cyrilzakka/clinical-trials huggingface dataset:
Post Operative Hyponatremia in the Renal Transplant Population

This study is designed to determine the causes of low sodium (salt) in the body fluids outside the cells for patients who have received a kidney transplant at the Mayo Clinic of Florida. The investigators will look at data collected on previous transplant patients at the Mayo Clinic to determine if the low sodium levels could be related to factors occurring in the course of surgery. The investigators hypothesize that the intravenous fluid used in the surgery, which is about half the concentration of normal saline, could contribute to the low sodium levels.

This study is designed to determine the cause of post operative hyponatremia in renal transplant patients at the Mayo Clinic of Florida. Recently, the investigators have noted a trend in post-operative hyponatremia (low serum sodium) in patients who are recipients of both living donor and cadaveric kidneys. To improve the quality of care of this patient population, the investigators propose the investigation of the sources of this decline in serum sodium levels to determine if this is preventable. The investigators propose that a potential source of post-operative hyponatremia may be related to intra-operative factors. Currently, the intravenous fluid of choice used intra-operatively is 0.45% normal saline. The investigators hypothesize that this fluid choice contributes to post-operative hyponatremia.

To further investigate this the investigators will perform a retrospective review using the renal transplant database to collect data regarding pre-operative diagnoses, co-morbidities, and method of dialysis used in the pre-transplant period. Pre-operative serum sodium level will be compared to post-operative serum sodium levels. Data including post-operative complications, need and reasons for post-operative dialysis, and hospital course will also be collected. Once the data are analyzed and a primary source or sources are identified as causative agents for post-operative hyponatremia, an intervention to prevent a decline in serum sodium post-operatively will be planned for future study.

Eligibility Criteria:
Inclusion Criteria:

-Presenting to hospital for renal transplantation

Exclusion Criteria:

-Renal transplant recipients who received simultaneous transplantation of a liver, heart, or lung
Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months

The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.


Eligibility Criteria:
Inclusion Criteria:

* Follow-on, healthy 40, 60 months old participants who have completed the V59P5 study and are in good health
* Control subjects: healthy 60 months old who had received a complete MenC immunization course

Exclusion Criteria:

* Subjects with any serious, acute or chronic progressive disease
Artificial Intelligence in EUS for Diagnosing Pancreatic Solid Lesions

We aim to develop an EUS-AI model which can facilitate clinical diagnosis by analyzing EUS pictures and clinical parameters of patients.

EUS is considered to be a more sensitive modality than CT in detecting pancreatic solid lesions due to its high spatial resolution. However, the diagnostic performance is largely dependent on the experience and the technical abilities of the practitioners. Therefore, we aim to develop an objective EUS diagnostic model based on the convolutional neural network, an artificial intelligence technique. In addition, clinical parameters such as risk factors, tumor biomarkers and radiology findings are also added to this artificial intelligence model in order to mimic the actual clinical diagnosis procedures and to increase the performance of this model.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent EUS using a curved line array echoendoscope (GF-UCT260; Olympus Medical Systems) since 2014 in our affiliation.
* For each patient, all available native EUS pictures are included.
* Patients' diagnosis are validated by surgical outcomes or fine-needle aspiration (FNA) findings and have a compatible clinical course with a follow-up period of more than 6 months.

Exclusion Criteria:

* The image is of poor quality.
* The images contain unique marks which can potentially bias the model, such as the biopsy needle.
Goal Attainment Scaling (GAS) Sub-Study

This is an optional sub-study that will enroll participants from LIFE-DSR parent protocol. The aim is to assess change over 16 months in individuals with Down syndrome through individualized goals set by their caregivers. This sub-study also aims to assess the feasibility of Goal Attainment Scaling in the DS-AD population.

People with Down syndrome are living longer. A longer life increases the chances of age-related risks of developing Alzheimer's disease and other forms of dementia. There is also growing evidence that people with Down syndrome respond differently to treatment than people without Down syndrome. This creates an important need to create a way to identify and follow changes in thinking and behavior as people with Down syndrome age and start to experience symptoms of dementia. Here, the investigators are testing a new method to monitor changes (in thinking and behavior) called goal attainment scaling.

During this study, the participant will be asked to take part in a goal attainment scaling interview, which means working with a clinical rater (the participant's health care provider or other study team) to identify personally meaningful goals to follow for the study. "Goals" are based on symptoms or challenges experienced by the person for whom cares for the participant with Down Syndrome. The identified goals may be related to potential early signs and symptoms of Alzheimer's disease. These goals will then be reviewed at 2 time-points over the next 16 months. The investigators want to learn whether this type of interview can help the investigators understand what symptoms or challenges are important to the participant and whether this type of interview can help the investigators understand how these might change over time. The investigators also want to hear the participant's feedback about the participant's experience with goal attainment scaling at the end of the sub-study.

The investigators will be asking about 45 participants to take part in this study.

This study is observational and does not test a study drug.

Eligibility Criteria:
Inclusion Criteria:

The participant with DS and caregiver must be currently enrolled in the LIFE-DSR parent protocol.

The participant with DS must be age 35 years or older.

Both the participant with DS, or LAR, and their caregiver must be able to understand and be willing to sign written informed consent.

In the opinion of the Investigator, a participant's caregiver must have frequent interaction with the participant on a regular basis, agree to participate in clinic and remote visits, be able to provide accurate responses to questions about the participant with DS, and be capable of facilitating participation in the study visits.

Participant with DS and caregiver must be capable of reliably completing all study assessments at each time-point.

The caregiver must be able to converse in English.

Exclusion Criteria:

Unable to complete trial procedures or adhere to the schedule of study assessments, in the opinion of the site PI.
Urdu Version of Parkinson's Disease Questionnaire: Reliability and Validity Study

In the study , the researchers will investigate the reliability and validity of Urdu version Parkinson's Disease Questionnaire in Pakistani population having Parkinsonism

The study is aimed to translate and culturally adapt Parkinson's Disease Questionnaire-39 into Urdu language and to investigate validity and reliability of Parkinson's Disease Questionnaire-39 in Parkinson's diseased patient among Pakistani population.The study will be a cross sectional survey in which non-probability purposive sampling technique will be used to enroll the participants into the study as per criteria.

The results of the study will help to establish an understanding of validity and reliability of Urdu version of Parkinson's Disease Questionnaire-39 with quality of life of Parkinson's Disease patients in Pakistani population having Parkinson's Disease. Reliability of the scale will be checked through internal consistency and test-retest methods. Cronbach's alpha value will be used to analyze internal consistency and for analyzing test-retest reliability an intraclass correlation coefficient with 195 patients will be used

Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic Parkinson's Disease
2. Minimum age of 40 years
3. Minimum level of 5 years of education
4. A score equal to or greater than 23 on the Mini-Mental State Examination
5. Patient experiencing at least two of the three cardinal symptoms of idiopathic Pairkinson Disease (rigidity, resting tremor, and bradykinesia.)

Exclusion Criteria:

1. Patients with non-idiopathic Parkinsonian variants
2. Patients with a history of drug or alcohol abuse in the last two years
3. Patients with unstable medical problems that may place the patient at increased risk or may interfere with the assessment or treatment of Parkinson's
4. Neurological operation on the brain within one year prior to study entry
Efficacy and Safety of Qinbudan as an Adjunct Therapy for Retreatment Pulmonary Tuberculosis

The purpose of this study is to assess the efficacy and safety of Chinese medicine Qinbudan in Patients Receiving Standard Combination Therapy for Retreatment Pulmonary Tuberculosis.

Retreatment of tuberculosis involves the management of entities as diverse as relapse, failure, treatment after default, and poor patient adherence to the previous treatment. The emergence of conditions for selection of resistance (failure and partial abandonment) is a matter of great concern. The current chemotherapy is the primary interventions, but the long-term drug combination therapy often leads to adverse reactions. The purpose of this study that is to exploring the role of Chinese medicine Qinbudan on Patients who are initially sputum smear positive or culture-positive who have been treated previously for pulmonary tuberculosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are initially sputum smear positive (at least two smears as "1+" or at least have a smear as "2+" and above) or culture-positive for pulmonary tuberculosis who have been treated previously
* Aged 18 -65 years of age
* Patients who are willing to give written informed consent

Exclusion Criteria:

* Participation in another clinical trial 1 month prior to study entry
* Female patients in lactation period, pregnancy or planning to get pregnant during the trial
* Patients who are allergic to the therapeutic medicine
* Patients with severe primary diseases such as cancer, cardiovascular system, digestive system, kidney and hematopoietic system diseases
* Patients co-infected with HIV, hepatitis B or hepatitis C
* Patients with mental illness, acrasia
* Abnormal liver function or combined with other underlying liver disease (fatty liver, alcoholic liver)
* Patients with diabetes, Plasma glucose poorly controlled undertaking
* Patients with auditory dysfunction
Osteopathic Manipulative Treatment Efficacy in Postoperative Pain

Effectively controlling sternal pain during cardiac rehabilitation after heart surgery is very important as it reduces the risk of postoperative complications.

However, the contraindications and side effects of analgesic drugs may induce physicians to use them so cautiously that pain may actually be under-treated.

The aim of this open label, controlled study is to assess whether osteopathic manipulative treatment (OMT) can contribute to pain relief and improve rehabilitation outcomes.

The currently predominant means of controlling postoperative pain is the peri-operative administration of opioid or non-opioid (acetaminophen) analgesics, alone or in combination, and non-steroidal anti-inflammatory drugs (NSAIDs). However, anti-inflammatory drugs are contraindicated for many patients because they may impair renal function, interact with platelet aggregation, and increase the risk of gastrointestinal damage and bleeding. The spectrum of available options is narrow.

Osteopathic manipulative Treatment (OMT) intervenes in the process that transforms nociceptive information into the subjective experience and it may be useful.

It has been found to be effective in controlling pain after abdominal surgery, it has a beneficial effect on patients recovering coronary artery by-pass surgery and also improves cardiac function The aim of this study was to assess whether complementary OMT is an effective means of reducing post-surgical sternal pain and improving rib cage mobility after heart surgery involving sternotomy, and to investigate its advantages during in-patient rehabilitation in terms of functional recovery, and perceived anxiety and depression.

This open, randomised, semi-blinded, controlled trial involves inclusion of 80 adult patients of both genders consecutively admitted as in-patients to cardiac rehabilitation unit after undergoing elective coronary artery by-pass grafting (CABG), valve replacement or repair and/or ascending aorta surgery with sternotomy, and capable of voluntarily providing their written informed consent. The patients are divided in 2 groups, the intervention group receiving OMT and the control group. Both groups are following the same rehabilitation programme and receiving usual care.

All of the subjects taking part in the study are receiving standard care in accordance with the international guidelines for in-patient cardiac rehabilitation; the only experimental intervention is the addition of OMT

Eligibility Criteria:
Inclusion Criteria:

* Recent artery bypass grafting (CABG)
* Recent valve replacement or repair
* Recent ascending aorta surgery

Exclusion Criteria:

* Heart surgery using mini-thoracotomy.
* Heart transplantation
* Implant of a ventricular assistance device
* Diabetes mellitus
* Rheumatoid arthritis
* Autoimmune diseases
* Altered cognitive capacities
Obesity: Cesarean Health by Incision Placement

Hypothesis: A Pfannenstiel cesarean skin incision placed under the pannus (should a pannus exist) will have a higher maternal morbidity composite rate than a Cohen cesarean skin incision placed above the pannus (should a pannus exist).

Introduction: Obesity affects approximately 1/3rd of all reproductive-aged women and is associated with increased maternal morbidity during and after cesarean section. The optimal surgical approach has not been well elucidated for obese individuals.

Materials and Methods: This is a randomized controlled trial comparing a Pfannenstiel incision placed below the pannus (should a pannus exist) with a Cohen incision placed above the pannus (should a pannus exist); allocation is 1:1 with stratification for pre-gestational diabetes and presence of pannus. The study will be assessed by intention-to-treat analysis looking composite maternal morbidity (wound complications within 6 weeks, endometritis, postpartum hemorrhage) as the primary outcome with secondary outcomes including wound complications, operative time, estimated blood loss, pain management, and patient and surgeon satisfaction. Significant confounders will be assessed and adjusted in the multiple regression analysis accordingly.

Results: The investigators propose the Cohen cesarean incision will result in statistically less maternal morbidity from cesarean section than the Pfannenstiel incision.

Comment: The benefits of a Cohen incision have been encouraged in non-obese pregnant women; the investigators propose that they be considered in obese women as well.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> or = 35 kg/m2 at time of presentation for delivery
* Speaks English

Exclusion Criteria:

* BMI \< 35 kg/m2 at time of presentation or delivery
* Unable to consent (including language spoken other than English)
* Prior abdominal incisions or obstetric factors necessitating placement of incision in specified location, at the discretion of the attending surgeon
* Infection present (ie cellulitis) precluding incision placement at one of the randomization sites
Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children

This study will explore whether a relationship exists between insulin and leptin resistance, sweet taste responsiveness, and adiposity.

Compared to healthy weight peers, some reports have shown that they are less sensitive to, or perceptive of, sucrose solutions and sweet foods, whereas others have observed the opposite pattern of findings or no difference at all. Among those seeking weight loss treatment, one investigation found perception and preferences for sweet taste remained unchanged after weight loss, and another observed a decreased ability to distinguish sweet taste from other taste solutions. Given these discrepancies in the literature, the proposed study will explore whether a relationship exists between insulin and leptin resistance, sweet taste responsiveness, and adiposity.

Eligibility Criteria:
Inclusion Criteria:

* Patient of Children's Healthy Weigh of Buffalo
* ages of 8-14

If enrolled in the bariatric arm:

• must be scheduled for bariatric surgery prior to enrollment

Exclusion Criteria:

* Patients unable to get labs drawn at a Kaleida facility
* Severe hay fever or seasonal allergies within 2 weeks of enrollment
* smoker or are exposed to second-hand smoke at home,
* has been dieting to lose weight within the past 6 months of enrollment
* currently taking any prescription medications that can influence taste or small functions or are pregnant.
* pregnancy
* Bariatric arm patients will be excluded if they fail to have the surgery.
Identification of New Biomarkers to Promote Personalized Treatment of Patients With Inflammatory Rheumatic Diseases

Introduction: The medical treatment of inflammatory rheumatic diseases has improved dramatically during the last decades primarily due to the introduction of biological disease modifying anti-rheumatic drugs (bDMARDs). However, bDMARD treatment failure occurs in 30-40% of patients due to lack of effectiveness or side effects. The tools to predict treatment outcomes in the individual patient are currently limited. The objective of the present study is to identify diagnostic, prognostic and predictive biomarkers, which can be used to 1) diagnose inflammatory rheumatic diseases early in the disease course with high specificity and sensitivity, 2) improve prognostication or 3) predict treatment effectiveness and tolerability for the individual patient.

Methods and analysis: Observational and translational open cohort study with prospective collection of clinical data and biological materials in patients with inflammatory rheumatic diseases treated in routine care. Patients contribute one cross-sectional blood sample (i.e. whole blood, serum, EDTA-plasma and -buffy coat, and blood in PAXgene RNA tubes) and/or are enrolled for longitudinal follow-up upon start of new DMARD (blood sampling after 0/3/6/12/24/36/48/60 months' treatment). Demographics, disease characteristics, comorbidities and lifestyle factors are registered at inclusion; DMARD treatment and outcomes are collected repeatedly during follow-up. Currently (June 2017) \>5,000 samples from ≈3,000 patients have been collected. Data will be analysed using appropriate statistical analyses.

Ethics and dissemination: The protocol is approved by the Danish Ethics Committee and The Danish Data Protection Agency. All participants give written informed consent. Biomarkers will be evaluated and published according to REMARK, STROBE and STARD guidelines. Results will be published in peer-reviewed medical journals and presented at international conferences.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with or suspected for the following diseases: rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA) or other inflammatory rheumatic diseases, connective tissue disorders or gout
* Aged 18 year or older
* Able to give informed consent

Exclusion Criteria:

* None
Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children

The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.


Eligibility Criteria:
Inclusion Criteria:

* have a height less than two standard deviations (SD) below the median height for individuals of the same age or height, a growth velocity (GV) ≤4 cm/yr, a GH peak concentration \<7 ng/ml in two different provocative tests, a bone age (BA; ≤9 years in girls and ≤10 years in boys) at least 2 years less than his/her chronological age (CA);
* be in preadolescence (Tanner stage 1) and have a CA \>3 years;
* have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV;
* receive no prior GH treatment.
* sign informed consent

Exclusion Criteria:

* patients with severe cardiopulmonary
* patients with hematological diseases
* a current or past history of malignant tumors
* immunodeficiency diseases
* mental diseases
* patients positive for hepatitis B e-antibody (HBeAb)
* hepatitis B surface antigen (HBsAg)
* hepatitis B e antigen (HBeAg)
* patients with other growth disorders, such as Turner syndrome
* constitutional delay of growth and puberty, and Laron syndrome
'Single Hand Used inTubaTing Laryngoscope Evaluation' Study

This is a study to compare the new ShuttleScope with the standard Macintosh Laryngoscope

Following a 5 minutes workshop with an instructor structured demonstration and practice with both devices, the participants attempt intubation in a normal airway scenario with the Macintosh Laryngoscope and the novel ShuttleScope®, in a manikin model.

Eligibility Criteria:
Inclusion Criteria:

* Medecine students from the Basque Country University (UPV/EHU)

Exclusion Criteria:

* Other operators different from the ones described above
* Previous experience with ShuttleScope videolaryngoscope
* informed consent non available
An Observational Study of the Ethnic Impact of Patients Undergoing Second (2nd) Line Treatment for Non-Small Cell Lung Cancer Using Pemetrexed

This large, non-randomized observational study is being conducted to provide data about the impact of ethnic origin on outcomes and resource utilization during the 2nd line treatment of non-small cell lung cancer (NSCLC) in a routine medical care setting.

This is a large 1000 patient single arm observational study being conducted to determine the impact of ethnic origin (Caucasian, African-Americans, Asian-Americans, and Hispanics) on patients being treated for 2nd line advanced NSCLC with pemetrexed given in routine clinical practice. Data will be collected on disease control rate by pemetrexed as defined by Response Rate (RR) (Complete Response (CR) + Partial Response (PR)), Stable Disease (SD) and toxicities. In addition, overall survival, progression-free survival, treatment toxicities, activities of daily living, symptom burden and resource utilization will also be observed. To meet the study goals, a total of 400 Caucasians, 200 African- Americans, 200 Asian-Americans, and 200 Hispanics will be accrued to this study.

Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung cancer (NSCLC) (any histologic type)
* Stage IIIB or IV disease
* Should have had 1 line of chemotherapy for Metastatic disease
* Adequate hematologic, hepatic and renal function
* Measurable or evaluable disease

Exclusion Criteria:

* Pregnant or lactating females