cyrilzakka/clinical-trials huggingface dataset:
Gastric Insufflation During Positive Pressure Ventilation

Effect of peak inspiratory pressure on the gastric insufflation is evaluated using ultrasonography during face mask ventilation in obese adults. Effect of facial mask holding techniques on the gastric insufflation is also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with body mass index ≥ 30 kg/m2 who are scheduled for general anesthesia

Exclusion Criteria:

* Risk of delayed gastric emptying or gastroesophageal reflux (gastroesophageal reflux disease, achalasia, history of stomach surgery, gastrointestinal obstruction, uncontrolled DM)
* Pregnancy
* Known or predicted difficult airway
Capsular Tension Rings in Intraocular Lens Rotation

To investigate whether implantation of a capsular tension ring device will affect the degree of rotation of an implanted toric intraocular lens following cataract surgery.

The study is a prospective, subject-blinded investigation of whether implanting capsular tension rings with intraocular lenses affects rotational stability of the lens.

Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care).

Randomization: Each eye undergoing cataract surgery will be randomized into a control or treatment group. If both eyes meet enrollment criteria, then each eye will be randomized independently.

* Control group: toric IOL only
* Treatment group: toric IOL plus capsular tension ring

Eligibility Criteria:
\*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Active duty and DoD beneficiaries aged 30 years or older undergoing cataract surgery
* Corneal astigmatism ≥ 1.0 D and a surgical plan that includes a toric intraocular lens for astigmatism correction. (The lens used will be the TECNIS IOL. It will be used on label)
* No observed zonular or capsular problems prior to, or at the time of, capsular tension ring insertion

Exclusion Criteria:

* Patients undergoing cataract surgery who do not have corneal astigmatism ≥1.0 D.
* Any observed zonular or capsular problems prior to, or at the time of, capsular tension ring insertion.
* Pre-existing ocular conditions, including:Pre-existing ocular conditions, including:

  * Pseudoexfoliation syndrome in one or both eyes
  * Prior incisional ocular surgery
  * Lens subluxation
  * Poor dilation or inability to position at the slit lamp (making postoperative outcome measurements difficult or impossible)
  * Plans for extensive travel or to move away during the postoperative evaluation period
  * Other conditions that would influence the capsule or lens positioning
* Surgical plan to include other procedures at the time of initial cataract surgery, such as Limbal Relaxing Incisions (LRIs), Micro-Incisional Glaucoma Surgery (MIGS), etc.
Study to Evaluate the Safety and Pharmacokinetics of Oral OPRX-106 (TNFR-Fc Fusion Protein) in Healthy Volunteers

: This is a Phase I, study to evaluate the safety and pharmacokinetics of oral OPRX-106 in healthy volunteers. Up to 18 healthy male subjects (age 18 years and older) will be randomized to one of three dose cohorts (up to 6 subjects per cohort), receiving OPRX-106 doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein. Subjects will receive once daily oral administrations of OPRX-106 for 5 consecutive days. Subjects will remain at the clinical center for 24 hours after the first administration (Day 1) of OPRX-106 including PK sampling and then return to the site daily for additional administrations and study procedures.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male age 18-45
* Body mass index (BMI) 18-30 kg/m2
* Male subjects or their partners must use an adequate method of contraception at all times during the study.
* Negative laboratory tests for HIV, HBcAb and HCV at the screening visit
* Naïve to any previous recombinant protein therapy
* Provide written informed consent
* Have the ability to understand the requirements of the study and to comply with the study protocol and dosing regimen

Exclusion Criteria:

* Clinical evidence of any active significant disease that could potentially compromise the ability of the Investigator to evaluate or interpret the effects of the study treatment on safety assessment, thus increasing the risk to the subject to unacceptable levels
* Presence of any acute or chronic diseases
* History of any allergies or protein-drug hypersensitivity
* Exposure to long-term steroid treatment within the last 12 months prior to the study
* Subject had a major operation in last 6 months
* Subject has received immunosuppressive treatment prior to the study
* Chronic use of any medication including vitamins
* Participation in another clinical trial during the previous 3 months (subject report)
* Reported history of alcohol or drug abuse
* Subjects with short bowel (more than 1 m removed of small bowel).
Altshock-2 REGISTRY

The study will provide data on profile, management, outcome, and evolution over time of cardiogenic shock patients admitted to the Intensive Coronary Care Units

Cardiogenic shock (CS) is the most severe form of acute heart failure. Data on epidemiology of CS have been drawn from previously published registries focussing on acute coronary syndrome (ACS) and myocardial infarction (AMI). Indeed, CS occurs in 5-7% of patients presenting with ACS and ACS has been reported as the most prevalent cause of CS, accounting for about 80% of cases.

However, recent evidences in a contemporary cohort in North America have shown that more than two-thirds of all cardiogenic shock cases were related to causes other than AMI and that these patients had outcomes at least as poor as patients with AMI-CS.

Given the high short-term mortality of these patients and the need for developing dedicated cardiac shock centres and systems of care to time our interventions, it is of utmost importance to achieve a better clinical phenotyping of the heterogeneous causes and presentations of CS patients and carefully perform research outcome.

Accordingly, the Altshock-2 registry will represent a unique opportunity to evaluate the full spectrum of CS admitted in Intensive Coronary Care Units and to collect a selected number of variables related to aetiology, clinical presentation, ongoing pharmacological treatments, use of mechanical support devices and outcome.

Eligibility Criteria:
All consecutive CS patients hospitalized in the above reported centres between January 2020 and December 2030.

Cardiogenic shock is defined as:

1. Systolic blood pressure (SBP) \<90 mmHg or mean arterial pressure (MAP) \<60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload, OR need of vasoactive agents to maintain SBP \> 90 mmHg or MAP \> 60 mmHg, OR need of MCS;
2. At least one of the following criteria/signs of overt hypoperfusion: mixed venous oxygen saturation \<60%; arterial lactates \> 2 mmol/L; oliguria \< 0.5 ml/Kg/h for at least 6 hours.
Real-world Study for the Safety of Albumin-Bound Paclitaxel in Malignant Tumors

This is a multi-center, Prospective, observational study，to evaluate the safety and influencing factors of albumin-bound paclitaxel in the real-world chinese population，and evaluate of the efficacy of albumin-bound paclitaxel in patients with malignant tumors and its impact on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* In patients with malignant tumor who have been treated with albumin-bound paclitaxel for the treatment.

Exclusion Criteria:

* No
Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY94-9392 in patients with cancer or inflammation.


Eligibility Criteria:
Inclusion criteria:

In Germany Healthy volunteers

* Males/females ≥ 50 and ≤ 65 years Patients
* Males/females ≥ 35 and ≤ 75 years
* histologically confirmed diagnosis of non small cell lung cancer or adenocarcinoma of the breast with a positive FDG-PET or
* patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or
* inflammation with a positive FDG-PET

In Korea Patients

* Males/females ≥ 35 and ≤ 75 years
* histologically confirmed diagnosis of non small cell lung cancer, adenocarcinoma of the breast or hepatocellular cancer with a positive FDG-PET or
* patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or
* inflammation (positive FDG-PET mandatory, could be also done as screening examination)

Exclusion criteria:

* Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY 94-9392, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
* Known sensitivity to the study drug or components of the preparation
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria for schizophrenia confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) Version 7.0.2
* Participants must have well-controlled positive symptoms and prominent negative symptoms as defined by Positive and Negative Syndrome Scale (PANSS) criteria.
* Participants currently receiving a second-generation atypical antipsychotic drug (SGA) are eligible if they are stable and adherent to their dosing schedule.
* Participants must have a reliable informant (e.g., case manager, social worker, family member). The informant should be able to spend an adequate amount of time with the participant to be able to address behaviors, activities, and symptoms.

Exclusion Criteria:

* Participants with current major depressive disorder (MDD)
* Participants with pseudo-parkinsonism secondary to their ongoing antipsychotic medication
* Participants currently using anticholinergic medications
* Participants recently hospitalized as in-patients
NIPPV Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation

Mechanical ventilation is important in the care of preterm infants with respiratory failure, but may be associated with lung injury. Efforts are needed to avoid or minimize the use of mechanical ventilation. However, there is no consensus on the best non-invasive ventilation mode after extubation in preterm infants.

Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation (NIPPV) versus bi-level nasal continuous positive airway pressure (BIPAP) following extubation in preterm infants ≤ 1250 g birthweight.

In this study , mechanically ventilated preterm infants with birthweight ≤1250 g will screen for eligibility. Infants with major congenital malformations, neuromuscular disease and lack of parental consent were excluded. Enrolled infants will randomize into two study groups (NIPPV group and BIPAP group) following the decision to extubate by using sealed opaque envelopes. Extubation criteria are; loaded with caffeine according to standard clinical protocol, satisfactory blood gases (pH of more than 7.25), mean airway pressure of 7 cm water or less, fractional inspired oxygen concentration of 35 % or less and good respiratory effort.

Non-invasive respiratory support will deliver using the device of SLE 5000 (Specialised Laboratory Equipment, South Croydon, United Kingdom) in NIPPV group and infant flow- deriver device (Viasys Corp, Care Fusion, CA) in BIPAP group. The short binasal prongs will use as interface. The initial ventilator parameters for NIPPV were: PIP levels set 2 cm H2O above the pre-extubation PIP, PEEP: 5 cm H2O, rate the same as was being given before extubation and for BiPAP were: lower CPAP levels 4 to 6 cmH2O (maximum 7 cmH2O) and higher CPAP levels 8 to 9 cmH2O (maximum 10 cmH2O), Thigh 0.5-0.6 second, and a pressure exchange rate of 20-30/ minute, with the lowest adjusted FiO2 to maintain an oxygen saturation of 90% to 95%.

Extubation failure was defined as: development of respiratory acidosis (blood gases with pH \< 7.2 and PaCO2\> 60 mmHg), or hypoxemia (blood gases with PaO2 \< 50 mmHg despite oxygen supplementation of 60 percent), or severe apnea requiring mask ventilation.

Surfactant requirement is goingto evaluate in all infants after NICU admission. Poractant alfa was administered if necessary.

The primary end-point, rate of extubation failure within 96 hours following first extubation, will compared between the groups. Short and long-term neonatal outcomes will also evaluate.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated preterm infants with birthweight ≤1250 g

Exclusion Criteria:.

* Infants with major congenital malformations, neuromuscular disease and lack of parental consent
Oculomotor and Spatial Cognition Deficits in Schizophrenia

DESCRIPTION: (Verbatim from the Applicant's Abstract) Abnormalities of eye movement control and spatial cognition are well-established deficits in schizophrenia. However, the regional disturbances in brain function causing these deficits are not yet known. This application proposes a series of integrated behavioral studies designed to identify causes of deficits in schizophrenia.

We will be assessing clinical symptoms and cognition before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria: Inclusion criteria for this study are (1) able and willing to give written informed consent; (2) no contraindications to MRI (cardiac pacemaker, aneurysm clip, cochlear implants, IUD, shrapnel, history of metal fragments in eyes, neurostimulators or other metal devices, weight of 250lbs or more, claustrophobia) and (3) medically stable. Sedation will not be used for MRI studies because cooperation is essential.

Exclusion Criteria:

* Any subject is excluded from the imaging studies if they have any contraindications to MRI such as cardiac pacemaker, aneurysm clip, cochlear implants, pregnancy in the later stages (because of body size and limited comfort for MRI studies), IUD, shrapnel, history of metal fragments in eyes, neurostimulators, weight of 250 lbs. or more, or claustrophobia. Individuals with mental retardation, neurologic disease or significant medical illness that might effect neuronal or vascular physiology will not be recruited.
The Effect of Five-Toed Socks on Postural Control Among Active Individuals Who Have Chronic Ankle Instabilities

Lateral ankle sprain (LAS) is one of the most common injuries in sports. There is a unique style of socks that have become popular in Japan among athletes that could also improve postural control. The purpose of the study is to determine the effectiveness of five-toed socks on dynamic postural control in individuals with and without chronic ankle instability.

Lateral ankle sprain (LAS) is one of the most common injuries in sports. Ankle braces and orthotic insoles also have been shown to influence the neuromuscular control system by enhancing the proprioceptive and cutaneous afferent inputs to the central nerve system; thereby improving postural control. There is a unique style of socks that have become popular in Japan among athletes that could also improve postural control by enhancing cutaneous afferent inputs from the plantar surface of the foot and toes. The purpose of the study is to determine the effectiveness of five-toed socks on dynamic postural control in individuals with and without chronic ankle instability.

Eligibility Criteria:
Inclusion Criteria:

* member of university community
* All subjects will be physically active (at least 30 minutes of sustained exercise 3 times/week

Exclusion Criteria:

* history of: knee or hip musculoskeletal injury or surgery
* history of: fracture or dislocation of the testing ankle or leg
* neurological problems
* vestibular disorders or concussions within the last 6 months
Effect of Multisensory (Snoezelen) Environment on Birth Outcomes

Giving birth is a fundamental life event that women will remember throughout their lives. While seeking perfection for the birth environment, much can be learned from other areas of expertise and different pursuits can be undertaken. An example of this is "Snoezelen rooms". In the Snoezelen environment, it is aimed to relax the woman by stimulating various senses, including visual and auditory, and by diverting attention. The room design is a combination of light music, aquarium, optical illusions and aromatic oils. This study will be conducted in a randomized controlled manner to examine the effects of a multi-sensory (snoezelen) environment on birth outcomes, newborn health parameters and birth memory.


Eligibility Criteria:
Inclusion Criteria:

* Those who are between the ages of 18-35
* Having a singleton pregnancy between 38-42 weeks of pregnancy
* Primiparous
* Labor started spontaneously
* In the latent phase of labor
* Without uterine contraction anomaly
* The leading part of the fetus is the head (in vertex position)
* No analgesia was applied
* There is no indication for cesarean section
* Amniotomy is not performed
* Fetal weight over 2500 g, fetal weight not over 4000 gr
* Pregnant women who do not have communication problems will be included in the study.

Exclusion Criteria:

* Reporting hearing, vision, smell and balance problems
* Allergy, asthma, COPD, migraine, vertigo, epilepsy, etc.
* Declaring that they have a chronic disease
* Declaring that they have a psychiatric history or a diagnosed psychological disorder
* Declaring that they have a risky health condition related to pregnancy (preeclampsia, gestational DM, etc.),
* Those who report smoking, alcohol and/or substance use
* Reports that he/she has sensory sensitivity
* Declaring an allergy to lavender (Lavandula angustifolia Mill.) or lavender oil
* Declaring that there is a person with special needs in the family
* Participated in the study voluntarily and then gave up
* Pregnant women who develop any possible side effects during the study will not be included in the study.
Immediate Effect of Light on Reproductive Hormones in Women: a Role of the Spectrum

The study investigates an acute effect of white-appearing LED light (with a peak in blue portion) vs. red LED light of similar irradiance on reproductive hormones in healthy women.

Sixteen healthy women came to the laboratory at 7:30 (wearing dark goggles) at two occasions (separated by 2-3 days, first time - at the 3rd-8th day of their menstrual cycle) to be exposed for 45' to white-appearing or red LED light (sequential allocation). The white light has a distinct peak at 460 nm, the narrow-band red light peaked at 651 nm. The LED devices were positioned at the distance of 50 cm (white) and 45 cm (red) from the eyes to be matched by irradiance (approximately 7.0 microWt/m2); background light in direction of gaze was 5-10 lux. Blood and saliva samples were collected before, in the middle, and during the last minutes of the 45' exposure to be measured later for concentration of luteinizing hormone, follicle-stimulating hormone, prolactin, estrogen, progesterone, and also - for cortisol and melatonin (the last one - in saliva) as well-studied indicators of the direct effect of light.

Eligibility Criteria:
Inclusion Criteria:

* age 18-45 y
* normal (21-35 days) menstrual cycle
* good and stable general health
* normal body weight index 18.5-29.9
* normal sleep-wake regimen
* living close to the laboratory (\<7' by walk)
* "good"cubital veins

Exclusion Criteria:

* difficulty to contact
* travel over several time zones during last month
* medications known to interfere with hormone release
Inter Individual Variation in Weight Loss Response to Exercise

The identification and characterization of individuals who vary in their response to exercise-induced weight loss is important. Weight loss in response to exercise is variable and it remains unknown who will succeed, why, and more importantly how to improve weight loss efficacy.

This study will examine changes in behavioural, metabolic, physiological and biochemical variables in response to a 12 week supervised exercise programme and evaluate their association with weight loss in overweight and obese sedentary individuals.

Our hypothesis is that changes in the plasma levels of appetite related hormones undermine the inter individual variation in weight loss in response to exercise.

This study will improve the understanding of variability to exercise-induced weight loss and allow more individually tailored and appropriate strategies for weight management programmes.

Purpose - To identify predictors of weight loss in overweigh/obese volunteers following a 12 week supervised exercise programme, and to characterise the variability in weight loss response.

Method - Longitudinal study aiming to identify predictors of weight loss in response to a 12-week exercise programme in healthy overweight/obese volunteers.

Subjective and objective measures of appetite, cardiovascular fitness, anthropometry, body composition, resting metabolic rate (RMR), fat and carbohydrate oxidation in the fasting state will be measured at baseline, before participants enroll for the study and after the exercise intervention.

The preload/test-meal paradigm (using a high and low-energy preload: HEP vs LEP) will be used to assess short-term appetite control before and after the exercise intervention following a randomized single-blinded crossover design. Moreover, the long-term effects of exercise on cytokine plasma levels and fasting and postprandial levels of appetite related hormones/metabolites will also be assessed at baseline and end of the study. Participants will act as their own controls throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* 25\<BMI\<35 Kg/m2
* weight stable on the last three months (\<2kg)
* not currently dieting to lose weight
* with an inactive lifestyle (not engaged in strenuous work or in regular brisk leisure time exercise more than once a week or in light exercise for more than 20 minutes/day in more than 3 times/week)

Exclusion Criteria:

* History of endocrine/cardiovascular/pulmonary/kidney disease, anaemia, gout, depression or other psychological disorders
* Eating disorders
* Drug or alcohol abuse within the last two years
* Current medication known to affect appetite or induce weight loss.
* Those with a planned surgery during the study period or participating in another research study will also not be accepted to take part in this study