cyrilzakka/clinical-trials huggingface dataset:
The Drug-drug Interaction of SP2086 and Valsartan

The purpose of the study is to investigate the potential interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy adult volunteers.

This is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of SP2086 and Valsartan in healthy adult volunteers. All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences, all subjects must completed the two stages(A and B). The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12.There were 6 days washout period between the two stages. The whole study needs 31 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2
* Had signed the informed consent himself or herself.

Exclusion Criteria:

* Have the abnormal lab or other examination results and the change have clinical significance.
* History of or current clinically significant medical illness as determined by the Investigator.
* Have a family history of thyroid cancer, submandibular gland cancer or long QT syndrome
* Known allergy to SP2086 or Glyburide or any of the excipients of the formulation of SP2086 or Glyburide.
* History of using the sulfa or sulfonylureas or DPP-IVor GLP-1 drugs or other similar structure drugs.
* History of severe unconsciousness hypoglycemia
* History of any surgery prior to screening in 6 months.
* History of blood donation≥400 mL prior to screening in 3 months or participate in blood donation,or by blood transfusion in one month.
* History of participate any drug or medical device prior to screening in 3 months.
* Within a month before the screening using any prescription drugs, over-the-counter drugs, Chinese herbal medicine (especially oral antidiabetics drugs) or food supplements( vitamins).
* 2 days before the randomization ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion.
* The hepatitis B surface antigen, hepatitis c antibody, HIV antibody and syphilis antibody was positive.
* Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
* Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.
The Application of Soluble Triggering Receptor Expressed on Myeloid Cells-1 in Sepsis & Relevant Acute Kidney Injuries

Triggering receptor expressed on myeloid cells-1 is a member of the immunoglobulin superfamily of receptors that is specifically expressed on the surfaces of monocytes and neutrophils.TREM-1 expression is increased in infectious diseases and is associated with the release of soluble TREM-1 (sTREM-1).There has been demonstrated that the value of plasma sTREM-1 levels as an indicator of sepsis was superior, although other studies reported that the value of sTREM-1 for diagnosing sepsis was inferior.An increasing number of studies indicate that there are increased levels of sTREM-1 in body fluid samples for the following diseases and conditions: sepsis, pneumonia, pleural effusion, septic arthritis, meningitis, peritonitis, and uterine cavity infection.

Inflammation is now believed to play a major role in the pathophysiology of AKI. It is hypothesized that the initial insult results in morphological and/or functional changes in vascular endothelial cells and/or in tubular epithelium in sepsis models. Then, leukocytes including neutrophils, macrophages, natural killer cells, and lymphocytes infiltrate into the injured kidneys and induce the generation of inflammatory mediators. Whether urine sTREM-1 could also be detected and its significance in sepsis and AKI has not been reported yet.

The present study focused on the value of serum \& urine sTREM-1 for sepsis identification, severity and prognosis assessments, and potential sepsis-related AKI. We also made comparisons between sTREM-1 and WBC counts, serum CRP, serum PCT, urine output,CC SCr, and BUN among sepsis patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female aged 18 years old and over;
2. clinically suspected infection;
3. fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °C or lower than 36 °C (b)respiratory rate above 20/min, or PCO2 below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.

Exclusion Criteria:

Those who fulfilled one below:

* neutropenia (≤ 500 neutrophils/mm3)
* HIV infection, and
* patients or their relatives refused
Motor Imagery and Rehabilitation of Orthopaedic Patients

Motor imagery is increasingly used as a plasticity-booster to complement conventional rehabilitation. Here the investigators test the hypothesis that the combination of mental training with conventional rehabilitation may speed up the recovery in patients with total knee arthroplasty. The investigators also characterize the brain correlates of such recovery with imagery tasks for virtual reality environments.


Eligibility Criteria:
Inclusion Criteria:

* Right handed
* No contraindication to the fMRI exam

Exclusion Criteria:

* Contraindication to the fMRI exam
Language in Primary Progressive Aphasia

The purpose of this study is to further define the neurological and linguistic deterioration in primary progressive aphasia.

The Language in Primary Progressive Aphasia (PPA) aims to understand the behavioral, anatomical and physiological changes in people with PPA throughout the course of the illness. The researchers in this study want to increase awareness of PPA, educate others about this unique disorder, and to encourage more research to eventually develop therapies.

During the three-day research program, participants will be asked to undergo neuropsychological testing (paper and pencil tests that evaluate cognition), advanced imaging (MRI and PET), cognitive experiments, and other computer and language testing batteries. Participants may be asked to return every two years to complete the same measures.

For participants not living near Chicago, IL, flights and accommodations (for both the person with PPA and their companion) will be covered by the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary progressive aphasia
* Right-handed
* Native English speaker
* Visual acuity of 20/30 corrected
* Adequate hearing to follow conversation
* Safe for an MRI scan

Exclusion Criteria:

* Left-handedness
* Claustrophobia
* Presence of significant medical illness that initially or in the future could interfere with continued participation in the study
Neocortical Microarchitecture of Executive Function

This study is being done to the determine the ability and utility of using the Neuropixels probes in the human brain. A Neuropixels probe will be inserted into and removed from the brain of awake human patients who are undergoing awake Deep Brain Stimulation (DBS) surgery.

This project aims to use Neuropixels probes to record hundreds of neurons during awake human intracranial surgeries. Using this probe, we will take advantage of access to a key area in the network involved in executive function, the middle frontal gyrus of the dorsal lateral Pre Frontal Cortex (approximately the mid portion of dlPFC, part of Brodmann area 9/46), to test emerging concepts that cognitive flexibility so crucial to human EF is encoded in neural population geometry and layer-specific interactions.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Parkinson's disease and refractory to medications requiring deep brain stimulation
2. Aged 45-85
3. Able to provide informed consent
4. Normal neuropsychiatric evaluation that includes tests of executive function. 5. Medically able to undergo deep brain stimulation surgery as evaluated by study neurosurgeon.

6. Surgical plan includes an entry point that can safely be placed in the dorsal lateral PFC.

7. Able to tolerate awake deep brain stimulation surgery with a plan for the case to be done awake.

8. Able to tolerate 25 additional minutes of awake surgery. 9. Able to participate and comply with tasks adequately, including instructions provided in English.

Exclusion Criteria:

1. Moderate, or severe cognitive impairment as determined by a licensed neuropsychologist during routine neuropsychological evaluation.
2. Inability to tolerate awake surgery as determined by the treating neurologist and study neurosurgeon.
3. Inability to safely access the dorsal lateral prefrontal cortex for an entry location.
4. Cognitive impairment or executive function deficits as determined by neuropsychological testing
5. Evidence of a clinically significant abnormality on preoperative imaging.
Evaluation of Geriatric Questionnaires to Predict Toxicities of CDK 4/6 Inhibitors in Older Breast Cancer Patients?

CDK 4/6 inhibitors (palbociclib, ribociclib) have taken their place in our practice recently with their clinical benefits in the treatment of hormone-positive and HER2 negative metastatic breast cancer. Abemaciclib, another CDK 4/6 inhibitor, is not frequently preferred because of reimbursement problems in Turkey. The most obvious advantages of CDK 4/6 inhibitors are that they are used orally and have relatively fewer side effects against chemotherapy. Neutropenia, diarrhea, elevation in liver function tests are the main dose-limiting side effects. In the geriatric age group, it can be thought that the expected benefit from the treatment will not be achieved in cases where these side effects cannot be predicted or managed well. The geriatric age group (65 years and older) deserves special attention in oncology practice, considering both the treatments and the disease itself. Although a number of very useful clinical scales have been developed regarding this subject, it is important that the scale used should be comprehensive as well as being easily applicable for integrating it into daily practice. Geriatric 8 (G8) was found to be a highly sensitive test based on a comprehensive geriatric examination, while the Groningen frailty scale with high specificity. The common feature of these two tests is that they are suitable for daily practice as they are easy to fill. In the light of this information, we aimed to examine whether the G8 and Groningen frailty scale could shed light on clinicians in predicting side effects during the use of CDK 4/6 inhibitors (palbociclib and ribociclib) in geriatric breast cancer patients. We also aimed to reveal the adverse events of these CDK 4/6 inhibitors as real-life experience.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer 65 years and older Treated with CDK 4/6 inhibitors (Palbociclib or Ribociclib)

Exclusion Criteria:

* Below 65 years old
Effect Of Different Lining Materials in Stepwise Excavation

Deep carious lesions will encounter the dentist with the challenge of selecting a treatment method that could avoid the pulpal exposure and maintain the pulp vitality.Conventional restorative treatments suggest complete removal of the caries in one visit which could cause pulpal exposure in 53% of the cases which in next step needs pulpotomy, pulpectomy or Root Canal Therapy (RCT).

Stepwise Excavation(SE)is an old concept but has been researched recently to reduce the possibility pulpal exposure during the removal of the lesion. Contrary to Indirect Pulp Capping (IPC), in this technique only the central infected part of the caries is removed in first visit and the rest of the caries will be lined by a suitable material to suppress the remained cariogenic biomass and seal the cavity. This will help the pulp to defend and survive. After a period, the cavity is re-opened and the rest of the caries which is darker, harder and with less bacteria will be removed and the tooth is restored permanently.The aim of this study was to compare the effect of different lining materials in clinical and radiographical symptoms in stepwise excavation without re-enter after one year.

In this randomized clinical trial of 4 lining materials have been applied in deep caries teeth in stepwise excavation. The common material which is applied as a liner over the remained caries in SE is Calcium Hydroxide(CH). There are several reports of the solubility of this liner over time which could interact with sealing of the cavity in long term. It seems that a material with antibacterial activity, good sealing ability and suitable mechanical properties could cause SE be done efficiently with good prognosis.

MTA is a biomaterial that has been introduced since 1993 with antibacterial property and good sealing ability. A New Endodontic Cement, Calcium Enriched Mixture (CEM) cement with good antibacterial effect like CH with sealing ability that is proposed to be similar to MTA according to its double sealing property. CEM cement has been suggested as a suitable material in pulp capping of permanent molars with irreversible pulpitis.

Eligibility Criteria:
Inclusion Criteria:

A tooth with deep caries lesion - Tooth at risk of pulpal exposure - No pulpal , instantaneous , night pain

Exclusion Criteria:

Unbearable pain of the involved tooth- Apical radiolucency of the tooth- PDL widening
Osteopathic Manipulative Medicine to Reduce Developmental Delays

This randomized clinical trial seeks to determine if osteopathic manipulative medicine (OMM) increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of Infant Motor Performance (TIMP).

Hypothesis: High risk preterm infants born \<34 weeks of gestation who receive OMM, compared to the standard supportive care, will have improved neuromotor development scores on the TIMP.

Specific Aims and Objectives:

Primary aim: To determine the difference in TIMP scores between infants who receive OMM and those who receive only standard neonatal intensive care unit (NICU) care.

Secondary aims:

* To compare length of stay between infants who receive OMM and those who receive only standard NICU care.
* To compare growth parameters including weight, length, and head circumference, (both means and Z scores) prior to discharge between infants who receive OMM and those who receive only standard NICU care.
* To compare percentage of subjects requiring nasogastric, orogastric, or gastrostomy tube feeds at discharge between infants who receive OMM and those who receive only standard NICU care.

Eligibility Criteria:
Inclusion Criteria:

* 23 0/7- 33 6/7 weeks' gestational age (GA) at birth, ≥28 0/7 weeks' GA at time of consent
* stable enough to tolerate gentle manipulation

Exclusion Criteria:

* \> 33 6/7 weeks' GA at birth
* known congenital and genetic abnormalities affecting neurodevelopment
* known conditions requiring surgical intervention
* severe intracranial hemorrhage or other severe neurologic complications
* parents unable to read and understand English
Dance and Movement Therapy in Patients With Schizophrenia

Introduction: Schizophrenia is a mental disorder that starts at a young age and progresses with positive (hallucination, delusion) and negative (decreased emotional participation, reluctance) symptoms. While drug therapy in schizophrenia targets positive symptoms; psychotherapies are needed in the treatment of negative symptoms. It is seen that especially art therapies such as occupational and music support recovery and rehabilitation. In addition, it is stated that dance and movement therapy is effective in ensuring social participation of patients. There are a limited number of studies demonstrating the effect of dance and movement therapy on schizophrenia patients.

Aim: This project was planned to examine the effects of dance and movement therapy techniques to be applied to patients with schizophrenia on patients' negative symptoms and disability.

Method: In this project, which was planned in a repetitive measure design with a pretest-posttest control group, dance and movement therapy techniques, consisting of 12 sessions in total, will be applied to schizophrenic patients in a Community Mental Health Center once a week. Negative symptoms and disability levels will be determined before, after and a month after the application. The findings obtained as a result of these three follow-ups will be evaluated.

Project Outputs: Reduction of negative symptoms and disability will enable schizophrenic patients to become individuals who can express themselves better in their family and society and have an increased quality of life. It is thought that these gains will increase patients' compliance with treatment, prevent recurrent symptoms and reduce hospitalizations. The results will also constitute a scientific source for the studies to be carried out in the field.


Eligibility Criteria:
Inclusion Criteria:

* have been diagnosed with schizophrenia for at least two years
* not have been hospitalized in the past 3 months

Exclusion Criteria:

* have a therapy/psychoeducation program that they attend regularly
* have a known physical or neurological disease
* having just started the Community Mental Health Center
Effectiveness of Nurse-led Physical Therapy in Terms of Patient Competency, Patient Engagement and Physical Performance.

Due to Prolonged diseased Condition, Patients are not able to care for themselves and even avoid movement their range of motion is limited which may develop frailty among Liver disease Patients.

This Study aims at assessing Engagement, Competency and Physical Performance of Physical Frail Chronic Liver disease Patients before and after Nurse led Physical therapy.

Besides these Parameters effect of Intervention on Physical frailty will also be assessed.

Research Approach: Quantitative Study Research design: Quasi Experimental Research design ( Pre-test - Post test Control group design) Setting: Study is planned on OPD patients of ILBS, New Delhi. Sampling Technique: Random Allocation in Experiment and Control group after matching for age and gender Sample size: 80 Patients Variables: Independent variable- Nurse-led Physical therapy Dependent Variable- Patient Competency, Patient Engagement, Physical Performance.

Eligibility Criteria:
Inclusion Criteria:

* Prefrail and Frail CLD Patients (MELD \<24)
* Follow up of Prefrail and Frail CLD Patients (MELD\<24)
* Participants willing for Research

Exclusion Criteria:

* Frail Patients who are bedridden
* presence of hepatopulmonary disease
* Presence of neurological defects
* Previous history of Liver Transplantation
* Severe COPD, Heart Failure
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO

This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction. Clinicians will be asked to follow their current standard of care practices with the aid of this technology. About half of participants will receive care in NICU rooms with the Dashboard installed while the other half will receive standard care without the Dashboard.

The current NICU environment can be stressful and overwhelming for parents of babies admitted and for clinicians caring for the babies. There is a wide range of monitors in a very clinical environment that does not take into account the comfort of neonates.

The Dashboard works in parallel with EHR and systems of record, and provides a cohesive view of the patient's status and planned clinical workflow in a single location for both parents and staff. Accessories such as environmental sensors and cameras are used to ensure that the environment is comfortable and promotes optimal development of the baby. Caregivers can educate and coach parents to facilitate integrating them into their infant's care. The NICU Dashboard also supports a family view to facilitate education and assist the family in tracking core measures and developmental milestones.

Eligibility Criteria:
NEONATES AND THEIR PARENTS

Inclusion Criteria:

* Admission to the NICU
* At least one parent (biological, guardian, or adoptive) involved
* One parent can understand and speak the English language
* Parent aged 14 years or older
* Parent with sufficient mental capacity to provide written informed consent as determined by a RN
* Signed informed consent
* Aged 19+ yrs: Signed by parent of NICU baby
* Aged \<19 yrs (minor): signed by both parent of NICU baby and parent/guardian of parent

Exclusion Criteria:

* Expected discharge from the NICU in \<48 hours

CLINICIANS INTERACTING WITH THE NICU DASHBOARD

Inclusion Criteria:

* Employee of institution with direct patient care in the NICU (e.g. physician, NP, RN, therapist)
* Aged 19 years or older
* Expected interaction with the NICU Dashboard
* Signed informed consent

Exclusion Criteria:

* No interaction with the NICU Dashboard
Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions

investigating the level of malondialdehyde (MDA) \& nitric oxide (NO) in saliva in oral premalignant and malignant lesions in order to determine their diagnostic value for the malignant and potentially malignant lesions.

Being a detrimental disease, cancer development is a very complicated process that requires many sequential steps and depends on a various number of genetic alterations and factors(1). Among these factors are the free radicals which are derived either from endogenous or exogenous sources (5). Free radicals result in an oxidative stress of the affected cells generating a body imbalance between oxidants and antioxidants (6).

In this regard, saliva has been currently used to assess this possible oxidative imbalance through various salivary biomarkers including nitric oxide (NO) and malondialdehyde (MDA). Saliva could be used as a very interesting rich medium, known for its role in diagnosis, prognosis and treatment that has become more prominent in oral diseases (6).

Nitric oxide (NO) is an intercellular messenger molecule having many important biological functions. The levels of nitric oxide in salivary secretions could be used to monitor the severity of many underlying disease processes. Moreover, malondialdehyde (MDA) has been the most frequently used biomarker of oxidative stress in many pathological conditions such as cancer. It resulted from reactive oxygen species lipid degradation and induced toxic stress in affected cells, making both biomarkers a point of focus in monitoring clinical progress of suspected lesions

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals with one of the following oral lesions :

  * keratosis
  * Oral lichen planus
  * oral squamous cell carcinoma
  * oral leukoplakia

Exclusion Criteria:

* subjects having systemic disorders
* pregnant or lactating females;
* subjects who suffered from any other mucosal lesions;
* severe periodontal inflammation.