cyrilzakka/clinical-trials huggingface dataset:
Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery

The purpose of this study is determine salivary gland disposition of d-limonene, the primary component in citrus peel and a common dietary supplement.

Salivary gland tissue and saliva will be collected to determine concentration of d-limonene and its metabolites in these tissues.

Primary Objective: To determine the bioavailability of Alda-341 in salivary gland tissue.

Secondary Objective: To determine the bioavailability of Alda-341 in saliva and blood

Eligibility Criteria:
Inclusion Criteria:

* Elected to undergo surgery for recent diagnosis of parotid or submandibular gland tumor
* Ability to adhere to study visit schedule and other protocol requirements
* Operable candidate base on the surgeon's note
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Nursing or pregnant
* Diagnosis of kidney disease, history of renal disease with creatinine \> 1.5 mg/dL, or currently on dialysis
* Diagnosis of end stage liver disease
* Any unstable medical condition
* Use of chemotherapy or radiotherapy within 4 weeks before first dose of study dietary supplement
* Unwilling to stop dietary supplements 3 weeks before first dose of study dietary supplement
Postoperative Delirium in Hip Fracture Patients

Risk factors for postoperative delirium in hip fracture patients.


Eligibility Criteria:
Inclusion Criteria:

* hip fracture
* age 65 or older

Exclusion Criteria:

* critical ill/ dying
* aphasia
Observational Study on the Course of Plasma Glutamine Levels During Critical Illness

Blood sampled for standard evaluation will be used for determination of plasma glutamine by Bioprofile Flex Glutamine Sensor at ICU admission

All patients who are admitted to the ICU after elective surgery and non-elective admissions. In both groups a total of 80 patients will be included.

(In the trials we mentioned in the introduction 80, 174 and 66 patients were included. In the study performed by Oudemans-van Straaten a decent distribution between lower and higher levels of glutamine was achieved in 80 non-elective patients.) Exclusion criteria are patients younger then 18 years and patients who need total parenteral nutrition (TPN).

The patients will receive standard care during their treatment on the ICU. Blood sampled for standard evaluation will be used for determination of plasma glutamine by Bioprofile Flex Glutamine Sensor at ICU admission. Hereafter plasma glutamine will be measured daily, a plasma sample will be taken from a standard evaluation blood sample at 6.00 am during admission on the ICU.

Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to the ICU

Exclusion Criteria:

* younger then 18 years and patients who need total parenteral nutrition
Radiofrequency Neurotomy In Relieving Chronic Knee Pain

Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful conditions. There have been a few attempts to use RF current for the treatment of painful conditions of joints of the extremities. It was also used for the treatment of painful conditions of the hip joint.

Osteoarthritis (OA) is commonest chronic arthritis affecting patients usually aged above 45 years. OA decreased health-related quality of life and increased economic costs. Radiofrequency (RF), was used for the treatment of chronic pain unresponsive to conservative therapies. RF has been used for several painful conditions. There have been a few attempts to use RF current for the treatment of painful conditions of joints of the extremities. It was also used for the treatment of painful conditions of the hip joint.

Eligibility Criteria:
Inclusion Criteria:

* chronic arthritis according to the American College of Rheumatology criteria
* diagnosed radiologically patients in stage 3 and 4, according to the Kellgren-Lawrence classification

Exclusion Criteria:

* other causes of pain such as radiculopathy, neurological disorders, or intermittent claudication.
* patients receive intraarticular steroid or hyaluronic acids during previous three months.
* patients did previous knee surgery.
* Patients with general contraindication to the application of invasive intervention such as hemorrhage, coagulation disorder, systemic infection or local infection.
* patients with other connective tissue disease affecting the knee. And 6-psychiatric disorders.
Diabetes and Cognitive Functions in Middle Age

This study will examine the effects of type II diabetes on cognitive functions and mood in middle-aged patients. In addition, the association between cognitive functions and glycemic controls is studied in patients. Sixty patients and sixty healthy controls will be recruited and assessed by a multiprofessional team (neuropsychologist, physician).

Sixty patients with type 2 diabetes will be recruited from the Tampere Diabetes outpatient clinic. Inclusion criteria for the patients are type 2 diabetes diagnosis, diabetes medication and age 35-65. Exclusion criteria are type 1 diabetes, hypothyreosis, neurological or psychiatric disorder, substance abuse and serious diabetes complications. Sixty healthy control persons are recruited from the personnel and occupational health care. Exclusion criteria for controls are type 1 or 2 diabetes, hypothyreosis, neurological or psychiatric disease and substance abuse.

A comprehensive neuropsychological assessment is made to all participants.The assessment consists of standardized neuropsychological tests, questionnaires and interview. Domains assessed include attention, executive functions, memory, information processing speed, general cognitive functioning, depressive symptoms, anxiety and fatigue. Medical information (such as glycated hemoglobin and blood pressure) from the patients is gathered from the medical records. Corresponding information from the control participants is gathered with medical examinations including laboratory tests. Informed consent is taken from all participants.

This study will examine the difference in cognitive functions between healthy controls and middle-aged patients with type 2 diabetes. There is evidence from previous studies that type 2 diabetes is related to an increased risk of dementia, but the association between diabetes and cognition at younger ages is less studies. The difference in mood and fatigue is also studied between the groups. In addition, the association between glycated hemoglobin level and cognitive functions is examined in patients, as poor glycemic control has been implicated to impact on cognitive decline in previous studies. Finally, the association between history of hypoglycemic episodes and cognition is studied.

Eligibility Criteria:
Inclusion Criteria:

* type II diabetes, age between 35-65 years

Exclusion Criteria:

* hypothyreosis, previous neurological diseases
ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System

The goal of the research study is to observe the clinical safety, effectiveness and patient satisfaction of the AXERA 2 Access System in subjects undergoing coronary angiographic and possible Percutaneous Coronary Intervention (PCI) through the femoral artery when compared to standard manual compression.

The study is a single center 1:1 randomized controlled trial in subjects undergoing coronary angiography and PCI.

It is anticipated that the enrollment period for this study will be two years.

The post procedure follow up period is up to 37 days following the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Subject is between 18 and 85 years of age.
* Cardiac catheterization procedure is indicated with involving access through a 5 French (F) or 6 French (F) introducer in the femoral artery.
* Subject is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.
* Subject or legally authorized representative has signed informed consent.

Exclusion Criteria:

* Subject is unable to routinely 20 feet without assistance (e.g. requires a walker or wheelchair to mobilize or has paralysis)
* Subject has an active systemic or cutaneous infection or inflammation (e.g. (septicemia at the time of the procedure).
* Subject undergoing emergent or urgent cardiac catheterization for acute myocardial infarction.
* Extensive calcification of the femoral artery as see on fluoroscopy.
* Subject has systemic hypertension unresponsive to treatment (\>180mm Hg systolic and \>110mm Hg diastolic).
* Subject has received thrombolytic therapy within the 72 hours prior to catheterization.
* Subject has known bleeding disorder,such as Factor 5 deficiency, Idiopathic thrombocytopenic purpura (ITP), thrombasthenia, Von Willebrand's disease.
* Is on warfarin with an International Ratio (INR)\>1.5.
* Platelet count is \< 100,000.
* Anemia (Hemoglobin \<10 g/dl or Hematocrit\<30%).
* Subject has compromised femoral artery access site.
* Subject procedure requires an introducer sheath size of \> 6 French (F).
* Subject has had prior vascular surgery or vascular grafts at the femoral artery access site.
* Subject presents with hemodynamic instability or is in need of emergent surgery.
* Subject has received femoral artery closure on the target access vessel with a collagen/PEG closure device within 90 days.
* Subject has a pre-existing severe non-cardiac systemic disease or illness that results in an expected life expectancy of \< 1 year.
* Subject is participating in an investigational drug or another device research study that interferes with the current research study endpoints.
* Pregnant or lactating subjects.
Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH) Perinatal Psychiatry Program.

Participants: 52 women, ages 18-45, who are 16-29 weeks pregnant and experiencing a depressive episode, and their partners.

Methods: Women and their identified partners will complete a diagnostic interview, complete measures of depressive symptom severity at baseline, and be randomized to treatment with PA-IPT or TAU. Women randomized to TAU will be treated by UNC physicians according to the UNC-CH Perinatal Psychiatry Program's algorithm for treatment of prenatal MDD (usually one of a number of antidepressant medications, tailored to the individual, although some women may opt against medication altogether and still be eligible to enroll). Women randomized to PA-IPT will participate in 8 therapy sessions with their identified partner over a 12-week period, along with one refresher session at or around 6 weeks postpartum. Women and partners will be assessed for change in depressive symptoms and relationship satisfaction during pregnancy at visits 4 and 8, and postpartum at 6-week and 6-month visits.

Hypothesis: The investigators anticipate notable improvement in both groups similar in magnitude, however it is hypothesized that couples participating in PA-IPT will have higher relationship satisfaction post-treatment (controlling for baseline satisfaction) than those receiving TAU.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 18-45 years
* 16-29 weeks estimated gestational age
* Able to provide informed consent
* English or Spanish language literacy
* In a committed relationship cohabiting for at least 6 months with a Dyadic Adjustment Scale rating \< 90 or with an identified family member or friend residing in the same home
* Meet criteria for Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition Text Revision (DSM-IV) diagnosis of Major Depressive Disorder (MDD)
* HRSD-17 score is equal or greater than 16 at diagnostic evaluation and randomization
* Medically healthy and without fetal anomaly according to history

Exclusion Criteria:

* No identified primary care, nurse midwife, or obstetrical physician to monitor pregnancy; participant or physician refuses to sign release of information
* By patient report, history of partner verbal, emotional, or physical abuse
* Partner unable or unwilling to participate
* DSM-IV diagnoses of bipolar 1 or 2 or any psychotic episode
* Substance abuse within the last 6 months
* Eating Disorder
* Current use of other therapies for depression including individual psychotherapy, herbal remedies or other complementary/alternative therapies, antidepressant medication outside the study protocol
* Active suicidal ideation
* Identified partner has DSM-IV diagnoses of bipolar 1 or 2 or any psychotic episode
* Interpersonal violence or abuse
Development and Content Validation of the Childhood Early Oral Aging Syndrome (CEOAS) Index for the Deciduous Dentition

Premature, non-physiological tooth wear in childhood has numerous repercussions for oral health. This is a growing problem with multifactorial causes and associated with the current lifestyle. The aim of the present study was the development and determination of content validity of the Childhood Early Oral Aging Syndrome (CEOAS) index for the primary dentition as a diagnostic and epidemiological survey tool considering the current changes found in this population.


Eligibility Criteria:
Inclusion Criteria:

-Dental surgeons

Exclusion Criteria:

-Other healthcare professionals
Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection

Inflammation of the trochanteric bursa is a common cause of hip pain. A bursa is a closed fluid filled sac or sac-like cavity found between tissues that function as a gliding surface to reduce friction. Bursitis is the inflammation of the bursa. Inflammation between the trochanteric process of the femur and gluteus medius tendon/ iliotibial tract is the cause of trochanteric bursitis. Several treatments exist for trochanteric bursitis, including a local steroid injection. The injection consists of a mixture of local anesthetic and steroid medications. The steroid is routinely mixed with a local anesthetic. The anesthetic acts to diluent the steroid as well as act as a pain reliever. Various steroid preparations have been used, at varying doses, for trochanteric bursitis. The steroid preparation, triamcinolone is commonly used for various reasons. Besides the procedure associated and injection site risks, risks associated with the use of steroids, though rare, exist. Short term, the steroid can raise blood sugar levels and should be used with caution and be appropriately monitored in diabetics. Additionally, the steroid can suppress the immune system. Long-term risks are related to the dose and frequency of use. These risks include thinning of the skin, easy bruising, weight gain, elevated blood pressure, cataract formation, thinning of bones and joints. Studies have shown the effectiveness of local steroid injections for trochanteric bursitis. Unfortunately, there is limited data on the ideal dose of the steroid preparation. Triamcinolone of 40mg/ mL is commonly used, but, studies have shown effectiveness at various doses, ranging 20 to 160 mg/mL. The aim of this study is to evaluate and compare the effectiveness of local steroid injections of various steroid dosages for the treatment of trochanteric bursitis.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of trochanteric bursitis
2. 18 years of age or older when written informed consent is obtained
3. Signed institutional review board approved informed consent form

Exclusion Criteria:

1. Meets any contraindication for treatment
2. Allergy to triamcinolone, lidocaine
3. Previous surgery to bursa
4. Coagulopathy
5. Active Infection
6. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
3D Model of Posterior Membranous Labyrinth of the Inner Ear

The aim of this work is to create a three-dimensional (3D) finite element model (FEM) of the human posterior membranous labyrinth, based on in vivo inner ear magnetic resonance imaging (MRI). This model has a pedagogical interest, and can serve as a basis for reflection in cases of atypical benign paroxysmal positional vertigos. It can also serve for mechanical studies of vestibular physiology.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over
* Adult who has performed an imaging of the inner ear

Exclusion Criteria:

* Refusal to participate in the study
Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images

To Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting \[18F\]flutemetamol Positron Emission Tomography (PET) Images.


Eligibility Criteria:
Inclusion Criteria:

* Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185 MBq to approximately 370 MBq.
* The subject was classified as one of the following:

  1. End-of-life subject who expired and underwent brain autopsy, with histochemical (HC) confirmation of brain amyloid status.
  2. Subject with known/suspected normal pressure hydrocephalus (NPH) who underwent brain biopsy, with HC confirmation of brain amyloid status.
  3. Elderly healthy volunteer (age ≥55).
  4. Young healthy volunteer (age ≤40).
  5. Subject with probable Alzheimer Disease (pAD).
  6. Subject with amnestic Mild Cognitive Impairment (aMCI).

Exclusion Criteria:

* Not Applicable
Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma

In this trial, we plan to evaluate further the role of arsenic trioxide in the treatment of patients with refractory multiple myeloma. Arsenic trioxide will be used in combination with thalidomide. Although both drugs have a similar mechanism of action, it is likely that the mechanisms may be additive or synergistic. Since neither drug produces much myelosuppression, this combination regimen should be tolerable in patients with compromised marrow function due to involvement with myeloma and/or previous cytotoxic chemotherapy

Upon determination of eligibility, patients will be receive:

* Arsenic Trioxide + Thalidomide

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Confirmed diagnosis of multiple Myeloma
* Received at least one previous chemotherapy regimen at most 3 previous
* Thalidomide with or without dexamethasone without chemotherapy will not factor in to total number of regimens.
* Age at least 18 years years
* Able to perform activities of daily living with minimal assistance
* Life expectancy more than 3 months
* Adequate bone marrow, liver and kidney function
* Must give written informed consent in order to participate.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Women pregnant or lactating.
* Pre-existing moderate neuropathy
* Patients with significant underlying cardiac dysfunction
* Uncontrolled hypercalcemia
* Active serious infections not controlled by antibiotics
* History of grand mal seizures (other than infantile febrile seizures)
* Receiving other medications that prolong the QT interval.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
The Effect of Fatigue on Static and Dynamic Balance in Healthy Young Male Athletes

Participants were randomized into control and experimental groups. They were examined on static and dynamic balance (pre- \& post-tests). Then, the experimental group went through a fatigue protocol, in which speed and incline increase one unit each minute passing, and stopped when rate of perceived exertion level reached ≥ 18, and the plasma lactate level differed from the baseline by ≥ 4mmol/L.


Eligibility Criteria:
Inclusion Criteria:

* male and aged between 18-24 years old,
* physically active (i.e. exercised ≥ 3 times weekly during the past three months).

Exclusion Criteria:

* reported a minor injury in the past two months,
* major injury in the past 12 months, and/or underwent a major primary surgery in their lower limb.
Clinical Research on Advanced Warning Factors Of Respiratory Injury in Dermatomyositis

Dermatomyositis (DM) is a highly heterogeneous autoimmune disease characterized by rash and myasthenia. Beside these, respiratory involvement is one of the common complications of DM. Interstitial lung disease (ILD) occur in approximately 90% of patients with DM, part of them may manifest rapidly progressive-interstitial lung disease (rp-ILD), which progresses into respiratory failure that is difficult to correct and leads to death. Early identification of rp-ILD high risk group is of great significance to improve the prognosis of patients and to conduct following clinical studies. A simple, easy, convenient and reliable diagnostic tool has not yet acquired till now.

Dermatomyositis (DM) is a highly heterogeneous autoimmune disease characterized by rash and myasthenia. Beside these, respiratory involvement is one of the common complications of DM. Interstitial lung disease (ILD) occur in approximately 90% of patients with DM, part of them may manifest rapidly progressive-interstitial lung disease (rp-ILD), which progresses into respiratory failure that is difficult to correct and leads to death. Early identification of rp-ILD high risk group is of great significance to improve the prognosis of patients and to conduct following clinical studies. A simple, easy, convenient and reliable diagnostic tool has not yet acquired till now.

MSG-Jiangsu, short for Myositis Study Group-Jiangsu, was founded by department of rheumatology and immunology of eighteen tertiary hospitals. Clinical Research on Advanced Warning Factors Of Respiratory Injury in Dermatomyositis (CRAWFORD) as a multicenter observational cohort study was started at Jun 1, 2020. Our cohort plan to recruit 1,000 adult inpatients. What's more, prognostic data from these DM patients were obtained by following up for 1 year. At the same time, clinical data and auxiliary examination results of the baseline DM patients were analyzed to look for factors that are associated with outcomes. Then, regression analysis of influencing factors will help us to set up a multi-factor weighted score to forecast the prognosis of DM patients. Finally, Biological specimen from patients at baseline are used to look for biomarkers that predict prognosis by RNA-sequencing, whole exon sequencing, proteomic screening and so on.

Eligibility Criteria:
Inclusion Criteria:

* adult patients meet the diagnostic criteria for dermatomyositis of Bohan and Peter

Exclusion Criteria:

* complicated with other connective tissue diseases
* complicated with cardiovascular and respiratory disease caused by other reasons
* interstitial lung disease caused by environment and drugs
* patients with key research missing data or without informed consent