non-invasive positive pressure ventilation and superior than conventional oxygen therapy. There are no clinical data of diaphragm electrical activity and cardiopulmonary function for using HHHFNC and UHFOM as post-extubation respiratory support.

Objectives： The aim of this study is to compare the Edi level and cardiopulmonary parameters between heated humidified high-flow nasal cannula (HHHFNC) versus unheated high-flow oxygen mask (UHFOM) in acute exacerbation of chronic obstructive pulmonary disease (COPD) patients with post-extubation respiratory support. This is the first clinical trial to investigate and analysis the variations of cardiopulmonary parameters and Edi level between HHHFNC and UHFOM in adult patients.

Eligibility Criteria:
Inclusion Criteria:

1. AE of COPD received intubation and ready to be weaning
2. P/F ratio \> 200 during SBT before extubation

Exclusion Criteria:

1. Unable to insert NG tube
2. Refuse to re-intubated when respiratory failure after extubation
3. Planned NIV use after extubation
4. Pregnancy
Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study"

Prospective, multicenter, observational study on the evaluation of efficacy of appropriate monotherapy vs combination treatment for non-complicated Enterococcus faecalis bloodstream infection (EF-BSI).

The aims of our study are:

Primary:

To compare the efficacy of appropriate monotherapy vs combination treatment for EF-BSI, according to standard of care.

Secondary:

1. To compare the impact on clinical outcome of the initial combination therapy in the subgroup of patients with enterococcal endocarditis. In this case we will evaluate only the antibiotic treatment administered before the diagnosis of endocarditis assuming that any case of endocarditis will be treated with a combination therapy.
2. To compare the efficacy of combination treatment (vs monotherapy) in the following subgroup of patients:

   A. Patients with low versus high risk of endocarditis according with the "Number of positive blood cultures, Origin of the bacteremia, previous Valve disease, Auscultation of heart murmur (NOVA) score".

   B. Patients with metastatic septic localizations. C. Patients with catheter-related BSI. D. Patients with indwelling cardiovascular device or prosthetic valve.
3. To validate the NOVA score as a predictor of enterococcal endocarditis in a large multicentre cohort of patients with EF-BSI.
4. To estimate optimal duration of treatment of EF-BSI in patients without endocarditis.
5. To evaluate the rate of 90-day development of Clostridium difficile infection.

The promoting center is S. Orsola-Malpighi Hospital is a 1,420-bed tertiary care University Hospital in Bologna with an average of 72,000 admissions per year. A dedicate team of Infectious Diseases (ID) specialists is active in the promoting center. Investigators of this team have already coordinated multicenter studies on infections topics. Centers from other countries will be invited to participate by email, they will be ask to fulfil an agreement form.

All consecutive, unselected patients with monomicrobial EF-BSI will be screened for study inclusion. We expect to enroll about 500 patients.

Period of data collection will be from september 2019 to 31th December 2020.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years)
* First monomicrobial EF-BSI
* Receipt of ≥ 5 days of at least one in vitro active drug (ampicillin, amoxicillin/clavulanate, ampicillin/sulbactam, piperacillin, vancomycin, teicoplanin, daptomycin and linezolid) with or without a synergistic drug (ceftriaxone, gentamycin, streptomycin), at common suggested dosages for EF-BSI in empirical or definitive therapy
* Written informed consent

Exclusion Criteria:

* Short term (within 3 days from BSI) mortality
* Other concomitant infection
The Effect of Hyperbaric Oxygen Therapy on Aerobic and Anaerobic Physical Fitness

Previous evidence showed hyperbaric oxygen can enhance aerobic and anaerobic performance during the exposure. The effect of continuous exposure of hyperbaric oxygen on performance was never evaluated.

In recent years, several options for physical performance enhancement by increasing blood oxygen content were explored. One option is increasing the number of red blood cells by blood transfusions. Another option is using the erythropoietin hormone. These methods showed an effective increase of maximal oxygen consumption rate (VO2MAX) by 10%. However, due to their inherent risks, the international sports associations banned their uses. A third option of training in high altitude environments, but this option was never proved to be effective.

Another strategy would be increasing the blood oxygen content by increasing the plasma dissolved oxygen concentration. This would only be possible using hyperbaric oxygen therapy -which includes inhaling 100% oxygen in a pressure higher than the normal atmospheric pressure.

Previous evidence showed hyperbaric oxygen can enhance aerobic and anaerobic performance during the exposure. These studies evaluated the effect during a single hyperbaric oxygen exposure. The effect of continuous exposure of hyperbaric oxygen on performance was never evaluated.

The study is designed as a randomized controlled study aiming to evaluate the therapeutic effects of hyperbaric oxygen therapy (HBOT) on the aerobic and anaerobic performance.

After signing an informed consent form, patients will be randomized into 2 groups: treatment and control group. Patients will be invited for baseline evaluations. All patients would be evaluated 2 times - at baseline and after 2 months of follow up, The evaluation will include physical examination, VO2MAX, muscle biopsy for mitochondrial function, aerobic function measurements, cognitive assessment, brain MRI, brain EEG.

Protocols:

Treatment: Patients will receive 40 daily sessions, 5 days/week, 60 minutes each with 5 minutes air break every 30 minutes, 100% oxygen at 2 atmospheres (ATA).

Control: Patients will receive 40 daily sessions, 5 days/week, 60 minutes each with 5 minutes air break every 30 minutes, 21% oxygen (air) at 1.01 ATA.

Upon completion of the study, control group would be offered to crossover and complete additional 40 sessions of 100% oxygen at 2 ATA. A third evaluation would be performed in case patients will complete the protocol.

Eligibility Criteria:
Inclusion Criteria:

* 18-25 or 40-50 age
* Professional performance of aerobic sports for ages 18-25 (at least 5 times a week)
* Moderate and above performance of aerobic sports for ages 40-50 (at least 4 times a week)
* no chronic illness
* no significant musculoskeletal injury in the past 3 months

Exclusion Criteria:

* Debilitating significant musculoskeletal injury
* Previous hyperbaric oxygen exposure
* Lung pathology
* Middle or Inner ear pathology
* Claustrophobia
* Chronic illness
* Smoking
* Chronic medications
A Pilot Randomized Controlled Trial of Repeated Hands-and-Knees Positioning During Labour

The investigators designed a pilot randomized controlled trial to assess the feasibility and acceptability of repeated hands-and-knees positioning during labour. The objectives were 1) to provide an estimate of enrollment rates, 2) to assess compliance with the study protocol by participants and care providers, 3) to obtain women's views about their experiences using the hands-and-knees position, and 4) to provide estimates of treatment effects to inform the sample size calculation for a large trial.

Women were enrolled in the pilot randomized controlled trial at two hospitals, one in Canada and one in the USA. Nurses at both hospitals were trained in how to assist women into the hands-and-knees position in bed. Repeated hands-and-knees position was defined as attempts to use the position for 15 minutes, hourly from randomization until delivery. Women were not asked to assume hands-and-knees for delivery.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous;
* \>37 weeks 0 days gestation
* in established early labour
* anticipating a vaginal delivery of a single fetus in the cephalic position
* competent to give informed consent .

Exclusion Criteria:

* delivery was anticipated within 3 hours
* a medical contraindication or physical limitation such that hands-and- knees position was contraindicated
* had a doula or midwife who encouraged the use of hands-and-knees position.
Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)

There is no prospective study published on the Essential Thrombocythemia and the correlation between this specific disease, its complications and the biological variations observed.

The aim of this study is to demonstrate a correlation between biological tests of haemostasis, as Multiplate analyser and thromboelastometry (ROTEM) and the occurrence of clinical complications, thrombosis and/or haemorrhage, in order to determine if this biological tests could be biological prognostic factors


Eligibility Criteria:
Inclusion Criteria:

* Adult aged more than 18 years old
* Patient followed in consultation for an Essential Thrombocythemia at diagnosis or during the follow-up
* Collection of the informed consent
* Patient affiliated to Social Security

Exclusion Criteria:

* Patients aged less than 18 years old
* Refusal of signature of the informed consent
* Patients under guardianship
Genetic Analysis of PHACE Syndrome (Hemangioma With Other Congenital Anomalies)

1. PHACE syndrome(OMIM database number 606519) is the association of a vascular birthmark (hemangioma) on the face along with one or more of the following conditions: congenital heart defects, congenital anomalies of the cerebral arteries,brain, eyes, or sternum.
2. A research study is currently being conducted at the Medical College of Wisconsin (MCW) to investigate if there is an inherited cause of PHACE syndrome.
3. We are hoping that this study will lead to a better understanding of how and why children develop PHACE syndrome.

If you and your child agree to participate in this study, the following will happen:

1. The principal investigator at MCW, or her appointed representative or collaborators at other sites, will review the study protocol and consent form with you and answer any questions- this can be done over the phone.
2. If you choose to participate, the investigator will obtain informed consent for study participation, consent to obtain medical records, and a small amount of logistical information such as address and phone number.
3. Subjects and parents may have a blood draw, saliva sample or buccal swab done.
4. If the subject undergoes surgery for another reason and there is tissue which would otherwise be discarded, we may ask to receive this sample for research purposes.
5. We will request completion of surveys about the individual's medical history as it relates to this condition.
6. The purpose of this study is to promote the understanding of the inheritance of hemangiomas associated with brain, eye and heart anomalies. The DNA obtained from participants are stored in a DNA repository and genetic data bank for current and future research projects related to their genetic disorders. The DNA specimens will be used to map disease-related genes. The principal investigator uses her discretion to decide which investigators will have access to this resource. The analysis of the specimens will vary depending on the investigator and his/her specific protocol.

Eligibility Criteria:
Inclusion Criteria:

* meets the clinical diagnostic criteria for PHACE syndrome.

Exclusion Criteria:

* fails to meet the clinical diagnostic criteria for PHACE syndrome.
Skin Refrigerant to Reduce the Pain Associated With IV Insertion

The purpose of this study is to determine whether or not the pain of IV catheter insertion in the Emergency Department can be reduced significantly with the use of a rapid acting topical anesthetic spray and to determine whether or not healthcare providers who undergo such treatment are likely to endorse its use in their future practice.

We recruited 38 emergency department healthcare providers (doctors, physician assistants, nurses and medics) to receive a total of two separate IV canulations - one in one arm and the other in the other. One IV canulation would be pretreated with Ethyl Chloride topical anesthetic (the study product) and the other would be pre-treated with a placebo (sterile water in an aerosol can). Both the participants and the nurses, PAs and medics who placed the IVs were blinded as to which was the Ethyl Chloride and which was the placebo. After the IVs were placed the participants were asked to rate the pain of IV canulation on a scale of 1 to 10 for each of the pre-treatments, to state which one they believed to be superior in reducing the pain of receiving the IV, to state whether or not they would like the intervention that they rated as superior to be used on themselves and finally how likely they were on a 5 point scale to incorporate the intervention they rated as superior into their future practice.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. A healthcare worker who routinely orders or places IV catheters.
3. Consents to participate in the study.

Exclusion Criteria:

1. History of hypersensitivity to Ethyl Chloride.
2. Break, or swollen in the skin at the proposed IV site.
3. Pregnancy or lactating female.
4. Recent tattoo in either of the two proposed anatomical areas for IV cannulation.
5. Skin infection in either of the two proposed anatomical areas for IV cannulation.
6. Missing a contralateral limb to place the second IV.
7. Recent trauma to one of the upper extremities or any neuropathic or radicular condition that could affect the participant's perception of pain in the antecubital fossa of each arm.

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A Prospective Study to Examine the Need to Adjust the Dose of Apixaban When Used in Atrial Fibrillation and Obesity

A prospective cohort study to determine whether a high body weight (BMI equal to or greater than 35 kg / m 2) has an effect on anticoagulant Apixaban level in the blood of patients with atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

- hospitalized Patients on Steady State level of Apixaban, based on the data given in the hospital ward . A level of Steady State is received within two days of treatment.

Exclusion Criteria:

* Anasarca
* acute renal failure
Efficacy and Outcomes of Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy Performed by Optometrists

The purpose of this study is to formally assess the efficacy and outcomes of optometrist-performed neodymium-doped yttrium aluminum garnet (Nd: YAG) laser capsulotomy procedures.

Participants will undergo a pre-procedure examination to establish baseline findings and to determine if they meet the inclusion criteria. Participants will undergo the Nd: YAG laser capsulotomy procedure and will be examined at 1 hour, 1 day (if necessary), 1 week, 1 month, and 3 months following the procedure. Follow-up examinations will evaluate visual acuity improvement and possible post-procedure complications. The complication rate following the laser capsulotomy procedure is typically minimal.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent;
2. At least 18 years of age, male or female;
3. Prior cataract surgery;
4. Diagnosed with posterior capsule opacification obstructing vision;
5. Best-corrected visual acuity less than 20/40 or visual acuity with glare that reduces by 2 lines or more on an ETDRS visual acuity chart or significant effect on activities of daily living

Exclusion Criteria:

1. History of underlying ocular disease (not including mild/moderate non-proliferative diabetic retinopathy or incidental findings)
2. Previous myopic refractive error greater than 6.00 diopters
3. Complications following previous ocular procedures (i.e. intraocular lens decentration)
4. Ocular surgery other than uncomplicated cataract or uncomplicated refractive surgery
The Influence of Significant Weight Lost on the Quality of Voice

The rate of obesity and bariatric surgery is rising steadily. Though Bariatric Surgery Influences on aspects such as endocrin analysis, finance, etc are well tested, quantitative and quality voice impacts have not been evaluated. The aim of the study is to recruit 50 patients who underwent bariatric surgery and compare voice quality in each of these patients before and after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Morbid obese
* Candidates for bariatric Surgery

Exclusion Criteria:

* History of benign \\ malignant disease of the larynx.
* History of head and neck tumors
* History of radiation therapy of the neck
* BMI under 30 pre-surgery
Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana

Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.

Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a hybrid (type III) and pragmatic Sequential Multiple Assignment Randomized Trial (SMART) design. The adaptive strategies are designed to target patient- and system-level determinants identified in preliminary data, including delayed communication of results, individual and structural barriers to accessing treatment, and suboptimal care coordination between referring and cancer treatment clinics. The strategies draw upon key principles in behavioral economics and are supported by systematic evidence of the effectiveness of nudge strategies in preventive, HIV, and cancer care. The overarching rationale for the study is that enhancing coordination, communication, and navigation through centralized outreach and nudge strategies will increase timely treatment adoption and be scalable and sustainable in the long-term.

Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible if they:

1. are biological females
2. are aged 18 or older
3. have pathology-confirmed invasive cervical cancer diagnosis
4. have pathology results evaluated at National Health Laboratory in Botswana
5. are citizens of Botswana
6. have no prior history of invasive cervical cancer

Exclusion Criteria:

Patients will be excluded if they:

1. are biological males or otherwise born without a cervix
2. are below the age of 18 due to the rarity of cervical cancer in this population
3. do not meet study inclusion criteria