cyrilzakka/clinical-trials huggingface dataset:
Ultra-protective Pulmonary Ventilation Supported by Low Flow ECCO2R for Severe ARDS

This study evaluates the use of ultra-protective ventilation, where very low ventilation volumes are used, in patients with severe acute respiratory distress syndrome (ARDS) meeting criteria to nurse in the prone position. Half the patients will receive ultra-protective ventilation support by extracorporeal carbon dioxide removal, while the other half will receive conventional lung protective ventilation.

Current best practices for management of severe ARDS include lung protective ventilation and nursing in the prone position. However, the best lung protective strategy is not currently established and using smaller ventilation volumes than standard lung protective ventilation suggest lung recovery is improved.

Application of smaller ventilation volumes requires extracorporeal carbon dioxide removal, using a device similar to a dialysis to remove carbon dioxide directly from the blood. One such device in the Prismalung, it removes blood through a catheter, much like a dialysis catheter, pumps it through a gas exchange cartridge which removes carbon dioxide. The gas exchange cartridge functions in a similar way to a dialysis filter, except it allow gases to pass through, unlike dialysis filters which allow passage of fluid and small molecules.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to MICU with respiratory failure and intubated
* ARDS criteria per Berlin definition
* PaO2:FiO2 ratio ≤ 200 mmHg for \> 6 hours with FiO2 ≥0.5
* Expected to require mechanical ventilation for \>48 hours
* Reversible disease

Exclusion Criteria:

* Anticoagulation contraindicated
* Proven HIT
* Unable to obtain central venous access
* Refractory hypoxia (PaO2:FiO2 ≤80 after recruitment and proning) or other indication for ECMO
* Home oxygen use
* Severe COPD
* Interstitial lung disease
* \> 7 days of mechanical ventilation
* Immunocompromised patient (bone marrow, untreated HIV, PJP)
* Advanced malignancy with life expectancy ≤ 6months
Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension

This application proposes to extend an ongoing NHLBI clinical trial (NCT02342808) examining the efficacy of a lifestyle intervention combining the Dietary Approaches to Stop Hypertension (DASH) diet with caloric restriction and aerobic exercise to lower and control BP in individuals with RH. In the parent trial, participants with RH will be randomized to either: (1) a 4-month adjunctive lifestyle intervention designed to lower BP through exercise and diet (C-LIFE), or; (2) a standardized education and physician advice (SEPA) control condition.

The current protocol will collect additional assessments of neurocognition (executive function, processing speed, and memory), endothelial function (brachial artery flow-mediated dilation), and cerebrovascular reserve (a measure of prefrontal cortex tissue oxygenation) in 120 participants at baseline, following completion of the 4-month intervention, and again after one year, in order to examine neurocognitive improvements and their potential mediators.


Eligibility Criteria:
Inclusion Criteria:

* Documented resistant hypertension (RH). In the absence of a specific RH diagnosis, individuals being treated for two or more weeks with 3 antihypertensive medications of different classes, including a diuretic if tolerated, with clinic SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg, will be eligible. Individuals being treated with 4 or more antihypertensive medications, including a diuretic if tolerated, with SBP ≥ 120 or DBP ≥ 80 mm Hg will also be eligible.
* Adherent to prescribed medications
* Overweight (BMI ≥ 25 kg/m2)
* Sedentary
* Willing to be randomized to one of the 2 treatment groups and able to fully participate in intervention
* Informed consent

Exclusion Criteria:

* Secondary HTN, non-adherence to anti-HTN medications
* Severe CKD (eGFR \<40 ml/min/1.73m2)
* Severe ischemic heart disease (CCS Class 3 or 4 angina or evidence of ischemia at \<85% heart rate reserve on treadmill testing)
* Severe heart failure (NYHA association Class 3 or 4), high grade arrhythmias, severe valvular heart disease
* Severe asthma or chronic obstructive lung disease
* Diabetes requiring insulin
* Musculoskeletal or neurologic problems that would preclude participation in aerobic exercise training
* Major psychiatric disorder, a history of drug abuse, alcohol consumption \>14 drinks/week
* Life-limiting comorbid medical condition such as cancer
* Prior gastric bypass surgery
* Currently pregnant
* Cognitively impaired
PNF vs Pertubation Based Balance Training in Subacute Stroke Patients.

To determine the effects of proprioceptive neuromuscular facilitation exercises versus perturbation-based balance training on balance, coordination, and proprioception in subacute stroke patients, it will be a randomized clinical trial.

Stroke is the major cause of disability and mortality worldwide. Stroke is defined as an abrupt neurological outburst caused by impaired perfusion through the blood vessels to the brain. Every year the number of strokes affected individuals are rising thereby putting an extra pressure on socioeconomic conditions in developing countries. Major complications of stroke include hemiplegia leading to upper limb dysfunction along with gait abnormalities. This study will be conducted to determine the effects of proprioceptive neuromuscular facilitation exercises versus perturbation-based balance training on balance, coordination, and proprioception in subacute stroke patients. The randomized clinical trial will be conducted, participants will be selected through Non probability convenience sampling technique and then randomly allocated into three treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Age:40-70 years.
* Gender: Male and female
* The Subacute stroke patients, at least 3 months post stroke.
* Patients able to stand without support from upper limb.
* Patients able to perform 10 meter walk test.

Exclusion Criteria:

* Neurological conditions other than stroke like Guillain barre syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy, Parkinson's disease, Transverse Myelitis etc.
* Patients with not intact higher mental function and cognition.
* Patients with grade 3 arthritis and traumatic injuries like spinal cord injuries and TBIs
* Other chronic disabling pathologies, orthopedic injuries that could impair locomotion
Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven.
2. Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy.
3. AUA/IPSS score is ≤ 15.
4. ECOG performance status is ≤2 (or Karnofsky score is ≥60%).
5. Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion).
6. Patient has the ability to complete required patient questionnaires.
7. Patient age ≥ 18 years (or greater than the local age of majority).
8. Patient has the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patient has baseline grade ≥3 GI or GU toxicity
2. Patient has had prior overlapping pelvic radiotherapy.
3. Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation.
4. Patient has node positive prostate cancer.
5. Patient has extracapsular extension (capsular abutment is permitted).
6. Patient has active inflammatory bowel disease or active collagen vascular disease.
7. Patient cannot undergo prostate MRI.
8. Patient cannot undergo prostate fiducial marker placement.
9. Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).
ALS Treatment Extension Study

Treatment extension study for ALS/MND patients who participated in phase 1 study CMD-2016-001, completed assessments following six 28-day cycles of treatment, and whom the Investigator considers would benefit from continued CuATSM treatment.

Treatment extension study for ALS/MND patients who participated in phase 1 study CMD-2016-001, completed assessments following six 28-day cycles of treatment, and whom the Investigator considers would benefit from continued CuATSM treatment. The same safety assessments as in the CMD-2016-001 study will be conducted after each cycle of treatment and the same efficacy assessments as in the CMD-2016-001 study will be conducted after every 3 cycles of treatment. Treatment will continue until the first to occur of (1) Investigator considers the patient is no longer deriving benefit from CuATSM treatment, (2) patient develops dependence on mechanical ventilation where dependence is defined as being unable to lie flat (supine) without it, unable to sleep without it, or daytime use, or (3) the patient withdraws consent.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to initiation of any study-specific procedures and treatment
* Documented completion of protocol-specific assessments following completion of six 28-day treatment cycles in study CMD-2016-001
* Principal Investigator considers the patient would benefit from continued treatment with Cu(II)ATSM
* Not taking riluzole or on the same (or lower) dose used during the CMD-2016-001 study
* Adequate bone marrow reserve, renal and liver function
* Women and men with partners of childbearing potential must take effective contraception while on study treatment

Exclusion Criteria:

* Inability to swallow oral medications or presence of a gastrointestinal disorder (e.g.,malabsorption) deemed to jeopardize intestinal absorption of study drug
* Dependence on mechanical ventilation (invasive or non-invasive) for any part of day or night, where dependence is defined as being unable to lie flat (supine) without it, unable to sleep without it, or daytime use
* Dementia that may affect either outcome measures or patient understanding and/or compliance with study requirements and procedures
* Current use of strong inducers or inhibitors of CYPs 2C19 and 2D6
Ultrasonographic Evaluation of Diabetic Neuropathy

The current study aimed to evaluate the cross-sectional area (CSA) of peripheral nerves in people with diabetic peripheral neuropathy using ultrasonography and correlate the CSA with clinical and demographic data.

Patients with diabetic peripheral neuropathy (n=53) and a matched healthy control group (n=53) underwent blinded ultrasonography imaging of the sciatic, tibial and median nerves. Matching was performed according to patient body mass index (BMI), sex and age. CSAs of the nerves were recorded, and the associations between pain intensity (measured with a visual analog scale \[VAS\]), the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale, diabetes mellitus duration, BMI, HbA1c and blood glucose levels were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scores ≥ 12
* probable diabetic peripheral neuropathy according to the diabetic peripheral neuropathy criteria.

Exclusion Criteria

* type 1 diabetes mellitus
* hypothyroidism
* LANSS pain scale scores \< 12
* body mass index (BMI) \> 35
* current pregnancy
* histories of hereditary neuropathy, inflammatory neuropathy, nerve trauma, or other known causes of polyneuropathy; and the use of anti-neuropathic drugs.
Dexmedetomidine vs. Remifentanil Undergoing Cataract Surgery in Geriatrics

Dexmedetomidine is an α2-adrenergic receptor agonist used for its sympatholytic effect, providing sedation, analgesia, and cardiovascular stabilization in the perioperative period. Remifentanil is a µ opioid agonist with a rapid onset and short duration of action, which is degraded by plasma esterase in tissues. Investigators aimed to compare the effects of dexmedetomidine and remifentanil infusions on sedation quality, side effects, and surgeon's satisfaction in geriatric outpatients who underwent cataract surgery.

Dexmedetomidine is an α2 agonist and remifentanil is a short-acting μ, opioid agonist. The aim of this study was to compare dexmedetomidine and remifentanil infusions used for conscious sedation in geriatric patients undergoing outpatient cataract surgery in terms of sedation quality, hemodynamic stability, and surgeon satisfaction.

Eighty patients were divided into two groups according to the administration of dexmedetomidine (Group D) and remifentanil (Group R) infusion in this randomized, prospective, double-blinded study. In group D (n = 40), after a loading of 1 µg/kg dexmedetomidine in 10 minutes, 0.4 µg/kg/h-1 infusion was administered. In Group R (n = 40), remifentanil at a dose of 0.05 µg/kg-1 was administered for 10 minutes, and then 0.05 µg/kg/min-1 infusion was continued.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 65-80,
* Who will undergo cataract surgery,
* With the American Society of Anesthesiologists (ASA) score I-III.

Exclusion Criteria:

* Second or third-degree heart block,
* Chronic α2-agonist use,
* Inability to communicate with the patient,
* Uncontrolled systemic disease,
* Allergy to local anesthetics,
* Chronic analgesic or sedative drug use,
* History of alcohol or substance addiction.
The Effect of Acupressure in Non-breastfeeding Mothers After Preterm Cesarean Delivery

The effect of acupressure in non-breastfeeding mothers after preterm cesarean delivery

One of the frequently encountered problems in breastfeeding is insufficient lactation. Numerous integrative treatments support to overcome this problem.

This randomized controlled experimental study will conduct to determine the effect of acupressure on lactation in non-breastfeeding mothers following preterm caesarean delivery.

The sample of the study will comprise of 64 mothers (32 acupressure-experimental and 32 control group), who will randomly select from among the primipara mothers of premature newborns delivered through cesarean section at Dursun Odabaş Medical Center of Van Yüzüncü Yıl University. Before the implementation, the Depression-Anxiety-Stress Scale and the Richard Campbell Sleep Quality Scale will apply. In post-operative three days, 15-minute acupressure will implement in the morning/evening, for acupressure-group mothers and pump milking will apply; control group mothers will only milked in mornings and evenings. Lactation symptoms will evaluate with Visual Analog Scale and acupressure satisfaction with Analog Patient Satisfaction Scale, and milk quantities will record.

Eligibility Criteria:
Inclusion Criteria:

* Mothers between the ages of 19-35,

  * Mothers who gave birth by cesarean operation,
  * Mothers who gave birth before 37th week of pregnancy,
  * Primiparous mothers,
  * Mothers whose baby is lying in NICU,
  * Mothers who do not have any chronic diseases,
  * Mothers who do not use breast milk enhancing drugs, vitamins and supplements,
  * Mothers who do not have any anotomic disorder in the breast,
  * Mothers who cannot breastfeed,
  * Mothers who do not have any injured skin, fracture, swelling or muscle pain, especially in the little finger.
  * Mothers without literacy problems, mental disabilities and communication problems,
  * Mothers living within the borders of the province of Van,
  * Mothers who agree to participate in the study.

Exclusion Criteria:

* Mothers of premature newborns who cannot be fed breast milk,

  * Mothers who are multiparous,
  * Mothers with chronic disease,
  * Mothers who have a condition preventing milking,
  * Mothers whose language is insufficient in understanding and speaking Turkish,
  * Mothers who have breast abscess problems,
  * Mothers who have babies with congenital anomalies,
  * They are mothers who do not volunteer to participate in the study
Metabolic Effects of Differential Organ Growth Rates

Young children have a high resting energy expenditure (REE) relative to their body weight and metabolically active compartment, fat-free mass (FFM). Both body weight and FFM are, however, metabolically heterogeneous and include organs and tissues varying widely in specific metabolic rate (i.e., organ REE/kg/d). One prevailing hypothesis is that most, if not all, of the higher REE observed in young animals and children compared to adults can be accounted for by a larger proportion of high metabolic rate components such as brain, liver, and heart..

FFM was the traditional and only means of adjusting REE for between-individual differences in metabolically active tissue components. The investigators seek to improve the understanding of variation in REE by developing new and improved rapid magnetic resonance imaging (MRI) methods of quantifying some of the major heat producing organs and tissues in children and adults. The long-term aim is to provide an improved understanding of human energy requirements. Specifically, the investigators propose to test whether: 1) a portion of the elevated daily REE adjusted for FFM observed in young children (Tanner Stage 1) could be accounted for by the relative fractions of body mass as high metabolic activity tissues (heart, liver, kidney, brain) and low metabolic activity tissues (skeletal muscle, adipose tissue), 2) a portion of the age-related decline in daily REE adjusted for FFM observed in children could be accounted for by changes in the relative fractions of body mass as high and low metabolic rate tissues during growth.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Aged from 7-11 years
* Pre-pubertal (based on Tanner staging)
* Africa-American, Asian, and Caucasian (by self-report of all 4 grandparents of same race group)

Exclusion Criteria:

* Actively involved in a weight management program
* Have co-morbidities of obesity (Blounts disease, hypertension, diabetes; sleep apnea)
* Have entered puberty
* Precocious puberty
* Have known metabolic abnormalities
* Were born prematurely, or were small or large for gestational age
* Lean individuals who have a family history (parents or siblings) of obesity or Type 2 diabetes
* Current or previous significant use of any medication known to affect any of the variables being measured
Adhese One F Upgrade in Direct Filling Therapy

Investigation on the clinical performance of a new dental adhesive when used in direct filling therapy after phosphoric acid etching.

Hypothesis: The new adhesive shows an acceptable clinical performance and allows a good filling quality.


Eligibility Criteria:
Inclusion Criteria:

* indication for class I or II filling
* max. 2 restorations per patient
* vital teeth
* sufficient language skills

Exclusion Criteria:

* dry working field cannot be established
* if the patient is known to be allergic to any of the materials' ingredients
* severe systemic diseases
* pregnancy
* non-vital or pulpitic teeth
* indication for indirect restoration
Head Mounted Eye Tracking Aide for Loss of Central Vision (HETALCEV)

A device has been developed that has eye trackers integrated within the Head Mounted Display (HMD) and can remap text and images around the scotoma in real time to prevent information loss from a central scotoma. It can also carry out other types of image processing such as contrast enhancement and image magnification. The aim of this study is to assess the efficacy of this device on the visual performance of participants suffering from central vision loss, with and without remapping

Participants with bilateral central scotomas will be selected for this study during their routine clinical visits at the University of Minnesota Eye Clinic. Written consent will be obtained from all participants.

Each participant will have their scotomas mapped using a Nidek MP-1 microperimeter housed in the psychology department to give exact size and shape information. This allows for the extent of each eye's scotoma to be put into the remapping software, and their intersection used in remapping calculation. Comparisons will be made between participants with small scotoma, less than 5 degrees, and participants with large scotoma, larger than 5 degrees. Experiments to be performed with the device are also divided into two categories. Category 1 involves reading of naturalistic text, and everyday task performance. Category 2 involves studying the effects of practice with the device on performance in category 1 experiments.

Participants will schedule an initial one-hour session for testing. During testing, participants will be told about the device and its functionality. Main instructions include what patients can expect to experience and see when wearing the HMD. Following this, the participants will be instructed on how to wear the HMD. If they have any glasses/ corrective lenses, they can be kept on. Once the patients don the HMD, testing will begin.

Initially, a calibration-free mode will be tested. This will entail asking the subject to focus on a particular point on the screen and checking if the gaze point determined by the eye tracker corresponds to this point. If good calibration is obtained, the investigators proceed with testing. Otherwise, a 3-point calibration sequence will be initiated following instructions on the software program. For the 3-point calibration sequence, the participant will be instructed to fixate at 3-5 different points on the screen one at a time. Following this calibration sequence, testing will resume and visual performance such as reading speed in words/minute will be measured as the primary outcome measure, with and without remapping.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Central vision loss from bilateral central scotomas
* No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE)

Exclusion Criteria:

* Failed MMSE
Accuracy of Commercially Available Heart Rate Monitors II

In 2015, over 85 million fitness wearables were sold worldwide and the market is projected to expand to 110 million units sold in 2017. Of all wearable technology, fitness devices that track heart rate are predicted to be the most popular. At the elite level, commercial heart rate monitors are being used by athletes like LeBron James, Blake Griffin, and Matthew Dellavedova to monitor and alter their behaviors for peak athletic performance. Millions of ordinary consumers purchase fitness trackers that include heart rate monitors in order to help them to maintain their health and wellness. As popularity of these fitness devices grows, assessment of the accuracy of heart rate measurements becomes increasingly important.

In a previous trial, investigators compared the accuracy of four devices (Apple Watch, Fitbit Charge HR, Mio Fuse, Basis Peak) worn by subjects while performing a graded exercise program on a treadmill. Investigators discovered that the Apple Watch and Mio Fuse had a correlation coefficient (rc) of .91, Fitbit Charge HR had an rc of .84, and Basis Peak had an rc of .83. That study has been submitted for publication.

Reviewers of the first study raised an important question: how do commercial optical heart rate monitors perform when measuring heart rate during other popular forms of exercise? This study addresses that question.

Objective:

The objective of this study is to evaluate the accuracy of four heart rate monitors when used during three different exercises: treadmill, stationary bicycle, elliptical trainer.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Able and willing to exercise for a total of fifteen minutes

Exclusion Criteria:

* Health issues that preclude or contraindicate walking and/or jogging, including cardiovascular, orthopedic, pulmonary and other conditions
* Presence of a cardiac pacemaker
* Known cardiovascular disease
* Known heart rhythm disorders
* Use of Beta-blockers or antiarrhythmic medications
* Tattoos around the wrist or forearm area