cyrilzakka/clinical-trials huggingface dataset:
Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery

This study is being conducted to determine what dexmedetomidine does to the body and in turn, what how the body handles the medication. This medication, for the purpose of this trial, is used as a short-term sedative for infants who are immediately post-operative from cardiac surgery and have a breathing tube and are breathing with the assistance of a mechanical ventilator or breathing machine.

This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in infants who are immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus doses and infusion doses will be administered to a total of 36 evaluable patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be greater or equal to one month or less than or equal to 24 months of age.
* Post operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
* Planned tracheal extubation within 24 hours post-operatively.
* Adequate renal function(1-12 months old creatinine less than or equal to 0.6mg/dL and \>12 months to 24 months creatinine \< or= to 1.0mg/dL)
* Adequate liver function(Total bilirubin \< or= 1.5mg/dL and ALT 1-12 months \< or = to 165 U/L and \> 12 months to 24 months \< or = to 90 U/L)
* Isolated heart surgery
* Informed consent

Exclusion Criteria:

* Patients who have received another investigational drug within the past 30 days.
* Receiving continuous infusions of muscle relaxants in the postoperative setting.
* Patients whoo have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection.
* Patients, who, int he opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
* Patients who show signs or symptoms of elevated intracranial pressure.
* Post-operative hypotension based on age.
* Preexisting bradycardia based on age.
* Heart block
* Weight \< 5kg
* Patients, who in the opinion of the investigator, are not appropriate candidates for an investigational drug study.
Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke

Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) has been found to improve neurological function and life ability of AIS patients and approved for the treatment of AIS by China Food and Drug Administration (CFDA). A recent study imply that the neuroprotective effect of DELP involved multiple neuroprotective mechanism such as anti-inflammation, free radical scavenging, and decreasing MMP-9. Based on the multiple mechanisms, the investigator argues that DELP may exert neuroprotective effect on acute cerebral hemorrhage (ACH). In this context, the prospective, random, open-label, blind-endpoint, multi-centre study is designed.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80;
* Spontaneous cerebral hemorrhage;
* Deep supratentorial intracerebral hemorrhage (basal ganglia) with hematoma volume 5-40ml, or supratentorial lobar hemorrhages with hematoma volume 5-30ml;
* NIHSS: 6-20;
* Time from onset to DELP: 6-48 hours;
* Premorbid mRS 0 or 1;
* Signed informed consent;

Exclusion Criteria:

* Secondary cerebral hemorrhage (secondary to trauma, tumor, vascular malformation, hemorrhage transformation of ischemic stroke, etc.);
* Comatose patients on admission (GCS score 3-8 on the Glasgow Coma Scale);
* Patients with intracerebral hemorrhage ruptured into the ventricle, which should be treated by surgery;
* Planed surgery;
* Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
* Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg), or hypotension (systolic blood pressure below 90mmHg or diastolic blood pressure below 60 mmHg);
* Previous allergy to heparin or calcium;
* Life expectancy is less than 6 months due to comorbidity
* Infected at the venipuncture site
* hypoproteinemia;
* Unsuitable for this clinical studies assessed by researcher.
Motor-cognitive Interventions Are Effective in Improving Cognitive Function in Older Adults With Mild Cognitive impairment--a Chinese Sample

Mild cognitive impairment (MCI) is a syndrome that occurs in the preclinical stage of Alzheimer, and early intervention can be effective in preventing Alzheimer, but further research is needed on intervention methods. In order to identify interventions that are more suitable for Chinese characteristics and to investigate the effects of a motor-cognitive intervention on the cognitive function of older adults with MCI, investigators screened 103 community-dwelling older adults with MCI aged 65 years and older in Qingdao, Shandong, China, and divided them into an intervention group and a control group, and administered a motor-cognitive intervention to the intervention group for 12 weeks. Investigators assessed the cognitive abilities of MCI participants using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA). There were no demographic differences between the intervention and control groups. Investigators found that the cognitive abilities of the intervention group were significantly improved at the end of the intervention as well as at the end of the follow-up compared to the control group. The results of the current study suggest that the motor-cognitive intervention investigators used significantly improved cognitive function in older adults with MCI and was easy for older adults to master, and that it was a good intervention for cognitive function in older adults with MCI in the Chinese community.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years old;
* The screening results were mild cognitive impairment;
* Those who have the ability to walk independently or use auxiliary tools and can ·Communicate with each other normally;
* Informed consent, willing to participate in the researcher.

Exclusion Criteria:

* People with mental disorders;
* Patients with serious organ diseases, such as kidney and heart failure;
* People with mobility disabilities.
Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients

Transfusion of stored blood has been associated with increased pulmonary vascular resistance in lambs. The investigators hypothesize that transfusion of one unit of red blood cells stored under standard conditions in intensive care patients will increase pulmonary arterial pressure and pulmonary vascular resistance to a greater extent than will one unit of fresh red blood cells.


Eligibility Criteria:
Inclusion Criteria:

1. The patient has a pulmonary artery catheter in place
2. Transfusion of 1 unit of packed red blood cells indicated for standard intensive care therapy
3. The patient has an arterial catheter

Exclusion Criteria:

1. Age \< 18 years
2. Clinical prediction that the patient will not survive at least 48 hours
3. Acute bleeding: \> 2 units of packed red blood cells/hour
4. Vasopressor use: noradrenalin \> 0.2 μg/kg/min or any use of adrenalin within 6 hours of inclusion into the study
5. Therapy with inhaled NO, inhaled prostacyclin, or phosphodiesterase-5-inhibitors
6. Sepsis
Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study

ZPE-201 Extension of treatment

This is an extension of the phase II, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of Proellex® was administered once-daily for four (4) months.

Eligibility Criteria:
Inclusion Criteria:

* Only subjects treated in the ZPE-201 study will be allowed to enter the extension study.
* Subjects who withdrew from ZPE-201 due to lack of treatment efficacy will also be invited to participate.

Exclusion Criteria:

* All other subjects
Association Between Levels of D-Dimer, Fibrinogen and PAI-1 in Elderly Patients With Infection and Occurrence of Cardio- and Cerebro-vascular Disease After Discharge

The association between the levels of d-dimer, fibrinogen and PAI-1 in plasma of elderly patients admitted to internal medicine departments because of infection and the occurrence of cardio- and cerebro-vascular disease after discharge


Eligibility Criteria:
Inclusion Criteria:

* Acute infection

Exclusion Criteria:

* Anticoagulant therapy
A Study to Evaluate the Safety of THR-687 in Subjects With Diabetic Macular Edema (DME)

This study is conducted to evaluate the safety of a single intravitreal injection of THR-687.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older
* Type 1 or type 2 Diabetes Mellitus
* Central-involved DME with central subfield thickness of ≥ 320µm on Spectralis® spectral domain optical coherence tomography (SD-OCT) or ≥ 305µm on non-Spectralis SD-OCT, in the study eye
* Best-corrected visual acuity (BCVA) ≤ 62 and ≥ 23 ETDRS letter score in the study eye
* Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

* Macular edema due to causes other than DME
* Concurrent disease in the study eye, other than central-involved DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
* Any condition that could confound the ability to detect a change in central subfield thickness in the study eye
* Previous confounding treatments / procedures, or expected to require confounding treatments / procedures at any time during the study period
* Presence of neovascularization at the disc (NVD) in the study eye
* Uncontrolled glaucoma in the study eye
* Any active ocular / intra-ocular infection or inflammation in either eye
* Poorly controlled Diabetes Mellitus
* Uncontrolled hypertension
Meropenem Dosage Strategy Based on PPK Model

To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract infection patients.

* Subjects:lower respiratory tract infection patients
* Study design:randomized control study.The patients in study group will accept meropenem therapy with the regimen decided by a software developed from a PPK-PD model. The patients in control group will accept meropenem therapy with the regimen decided by attending physician.
* Primary endpoint: clinical successful rate of meropenem therapy. The clinical efficiency of meropenem therapy will be evaluated one week later from stop of meropenem therapy.
* Second endpoint: amount of used antibiotics and bacteriological successful rate.

Eligibility Criteria:
Inclusion Criteria:

* Sixty years and older patients hospitalized at the Peking University Third Hospital with community-acquired or hospital-acquired lower respiratory tract infection.
* Bacilli was idolated from lower respiratory tract specimens within 48 hours prior to study enrollment.
* The pathogen was sensitive to meropenem.
* Received broad-spectrum antibiotic therapy less than 24 hours, or no improvement after antibiotic therapy and pathogen was resistant to the used antibiotics.

Exclusion Criteria:

* Had documented hypersensitivity to carbapenems.
* More than one pathogenic Gram-negative bacillus was isolated lower respiratory tract specimens.
* Positive HIV antibody titre.
* Had known or suspected tuberculosis or other infections caused by Gram-positive cocci, viruses or fungi at baseline.
Effectiveness of Counseling Interventions to Modify Risk Behaviors in Patients at the Hospital San Ignacio.

Randomized clinical trial that aims to determine the effectiveness of a counseling intervention to modify the stage of behavioral change in risk behaviors (smoking and risky alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at the Hospital Universitario de San Ignacio. Bogotá-Colombia

Objective: to determine the effect in the behavioral change stage of an intervention to modify risk behaviors (smoking and risky alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at the Hospital Universitario de San Ignacio. Design: controlled clinical trial with random assignment Population: patients candidates for scheduled surgery or diagnostic procedures in surgery rooms between 19 and 64 years attending the pre-anesthetic consultation of the Hospital Universitario de San Ignacio. Interventions: brief behavioral intervention to modify risk behaviors versus information material on healthy lifestyles. Measurements: the characteristics of the study population will be described and the intervention and control groups will be compared in their basic conditions. The level of advance in the stage of change in the intervention and control arm, the proportion of people with the presence of the risk factor, as well as the decrease in the consumption of tobacco and alcohol will be compared. Expected duration: 28 months. Financing: Hospital Universitario de San Ignacio and Pontificia Universidad Javeriana. Ethical aspects: the study is adjusted to international and national standards for research projects. Under this norm, it is classified in the category of minimum risk because it is a clinical experiment with a common intervention in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* candidates for scheduled surgery with a hospital stay of 3 days or less (including ambulatory surgeries) or who attend outpatient diagnostic procedures performed in surgery rooms.
* Current smokers (any tobacco product in the last month and more than 100 cigarretes in life) or risky alcohol drinkers (more than 4 or 5 alcohol standard drinks during the last year and AUDIT score between 8-15 points)
* patients with contact information
* Patients that want to participate

Exclusion Criteria:

* People who are being treated for smoking cessation or decreased consumption of alcohol.
* People with diseases that compromise their ability to understand information or their ability to verbal communication
* Patients with dependence or abuse of alcohol or other psychoactive substances other than tobacco
* Patients in action or maintenance stages of behavioral change against their risk factor
Supplemental Oxygen in Pulmonary Embolism (SO-PE)

A study of how supplemental oxygen helps patients with acute pulmonary embolism (PE).

Hypothesis: Oxygen affects right ventricular dysfunction (RVD) in patients with acute pulmonary embolism (PE) primarily by relieving hypoxic pulmonary vasoconstriction and reducing pulmonary pressure (PA) pressure, and that this process is metabolically driven.

In the Emergency Department (ED), investigators will perform a randomized, crossover trial of adult patients with acute PE.

Study subjects will be randomized to one of two interventions (supplemental oxygen delivered by facemask) vs. room air. Therapy will be alternated at t=30, t=60, t=90 minutes, and then maintained for 180 minutes.

After each treatment change, and at 180 minutes, investigators will: 1) perform echocardiograms to determine how oxygen affects right ventricular dysfunction (RVD) and, 2) draw blood for metabolomic analyses to determine the metabolic pathways that change in response to oxygen therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years old
* Confirmed Pulmonary Embolism (PE) on computed tomography pulmonary angiography (CTPA) performed \<24 hours prior to enrollment
* Symptom duration \<72 hours
* Confirmation of right ventricular dysfunction (RVD) by clinician
* Oxygen saturation ≥90% while breathing room air

Exclusion Criteria:

* Hemodynamic instability
* Use of vasopressors or mechanical circulatory support
* Planned use of thrombolytics or plan for embolectomy
* Oxygen saturation \<90% while breathing room air at any time in the Emergency Department (ED)
* New onset arrhythmia
* History of pulmonary hypertension, chronic obstructive pulmonary disease (COPD), hypoventilation syndrome, or congestive heart failure (CHF) with left ventricular ejection fraction \<40%
* Known pregnancy
* Use of chronic oxygen therapy at baseline
* Vasodilator medication used in the past 24 hours
* Symptom onset ≥72 hours
* Inability to wear a face mask
* Technically inadequate baseline echocardiogram
* Temperature \>39° C
* Positive test for Covid-19 or influenza within the previous 10 days
Using QPOP to Predict Treatment for Sarcomas and Melanomas

This is a multi-cohort proof of concept study involving patients with sarcomas or melanomas. Patient models, both two- and three-dimensional, will be derived from tumour samples. These will then be used to evaluate drug sensitivities ex vivo.

Enrolled patients will undergo resections or biopsies as part of standard-of-care, which will be used to generate patient models. Patients will receive standard-of-care systemic treatment. Patient models will also be subjected up to a 14-drug screening panel. The majority of drugs in the respective drug panels has been shown to have activity in the respective cancers and would be used in the standard-of-care setting by treating physicians.

Hypothesis: Ex vivo drug testing on patient-derived models using QPOP can identify drug sensitivities and combinations which may have clinical efficacy against sarcomas and melanomas.

Specific aim 1: To derive patient models, both two- and three-dimensional, of sarcomas and melanomas

Specific aim 2: To perform ex vivo drug testing on patient models of sarcoma and melanoma using QPOP

Specific aim 3: To assess the efficacy of phenotype directed therapy using QPOP to assign treatment after progression on standard-of-care treatment in sarcoma and melanoma

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sarcoma or melanoma
* At least 1 tumour lesion amenable to fresh biopsy or resection
* Signed informed consent from patient or legal representative
* Able to comply with study-related procedures

Exclusion Criteria:

* There are no specific exclusion criteria if patients meet the inclusion criteria
Assessment of Potential Interactions Between Cocaine and Tolcapone - 1

The purpose of this study is to assess the potential interactions between intravenous (IV) cocaine and tolcapone.

Double-blind, inpatient study by screening responses to cocaine infusions of 20 and 40 mg i.v. subjects into 1 of 2 treatment groups to assess potential interactions between i.v. cocaine infusion and treatment with tolcapone.

Eligibility Criteria:
Inclusion Criteria:

Volunteers dependent on cocaine and are non-treatment seeking; between 18-45 yrs of age; DSM-4 criteria for cocaine abuse or dependence

Exclusion Criteria:

Additional criteria available during screening at the site
Repeatability of Magnetic Resonance Imaging in Patients With IDH1 Mutant Glioma on Ivosidenib

The purpose of this study is to evaluate the repeatability of magnetic resonance imaging (MRI) in patients with isocitrate dehydrogenase 1 (IDH1) mutant (mIDH1) low-grade diffuse glioma \[World Health Organization (WHO) grade 2\] who are receiving off-label ivosidenib.

40 adult patients with histologically low-grade mIDH1 glioma (WHO grade 2) who are being seen at Duke Preston Robert Tisch Brain Tumor Center (PRTBTC) for treatment or evaluations, will be included in this protocol. Patients included in this protocol must currently be receiving off-label ivosidenib per recommendation of their treating physician and must be scheduled to receive a routine contrast-enhanced brain Magnetic Resonance Imaging (MRI) scan as part of their clinical care. The images from the routine MRI scan will be obtained as part of the patient's clinical care and will only be used in this research study if the patient agrees to be on-study by signing the informed consent form (ICF).

Subjects will undergo a routine Brain Tumor Imaging Protocol MRI scan with additional imaging sequences, in order to create a database of short interval "coffee break" repeat MRI sets. Subjects will begin their MRI by having T1-pre, T2w, and volumetric 3D Fluid Attenuated Inversion Recovery (FLAIR) images. The subject will be brought out of the magnet, sat up and then have the standard Brain Tumor Imaging Protocol MRI scan performed.

Subjects will remain on this study for the one day during which they are scheduled to receive their MRI scan

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent prior to beginning specific protocol procedures
2. Scheduled for contrast-enhanced magnetic resonance imaging (MRI) as part of clinical care
3. Histologically IDH1 mutant low-grade glioma (WHO grade 2) and actively receiving ivosidenib
4. Active patient treatment or evaluations at the Preston Robert Tisch Brain Tumor Center at Duke
5. Age ≥18 years and ≤70 years
6. Karnofsky performance index ≥70%
7. Primary treating physician approval

Exclusion Criteria:

1. Inability to have MRIs
Safety Study and Therapeutic Effects of Umbilical Cord Blood Treg on Autoimmune Diabetes

The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo expanded umbilical cord blood regulatory T cells on autoimmune diabetes.

The regulatory T cells (Treg) used in this study will be produced from human umbilical cord blood. The umbilical cord blood will be freshly collected and immediately separated to buffy coat in a GMP laboratory, thus to be further sorted into Treg and other subsets. Then the Treg will be expanded ex-vivo for approximately 14 days until tested for its surface markers and suppressive ability. During the time of ex-vivo expansion, eligible autoimmune diabetes patients will be recruited and admitted to our hospital in order to go through required examinations. Once the Treg product has reached the safety and efficacy standards, the patient will receive the Treg product infusion under close surveillance of doctors and then go through regular follow-ups to investigate the safety and therapeutic effect of the Treg product on autoimmune diabetes patients.

Eligibility Criteria:
Inclusion Criteria:

1. Autoimmune diabetes patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association
2. Diagnosis of Autoimmune Diabetes within 3 years of screening
3. Between 6 to 60 years of age
4. Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A
5. Fasting or postprandial plasma C-peptide more than 200 pmol/L
6. Written informed consent from the patient or the patient's parents for patients under the age of 18 years

Exclusion Criteria:

1. Any clinically significant diseases in liver (ALT and AST over 2 times upper normal limit), kidney (Scr over 133umol/L), and heart
2. Presence of anemia (Hb ≤100g/L), leukopenia (\<3.5×10\^9/L)
3. Presence of disorder in coagulation or anticoagulation, or thrombocytopenia (platelets \<100×10\^9/L)
4. Presence of acute metabolic disorders; In the case of acute ketone acidosis, with blood ketone over 0.3mmol/L and pH lower than 7.30
5. Presence of any kind of chronic infection or immune deficiency, including hepatitis B, hepatitis C, HIV, syphilis or tuberculosis
6. Chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3 months
7. Any history of malignancy
8. Female patients who are pregnant or breastfeeding; any female who is unwilling to use a reliable and effective form of contraception for 2 years afer recruitment
9. Presence of any infectious diseases, including active skin infections, flu, fever, upper or lower respiratory track infections; those who wish to participate in the study should keep the infection under control for at least 1 week before receiving Treg product infusion
10. Presence of diabetic microvascular or macrovascular diseases
11. Presence of hypertension
12. Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial