cyrilzakka/clinical-trials huggingface dataset:
Predictive Effect of TGF-β and INS-PI3K-AKT Related Proteins for POD in Diabetes Patients

To investigate the relationship between POD, TGF-β and INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, PGC-1α) in diabetic patients

The study was a two-center, prospective，single blind (blinded to subjects and evaluators)，control, observational clinical study. Participants will collect 3 milliliters of blood from enrolled patients before surgery begins. The collected blood samples were processed and stored in -80℃ refrigerator. All samples were tested TGF-β and INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, PGC-1α) by ELISA.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥65 years
2. History of diabetes ≥2 years and Glycated hemoglobin ≥6.5% or no history of diabetes and normal blood glucose
3. The ASA rating is Class I to III
4. The elderly patients of limited thoracic and abdominal tumor surgery

Exclusion Criteria:

1. Refused to participate
2. Previous history of schizophrenia, epilepsy, Parkinson's disease
3. History of alcohol abuse or drug dependence
4. Patients with ASA grade IV and above
5. Severe visual or hearing impairment, can not cooperate with the completion of cognitive function tests
6. Participants in other clinical trials within the last two months
7. Patients with severe arrhythmia or cardiac dysfunction(EF\<40%)
8. There was a clear history of neurological and psychiatric problems or long-term use of sedatives or antidepressants
9. History of cerebrovascular disease or brain surgery or trauma
10. Severe liver dysfunction (Child-Pugh class C) or severe renal dysfunction (requiring dialysis)
Respiratory Dysregulation and Breathing Training in Anxious Outpatients

This study will explore respiratory dysregulation in anxious outpatients and examine the effect of breathing training with biofeedback for those anxious patients.

In clinic testing and outside the clinic testing, we will assess the prevalence of respiratory dysregulation in a sample of 60 non-psychotic, not currently alcohol or drug abusing veteran outpatients from our MHC (Mental Hygiene Clinic) who experience episodic anxiety but who do not qualify and have never qualified for the diagnosis of PD (panic disorder). These patients will be compared to 30 patients who are not clinically anxious. Of these 60 anxious patients, 30 will be randomly assigned to a 4-week course of breathing training assisted by feedback of end-tidal pCO2 levels as an augmentation of their current treatment. They will be compared to 30 who simply will continue with their current treatment (TAU). The breathing training group will receive clinical and physiological assessments immediately before the treatment period, four weeks after the end of the treatment period, and at a 4-month follow-up. The TAU group will be assessed three times at equivalent intervals, and if they wish, may undergo breathing training after the third assessment. Treatment will take place mainly in the first two years, giving us adequate time for follow-up and data analysis. We expect that this therapy will be especially effective for treating anxiety in the patients with substantial respiratory dysregulation.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be rated 2 or more on both Q1 and Q3, but they must not meet the full criteria for PD as determined by the Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version (ADIS).
* In addition, they must be clinically stable enough that changes in the patients' anxiety levels can be attributed to the breathing training rather than to other new treatment initiatives during the training and 1-month evaluation periods or to spontaneous fluctuations in anxiety levels. Thus, potential participants taking SSRIs or other antidepressants, or benzodiazepines have to have been on a stable dose of these medicines for at least the previous two months.

Exclusion Criteria:

* Potential participants taking short-acting benzodiazepines such as alprazolam in excess of 2.0 mg/day or the equivalent on any day in the past month are excluded, because improvement might show up only in terms of reduction of medication dosage and not on the evaluation measures planned.
Extraction and Socket Preservation Before Implant Placement Using Freezed Dried Allograft (FDBA) and Platelet-Rich Fibrin in Smokers

the investigators aim from this study to evaluate platelet rich fibrin potential to heal the periodontal tissue and to form new native bone in smokers that require socket augmentation following dental extraction and before implant placement.

Materials and Methods: 18 adult smoker patients with 40 extracted sockets were recruited for this study, and the extracted sockets were distributed into four different groups as follows; Group 1- A-PRF alone, Group 2- Factors-enriched bone graft matrix (commonly known as sticky bone) using autologous fibrin glue combined with an FDBA with CGF-Enriched Fibrin Membrane to covered it, Group 3- an FDBA with a crosslinked collagen membrane and Group 4-Resorbable collagen plug (RCP) alone serving as a negative control group.

The patients were randomly grouped into a previously mentioned group, and the socket dimensions were measured four times, immediately after the extraction (0 days), after 10, 21, and 28 days to assess epithelial layer healing.

After six months and before placing the implant fixture, both soft and hard tissue samples will be harvested to be evaluated and compared histologically, also standardized CBCT will be taken before and after extraction to evaluate the amount of mineral content and vital bone formation radiographically.


Eligibility Criteria:
* Inclusion Criteria:

  * Current smokers
  * have at least one tooth indicated for extraction due to extensive decay, tooth fracture or failed root canal treatment.
  * 21 years of age or older.
  * give a written consent to participate in the trial.
  * have the desire to have an implant restoration for at least one non-restorable tooth
  * indicated for socket preservation procedures and generally healthy with no systematic disease
* Exclusion Criteria:

  * subjects who unable to undergo oral surgery procedures due to a medical condition.
  * women who are pregnant or nursing a child.
  * subjects with dental infection of bone, active periodontal disease and ankylosed teeth.
  * Subjects with following systemic diseases and conditions: Chemotherapy or radiation for the treatment of cancer and arthritis, seriously impaired cardiovascular or pulmonary function, uncontrolled diabetes, auto-immune compromised diseases, kidney or liver disease and history of severe, multiple allergies.
Effects of Multidomain Intervention on Cognitive Function in Community-dwelling Elderly

The aging population has contributed to an increase in cognitive decline. To mitigate the rise in the dementia population, it is crucial to prevent cognitive decline in older adults with normal functioning, subjective cognitive decline (SCD), and mild cognitive impairment (MCI). Maintaining cognitive abilities as early as possible is essential for improved overall health and quality of life.

Healthcare for the elderly should focus on strengthening health promotion related to aging factors, such as cognitive function, mobility, nutrition, chronic disease management, oral health, fall prevention, transportation safety, psychosocial factors, and sleep. Additionally, as the etiology of dementia is multifactorial, numerous studies have been devoted to multidomain intervention, targeting multiple factors and domains in combination to enhance functions. The cumulative or synergistic effects of multidomain have garnered significant attention for their effectiveness in improving or maintaining the function of the elderly.

Therefore, this study aims to evaluate the effects of multidomain intervention, including combined physical and cognitive training, nutrition, chronic disease management, oral health, fall prevention, transportation safety, psychosocial factors, and sleep, on cognitive function in community-dwelling older adults.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 60 years old
2. Mini-Mental State Examination (MMSE) score \> 20 (Folstein et al., 1975), able to follow instructions and participate in activities
3. With self-reported or caregiver-reported memory or cognitive-related problems
4. No diagnosis of any type of dementia

Exclusion Criteria:

1. Unstable medical condition that would prevent safe participation in exercise training (e.g., myocardial infarction, heart failure, recent cardiac surgery, severe asthma, concomitant neurological disorders, or joint deformities)
2. Participation in other studies
3. Inability to provide informed consent
Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Acute Myeloid Leukemia With t(8;21)

Acute myeloid leukemia (AML) is the most common hematological malignancies in adult patients with leukemia, and t(8;21) AML accounts for a substantial proportion of AML. AML patients with t(8;21) possess a favorable outcome and 3 - 4 course high dose cytarabine (3 g/m2) is the standard consolidation therapy for these patients with a 5-year overall survival approximately 60%. In China, intermediate dose cytarabine (1 - 2 g/m2) is used for consolidation therapy due to toxicities. After 3 - 4 course cytarabine consolidation, maintenance therapy is performed with conventional chemotherapy with a 5-year overall survival approximately 60% as well. However, continuous chemotherapy may cause toxicities and inhibit patients' immune response. Exploring new drug for maintenance therapy is urgently needed. Decitabine has a potent ability to inhibit proliferation and induce apoptosis of AML1-ETO positive leukemia cell line. Furthermore, the immunomodulatory effect of decitabine was also reported by several studies. In this study, the investigators plan to carry out a prospective, multicenter, randomized, controlled trail to compare decitabine versus conventional chemotherapy for maintenance therapy of patients with AML with t(8;21). Results of this trial may optimize the treatment for AML patients with t(8;21) in the setting of intermediate dose cytarabine consolidation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients are adults age ≥18 and ≤60 years
2. Patients are diagnosed as AML with t(8;21)
3. Continuous complete remission after induction and consolidation therapy with 3 - 4 course high dose cytarabine (2 g/m\^2)
4. Patients whose aspartate transaminase (AST)/alanine transaminase (ALT) are ≤ 2.5 times higher than the normal upper limit, total bilirubin ≤ 3.0 mg/dl, and serum creatinine ≤ 2.0 mg/dl.
5. Subjects that signed the informed consent, which indicated they understood the purpose, the procedure and potential benefits of the trial and were willing to participate in the trial.

Exclusion Criteria:

1. Pregnant or lactating women.
2. ECOG performance status score \> 2.
3. Patients are candidates for hematopoietic stem cell transplantation.
4. Patients with a history of use of azacitidine or decitabine.
5. Patients with mental or other disorders that cannot completely cooperate with the treatment or follow up.
6. Subjects that were allergic to decitabine vehicle.
7. Patients receive immunotherapy.
8. Patients also have other organ malignant tumor.
9. Participating in other clinical research in the same period.
10. The researchers estimate that patients cannot enter the clinical trial.
Observational Trial Evaluating Elevated Factor VIII Related Labs as a Biomarker for Incomplete Relapse Recovery

Nine Multiple Sclerosis (MS) patients suffering an acute relapse from the outpatient or inpatient settings will be consented to be followed prospectively for three months post relapse, in an effort to identify markers of incomplete relapse recovery. Factor VIII-related labs will be drawn for three months without influencing standard of care treatment decisions. During this time, patients will be followed with clinical and diagnostic assessments in addition to blood tests including: Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC), recovery surveys, and MRIs of the brain, cervical spine, and thoracic spine with and without contrast. Clinical, imaging, and Factor VIII-related lab data individually or in aggregate will be correlated with relapse presence, severity, and extent of recovery following standard treatment interventions.

The identification of blood tests that detect patients having disability provoking Multiple Sclerosis (MS) relapses in real time could lead to a new era of MS relapse treatment. The cross-talk between inflammatory and coagulation pathways in multiple sclerosis has been recognized on some level for decades. Accidental and anecdotal clinical observations suggest that excessive activation of the intrinsic coagulation pathway, namely with increased Factor VIII activity, occurs with some MS relapses, and that these are the relapses that don't recover with current standard of care treatments, leaving behind permanent disability.

To test this hypothesis that real time abnormally increased levels of Factor VIII activity related labs can identify disabling relapses in real time, nine adult patients with relapsing remitting MS with or without secondary progression will be consented and enrolled in this observational, longitudinal clinical trial. Patients will receive standard of care treatment per the investigator's discretion for their relapse, but will have additional blood tests testing Factor VIII activity, Factor VIII antigen, serum neurofilament among others drawn on days 1, 8, 22 and 90 of the study. The investigator and the patient will not know these lab test results. Patients will also have mris of the brain, cervical spine, and thoracic spine done with and without contrast as soon as possible upon study entry. On Days 1,8,22, and 90, in addition to blood tests, the patient will complete an EDSS and MSFC (that looks at ambulation, hand/arm coordination, and cognitive function, comprised of the 25 foot timed walking tests, with and without any assistive devices if possible), and fill out a recovery survey. Individual blood tests, aggregate blood tests, mri findings, EDSS and MSFC individual and summed scores will be scrutinized and evaluated for the ability to identify a MS relapse and to identify a treatment-resistant MS relapse

Eligibility Criteria:
Inclusion Criteria: Identified by prinicipal investigator as having an acute multiple sclerosis relapse of less than 30 days duration

-

Exclusion Criteria:

Inability to have a MRI
Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy

Studies suggest that the timing interval between oral intake and the 1-hour gestational diabetes screen may have a significant impact on gestational diabetes screening glucose levels. The investigators plan to conduct a prospective randomized trial comparing a 6-hour fast versus liberal oral intake within 2 hours prior to the glucose tolerance test in pregnancy in order to evaluate the effect of the fasting versus the fed state on routine gestational diabetes screening results.

Gestational diabetes (GDM) complicates approximately 400,000 pregnancies in the United States annually and is associated with significant adverse pregnancy outcomes, including increasing the lifetime risk of type 2 diabetes. The American College of Obstetricians and Gynecologists (ACOG) recommends that all pregnant women undergo GDM screening between 24-28 weeks gestation utilizing a 1-hour oral glucose tolerance test that was designed to be administered without regard to the last meal or time of day. However, studies suggest that the timing of one's last meal prior to the 1-hour GDM screen may have a significant impact on GDM screening glucose levels. In addition, providers routinely alter the timing of the 1-hour GDM screen based on patients' self reported oral intake prior to the exam. The investigators plan to conduct a prospective randomized trial comparing a 6-hour fast versus liberal oral intake within 2 hours prior to the glucose tolerance test in pregnancy in order to evaluate the effect of the fasting versus the fed state on routine GDM screening results.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant patients 18 years and older
2. Singleton gestation
3. Pregnancy managed at Lucile Packard Children's Hospital (LPCH) Stanford outpatient obstetrics clinic
4. Planned delivery at Lucile Packard Children's Hospital (LPCH) Stanford Labor and Delivery unit

Exclusion Criteria:

1. Pregestational diabetes
2. Gestational diabetes diagnosed in the 1st trimester
3. Less than 18 years of age
4. Planned delivery outside LPCH
5. Diabetes medication use prior to pregnancy
6. Inability to give informed consent
7. Chronic steroid use in pregnancy
8. Less than 24 weeks of gestation at the time of the 1 hour oral glucose tolerance test
9. Prior history of bariatric surgery
10. Multifetal gestation
Mesenchymal Stem Cells for the Treatment of COVID-19

This double blind, placebo controlled, multi-arm, multi-site study investigates the safety and efficacy of stem cell therapy for the treatment of patients admitted to hospital suffering complications from COVID-19 and the treatment of healthy subjects (healthcare providers) for prophylactic effect following those patients.

Recent preliminary data from Wuhan/China have claimed that intravenous injections of mesenchymal stem cells derived from human umbilical chords have resulted in complete recovery of COVID-19 infected elderly patients with respiratory failure.

This study investigates the efficacy and safety of a single umbilical cord derived stem cell intravenous injection in patients with suspected or confirmed COVID-19 infection with fever and respiratory illness.

A second arm will test efficacy and safety of a single umbilical cord derived stem cell intravenous injection to healthcare providers at high exposure rates to COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Ability to provide informed consent

Exclusion Criteria:

* Active or recent malignancy (within last 2 years)
* Inability to provide informed consent
* Current enrollment in any other COVID-19 treatment study
A Diagnostic Study on Patients With Drug-induced Liver Injury

This study is a multi-center, prospective, non-interventional cohort study with an estimated enrollment of 600 patients with acute DILI. According to the inclusion and exclusion criteria, the RUCAM scale and/or expert evaluation, patients with a clinical diagnosis of acute DILI will be included in the study to establish a multi-center, prospective DILI cohort. Depending on the presence or absence of associated chronic liver disease, the patients will be divided into the basic DILI group with chronic liver disease and basic DILI group without chronic liver disease. All enrolled patients should complete at least six months of follow-up.

This study is a multi-center, prospective, non-interventional cohort study with an estimated enrollment of 600 patients with acute DILI. According to the inclusion and exclusion criteria, the RUCAM scale and/or expert evaluation, patients with a clinical diagnosis of acute DILI will be included in the study to establish a multi-center, prospective DILI cohort. Depending on the presence or absence of associated chronic liver disease, the patients will be divided into the basic DILI group with chronic liver disease and basic DILI group without chronic liver disease. All enrolled patients should complete at least six months of follow-up.

This research will propose a new or optimized DILI diagnostic scheme based on the analysis of the problems existing in the practice of RUCAM scale, the clinical characteristics and prognosis of DILI, the exploration of biomarkers, and all the comprehensive information of big data from Hepatox platform, and establish a big data-based diagnosis model or auxiliary diagnosis decision system.

Eligibility Criteria:
Inclusion Criteria:

* No restriction on age and gender.
* Patients need to meet one of the following biochemical thresholds for acute liver injury recommended by the international consensus:

  1. ALT \< 5 x ULN
  2. ALP \< 2 x ULN
  3. ALT 3 ULN and TBIL 2 ULN
* The duration of liver biochemical abnormalities does not exceed 90 days.
* For the clinical diagnosis of acute drug-induced liver injury, the RUCAM scale ≥ 6 points is required. However, if the RUCAM scale score is 3-5 points, the opinions of 3 experts are needed to confirm the diagnosis of DILI, and the patients can only be enrolled after the experts agree to it.
* The patient signs the informed consent form after fully understanding the nature of the study, the nature of his/her disease, related treatment methods, and the potential risks associated with participating in the trial.

Exclusion Criteria:

* Non-drug induced liver injury
* An inability to complete the visits prescribed by the study
Human Fresh Corneal Lenticule Implantation Criteria in Progressive Corneal Disease Using Relex-Smile

Stroma is a fibrous, tough, transparent and the thickest layer of the corneae. The stroma is composed of organised collagen, which maintains transparency. Keratocytes are located between the lamella collagen fibers and secrete an extracellular matrix, which includes collagen, proteoglycan, crystalline proteins to maintain corneal transparency.

Knowing the importance of stroma(90%) in function and anatomy of corneae (transparence, curvature, strength, protection) the inner eye structures from external environment, we have examined the role and function of stroma as a main factor of corneal thickness in implanting fresh corneal lenticule in progressive corneal disease.

We have studied that in many clinical cases where the corneal epithelium and endothelium are healthy and functioning, the cornea can still lose it's transparency by different corneal stromal pathologies (infection ,keratoconus, inflammation ,neurodegeneration and corneal dystrophies).

Eligibility Criteria:
Inclusion Criteria:

* progressive corneal disease with thin corneal thickness
* corneal low transparenc
* low visual acuity

Exclusion Criteria:

* active anterior segment pathology
* previous corneal or anterior segment surgery
* other infection etc.
A Study Evaluating Near-infrared Zone II Imaging in Sentinel Lymph Node Mapping in Breast Cancer Patients

This study aims for evaluating near infrared zone II imaging in sentinel lymph node mapping in breast cancer patients.

Multi-wavelength fluorescence has been surveyed in various fields of surgery. However, it was still under investigation, and has not been matured for clinical use. This study will evaluate near infrared zone II spectrums for breast cancer patient undergoing sentinel lymph node mapping with near-infrared fluorescence navigation.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer, adults

Exclusion Criteria:

* Patient aged \< 20 years old
* Primary lesion without indication of sentinel lymph node biopsy in current guidelines (Low-risk ductal carcinoma in situ or metastatic breast cancer)
* Patient who is allergic to primary tracers (including Tc99m and blue dye)
* Patient who is allergic to indocyanine green