cyrilzakka/clinical-trials huggingface dataset:
Robot-assisted Training After Acquired Brain Injury and Disorders of Consciousness

The goal of this randomised cross-over feasibility trial is to investigate two intensive robot-assisted training therapies in the early rehabilitation phase after acquired brain injury and disorders of consciousness. The main questions it aims to answer are:

* Is the protocol feasible concerning inclusion in the study?
* Is the protocol feasible concerning protocol completion? Participants will randomly be assigned to either five days of robot-assisted gait training (GAIT), two days of pause, then five days of robot-assisted step training (STEP) or vice versa.

The investigators will explore and compare safety events, physiological measures and physical activity levels, behavioural measures, and functional disability outcomes. Further, the investigators report intervention and technical parameters in detail.

This is a randomised cross-over feasibility trial, carried out according to the Helsinki Declaration and approved by the scientific ethics committee of the Capital Region, Denmark. Participants are temporarily unable to consent why this obtained from the next of kin.

Participants start the intervention when 10 minutes of standing in a tilt-table does not cause orthostatic hypotension. Participants then recieve five days of intervention, two days pause and then cross over to the other intervention.

Groups:

1. GAIT --\> STEP
2. STEP --\> GAIT

Eligibility Criteria:
INCLUSION CRITERIA

* Admitted for rehabilitation at the Department of Brain and Spinal Cord Injury, Division of Brain Injury, Bodil Eskesen Centre, Rigshospitalet
* Patients 18 years or older
* In the unresponsive wakefulness or minimally conscious state after a moderate to severe acquired brain injury (ICD 10: S06, Intracranial injury; I60-I69, Cerebrovascular diseases)
* Obtained consent from nearest relative and study guardian.

EXCLUSION CRITERIA

* Weight \> 135 kg (maximum weight for the Erigo® tilt table)
* Height \> 200 cm (maximum height for the Lokomat®)
* In the confusional state or emerged to full consciousness
* If weight bearing is restricted due to, e.g., fractures of the spine, pelvis, or lower limbs.
* Known osteoporosis of a severity where use of robotic orthoses, according to a physician, is considered a contraindication
* If lower limb joints are fixated to a degree that cannot be compensated in the orthoses
* No valid consent from the nearest relative or study guardian
Intensive Monitoring of Renal Function

This study aims to examine the association between monitoring (Intensive and non-intensive) of renal function (urine output, serum creatinine) and outcomes among critically ill patients such as Acute Kidney Injury (AKI) and mortality.

Intensive monitoring of renal function provides an early opportunity to modify or attenuate certain risk factors (e.g., nephrotoxin exposure) for AKI. Intensive monitoring of urine output (UO) provides a real-time continuous assessment of renal function in the ICU. However, the association between intensive monitoring and less-intensive monitoring of urine output, with or without close monitoring of serum creatinine (sCr), on susceptibility to AKI and outcomes from AKI are unknown. Our preliminary data indicates that intensive monitoring of UO is associated with lower hospital mortality as compared to less-intensive monitoring for patients that develop AKI. If intensive monitoring of renal function is associated with lower risk of AKI and improved outcomes from AKI, then such monitoring techniques could be widely used in hospitalized patients including non-intensive care settings to either prevent AKI or progression of AKI.

Therefore, this observational retrospective cohort study aims to compare the outcomes of patients undergoing intensive monitoring of renal function (UO and/or sCr) with those of patients undergoing less intensive monitoring. Outcomes will include mortality within 30 days of ICU admission among critically ill patients with and without AKI. Development of severe AKI within 7 days of ICU admission and fluid overload on any ICU day in patients who develop severe AKI (KDIGO stage 3) will also be assessed.

This study will utilize a large, heterogeneous cohort (n=\~54,800) of critically ill patients admitted to the ICU over 8 year period at the University of Pittsburgh Medical Center. The study population will consist of patients who receive intensive monitoring of UO (defined as measured at least every 2 hours within the first 48 hours of ICU admission) and strict creatinine measurement (defined as at least daily). Patients who fail to meet criteria for intensive monitoring will be controls (less-intensive monitoring group). AKI will be diagnosed according to the KDIGO stage 1-3 criteria over a 7-day period. Mortality at 30-days from ICU admission will be ascertained using the social security death master file. In order to account for indication bias, a propensity score for intensive monitoring will be built using various risk factors. Risk and severity of illness-adjusted estimates will be generated for susceptibility to AKI and mortality from AKI between intensive and less-intensive monitoring groups.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patient admitted to ICU
* Required vasopressor support or mechanical ventilation in the 24 hours from ICU admission

Exclusion Criteria:

* History of chronic dialysis and/or renal transplant
* Baseline serum creatinine \>= 4 mg/dl
* Insufficient data to determine AKI stage in the 7 days from ICU admission
* Died within 48 hours from ICU admission
* ICU duration \<2880 minutes
Insertion Depth of Left-sided Double-lumen Tube: a New Predictive Formula

The authors developed a formula for predicting the accurate depth of DLT insertion into the appropriate bronchus based on height as follows \[The predicted insertion depth of left DLT (cm) equals 0.249 × (BH)0.916\] \[R\]. That pilot study showed comparable correlations between five formulae \[Brodsky et al, Bahk and Oh R, Takita et al, Chow et al, Lin\]. However, that formula developed has not been validated yet.

We hypothesized that previously published formula would predict the accurate depth of left-sided DLT insertion. We aimed to investigate the efficacy of this formula to estimate the optimum insertion depth of the DLT using a flexible bronchoscope and decrease the incidence of DLT displacement into the appropriate bronchus, the need for bronchoscopic adjustment, and complications including soreness of throat and mucosal injury.

Accurate placement of the double-lumen tube \[DLT\], the commonly used tool to provide one-lung ventilation during thoracic surgery, is a real challenge for the thoracic anesthesiologists. Optimal DLT depth, defined as the blue endobronchial cuff below the carina, would decrease the incidence of obstructing the trachea and the contralateral bronchus (Brodsky). Additionally, deep insertion of the bronchial cuff of the DLT would obstruct the upper lobe bronchus (Brodsky). The careful adjustment of the depth and optimal positioning of the DLT using a flexible fiberoptic bronchoscope need a skilled anesthesiologist to reduce the time to DLT intubation. (Charles D. Boucek et al)

There are several methods have been described to predict the proper depth of DLT insertion. Chow et al. documented the validity of the developed formula based on the clavicular-to-carinal distance of trachea and height in 78% of patients studied. Brodsky et al. demonstrated that a height-and-gender-based formula could predict the depth of DLT insertion. Liu et al. reported an accurate depth of DLT insertion in 90% of patients studied measuring the distance between the vocal cord and carina according to the chest CT.

Eligibility Criteria:
Inclusion Criteria:

* Underwent thoracic surgery
* Using a left-sided double-lumen tube for one-lung ventilation

Exclusion Criteria:

* Anticipated or known difficult airway
* Refuse to sign the consent
* Withdraw the consent
Does rTMS Induce Synaptic Plasticity?

The purpose of this study is to utilize the radioactive positron emission tomography (PET) tracer \[11C\]UCB-J to investigate the effect of repetitive transcranial magnetic stimulation (rTMS) on synaptic plasticity. UCB-J has been validated as a marker for synaptic density. We will use this tracer to examine if rTMS leads to changes in synaptic plasticity, specifically changes in synaptic density, in individuals receiving rTMS for MDD. If rTMS is proven effective for increasing synaptic plasticity, there is a significant potential of a new applicable treatment for a variety of diseases that affect brain physiology.

The objective of this project is to discover the neural mechanisms by which Major Depressive Disorder (MDD) is treated, so that we may gain insights into its pathophysiology, as well as to develop new biomarkers. We will utilize the PET tracer \[11C\]UCB-J, the first in human tracer of neural synapses, to test the hypothesis that the successful treatment of MDD with repetitive Transcranial Magnetic Stimulation (rTMS) is associated with increased synaptic density. We will use this tracer to measure synaptic density before and after rTMS treatment and compare change in synaptic density between subjects who respond to the rTMS treatment and those who do not respond to treatment.

The finding of a marked increase in synaptic density in participants who respond to rTMS treatment would point to the possibility of developing new treatments with the potential to modify disease through mitigating, preventing or remediating synaptic loss.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years in age
* U.S. Veteran
* Diagnosis of MDD
* On a stable medication regimen for at least two weeks prior to testing
* Stable social environment and housing to enable regular attendance at clinic visits
* Ability to undergo cognitive testing, clinical assessments, and PET/MR scans
* Stable medical health
* Will undergo rTMS treatment for MDD at the VA Palo Alto
* Able to complete a PET-MR scan without the use of sedation

Exclusion Criteria:

* Active substance use within three months of testing
* IQ \< 70
* Major medical neurological illness or significant head trauma
* Pregnancy or breastfeeding
* Contraindication to MR scanning, including magnetic-resonance incompatible metal or hardware including pacemakers, cochlear implants, and bullets near a critical organ
* Weight \> 350 lbs or a large body habitus that MR scanner cannot accommodate
* History of or current claustrophobia
* Inability to comply with basic study requirements such as following directions and punctuality
* Acute or unstable chronic medical illness that would affect participation or compliance with study procedures, e.g. unstable angina
* Unstable psychiatric symptoms that precludes consistent participation in the study, e.g. active current suicidal intent or plan, severe psychosis
* Inability to undergo PET/MR scan, e.g. claustrophobia, presence of ferromagnetic objects in subject's body
Clinical Performance of Thermoviscous Bulk Fill Resin Composites in Comparison to Conventional Packable Bulk Fills

This clinical trial will be conducted to compare the clinical performance of the thermo-viscous preheated bulk fill composite in the management of carious lesions in posterior teeth in adult patients over 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Have at least two molars supported permanent dentition free of any clinically significant occlusal interference and require posterior restoration and fulfilled the inclusion criteria, patients will be informed about the study and will be given an informed consent.

  * The two studied materials restorations should be used in approximately the same sized lesions or within the same extensions.
  * The patient will be reimbursed for attending for the clinical evaluation(s) of their restorations.
  * Be a regular dental attender who agree to return for assessments.

Exclusion Criteria:

* There is history of any adverse reaction to clinical materials of the type to be used in the study.
* There was evidence of occlusal parafunction and/or pathological tooth wear.
* Patients whose history revealed parafunctional habits or use of medications that potentially could cause hyposalivation.
A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients

The study is intended to test the safety, tolerability, and efficacy of long-term treatment with YM178 in patients with overactive bladder symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Subject has symptoms of overactive bladder for \>= 24 wks
* Subject experiences frequency of micturition at average \>= 8 times per 24 hrs confirmed by the 3-day patient diary

Exclusion Criteria:

* Subject is breastfeeding, pregnant, or intends to become pregnant during the study
* Subject obviously has stress incontinence
* Subject has an indwelling catheter or practices intermittent self catheterization
* Subject has evidence of symptomatic urinary tract infection, interstitial cystitis, bladder stone, etc
* Subject has an average total daily urine volume \> 3000 mL confirmed by patient diary
* Subject has uncontrollable hypertension (SBP \>= 180 mmHg or DBP \>= 110 mmHg)
Local Registration Trial in China Humalog Mix 50

The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in insulin-requiring diabetic patients treated twice daily with human insulin mix 50/50, versus the 2-hour PPBG excursion in patients treated twice daily with insulin lispro mix 50/50.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women who have had either type 1 or type 2 diabetes (World Health Organization\[WHO\]classification)for at least 2 months and are between the ages of 18 and 70 (inclusive) at the signing of the informed consent.
2. Have been treated with commercially available human insulin mix 50/50 or human insulin mix 30/70 twice daily as the only pharmacological treatment for their diabetes for at least 2 months prior to entering the study.
3. Have an HbA1c between 1.1 and 1.7 times the upper limit of the normal reference rang(inclusive) as determined by a local laboratory within 2 weeks prior to or at Visit 1.
4. Have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring.
5. Have given informed consent to participate in this study in accordance with local regulations.

Exclusion Criteria:

{1\] Have used oral antidiabetic agents, including biguanides, sulfonylureas, glucosidase inhibitors, and insulin-sensitivity enhancers within 30 days prior to entry into the study.

\[2\] Receive a total daily dose of insulin \>2 units/kg.

\[3\] Have had more than two episodes of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entry into the study.

\[4\] Have a body mass index \>35 kg/m2.

\[5\] Have serum creatinine \> the upper limit of normal (ULN), as determined by a local laboratory.
A Study of rTMS for Cognitive Deficits in Chronic Patients With Schizophrenia

In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.

This is a randomized, sham-controlled, double-blinded trial. 47 patients diagnosed with schizophrenia on stable antipsychotic treatment were randomly assigned to active rTMS treatment group (n=25) or a sham rTMS treatment group (n=22). 25 patients in the active rTMS group received 10 Hz 110% rTMS, while 22 patients were subjected to sham rTMS, both being given 4-week treatment (5 days per week). Efficacy of negative symptom was assessed with the Scale for the Assessment of Negative Symptoms (SANS), the Positive and Negative symptom scale (PANSS) at baseline, the end of 4 weeks and 8 weeks. The cognitive function was assessed with CANTAB at baseline, the end of 4 weeks and 8 weeks .The side effects were assessed with Treatment Emergent Symptoms Scale at baseline and the end of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Right-handed;
2. meeting the diagnosis of schizophrenia for at least 2 years;
3. had been on anti-psychotic medications for more than 12 weeks;
4. with unresolved negative symptoms (SANS\>20).

Exclusion Criteria:

1. with substance use disorders ;
2. with cerebral pathologies (e.g. seizure, aneurysm, stroke), intra-cranial metals, pacemakers, severe cardiovascular diseases;
3. receiving electroconvulsive therapy in the past 3 months.
ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling

The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in hypertensive patients.

Blood pressure was measured 10 weeks after starting treatment (visit 3). All patients who did not achieve the required blood pressure (\<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication were given 5 mg of amlodipine in addition to the study medication in order to reach the required BP (\<140/90 mmHg).

The patient's blood pressure was assessed at visit 4 (week 18) and if it was still not at the required level (\<140/90 mmHg), the dose of amlodipine was increased to 10 mg.

Blood pressure was again assessed at visit 5 (week 26) and if the required values had not been reached (\<140/90 mmHg), a 12.5 mg dose of hydrochlorothiazide (HCTZ) was prescribed

Eligibility Criteria:
Inclusion Criteria:

* Patient with hypertension
* Confirmed concentric left ventricular hypertrophy:
* LVMI \> 49.2 g/m2.7 for men and \>46.7 g/m2.7 for women
* Relative wall thickness \> 0.42

Exclusion Criteria:

* Sever or secondary HTN
* LV ejection fraction of \<40%
* Patient with compelling indication to ACEIs or ARBs or BB
* History of myocardial infarction, coronary artery bypass surgery, PTC intervention, TIA or stroke within 6 months of study entry
* History of collagenopathies, osteopathy
* eGFR \<30 ml/min/1,73 m2, serum potassium ≥5,2 mEq/L
* Morbid obesity (BMI ≥ 42 kg/m2
* Other protocol-defined inclusion/exclusion criteria may apply
Acute Comfort of Lubricant Eye Drop FID 111421

To evaluate the acute comfort and blurring profile between two artificial tears products in dry eye patients


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of dry eye
* Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria:

* Age related
Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder

This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.

This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition

Eligibility Criteria:
Inclusion Criteria:

* 3 years to \< 17 years
* Neurogenic bladder
* Neurological condition
* CIC

Exclusion Criteria:

* Have anatomical bladder abnormalities
* Sensitivity to anticholinergics
* Bladder augmentation
Social Network Based Intervention to Reduce Lead Exposure Among Native American Children

The purpose of this study is to examine whether adding an inter-generational component to an existing social network-based lay health advisor intervention increases its effectiveness in mobilizing a Native American community to respond to heavy metal contamination from lead and zinc mining.

Ottawa County, Oklahoma, the site of the research, was heavily mined for zinc and lead in the first half of this century. Mine tailings containing heavy metals are stored in large piles up to 200 feet in height. Ottawa County is home to 8 Indian tribes and much of the mine waste is on tribal land. Specifically, the study will: a) integrate existing Native American youth programs with the existing lay health advisor intervention (Society of Clan Mothers and Fathers) to form an inter-generational intervention, b) expand the existing lay health advisor intervention to address cadmium in addition to lead, c) use participatory research methods to involve tribal youth and adults in an air monitoring study, d) assess the extent to which the intervention contributes to belief, attitude and behavior changes that will reduce heavy metal exposure and absorption in Native American children; and e) assess the contribution of the intervention to creating changes in organizational, community, tribal and government (city, county, state, federal) capacity to address heavy metal contamination in Ottawa County, Oklahoma.

Eligibility Criteria:
Children ages 1-6

Live in Ottawa County, Oklahoma