cyrilzakka/clinical-trials huggingface dataset:
Tacrolimus Blood Concentration and Transplant-related Outcomes in Pediatric HSCT Recipients

The goal of this retrospective observational study is to investigate any possible association among tacrolimus (TAC) blood concentrations, clinical efficacy and tolerability.

Therefore, the main questions it aims to answer are:

1. to clarify which variables, how and to what extent influence daily TAC blood concentrations in pediatric allo-hematopoietic stem cell transplantation (HSCT) recipients;
2. to investigate the incidence of graft-versus-host disease (GVHD) and graft failure according to TAC exposure.

Pediatric patients administered TAC to prevent GVHD after an allogeneic bone marrow transplantation.

Patients undergoing allo-HSCT will be recruited at IRCC Burlo Garofolo, collecting demographic and clinical characteristics from electronic medical records in a retrospective manner: age, sex, primary disease, donor type and stem cell source, body weight (BW), white blood cell (WBC) count, platelet count, red blood cell (RBC) counts, hemoglobin (HGB) and hematocrit (HCT) levels, red cell concentrate (RCC) transfusions. Other clinical laboratory data (i.e., liver and kidney function) will be included, as well as concomitant drugs administered to patients after allo-HSCT (i.e, mycophenolate mofetil, steroids, pantoprazole, voriconazole, methotrexate). Data will be collected, validated, and presented according to Good Clinical Practice (GCP) principles to support the statistical analyses and subsequent reporting. Once selected according to predefined inclusion requirements, data will be collected anonymously; an identification code will be assigned to each case. As per GCP, all collected information will be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification with user access restriction, and data will be retrievable by designated personnel only.

Because of the retrospective nature of the present research protocol, all eligible patients will be included in the study population only if their medical and laboratory records will be complete.

Statistical analyses (for descriptive and comparative aims) will be performed stratifying patients by body weight, age, gender, and source of stem cells. Univariate and multivariate tests will be used, together with Kaplan-Meyer tes, Cox proportional hazard model and ROC curve analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age of the patients between 0 and 18 years (pediatric)
* Patients undergoing allogeneic bone marrow transplantation
* Patients' GVHD prophylaxis with tacrolimus
* Signed informed consent

Exclusion Criteria:

* Patients undergoing autologous bone marrow transplantation
* Patients not undergoing GVHD prophylaxis
* Patients undergoing cyclosporin prophylaxis
* Incomplete pharmacokinetic/pharmacodynamic data
* Lack of any informed consent
Biomarkers of Brain Injury: Magnitude and Outcome of Mild and Moderate TBI

The purpose of this study is to determine if specific brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI as well as in orthopedic control subjects.


Eligibility Criteria:
Mild/Moderate TBI Group

Inclusion Criteria:

1. 18 years or older
2. GCS 9-15
3. CT scan as part of clinical evaluation
4. experienced some level of altered mental state at time of injury
5. determination of study eligibility within 4 hours of injury

Exclusion Criteria:

1. Pregnant females
2. Prisoners
3. Anemia or significant blood loss (hemoglobin \< 12 mg/dL and/or hematocrit \< 35%, and/or clinical state requiring resuscitation with more than 6L of colloid or crystalloid fluid)
4. no clear history of trauma as primary event
5. previous history of stroke, or head injury requiring hospitalization
6. dementia or psychotic illness or neurological condition which may affect outcome
7. unable to speak or understand English

Orthopedic Control Group

Inclusion Criteria:

1. 18 years or older
2. Isolated extracranial orthopedic injury, including fractures
3. Stable vital signs on presentation to ED (pulse \< 100bpm and systolic blood pressure \> 100 mmHg)

Exclusion Criteria:

1. evidence of brain injury, including abnormal neurological examination, alteration in consciousness, memory or mental status, headache, dizziness, or vomiting following injury
2. not enrolled within 4 hours of injury
3. Pregnant females
4. Prisoners
5. Anemia or significant blood loss (hemoglobin \< 12 mg/dL and/or hematocrit \< 35%, and/or clinical state requiring resuscitation with more than 6L of colloid or crystalloid fluid)
6. previous history of stroke, or head injury requiring hospitalization
A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2

The purpose of the study is to determine if by performing surgery we can cure Type II Diabetes.

The surgical procedures:

1. a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction of caloric intake and rapid gastric emptying.
2. ileal transposition which involves repositioning a 150cm segment of the ileum into the jejunum causing improved glucose homeostasis.


Eligibility Criteria:
Inclusion Criteria:

* age- 21-55 years.
* Body Mass Index between 25-35 kf/m2.
* currently being treated for type 2 diabetes mellitus with oral hypoglycemic, insulin or both for the at least 3 years.
* Documented HbA1c\>7.5% for at least 3 months.
* Stable weight for 3 months (+/-)
* Evidence of stable medical treatment for diabetes over the past 12 months.
* Able to provide informed consent -Female subject agrees to participate in accepted birth control methods -

Exclusion Criteria:

* Type I diabetes/juvenile onset
* C-Peptid levels below 1.0 ng/ml
* Previous major upper abdominal surgery

  --Pregnant or plans to become pregnant with in the next 12 months
* Current Malignancy
* Severe pulmonary, cardia, or renal disease
* Eating disorders such as bulimia or binge-eating
* Severe mental health disorders such as schizophrenia and bipolar disorder
* Obesity due to other metabolic disorders
* taking appetite suppressants
* currently abusing illicit drugs,alcohol or using tobacco products
* Unable to provide informed consent
* Unwillingness or unable to comply with study procedures
* any condition that deems them unsuitable for the study in the opinion of the investigators
Comparison of Kinesio Tape and Dry Needling for the Management of Rotator Cuff Tendinopathy: A Randomized Control Trial

Its a single blind RCT

Kinesio tape and dry needling were compared for the management of rotator cuff tendinopathy

Eligibility Criteria:
Inclusion Criteria:

* age between 25-50 years old
* Both genders
* Not any comorbidity

Exclusion Criteria:

* Parkinson disease
* DM
* HTN
Perioperative Three-dimensional Echocardiography in Cardioanesthesia.

The aim of this study is to investigate the significance of intraoperative echocardiography on the surgical course and association with patient outcome. Of particular interest is the three-dimensional assessment of cardiac and valvular function. The patient course from surgery to the time of hospital discharge will be followed up.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery or surgery on the vessels near the heart

Exclusion Criteria:

* Pregnant patients
* Unfeasibility of intraoperative echocardiography in contraindications to transesophageal echocardiography: esophageal carcinoma, varices, diverticula, strictures, acute esophagitis, previous esophageal or gastric bleeding, symptomatic hiatal hernia.
* No written consent obtainable.
Psychiatric Nursing Students Therapeutic Communication

This research was carried out to determine the effect of virtual reality application on the therapeutic communication skill levels of Mental Health and Psychiatric Nursing course students. The research was carried out in experimental research design. The independent variable of the research is virtual reality simulation; The dependent variable is the therapeutic communication skills of the students of the Mental Health and Psychiatric Nursing course. Nursing students' individual characteristics were determined as the control variable. The hypothesis of the research H1: The therapeutic communication skill level scores of the nursing students in the intervention group participating in the virtual reality simulation will increase compared to the nursing students in the control group.

This research was carried out to determine the effect of virtual reality application on the therapeutic communication skill levels of Mental Health and Psychiatric Nursing course students. The analysis was carried out in an experimental research design. The independent variable of the study is virtual reality simulation; The dependent variable is the therapeutic communication skills of the students of the Mental Health and Psychiatric Nursing course. Nursing students' characteristics were determined as the control variable. The hypothesis of the research H1: The therapeutic communication skill level scores of the nursing students in the intervention group participating in the virtual reality simulation will increase compared to those in the control group. The population of the research consists of 65 students who are enrolled in the nursing department of a foundation university in Istanbul and took the mental health and psychiatric nursing course in the spring term of the 2022-2023 academic year. Sample: A list from 1 to 65 was prepared to determine the students who will take place in the intervention and control groups. Simple random sampling method was used to differentiate between intervention and control groups. The numbers to be sampled were determined by www.random.org generate number. The intervention group consisted of 36 students and the control group consisted of 29 students.

Eligibility Criteria:
Inclusion Criteria:

* • To be registered in the Mental Health and Psychiatric Nursing course in the spring semester of the 2022-2023 academic year,

  * To be taking the Mental Health and Psychiatric Nursing course for the first time in the nursing department,
  * To attend school regularly,
  * Not having received training with virtual reality simulation within the scope of Mental Health and Psychiatric Nursing course.

Exclusion Criteria:

-
Balance Training for Chronic Obstructive Pulmonary Disease (COPD)

The study will involve direct knowledge translation of a laboratory-based study of balance training for patients with COPD, first to the investigators PR program and then, after disseminating the results, this approach could be used to impact on clinical practice in any PR program.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* Self-report of decline in balance or fall in the last 5 years or a recent near fall
* Smoking history greater than 10 pack years
* Are able to provide written informed consent.

Exclusion Criteria:

* An inability to communicate because of language skills, hearing or cognitive impairment
* Evidence of a neurological or musculoskeletal condition that severely limits mobility and postural control (e.g., cerebrovascular accident, advanced Parkinson's disease, amputation).
AI4HOPE Dementia Pain Assessment Pilot Study 1

The pilot study will develop and test a standardized assessment toolkit that will provide conclusive information with a tolerable burden for cognitively impaired patients with dementia.

The clinical study is part of an EU-funded project on the use of artificial intelligence for patients with dementia. This study will test a digital toolkit fo assessment and monitoring of patients with mild or moderate dementia and pilot-test this toolkit for feasibility and acceptability.

Patients with mild to moderate dementia will be recruited for the pilot study in the six participating countries. The study population includes all types of dementia without stratification, as the aim of the study is to construct a digital assessment and intervention toolkit for clinical practice in any patient with cognitive impairment from any type of dementia.

Even though the final assessment and intervention toolkit could also be useful for patients with advanced dementia and more severe cognitive impairment, the pilot study will recruit only patients with mild or moderate dementia, who will still be able to provide informed consent, and who will be able to self-assess at least minimum patient-related outcome or patient-related experience measures to validate the behavioural and observational scales and biomarkers used in the toolkit.

Patients with dementia treated in the participating study centers will be screened for inclusion criteria and, if suitable will be invited to participate. The study will be performed for seven days, with optional extension to 30 days according to patients' preferences.

Patients with baseline data and at least one intervention performed from the digital toolkit and data completed before and after that intervention will be included in the evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Mild or moderate dementia of any type
* Able to provide informed consent, or consent from surrogate decision maker
* Able to self-assess patient-related outcome (PROM) or experience (PREM) measures

Exclusion Criteria:

* Ongoing delir
* Severe cognitive impairment (MMSE \< 10 \[22\])
* Unable to provide informed consent
* Life expectancy estimated less than 3 months
Gong's Mobilization and Sustained Natural Apophyseal Glide in Office Workers With Cervical Spine Overload

Neck pain is a frequent and disabling complaint in the general population. One of the most common causes of neck pain is mechanical dysfunction of the cervical spine. Although diverse methods have been proposed for increasing cervical range of motion (ROM), joint mobilization has been confirmed as effective in several studies. Typically, joint mobilization methods for increasing cervical ROM include spinal manipulative therapy, the activator and diversified techniques. There are different mobilization techniques for neck pain, and mulligan's technique is one of them. It has two techniques Sustain Natural Apophyseal Glides (snags) and Natural Apophyseal Glides (nags). Gong's mobilization technique helps to heal physical pain as well as distract the mind from stress. In this study, the effectiveness of gong's mobilization and Sustained Natural Apophyseal Glides (snags) will be compared in office workers who have problems with cervical posture and range of motion (ROM) in order to examine the effects of gong's mobilization on cervical pain and cervical ROM. Twenty office workers with problems of cervical posture, pain and ROM is divided into a gong's mobilization group (n=10) and a Snags group (n=10). Gong's mobilization and nags will be administered three times a week for four weeks to each respective group and then changes in cervical posture, pain and cervical ROM will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* • Both Gender

  * Aged 25 to 45 years
  * Participants actively working in offices and who had been diagnosed with or self-reported chronic non-specific neck pain.
  * NPRS \>4

Exclusion Criteria:

* • Surgical treatment of cervical spine (Cervical Diskectomy)

  * Tumor around the neck
  * Rheumatoid arthritis
  * Nervous system disorder(Vestibular disorder)
  * Whiplash Injury
Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a

Heart failure with preserved ejection fraction or HFpEF, represents nearly 50% of all heart failure cases and is particularly common in the elderly. The disease has no current treatment options. Symptoms typically occur during exertion or exercise and is likely the result of increased cardiac and pulmonary congestion as a result of impaired diastolic function. Istaroxime is a novel activator of SERCA2a, an important regulator of calcium uptake within the myocyte. We will test the hypothesis that Istaroxime will improve diastolic function during exercise in HFpEF patients which in turn will reduce cardiac and pulmonary congestion.

About half of all elderly patients with a diagnosis of congestive heart failure have apparently normal systolic function, so called "heart failure with a preserved ejection fraction" or HFpEF. To date, no effective therapy for HFpEF has been found, in part because of failure to discern key pathophysiologic pathways.

An extensive amount of pre-clinical work has identified that altered sarcoplasmic reticulum (SR) Ca2+ uptake, storage, and release play a major role in the changes in cardiac relaxation associated with aging, especially regarding sequestration of Ca++ by the sarcoplasmic reticular Ca++-ATPase (SERCA2a), which causes cardiac muscle relaxation by reducing cytosolic Ca++. Istaroxime is a relatively new drug that augments lusitropic function by upregulating SERCA2a activity in the heart.

Because of the clear importance of slowed relaxation in HFpEF, and the evidence that depressed SERCA2a activity contributes to the slowed relaxation with aging, the proposed study may be establish the "impairment of SERCA2a" hypothesis as a mechanism of impaired relaxation in HFpEF subjects.

Eligibility Criteria:
Healthy Senior Controls

Inclusion Criteria:

* age \> 60 years

Exclusion Criteria:

* Coronary Ischemia
* No chronic medical problems
* BMI \> 30 kg/m2

HFpEF Subjects

Inclusion Criteria:

* age \> 60 years
* signs and symptoms of heart failure
* ejection fraction \> 50%
* objective evidence of diastolic dysfunction

Exclusion Criteria:

* Coronary Ischemia
* Chronic Kidney Disease, stage 4 or greater
* Persistent atrial fibrillation
* Severe valvular disease
* BMI \> 45 kg/m2
Fronto-limbic Functional Connectivity Via Real-time fMRI Neurofeedback

Real-time fMRI neurofeedback training induced volitional control of brain activity and connectivity could help individuals to gain better control over their emotions.

In the present proof-of-concept study, investigators plan to evaluate whether real-time fMRI neurofeedback training can enable individuals to gain volitional control over their fronto-limbic circuitry. Given that this circuitry has been abundantly implicated in emotional perception and regulation this could facilitate emotional control. Suitable participants underwent fronto-limbic connectivity feedback training and sham training in a cross over design. During both trainings participants are instructed to regulate the neural indices during feedback. We expect that receiving fronto-limbic feedback enhances emotion regulation during the training.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* pregnant, taking oral contraceptives
Comparative Study for Incidence of Proximal Junctional Kyphosis Between Parathyroid Hormone and Denosumab Following Adult Spinal Deformity Surgery : A Prospective, Randomized Controlled Trial

Medical therapy that can lower PJK rates are also being sought. Teriparatide (TP), a recombinant human parathyroid hormone (PTH 1-34), is a bone forming agent mainly used to treat osteoporotic patients with high risk of osteoporotic fracture. There has been reports suggesting protective effect of prophylactic TP to osteoporotic patients receiving ASD surgery concerning PJK.6 Although it had limitations of small sample size and surgical selection bias owing to study design being retrospective. We hypothesized prophylactic TP would act as to reduce the incidence of PJK and therefore reduce PJF and necessity of revision surgeries in patients after ASD correction surgery. Our study can consolidate the beneficial effect of prophylactic TP to patients receiving ASD surgery by reducing the incidence of PJK.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients between 50 years to 80 years of age with ASD
2. Multilevel instrumented fusion
3. Cobb angle above 25̊ in coronal plane deformities, Lumbar lordosis below 20̊ in sagittal plane deformities
4. Minimum follow-up of 1 years

Exclusion Criteria:

1. Diagnosis being tumor or infectious condition like Tb spondylitis were excluded
2. Patients with adverse reactions or contraindications to TP were excluded; side effects to TP or bone cancer or metastasis
Identification of Outcome Relevant Indicators in Routine Data

The availability of electronic documentation systems in patient care means that large amounts of clinical routine data are available from which conclusions can be drawn for improving patient care. Compared to conventional research approaches, a data science-oriented approach offers the possibility of identifying patterns in routine data ("pattern recognition") that are relevant for patient-centered outcomes.

Numerous projects and sub-projects can be evaluated from this data set.

The patterns that are relevant for patient-centered outcomes can be combinations of different parameters (e.g. vital signs, laboratory values, previous illnesses), which in themselves do not necessarily have a pathogenic effect, but in a specific combination may have a high relevance for the patient-centered outcome.

This project pursues as research goal the anesthesiological and intensive care risk reduction. To this end, the existing data sets of routine care are to be used to identify outcome-relevant patterns in order to derive recommendations for improving treatment in line with the patient's wishes. Standard Operating Procedures (SOPs) and Quality Indicators (QIs) in combination with the data of routine clinical care will be used as a basis. The approach outlined is closely linked to the development of quality-based treatment structures. In order to be able to offer medical treatment at a high level, associated processes must be known and operationalized, i.e. measurable. QIs (quality indicators) are an established instrument for measuring individual dimensions of treatment quality, and our clinic is a leading participant in this process at both national and international level (see Spies et al. Guidelines for Delirium, Analgesia and Sedation). The mapping of quality-based treatment structures as SOPs (Standard Operating Procedures) is also essential in this context (see Spies et al. SOPs in Anesthesiology and Pain Therapy, Thieme Verlag). By applying data science-based methods, this study pursues the overall goal of supporting the transfer of evidence-based findings in the form of QIs and SOPs into patient care.

Numerous projects and sub-projects can be evaluated from this data set.

Eligibility Criteria:
Inclusion Criteria:

* Age: 0 to 120 years
* Gender: female, male, diverse
* Electronically documented anesthesiological or intensive care treatment in the HIS (Hospital Information System) and PDMS (Patient Data Management System) of the Charité (Department of Anesthesiology and Intensive Care Medicine, CCM/CVK/CBF) since 2006

Exclusion Criteria:

-none
CD34 Selection of the Peripheral Blood Stem Cell Graft for Autologous Transplant

Evaluate the feasibility and safety of autologous transplantation of CD34+Thy-1+ hematopoietic stem cells afer high dose marrow ablative chemotherapy in patients with breast cancer.

Selection of CD34+THY-1 Positive Cells From Peripheral Blood Cells Procured for Autologous Hematopoietic Support Following High Dose Treatment with BCNU, Cyclophosphamide \& Cisplatin for Stage IV Breast Cancer \& Limited Prior Treatment

Eligibility Criteria:
Inclusion Criteria:- stage IV breast cancer

* primary breast cancer does not express CD34+
* adequate organ function
* no evidence of active infection Exclusion Criteria:- chemotherapy within 4 weeks
* CNS disease