cyrilzakka/clinical-trials huggingface dataset:
A Randomised-controlled Trial of an Oral Microbiome Immunity Formula in Recovered COVID-19 Patients

This study aims to evaluate the effectiveness of an oral microbiome immunity formula in modulating gut microbiota, enhancing immunity and reducing long-term complications and co-morbidities in patients who have recovered from COVID-19.

SARS-CoV-2, the cause of COVID-19, emerged as a new zoonotic pathogen of humans at the end of 2019 and rapidly developed into a global pandemic. It may develop severe or critical disease with respiratory failure requiring oxygen support and intensive care.

Natural infection by virus triggers an effective system immunity so that the host can resist or highly reduce the chance of re-infection.

In many cases, this protection can maintain a long period of time. However, the long-term immunities (over a year) and complications from the patients are not yet very clear. We found that COVID-19 survivors who have cleared the virus continued to have persistent altered gut microbiota and up to 80 percent had residue COVID-19 related symptoms including fatigue, difficulty in breathing, impaired memory and hair loss up to 6 months after discharge (LONG COVID-19).

Earlier studies from our CU Medicine have shown a link between altered gut microbiome and COVID-19 severity, and more patients who received a novel microbiome immunity formula (SIM01) achieved complete symptom resolution and developed neutralising antibody than those who did not (unpublished data). Research from the Faculty also reported that almost 40% of people in Hong Kong had significant gut dysbiosis especially in elderly and patients with diabetes, obesity or chronic diseases.

This study is a single-centre, triple-blind, randomized, placebo-controlled clinical trial that aims to evaluate the effectiveness of an oral microbiome immunity formula (SIM01) invented by the Chinese University of Hong Kong (CUHK) in modulating gut microbiota, enhancing immunity and reducing long-term complications and co-morbidities (e.g. sepsis, cardiopulmonary complications, metabolic syndrome, neuropsychiatric disorders) in patients who have recovered from COVID-19.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 18 and above;
2. Subjects who are mentally capable to participate in the study and provide informed consent;
3. Subjects who can communicate in Chinese or English;
4. Subjects who are ambulatory and do not have difficulties travelling to the clinics for follow-up;
5. Subjects who do not have plans to leave Hong Kong in the subsequent two years after recruitment; and
6. Subjects who agree to give informed consent voluntarily.

Exclusion Criteria:

1. Subjects who are unable to receive oral fluids;
2. Subjects who have received surgery involving the intestine within past 30 days;
3. Subjects who are pregnant or breastfeeding; and
4. Subjects who are immunocompromised, e.g. on cancer treatment, bone marrow/organ transplant, immune deficiency, poorly controlled HIV/AIDS.
Surgical Management of Complex Intracranial Aneurysms With Hybrid Operating Techniques

To evaluate the clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms, which could coexists with multiple risk factors.

Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms (CIAs), which could coexists with multiple risk factors. Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.

Objects: Patients with CIAs, coincident with inclusion and exclusion criterion and admitted in participating organizations.

Methods: Patients will be distributed into 2 groups, including traditional therapy group(control group) and hybrid operating group(trial group), and conduct with traditional neurosurgical management or one-stage hybrid operating management correspondingly. Peri-operative mortality rate is considered to be the primary observing indicator, and morbidity rate of peri-operative cerebral hemorrhagic/ischemic event, morbidity rate of aneurysmal residuals, morbidity rate of neural functional deteriorations, and health-economic indicators are secondary indicators.The information of operations will be recorded in detail as evidence of optimization of workflow and technical key knots.

Eligibility Criteria:
Inclusion Criteria:

* with diagnosed complex intracranial aneurysm by digital subtraction angiography(DSA);
* got SAH in history;
* neural functional deficits due to aneurysms;
* with \<4 in Hunt-Hess Grades;
* ≥5.0mm in the maximum diameter;
* \<70 years old;
* with irregular morphological features and high rupture risk.

Exclusion Criteria:

* \>70 in age, with low rupture risk;
* cannot tolerant the operation;
* patient or relative refuses to participate the trail;
* SAH patient with ≥4 Hunt-Hess grading system;
* \<5.0mm in the maximum diameter.
A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours

This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of \[225Ac\]-FPI-2059 and \[111In\]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours.

This is a first-in-human, Phase 1, non-randomized, multi-centre, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \[225Ac\]-FPI-2059 and \[111In\]-FPI-2058, as well as the pharmacodynamics and preliminary anti-tumour activity of \[225Ac\]-FPI-2059 in participants with neurotensin receptor 1 (NTSR1)-expressing advanced, metastatic and/or recurrent solid tumours.

The study will employ a 3+3 dose escalation design to identify the recommended phase 2 dose (RP2D) and regimen of \[225Ac\]-FPI-2059 administered intravenously every 56 days.

After the RP2D for \[225Ac\]-FPI-2059 is determined, enrolment will continue into an expansion cohort, to confirm the safety and tolerability of the RP2D, as well as to identify any preliminary evidence of efficacy in selected NTSR1-expressing tumour types.

Eligibility Criteria:
Key Inclusion Criteria:

* Signed ICF prior to initiation of any study-specific procedures
* Histologically and/or cytologically confirmed solid tumor that is metastatic or locally advanced, inoperable, or recurrent. Solid tumors indications may include PDAC, CRC, NED prostate cancer, gastric cancer, SCCHN, and Ewing sarcoma.
* Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the patient refuses standard therapy
* Measurable disease per RECIST v.1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Sufficient target expression in at least one measurable lesion as determined by imaging following injection of \[111In\]-FPI-2058
* Adequate organ function
* Tumor tissue (either archival within the last 24 months or fresh biopsy)

Key Exclusion Criteria:

* Previous treatment with any radiopharmaceutical
* Contraindications to or inability to perform the imaging procedures required in this study
* Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within certain amount of time prior to administration of the first dose of \[111In\]-FPI-2058
* Radiation therapy (RT) within 28 days prior to the first dose of \[111In\]-FPI-2058
* Patients with known CNS metastatic disease
* Concurrent severe and/or uncontrolled illness that would limit compliance with study requirements
* Known or suspected allergies or contraindication to the investigational treatment
* Received any type of vaccine within 30 days prior to the first dose of \[111In\]-FPI-2058
Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension

This study will evaluate the tolerability and safety of SAD448 and explore the compound's effect on intraocular pressure in subjects with ocular hypertension.


Eligibility Criteria:
Key inclusion criteria:

* Males and females, 18 - 65 years of age, with ocular hypertension
* Females must be post-menopausal or surgically sterile

Key exclusion criteria:

* Diagnosis of glaucoma in either eye
* A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug
Prolonged Cardiopulmonary Bypass Time as a Predictive Factor for AGI After Heart Valve Replacement

In this retrospective study, the investigators will analyze the correlation between cardiopulmonary bypass (CPB) time and acute gastrointestinal injury (AGI), and the outcomes of AGI in patients undergoing heart valve replacement.

Patients with heart valve diseases often have chronic cardiac insufficiency. Patients undergoing heart valve replacement with CPB are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually leads to AGI. AGI after cardiovascular surgery, especially in that use CPB, is associated with significant morbidity and an increase in peri-operative mortality. Prolonged CPB time could be predictive of AGI following heart valve replacement. This study is to analyze the correlation between CPB time and AGI, and the outcomes of AGI in patients undergoing heart valve replacement. The investigators hope that the benefits will include fewer patients becoming seriously postoperative AGI and mortality after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing heart valve replacement surgery with CPB
* Age \> 18 years and ≤ 70 years

Exclusion Criteria:

* Patients combined with severe hematological disease, respiratory disease, and other critical diseases
* Patients had severe disorder of multiple systems and organs or severe pulmonary hypertension
* Have received major gastrointestinal surgery within 5 years
* Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis
* Acute gastroenteritis
* Clostridium difficile or Helicobacter pylori infection
* Chronic constipation
* Peptic ulcer
* Polyps in the stomach or intestines
* Gastrointestinal neoplasms
* Abdominal hernia
* Irritable bowel syndrome
* Acute or chronic cholecystitis, hepatitis
* Patients who died during surgery
* Patients with digestive system tumors
A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC

The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is more effective than docetaxel alone in regards to PFS in patients with heregulin-positive NSCLC.

This study is a randomized, open-label, international, multi-center, phase 2 study in patients with Heregulin-positive NSCLC histologically classified as adenocarcinoma that have progressed following no more than two systemic therapies for locally advanced or metastatic disease, one of which must have been a platinum containing regimen. All patients will initially be screened for heregulin status. Eligible patients will be randomized to receive MM-121 in combination with docetaxel versus docetaxel alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of cytologically or histologically documented adenocarcinoma of the lung with either metastatic disease (stage IV), Stage IIIB or Stage IIIC disease not amenable to surgery with curative intent
* Not received more than 2 prior systemic therapies- one of which must have been a platinum based regimen- for primary or recurrent disease
* Tissue submitted for HRG-biomarker testing
* ECOG performance status (PS) of 0 or 1

Exclusion Criteria:

* Known ALK mutation
* Presence of exon 19 deletion or exon 21 (L858R) substitution of the EGFR gene
* Received \>2 prior systemic anti-cancer drug regimen for locally advanced disease
* Prior treatment with an anti-ErbB3 antibody
* CTCAE grade 3 or higher peripheral neuropathy
* Symptomatic CNS metastases or CNS metastases requiring steroids
* Any other active malignancy requiring systemic therapy
* Clinically significant cardiac disease
The Impact of Genotype on Pharmacokinetics and Antiplatelet Effects of Ticagrelor in Healthy Chinese

This study is a open and single center clinical trial in healthy Chinese.The objective of the study is to clarify the pharmacokinetics characteristics and antiplatelet effects of ticagrelor in Chinese and to investigate the impact of genotype.

This is an open-label, single-does, nonrandomized study of ticagrelor in healthy volunteers carried out at a single center. Written informed consent will be obtained from all volunteers before initiation of the study. The study is approved by the Research Ethic Committee of Guangdong General Hospital. Fifty-one healthy Chinese will be recruited.

Venous blood will be collected at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48h after taking 180mg ticagrelor orally. Urine collection intervals are at predose and 0 to 2, 2 to 4, 4 to 6, 6 to 9, 9 to 12, 12 to 16 and 16 to 24h after dosing. The concentration of ticagrelor and its metabolites will be analyzed using a separately validated liquid chromatography technique with tandem mass spectrometric detection (LC-MS/MS).

Besides，the basic principle of population pharmacodynamics(PPD) is applied to evaluate antiplatelet effects. Adenosine diphosphate(ADP)-stimulated platelet aggregation will be assessed at baseline, and 0.5h/1h, 2h, 4h/8h/24h, 48h/3d/5d and 7d after dosing.

The effects of genetic variants on antiplatelet and pharmacokinetic response to ticagrelor are investigated through a genome-wide association study (GWAS).

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 - 45 years;
2. Sex: male and female;
3. Ethnicity: Chinese;
4. Good health as evidenced by the results of physical examination, vitals signs, electrocardiogram, and clinical laboratory test results, but there were exceptions if an abnormal value was considered not to be clinical significance;
5. Written informed consent.

Exclusion Criteria:

1. Any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs;
2. Intolerance or hypersensitivity to drugs whose mechanism is similar to that of ticagrelor;
3. Any history of taking medicines within half a month before enrollment;
4. Any history of whole blood transfusion within 2 months, blood elements transfusion or blood donation within 1 months before enrollment;
5. Participation in a clinical study within 3 months before enrollment;
6. Abuse of caffeine (\> 5 units/day), alcohol(\> 21 units /week), smoking(\> 10 cigarettes/day);
7. Positive serology for Hbs antigen and HIV;
8. History of coagulation disorders.
Effects of an 8 Component Botanical Supplement on Mild and Moderate Alzheimer's Patients

This placebo-controlled, double blind study evaluates the treatment effects of adding a multi-pathway botanical dietary supplement (ReBuilder) to the standard treatment regimens of subjects diagnosed with mild or moderate stage Alzheimer's Disease. The objective of the study is to determine if mild and moderate AD patients exhibit improved or stabilized cognitive function when this supplement is added to maximum tolerated doses of their standard treatments.

Currently, there is no treatment that can stop the progression of Alzheimer's Disease. The investigators in this study have used transgenic Drosophila melanogaster models and machine learning to develop an eight component botanical mixture (Geneaire™\* ReBuilder™) that targets multiple genetic pathways involved in brain aging and dementia that are homologous between Drosophila and humans.

While beta-amyloid plaques and phosphorylated-tau tangles are diagnostic for AD, the cause(s) of their soluble precursors that kill neurons has not been determined. The majority of AD patients are diagnosed after 60 years of age. Many studies point to aging related processes like inflammation, neural vascular damage, neural stress, altered cell metabolism, inefficient cellular autophagy, microglial dysfunction, mitochondrial dysfunction, and poor diet as potential causal factors in the decline of brain function over the decades that precede an actual AD diagnosis. AD is a multifaceted pathology involving many biochemical pathways and thus a multifaceted therapeutic approach may prove beneficial.

The goal of this study was to test ReBuilder on human cognitive function. During the 12-month pilot study, the subjects were evaluated quarterly on the Mini Mental State Exam (MMSE), Alzheimer's Disease Cooperative Study's Activities of Daily Living (ADCS-ADL), and the Clinical Dementia Rating Sum of Boxes (CDR-SB).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed mild or moderate Alzheimer's Disease

Exclusion Criteria:

* History of heart disease
* History of heart attack
* History of cancer
* History of stroke or transient ischemic attack
Safety Study of Depakote Versus Lithium in African Americans With Bipolar Disorder

It is hypothesized that Depakote will be better tolerated then lithium in treating African Americans with bipolar disorder.

This is a 14 week randomized open study of 50 inpatients or outpatients with bipolar I r II. African American subjects will receive lithium or depakote ER. Measures will be made of psychopathology, reported side effects, and study completers. Measures will also be made of RBC/plasma lithium to determine if this level is better predictive of lithium tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Females must be using a contraceptive
* Understand and sing informed consent
* Meet criteria for DSM IV bipolar I or II
* Must have been receiving treatment with depakote or lithium for at least 4 weeks
* Must not have used illicit substances 48 hours before the study

Exclusion Criteria:

* Not takin g lithium o valproate at time of screening
* Alcohol intoxicated or using drugs of abuse other then cannibis
* Presence of psychotic features
* Participation in clinical trail within 1 month of study
* Female subjects pregnant or nursing
* Serious unstable medical or psychiatric illness
* Uncorrected hypothyroidism or hyperthyroidism
* Seizures without a clear and resolved etiology
* Hypersensitivity or intolerance to lithium or valproic acid
* Treatment with injectable depot neuroleptic less then one dosing interval
* Treatment with reversible MAOI, guanethidine, or guanadrel within i week of study
* Treatment with fluoxetine within 8 weekS of study
* treatment with clozapine or ECT 3 months prior to study
* current diagnosis of schizophrenia or other psychotic disorder
* judged to be at serious suicidal risk
A Decision Aid on End-of-life Care for Patients With Advanced COPD and Their Family

This study aims to support EOL decision-making in patients with advanced COPD and their family members. A parallel two-arm single-blinded randomised controlled trial will be conducted to evaluate the effects of a specific decision support intervention. A total of 226 patients with advanced COPD and their designated family members will be recruited from hospital wards and outpatient clinics.

Chronic Obstructive Pulmonary Disease (COPD) is a progressive life-limiting condition. However, patients with advanced COPD and their family members generally are unprepared for end-of-life (EOL) situations. The Ottawa Decision Support Framework model is adopted to address the patients' decisional needs for the difficult decisions in EOL care. The participants will be randomly allocated to either the intervention group to receive the decision support intervention or the control group to receive general health coaching. Outcomes will be measured at baseline and 1- and 6-month post-allocation. Subsequently, a descriptive qualitative study will be conducted with a subsample of 30 dyads to explore how the intervention influenced the study outcomes.

Eligibility Criteria:
Inclusion Criteria of patients:

* are aged 50 years or over
* have been diagnosed with COPD
* are cognitively sound (scored \> 5 on the validated Abbreviated Mental Test (Hong Kong version) \[AMT-HK\])
* meet at least two of the six specific clinical indicators related to advanced COPD in the Gold Standards Framework (GSF) Proactive Identification Guidance, 6th Edition
* can nominate a family member who would take part in their healthcare decision- making.

Inclusion Criteria of patients' family members:

* are aged 18 years or over,
* can communicate in Cantonese,
* have at least one personal contact per week with the patient in the past 6 months and
* are willing to join the study. Family members will be excluded if they score \< 6 on the AMT-HK or are expecting to leave Hong Kong within the next 6 months.

Exclusion Criteria:

* non-communicable due to a severe hearing impairment, dysphasia or a language barrier;
* are receiving palliative care services or
* have already completed ACP or an advance directive.
Improving Future Thinking Among Mothers to Reduce Harsh Parenting and Improve Child Outcomes

Parents of children from impoverished communities are disproportionately more likely to engage in harsh physical discipline, which can lead to serious clinical outcomes, including suicidal ideation and attempts. One mechanism linking low resource environments and maladaptive parenting strategies is maternal delay discounting, or the tendency to value smaller, immediate rewards (such as stopping children's misbehavior via physical means) relative to larger, but delayed rewards (like improving the parent-child relationship). This study will examine the efficacy of implementing a low-cost, brief intervention targeting the reduction of maternal delay discounting to inform broader public health efforts aimed at improving adolescent mental health outcomes in traditionally underserved communities.

Harsh parenting is associated with serious and costly mental health problems among youth, including substance use, mood disorders, and suicidal ideation and behaviors. Of concern, these parenting practices are most common among families from impoverished communities; however, many behaviorally-based parenting interventions do not take into account the unique mechanisms linking environmental disadvantage to parenting approaches. While the causes of harsh parenting are complex and varied, one such mechanism may be parents' tendencies to prioritize immediate rewards (such as stopping a child's misbehavior via physical punishment like spanking and hitting) relative to larger, but delayed rewards (including improved parent-child relationship quality), known as delay discounting. This case series will examine the efficacy of episodic future thinking (EFT) to target reduction of parenting-related delay discounting. Outcomes will evaluate the effect of EFT on reducing maternal delay discounting and harsh parenting, and improving child clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Be the mother from the Flint area of a child between the ages of 5-10 who can provide legal consent for that child to participate in this study
2. Self-report that the child lives with them for at least 50% of the time
3. Willing to participate in the study
4. Able to participate in written assessments and an intervention conducted in English
5. Have a working cell phone that can receive and send text messages and be willing to receive/send text messages as part of the study
6. Have a phone or device that's able to use video conferencing software

Exclusion Criteria:

1. Self-disclosed active suicidality/homicidality
2. Self-disclosed current bipolar disorder, schizophrenia, or psychosis
3. Current and ongoing involvement with child protective services