cyrilzakka/clinical-trials huggingface dataset:
The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation

The aim of this research is to design a randomized controlled clinical study, which is based on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD and rejection reaction will be observed, and the occurrence time and degree of adverse reactions caused by immune inhibitors will be identified. In the meantime, providing a possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.

Liver transplantation is the most effective treatment for end-stage liver disease, yet long term survival is limited by acute and chronic rejection reaction and adverse reactions caused by immune inhibitors. However, effective guideline of immune inhibitors regimen after liver transplantation is lacking. Human major histocompatibility antigens (HLA) is crucial in renal transplantation, while the role in liver transplantation is unclear. It is reported that HLA matching was closely related to the occurrence of graft versus host disease (GVHD) after liver transplantation. And by reducing or removing the immune inhibitors can change the course of illness, improve prognosis, at the same time conduce to induce immune tolerance. Therefore, the investigators have the reason to believe that HLA matching rate has closely association with postoperative immune status of patients after liver transplantation, which may guide immune inhibitors regimen. The aim of this research is to design a randomized controlled clinical study, which is based on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD and rejection reaction will be observed, and the occurrence time and degree of adverse reactions caused by immune inhibitors will be identified. In the meantime, providing a possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* patients signed informed consent，patients with good compliance

Exclusion Criteria:

* autoimmune liver disease,ABO incompatibility,combined organ transplantation,re-transplantation
PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase

The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intraventricular hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase.

The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intracerebral hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase.

The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.

The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.

The enrollment period will end once 20 evaluable subjects have been enrolled in the registry. Each subject will be in the registry for approximately 1 month.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years in age
2. Patients presenting with Intraventricular Hemorrhage (IVH) qualifying for hematoma evacuation
3. Controlled SBP ≤ 180 mmHg after initial NCCT scan and prior to the initiation of the MIS procedure
4. Hyper-acute phase, as defined by initiation of the MIS procedure no longer than 12 hours from initial NCCT scan and no longer than 18 hours since time patient last known well
5. Symptomatic with radiographic evidence of cerebral compression edema
6. Pre-stroke mRS 0 - 2

Exclusion Criteria:

1. Presence of tentorial herniation and/or Kernohan's phenomenon
2. Uncontrolled ICP as defined as \> 25 mmHg for more than 30 min for 3 consecutive hours after External Ventricular Drain (EVD) placement
3. Requirement of insulin drip
4. Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment
5. Unable to obtain consent from patient or legally authorized representative (LAR) (for patients without competence)
6. Presenting epilepticus that is not controlled
7. Nonreversible coagulopathy (INR \> 1.4) or platelet deficiency (\< 75 x 103 cells/mm3) not able to be corrected with currently accepted treatment medications
8. Contraindication to conventional angiography, CTA, and MRA
9. Life expectancy of \< 2 months
Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction

The aim of the study is to prove that early discharge (within 72 hours) in selected group of patients after myocardial infarction with elevations of ST-segment is feasible and safe

The aim of the study is to prove

* that early discharge (within 72 hours) in selected group of patients with low risk of follow-up complications after myocardial infarction with elevations of ST-segment, treated with primary percutaneous coronary intervention, is feasible and safe
* that early discharge is comparable with the group of patients, discharged in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day), thus it is not associated with higher incidence of complications in 90th day after myocardial infarction

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age ≥18 do ≤ 75 years
* Acute myocardial infarction with ST-segment elevation, treated with successful percutaneous coronary intervention within 12 hours from the onset of symptoms
* Left ventricle ejection fraction ≥ 45% by echocardiography
* Single- or two-vessel disease (stenosis of major epicardial artery ≥ 70%)
* Haemodynamic and rhythmic stability (Killip class I, no arrythmia requiring treatment occurring \> 2 hours after PCI)
* Assumed good cooperation and social background

Exclusion Criteria:

* Symptoms of residual ischemia
* Significant comorbidities or abnormalities in paraclinical tests, requiring additional evaluation within continuing hospitalization
* Contraindication of dual antiplatelet therapy or need for anticoagulation therapy
* Hihg risk of bleeding complications
* Participation in other clinical study
Probiotics Attenuate Postoperative Cognition Decline

The aim of this study was to evaluate whether perioperative probiotics can reduce the incidence of postoperative cognitive dysfunction and postoperative delirium.


Eligibility Criteria:
Inclusion Criteria:

1. . Age is greater than or equal to 65 years old
2. . Can communicate normally
3. . Selective knee ankle, hip replacement or lumbar open reduction and internal fixation under general anesthesia
4. . ASA graded at I-II level
5. . Patient or family informed consent

Exclusion Criteria:

1. . Have a brain disease, or have a history of brain disease
2. .MMSE check of less than 24 points.
3. . History of neurological and psychological disorders including AD, stroke, psychosis
4. . Serious hearing or visual impairment
5. . Preoperative systolic blood pressure \>190mmhg, or diastolic blood pressure \>100mmhg
6. . The patient or family refuses
To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer

The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.

An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease

Eligibility Criteria:
Inclusion Criteria:

* Written consent from Female or male patients aged 18 years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous 14 months prior to enrolment, and/or
* Have one or more symptoms that the Investigator believes to be related to the patient's MTC.
* World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
* Has measurable disease (at least one lesion, not irradiated within 12 weeks of study randomisation, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).
* Lesions must be amenable to accurate and repeat measurement.

Exclusion Criteria:

* Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization.
* Abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 2.5xULRR or 5.0xULRR if related to liver metastases).
* Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than 450 ms.
* Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
* For women only - currently pregnant or breast feeding.
A Study of BGM0504 in Participants With Obesity

To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* ● Able and willing to provide a written informed consent.

  * Male or female subjects, 18-65 years of age at the time of signing informed consent.
  * At screening visit, 35.0 ﹤BMI﹤ 45.0 kg/m2;
  * Diet and exercise control for at least 3 months before screening visit, and be of stable weight (± 5%) self-reported change within the last 3 months.

Exclusion Criteria:

* ●History of chronic or acute pancreatitis.

  * History of severe drug allergy or specific allergic disease or severe allergies.
  * Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2(MEN-2).
  * History of malignant tumors \[except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma\].
  * Suspected or confirmed history of alcohol or drug abuse;
  * Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
  * Donation or loss of 400 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial.
  * Pregnant or lactating woman.
  * Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients

The intention of this study is to determine whether the precision of the measure of cardiac output can be optimized by conducting the measurement while the participant is instructed to exhale slowly. This will be compared to measurements done at random to respiration and timed with the participant's spontaneous expiration.


Eligibility Criteria:
Inclusion Criteria:

* Every patient that receives a pulmonary artery catheter (PAC) related to elective cardiac surgeries,
* informed and written consent to participation in the study in accordance with the Helsinki declaration
* hemodynamic stability

Exclusion Criteria:

* Hemodynamical instability
* atrial fibrillation
* tricuspid insufficiency ≥ grade 2
* hemodialysis or other conditions where extra volume load can be negative,
* lack of ability to give a written consent to participate in the study
Improving Care Provided to Patients Treated in a Level 1 Trauma Center Post-suicide Attempt

The aim of the study is to refine, elaborate, and pilot a brief intervention for adult patients following a suicide attempt provided during hospitalization in an acute medical setting. 40 participants will be randomized to receive the brief intervention + care as usual or only care as usual. It is hypothesized that the intervention will be acceptable and feasible to both patients and intervention clinicians.

The aim of the study is to refine, elaborate, and pilot a brief intervention for adult patients following a suicide attempt provided during hospitalization in an acute medical setting, and will be addressed with a sample of cases (N = 40) from Harborview. The participants will be randomized into one of two groups: those that receive the intervention and those that do not. All participants will complete a battery of assessments The intervention is based on the theory of teachable moments, wherein timing in proximity to injury and appropriate treatment setting provide a unique opportunity to create patient behavioral change. The brief intervention consists of engaging the patient in conversation regarding suicidal ambivalence (desire to live vs. desire to die), collaborative discovery of primary and secondary drivers of suicidality, and safety planning. A guide to delivering the intervention has been completed and may undergo changes throughout the study. Adherence measures will be developed in order to assess the degree to which the clinician accurately provided the brief intervention without including additional therapeutic elements or leaving out elements required in the intervention guide. Best methods for integrating the brief intervention into services provided on medical and surgical units will be determined, as well.

Eligibility Criteria:
Inclusion Criteria:

* at least 15 years of age
* Inpatient on medical/surgical unit
* Admitted following a suicide attempt
* Sufficient English to benefit from psychotherapy in English
* Consents to be a research participant

Exclusion Criteria:

* Lack of sufficient English to participate in psychotherapy in English
* Prisoner/inmate at time of admission
* Too cognitively impaired, delirious, or psychotic to respond to psychotherapeutic intervention before end of stay on medical/surgical unit. Determination of cognitive impairment, delirium, agitation, and psychosis will be determined through the referral phone call between the PI and the referring care provider, as well as the PI's own clinical assessment of the patient at the outset of the brief intervention.
A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors

This is an open-label, first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK138D1 in subjects being treated for advanced solid tumors.

This study is comprised of two parts: the dose-escalation and dose-expansion stages. Dose-escalation stage aims to determine the MTD/MAD, while the dose-expansion stage is designed to establish the RP2D.

Eligibility Criteria:
Inclusion Criteria:

1. The subject must sign the written informed consent form (ICF) voluntarily;
2. At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
3. ECOG performance status score of 0 or 1;
4. Has a life expectancy of ≥ 3 months;
5. Subjects who have histologically or cytologically diagnosed locally advanced or metastatic solid tumor, which Is refractory to or intolerant to standard treatment;
6. At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.
7. Adequate organ function.

Exclusion Criteria:

1. Prior human epidermal growth factor receptor 3 (HER3) -targeted therapies, including antibodies, antibody-drug conjugates (ADCs), chimeric antigen receptor T-cell immunotherapy (CAR-T), and others;
2. Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
3. Presence of active central nervous system (CNS) metastases.
4. Patients with a history of non-infectious pneumonitis requiring systemic corticosteroid therapy; a history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis); currently suffering from ILD/pneumonitis or suspected of having such diseases based on imaging during screening;
5. Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;
6. Untreated subjects with active hepatitis B (HBsAg positive and HBV-DNA exceeding 1000 copies/mL (200 IU/mL) and above the lower limit of detection). For HBsAg-positive subjects, anti-hepatitis B therapy is required during the study; subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection) is also an exclusion;
7. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
8. Active syphilis infection;
9. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
10. Other reasons for ineligibility as evaluated by the investigator.
Effectiveness of Occupation-Based Intervention Compared With Therapeutic Exercise for Older Adults With Shoulder OA.

As a registered and licensed occupational therapist, I completed a six-week evidence based research study to determine the effects of occupation-based intervention and therapeutic exercises versus therapeutic exercises alone.

Importance: There is a need for evidence to support occupation-based intervention (OBI) for older adults with shoulder osteoarthritis (OA).

Objective: To evaluate the effectiveness of OBI on function in older adults with shoulder OA compared to therapeutic exercise (TE).

Design: Randomized controlled trial. Six-week intervention. 1-week and 4-week follow-up.

Setting: Outpatient clinic. Participants: Ten older adults with diagnosis of shoulder OA via convenience sampling.

Intervention: Participants were seen two times/week for six weeks. The OBI group completed 30 minutes of TE followed by 30 minutes of OBI. The TE group completed 60 minutes of TE.

Outcome and Measures: Functional outcomes were assessed at pre-, 1-week post, and 4-weeks posttreatment using the QuickDASH as the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of shoulder osteoarthritis (confirmed by physician examination or radiographic imaging)
* Aged 65 years or older

Exclusion Criteria:

* Previous shoulder injuries
* Acute pathology
* Previous shoulder surgery
* Current use of pain medication
* Inflammatory arthritis
* Upper extremity neuropathy or myopathy
* Current participation in a home exercise program
* Score of \<18 on the Mini-Mental State Examination (MMSE)
Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Clinical Effectiveness Study

Given the widespread use of anticonvulsants in the pediatric chronic pain population and the absence of scientific data supporting their use, the investigators propose a randomized, double blind, two group parallel design in which a broad group of children and adolescents with chronic neuropathic pain would be randomized to receive either Gabapentin or Oxcarbazepine.

The Primary Aim of the Study is to assess the frequencies of successful treatment of pediatric patients with neuropathic pain treated with either Gabapentin or Oxcarbazepine.

The Primary Hypotheses are as follows:

Hypothesis I: Both Gabapentin and Oxcarbazepine will result in significant reduction in pain scores when compared to each patient's baseline.

Hypothesis II: Patients who continue on active drug (Gabapentin or Oxcarbazepine) during the second phase of the trial will report greater pain reduction relative to baseline than patients who are randomized onto placebo at this randomization point.

Secondary Aims of the Study are to compare groups treated initially with Gabapentin or Oxcarbazepine with regard to reduction in pain scores (both at rest and with evoked maneuvers), functional disability scores, tolerability, and measures of mood and cognitive functioning.

Secondary Hypotheses are that Gabapentin and Oxcarbazepine differ in their effects on:

1. Pain scores at rest and with evoked maneuvers
2. Functional disability scores
3. Tolerability (frequencies of side-effects)
4. Depression and anxiety scales
5. Neuropsychological measures of cognitive processing speed, working memory, and attention.


Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 8 and 18 at the time of the study with history of chronic (lasting ≥ 4 weeks) neuropathic pain that includes a known injury to a peripheral nerve and/or a pattern of pain responses that includes allodynia, burning, paresthesias or dysesthesias will be included in this study, provided that informed consent has been given by parents.
2. Patient's whose pain rates between moderate to severe at the time of inclusion (ranging from 4-10 in a numeric pain rating scale)
3. Eligible diagnoses include Complex Regional Pain Syndrome, Fibromyalgia, Lumbar Radiculopathy, Spinal Cord Injury, Erythromelalgia, Small Fiber Neuropathies, Traumatic or Post-surgical Peripheral Nerve or Plexus Injuries, and Extremity Pain with severe pain to light touch (allodynia).
4. Child has age-appropriate spoken and written knowledge of English.
5. Parent may be able to utilize an interpreter if need be.

Exclusion Criteria:

1. Unstable psychiatric illness (suicidal ideation, disorganized behavior)
2. Uncontrolled Seizure disorder
3. Chronic Headaches only
4. Abdominal Pain only
5. Prior experience with anticonvulsants for pain treatment.
6. Patients with Syndrome of Inappropriate Secretion of Antidiuretic Hormone