cyrilzakka/clinical-trials huggingface dataset:
Comparison of Volume Controlled Ventilation With 1:1 Inspiratory to Expiratory Ratio and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum

The purpose of this study is to compare the 1: 1 I: E ratio VCV and the autoflow VCV in patients undergoing robot assisted laparoscopic prostatectomy


Eligibility Criteria:
Inclusion Criteria:

1. adult (20-80 years old)
2. patients undergoing robot assisted laparoscopic prostatectomy

Exclusion Criteria:

1. history of COPD
2. decreased heart function (EF \<50%)
3. BMI\>30
4. patients who cannot read the consent form (e.g., blind, foreigner)
Dynamic Aspects of Amino Acid Metabolism

This protocol seeks to define aspects of intestinal and hepatic uptake and metabolism of several amino acids. The major hypothesis to be tested is that the splanchic bed (intestine and liver) conserves essential amino acids and metabolites while synthesizing and metabolizing nonessential amino acids. The aims of the study include defining the relative roles of enteral and hepatic extraction/metabolism in the disposition of glutamate, alanine, methionine and other amino acids. Emphasis will also be placed on studies of the transamination of alpha-ketoisocaproic acid (KIC) to leucine since this reaction is of potential importance in the design of nutritional regimens for patients with renal disease.


Eligibility Criteria:
Inclusion Criteria:

* normal weight-for-height weight 50-80 kg
* normal physical activity
* no significant medical history
* healthy by medical exam and lab blood testing

Exclusion Criteria:

* subjects who exercise vigorously
* subjects who smoke
Cerebral Oximeter Comparison Study

In this prospective study to try to standardize the care for patients, the investigators are planning to compare two cerebral oximeters currently in use at NCH in terms of their accuracy in determining the cerebral oxygen saturation as determined by jugular bulb oxygen saturation. Also, the investigators will compare these devices in terms of their response to changes in hemodynamics that occur during cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery

Exclusion Criteria:

* None
Energy Turnover in Patients With Anorexia Nervosa

Pilot study to assess energy turnover at end of inpatient treatment in 10 patients with Anorexia nervosa.


Eligibility Criteria:
Inclusion Criteria:

* Anorexia nervosa
* anabolic metabolism
* high compliance
* end of inpatient treatment

Exclusion Criteria:

* any further disease than eating disorder
* smokers
Inflammation and Daily Life Study

UCLA researchers looking for healthy individuals (age 45-60) to participate in a study investigating whether an anti-inflammatory medication can impact daily life experiences.

Everyday for two weeks, participants will take either an anti-inflammatory medication (naproxen) twice daily, or a placebo pill twice daily. Participants will also answer daily questions during the 2-week period. Participants will also fill out questionnaires and complete a few tasks on the computer: once prior to the 2-week period and once immediately after the 2-week period, both during online study sessions.

Participants (ntotal=50) will be men and women, ages 45-60. All interested participants will first complete a structured telephone interview in order to assess eligibility.

The study will begin with filling out questionnaires, as well as an online session to complete some tasks. You will then be randomly assigned to take either an anti-inflammatory medication (naproxen) or placebo (inactive substance) to take twice daily everyday for the following two weeks. You will also be contacted by text message to remind you to take your pills, to ask if you have taken your pills, and to send you a link to fill out questionnaires once daily. After the two weeks are over, you will again complete questionnaires and the online study session with tasks. Finally, two weeks after the second session, you will receive an email to fill out questionnaires online.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults 45-60

Exclusion Criteria: Following a structured telephone interview, participants with the following conditions will not be able to participate:

* certain active, uncontrolled medical disorders
* use of certain medications (e.g., hypnotic and psychotropic medication, steroid use, opioid use)
* psychiatric disorders (e.g., current major depression, bipolar disorder)

Other exclusion criteria may apply.
Effect of Smartphone Addiction on Pregnancy

This study will investigate the effect of smartphone addiction on neck disability during pregnancy and its mediating role on stress. The study will be conducted between September 2023 and April 2024. Data will be collected using the information form, Smartphone Addiction Scale-Short Version (SAS-SV), Perceived Stress Scale (PSS-10) and Neck Disability Index (NDI). Multiple regression and structural equation modeling will be used in the analysis of the data.

Objective: After reviewing the relevant studies, we thought that smartphone addiction may negatively affect neck injury and perceived stress may play a mediating role in this relationship. In this context, our research questions are as follows:

* Do smartphone addiction and certain characteristics significantly predict stress in pregnant women?
* Do smartphone addiction and certain characteristics significantly predict neck injury in pregnant women?
* Does stress have a mediating effect on the relationship between smartphone addiction and neck injury in pregnant women? The research is a cross-sectional, analytical and screening study. The research will be conducted face-to-face with pregnant participants who apply to the pregnancy follow-up clinic of a public hospital and meet the research criteria and voluntarily participate in the research. Verbal and written consent will be obtained from all participants before data collection. The principles of the Declaration of Helsinki will be followed throughout the study. Data of the study will be collected using the Information Form, Smartphone Addiction Scale-Short Version (SAS-SV), Perceived Stress Scale-10 (PSS-10) and Neck Disability Index (NDI). Statistical analyses will be given as mean, standard deviation, median, minimum and maximum. T-tests will be used to compare categorical variables with scale scores, Pearson correlation to examine the relationship between scales and ANOVA to compare scale scores with three or more groups of categorical variables. Linear regression analysis will be used to examine the effects of SAS-SV scores and sociodemographic characteristics on PSS-10 and NDI. In addition, the mediating effect of PSS-10 on SAS-SV and NDI will be examined using a linear regression model. Analysis results will be considered significant at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18 and 49 years,
* With a gestational age of 20 weeks or more,
* No pregnancy complications,

Exclusion Criteria:

* Those with musculoskeletal system diseases (such as rheumatoid arthritis, ankylosing spondylitis, Scheuermann's disease, Ehlers-Danlos syndrome, spinal surgeries, nerve root compression, spondylolisthesis comorbidities)
* Those with diagnosed mental disorders
Incidence of Esophageal Lichen Planus in Patients With Known Oral Lichen Planus

The lichen planus is a mucocutaneous disease of unknown etiology with an incidence of 1-2%, that affects in 30-70% of cases either the mucosa of the mouth, or partly in combination with infection of the skin, the oral with his known premalignant potential in up to 2-3% predisposed to the development of an oral squamous cell carcinoma.In rare cases, there is also an manifestation of the lining of the esophagus, which can then be associated with symptomatic strictures of the esophagus.

The value of moreover increasingly established endoscopic imaging procedures are investigated as well as data of the natural long-term outcome in esophageal lichen planus infestation especially in view of malignant transformation.

The lichen planus is a mucocutaneous disease of unknown etiology that manifests itself with an incidence of 1-2% in 30-70% of cases either at the mucosa of the mouth, or partly in combination with infection of the skin, the oral with his known premalignant potential in up to 2-3% predisposed to the development of an oral squamous cell carcinoma. In rare cases, there is also an manifestation of the lining of the esophagus, which can then be associated with symptomatic strictures of the esophagus. In addition, four cases have been reported with esophageal squamous cell carcinoma in patients with esophageal lichen planus.

The value of moreover increasingly established use of narrow-band imaging (a process for improving the detection of early cancers in the gastrointestinal tract by creating a maximum contrast between outright and altered mucosa, which could have already shown an improved detection rate of early lesions of the esophagus as well as squamous cell carcinoma), or the chromoendoscopy has means for example Lugol solution in correlation to the histopathologic findings in lichen planus), has not been investigated to date.

Also, data of the natural long-term outcome in esophageal lichen planus infestation especially in view of malignant transformation are currently not available.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Known lichen planus of the oral mucosa

Exclusion Criteria:

* Severe cardiopulmonary disease - ASA (American Society of Anaesthesiology) class \> III
* Antisecretory and nonsteroidal anti-inflammatory medication within the last month
E-Stim and Achilles Tendon Repair Study

Calf muscle atrophy (muscle degeneration) is common following Achilles tendon repair due to the immobilization period necessary to ensure optimal healing.

The purpose of this study is to determine if the use of neuromuscular electrical stimulation (NMES) after Achilles tendon surgery will reduce calf muscle atrophy.

The specific aims of this study are to evaluate the use of electrical stimulation on muscle cross-sectional area and muscle fascicle length following post-operative Achilles tendon surgery.

Patients will be randomly assigned to receive an electrical stimulation unit (Compex®, DJO Global, San Diego, CA). Twenty of these units will be experimental and 20 will be sham.

Eligibility Criteria:
Inclusion Criteria:

* 1. Any patient who is having surgery to treat an acute Achilles tendon rupture or any surgery that involves reflecting or repairing the distal Achilles tendon.

Exclusion Criteria:

1. Body mass index (BMI) greater than or equal to 45
2. Inability to consent to participate in clinical research
3. Any patient younger than 18 years old
4. Any limitations that would interfere with the delivery of electrical stimulation including, but not limited to:

   1. Presence of an insulin pump
   2. Pacemaker, defibrillators or other implanted electrical device
   3. Neurostimulation implants
   4. History of epilepsy/seizure
   5. Current pregnancy. A pregnancy test will be performed for any female prior to surgical intervention per hospital protocol unless she is post-menopausal or has been sterilized.
   6. Active malignancy
   7. Peripheral neuropathy
   8. Diabetes Mellitus
   9. Ischemia of lower limbs
   10. Active infection
   11. Following acute trauma or fracture
Cancer Stem Cell Specific Aptamer's Ability to Detect Blood Circulating Cancer Stem Cells and Its Role as a Predictor of Prognosis in Pancreatic Cancer

The treatment performance of pancreatic cancer has not changed significantly over the past 20 years and is still less than 10%. In addition, 80-90% of pancreatic cancer patients are found to be already advanced at the time of diagnosis, and it is the best malignant tumor in the human body with a 5-year survival rate of less than 10% and a median survival period of less than 1 year. However, early diagnosis of pancreatic cancer is still difficult, and there is no effective treatment other than surgery, so the increase in long-term survival rate over the past 20 years has been insignificant or stagnant. The response rate to anticancer drug treatment after surgery or anticancer drug when surgery is not possible is only around 20%, so it is very urgent to discover new biomarkers in predicting drug resistance and recurrence after surgery and predicting prognosis in advance. Minimally non-invasive diagnostic techniques are very important to detect and track cancer progression in the clinic. In particular, histological diagnosis and analysis have limitations in carcinomas, such as pancreatic cancer, which are small and distant, making it difficult to obtain tissue samples. CA 19-9, a prognostic marker for existing pancreatic cancer, 1) has low specificity for early diagnosis of pancreas, 2) is not detected in lewis A, B antibody-negative patients, and 3) shows false positive in cases with cholangitis at the same time. Because it has many disadvantages, the development of prognostic biomarkers in blood is urgently needed.

Recently, a study has been reported that the presence or absence of detection of circulating tumor cells is directly related to the prognosis of pancreatic cancer patients, and can be used for monitoring the patient's treatment response and for recurrence after surgery. In particular, the process of cancer metastasis consists of epithelial-to-mesenchymal transition and migration of cancer cells into the blood, and the existence of cancer stem cells is very important for metastasis and drug treatment resistance. Eventually, it is known to cause pancreatic cancer metastasis and recurrence.

Cancer stem cells have the ability to self-renew, the capability of developing, multiple cell lineages, and the potential of extensive proliferation, and the ability to detect cancer stem cells in the blood is important in pancreatic cancer patients who are at high risk of metastasis and recurrence. It is a non-invasive screening tool. Comparatively evaluate the treatment response and prognosis of pancreatic cancer patients according to the characteristics and subtypes of circulating cancer cells.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 20 years of age
* Patients diagnosed with pancreatic cancer histologically or radiologically

Exclusion Criteria:

* non-pancreatic cancer
* Patients who failed to obtain informed consent from the patient
Gabapentin for Bipolar & Cannabis Use Disorders

The proposed 2-week, double-blind, crossover, proof of concept study aims to measure and manipulate core neurochemical (i.e., dysregulated brain GABA/glutamate homeostasis) and neurobehavioral (i.e., elevated impulsivity) dysfunctions characteristic of individuals with cannabis use disorder (CUD) and Bipolar Disorder (BD), using a medication that has been shown to increase cortical GABA (i.e., gabapentin) levels in past research, and to evaluate medication-related changes in response inhibition (go no-go) and cannabis cue reactivity functional Magnetic Resonance Imaging tasks, as well as cannabis use, mood symptoms (including anxiety and sleep), and impulsivity in individuals with CUD+BD.

Bipolar disorder (BD) is the Axis I condition most strongly associated with cannabis use disorder (CUD); there is a six-fold increase in the prevalence of CUD in individuals with BD relative to the general population. Individuals with co-occurring CUD and BD (CUD+BD) have substantially worse clinical outcomes than those with either BD or CUD alone. Response to mood stabilizing medications appears to be poor, yet little is known about optimal treatment for CUD+BD, as there have been no randomized medication trials for CUD+BD to date. Convergent evidence supports dysregulated brain γ-Aminobutyric acid (GABA)/glutamate homeostasis as a candidate target for pharmacological intervention in CUD+BD. Preclinical and clinical studies have demonstrated that CUD and BD are each associated with prefrontal GABA and glutamate disturbances and that impulsivity, a core neurobehavioral feature of both CUD and BD and a key Research Domain Criteria (RDoC) construct, is causally related to GABAergic/glutamatergic functioning. Gabapentin has been consistently shown in preclinical research to modulate GABA and glutamate transmission. In human Proton Magnetic Resonance Spectroscopy (1H-MRS) studies, both acute and chronic gabapentin dosing have been shown to increase brain GABA levels, however, few studies have investigated gabapentin effects on glutamate levels. Researchers propose that gabapentin may impact clinical outcomes in CUD+BD individuals both directly and indirectly through their impact on impulsivity.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-V criteria for Bipolar Disorder
* Meets DSM-V criteria for Cannabis Use Disorder
* Using at least one mood stabilizing medication

Exclusion Criteria:

* Serious medical or non-inclusionary psychiatric disease
* Concomitant use of benzodiazepine medications or any medications hazardous if taken with gabapentin
* History of clinically significant brain injury
* Presence of non-MRI safe material, or clinically significant claustrophobia.
Electrical Stimulation for Spasticity in Spinal Cord Injury

This study examines the immediate and long-term effects of lumbosacral TENS on spasticity and residual voluntary force control in spinal cord injury in comparison to no TENS. Participants in the intervention group will receive 2 months of TENS. Participants in the control group will receive TENS after a 2-month delay. Modified Ashworth score and pendulum test will be used to assess spasticity and force control. Electrophysiological measures will be used to assess the activity profile of motorneurons.

Transcutaneous electrical nerve stimulation (TENS) has been used to control pain in stroke, MS, cerebral palsy and spinal cord injury (SCI) and its effect on spasticity reduction, although not used clinically, has been examined recently. In the few SCI studies done to date, the TENS electrodes have been placed on the nerve to the muscle under study and initial reports show a consistent decrease in spasticity measures, like the Modified Ashworth Score (MAS) and reflexes, during or hours after the TENS application. Recently, study team members from the ReYu Recovery Centre in Edmonton have observed that when TENS is applied with both electrodes over the lower back (lumbosacral TENS), varying amounts of immediate and long-term spasticity relief are produced in both legs.

The investigators have observed 3 clients from ReYU and all have shown immediate reductions in spasticity for at least 2 joints in both legs. The effect of the lumbosacral TENS varied from an immediate dramatic reduction to a more moderate reduction when applied over several days. This study will examine the immediate and longer-term (2 months) effect of using spinal TENS in reducing spasticity of the lower limbs in a larger number of participants with SCI. The investigators want to understand how spinal TENS affects spinal circuits and motoneurons below the lesion to reduce spasticity to observe improvement in its effect in those with more moderate responses. Lumbosacral TENS has the potential for a non-pharmacological, on-demand control of SCI spasticity to greatly improve the quality of life of those affected.

Eligibility Criteria:
Inclusion Criteria:

* SCI adults 18 years and older
* injury levels between C5-T12

Exclusion Criteria:

* severe head injury
* uncontrolled autonomic dysreflexia
* other medical conditions precluding TENS
Quality of Life After Denture Relining

Purpose: the aim of the present study was to analyze the impact of mandibular denture relining with soft or hard denture liners in the oral health related quality of life (OHRQoL) of edentulous patients.

The null hypothesis was that there would be no difference in OHRQoL findings after mandibular denture relining between patient groups treated with hard or soft denture liners.

Complete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22) or a hard acrylic resin based denture liner (Kooliner; Group 2; control n=22) with chairside procedures. The OHIP EDENT (Oral Health Impact profile) questionnaire was given to patients prior to reline procedures (baseline-T0) and 90 days (T90) post relining. Three possible answers and scores were proposed for each question: never (0), sometimes (1) and almost always (2). Results were analyzed by means of the generalized linear model (p≤0.05) considering two factors: time (T0 and T90) and group (hard and soft denture liners).

Eligibility Criteria:
Inclusion Criteria:

* Edentulous in both jaws
* Complete denture wearers
* Clinically acceptable occlusal relationships
* Healthy mucosa, i.e. with no signs of inflammation, traumatic lesions, candidiasis or hyperplasia.

Exclusion Criteria:

* Residual vertical bone height of 10 mm or less
* No attached mucosa in any region of mandible (type E)
* Dentures with deteriorated intaglio surfaces
* Dentures with large pre-existing fractures
* Dentures with severely altered occlusal vertical dimension
* Extremely worn artificial teeth
* Dentures with unsatisfactory occlusions
* Neurological diseases
* Lack of motor coordination
* Difficulty of understanding instructions and the conditions of the study
* Patients with residual roots, cysts or bone spicules
* Patients with allergies to methyl methacrylate or silicone
* Knife-edge mandibular ridges.
Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria

The study is designed to evaluate the proportion of patients with tenofovir induced proteinuria that will resolve their proteinuria when the tenofovir containing nucleoside/nucleotide backbone is switched to a raltegravir backbone. Common HIV treatment regimens contain nucleoside/nucleotide combinations that may have long-term side effects including nephrotoxicity. Switching these backbones out for an integrase inhibitor based regimen has not been systematically evaluated.

Hypothesis: Proteinuria developing during treatment with tenofovir improves or resolves when tenofovir is switched out with raltegravir. Switching to a nuc- sparing regimen, containing raltegravir and a boosted protease inhibitor in patients without preexisting protease inhibitor mutations is safe and does not lead to virologic failure

As described in the brief summary, this is a pilot study to evaluate for improvements in proteinuria when switched off from Tenofovir

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection
* Ability to comply to protocol requirements
* On stable HAART for minimum of 12 weeks
* Evidence of TDF induced proteinuria
* No evidence of prior Protease inhibitor failure
* Treatment-naïve to integrase inhibitors
* VL\<200 x 12 weeks (minimum of 2 viral load measurements)

Exclusion Criteria:

* Active Hepatitis B infection
* Proteinuria predating tenofovir use
* PRAMs on historic GT or PT
* Life expectancy less than 6 months
* Subjects with any ongoing AIDS defining illness
* Any condition which could compromise the safety of study subject
* Grade 3 or 4 lab abnormalities (excl. grade 3 bilirubin elevations)
Phase 2a Study for PK/PD of NC-001

CHRONIC EUVOLEMIC HYPONATREMIA


Eligibility Criteria:
Inclusion Criteria:

1. Men or women ≥18 and ≤85 years of age
2. Diagnosis of chronic euvolemic hyponatremia

Exclusion Criteria:

* 1. Hyponatremia assessed by the Investigator to be hypervolemic, hypovolemic, or due to psychogenic polydipsia