cyrilzakka/clinical-trials huggingface dataset:
A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma

A Phase I/II study to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.

This first-time in human, single-arm, open-label multicentre Phase I/II study will evaluate the safety, tolerability, antitumour activity, cellular kinetics, pharmacodynamics, and immunogenicity of AZD5851 in adult participants with GPC3+ advanced/recurrent HCC, where at least one line of prior therapy has failed/or was intolerable, or participant/investigator decision.

Eligibility Criteria:
Inclusion Criteria:

1. Participant must be 18 years or older and has voluntarily agreed to participate by giving written informed consent.
2. Participants with confirmed advanced/recurrent or metastatic and/or unresectable HCC based on histopathological findings
3. Completed or were unable to tolerate at least one prior line of standard systemic therapy for HCC and/or participant/investigator decision.
4. GPC3-positive tumour as determined by a central laboratory using an analytically validated IHC assay
5. Barcelona Clinic Liver Cancer Stage B (if not amenable to local treatment/surgery) or C prior to apheresis
6. Child-Pugh score: Grade A
7. Participants with HBV and HCV undergoing management of these infections per institutional practice.

Exclusion Criteria:

1. Active or prior documented gastrointestinal (GI) variceal bleed or history of upper GI bleeding, ulcers, or esophageal varices with bleeding within 12 months
2. History of liver transplantation or on waiting list
3. Current clinically significant ascites
4. Main portal vein thrombus, or tumor thrombus invasion of mesenteric vein / inferior vena cava
5. Uncontrolled intercurrent illness
6. Active Infections
7. Positive serology for HIV
8. History of hepatic encephalopathy within 12 months prior to treatment allocation
9. History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.
10. Prior treatment with any CAR-T therapy directed at any target or any therapy that is targeted to GPC3.
11. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolisation, or monoclonal antibodies, investigational product) within 5 half-lives or ≤ 21 days (whichever is shortest).
Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial

PRACTECAL-PRO is a sub-study of a TB-PRACTECAL clinical trial for multidrug resistant Tuberculosis. It evaluates the effectiveness of TB-PRACTECAL interventions from the patient perspective in terms of their quality of life, shared decision making and satisfaction with services.

Tolerability of drugs for TB is a complex and dynamic course for patients with drug resistance and can be affected by many different factors. A deeper understanding of the perspectives and experience of men and women participating in novel TB treatment trials will add to the understanding of the safety and efficacy of treatment.

TB-PRACTECAL is a multicentre, open label, phase 2-3 randomised controlled trial evaluating exclusively oral 6 months regimens containing bedaquiline, pretomanid, linezolid +/- moxifloxacin or clofazimine for the treatment of microbiologically confirmed pulmonary M/XDR-TB. It is registered with the ClinicalTrials.gov with identifier number NCT02589782. The trial aims to recruit 630 adults from two sites in Uzbekistan (Nukus and Tashkent) and one site each from Belarus and South Africa.

The TB-PRACTECAL trial assumes that even if the investigational arms would have non-inferior efficacy and safety compared to the standard of care outcomes, patients would prefer a shorter, exclusively oral regimen with a lower pill count. This study therefore aims to describe patient experiences (i.e. the quality of the treatment experience as opposed to the quantity of treatment or the amount of time spent on it).

The PRACTECAL-PRO sub-study aims to answer the question: "What are the perceptions, expectations and experiences of novel TB treatment for adult patients participating in a six-month regimen clinical trial in Uzbekistan, South Africa and Belarus?"

The objectives for the analysis are:

* To compare baseline scores between trial patients (all interventional arm patients plus standard of care patients) with healthy controls.
* To assess changes in scores over time in patients on the intervention arms and patients on the standard of care arm.
* To assess the utility of the SF 12 and SGRQ in a TB clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients recruited into the TB-PRACTECAL trial in the approved sites OR
* Local healthy-controls of a similar profile in terms of age and gender aged ≥18 years AND
* Literate in the study questionnaire languages
* Able to sign the sub-study informed consent form after agreeing to the additional interviews and completion of questionnaires.

Exclusion Criteria:

* TB patients excluded from TB-PRACTECAL clinical trial
* Healthy volenteers with co-morbidities
* Healthy volenteers found to have TB
Effect of Eight-week Concurrent Training on Functional Capacity in Patients With Unilateral Transtibial Amputation

OBJECTIVES: To assess the effect of concurrent training (CT) of an eight-week on strength, power and cardiorespiratory fitness on muscle condition, balance, load distribution in the lower limbs and aerobic capacity in patients with unilateral transtibial amputation (UTA). MATERIAL AND METHODS: Twenty-six individuals with prosthesis over 3-months were selected. Patients were randomly divided into two groups. Group 1 (n = 17) denominated UTA who performed the evaluation and training recommended by the prosthesis (bodybuilding vs. aerobic interval-training on the exercise cycle ergometer). Group 2 (n = 9) denominated untrained unilateral transtibial (UUT) amputees who after the evaluation were not included for the recommended training. All patients were evaluated at the baseline time of randomization and eight weeks after

OBJECTIVES: To assess the effect of concurrent training (CT) of an eight-week on strength, power and cardiorespiratory fitness on muscle condition, balance, load distribution in the lower limbs and aerobic capacity in patients with unilateral transtibial amputation (UTA). MATERIAL AND METHODS: Twenty-six individuals with prosthesis over 3-months were selected. Patients were randomly divided into two groups. Group 1 (n = 17) denominated UTA who performed the evaluation and training recommended by the prosthesis (bodybuilding vs. aerobic interval-training on the exercise cycle ergometer). Group 2 (n = 9) denominated untrained unilateral transtibial (UUT) amputees who after the evaluation were not included for the recommended training. All patients were evaluated at the baseline time of randomization and eight weeks after. The evaluation consisted of anamnesis (inclusion criteria), clinical and functional evaluation, cardiopulmonary exercise testing, isokinetic knee testing, static and dynamic posturography. The age of the group was 28.5 ± 7.1 years old, BMI 25 ± 4.8 kg.m-2, amputation time 22 ± 27.5 months, 83% were men and 57% with amputation on the left side, 11% used antidepressants and 11% antihypertensive medicine.

KEYWORDS: Transtibial amputation; Concurrent training; Rehabilitation, Comparative Study.

Eligibility Criteria:
Inclusion criteria

* Transtibial amputation (any etiology)
* Age between 18 - 50 years
* Absence of any musculoskeletal and/or inflammatory diseases; central and/or peripheral neuropathy; psychiatry alteration
* Discharge of the rehabilitation program and the use of a prosthesis for three or more months and more.

Exclusion criteria

* Pain or inability to complete any of the tests
* High blood pressure (over 130 x 90 mmHg) before strength evaluation
* Loss of three consecutive training sessions and no return for the reevaluation session
Establishing Alpha-synuclein RT-QuIC Assay as a Diagnostic Technique in REM Sleep Behaviour Disorder

We hypothesise that a real-time quaking induced conversion assay for the detection of pathological alpha-synuclein (α -syn RTQuIC) can be used to differentiate between cases of idiopathic REM-sleep behaviour disorder (RBD) and RBD that is symptomatic of prodromal α-synucleinopathies.

This study will be the largest analysis of cerebrospinal fluid (CSF) α-synuclein in Rapid Eye Movement Behaviour Disorder (RBD) patients to date. In line with the The National CJD Research \& Surveillance Unit (NCJDRSU)'s recent inclusion of a positive RT-QuIC for pathological prion protein in the diagnostic criteria for Creutzfeldt-Jakob Disease (CJD) \[1\], we aim to deploy this novel method to establish it as an accurate research and diagnostic resource in the assessment and prognosis of RBD. This research is transformative and has the potential to change practice.

Currently, there is no simple method with high sensitivity and specificity available which can identify patients who will go on to develop an α - synucleinopathy. Clinical assessment of a panel of markers (e.g. Postuma et al. 2015) are time-consuming and impractical in normal clinical settings, with the majority of patients presenting to sleep physicians, geriatricians, and non-specialised neurology clinics, both publicly and privately. This has a major impact on counselling strategies for RBD patients, appropriate follow-up, trials of novel neuro-protective agents in alpha-synucleinopathies before full-blown phenotype is manifest and enhancing understanding of pathways involved in RBD out-with the dopaminergic system.

RBD is a common, sometimes fatal disease (through injury to self/others) and treatments are indiscriminate regarding aetiology with limited evidence-base. A simple test using CSF (analogous to measuring CSF-orexin levels to diagnose narcolepsy+cataplexy) with high sensitivity and specificity is ideal. Thus, we believe that the central thesis of our work will not only inform subsequent behavioural, genetic and neuroimaging characterisation of our established RBD cohort, but will also translate the α-syn RT-QuIC concept into evidence-based and effective clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Rapid Eye Movement Behaviour Disorder (RBD) using the International Classification of Sleep Disorders version 3 (ICSD-3) criteria \[18\] - Patients aged 18 years and over - Patient able to give written informed consent

Exclusion Criteria:

* RBD secondary to medication or withdrawal state. - \<18 years old - Inability to give written informed consent - Contraindication to lumbar puncture procedure (e.g. patients taking Warfarin)
Short Term Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

OBJECTIVES: I. Confirm the inhibitory effect of recombinant human insulin-like growth factor I (IGF-I) on insulin secretion in children with hyperinsulinism.

II. Define the effects of short term IGF-I therapy on postprandial blood sugar levels in this patient population.

III. Characterize the effects of short term IGF-I therapy on fasting behavior, and other insulin dependent parameters, in this patient population.

PROTOCOL OUTLINE: Octreotide and/or diazoxide are discontinued on day 1, and fasting blood glucose is monitored. Patients receive test meals of Sustacal on days 3 and 4 and are assessed for insulin response.

Beginning on day 5, patients are given recombinant human insulin-like growth factor I subcutaneously every 12 hours for a total of 3 doses. The first dose (on day 5) is given 30 minutes before a Sustacal challenge, the second dose is followed by a bedtime snack, and the third dose (on day 6) is followed by a supervised fast.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of hyperinsulinism (i.e. evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action)

Suboptimal control of blood sugar (i.e. inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater)

No suspected insulinoma

Must be currently managed on a regimen of diazoxide, octreotide and/or frequent feedings to control hypoglycemia

--Prior/Concurrent Therapy--

See Disease Characteristics

--Patient Characteristics--

Hematopoietic: No anemia or other concerns of blood volume depletion

Renal: No renal dysfunction

Other:

* No known malignancy
* No other major medical conditions
To Evaluate Plasmajet in Achieving Complete Cytoreduction of Advanced EOC- Initial Feasibility Study

Surgery for ovarian cancer involves a big cut on your tummy (abdomen) followed by removal of pelvic organs (womb, tubes and ovaries), abdominal organs (fat tissue {omentum}, appendix) and any other tissues involved with cancer. Several studies worldwide have reported that women survive longer and enjoy a longer disease free interval before their disease returns if all visible disease is removed at the time of their surgery. Achieving this is not easy and often there is widespread disease and the surgeons are unable to remove every tumour nodule present as it is attached to the surface of the bowel, diaphragm and other important Extensive surgery with prolonged operating is associated with higher risks. Plasma energy is commonly referred to as the 4th state of matter after solid, liquid and gas. When a gas is heated, it partially or wholly ionizes resulting in high energy particles like ions, electrons and atoms referred to as 'plasma'. PlasmaJet® (PJ) is a new device which uses fine jet of neutral argon plasma from the handpiece that has been shown to have the ability to vaporise nodules close to sensitive organs like the bowel. It may offer the potential to treat the tumour nodules close to sensitive areas like the bowel. There have been no studies exploring its role in vaporising tumour nodules and its impact on survival. The PJ may be used by the surgeon to seal bleeding tissues (coagulate) or to burn away thin layers of tissue (ablate) by vaporization. It is licensed for use to achieve effects of coagulation and ablation. It is similar to conventional surgical devices that are routinely used (called diathermy) to achieve these effects. The PJ however is slightly different in that it may also be used on tissue to vaporise tumour nodules in women with ovarian cancer during surgery though the full extent of this role remains unclear.


Eligibility Criteria:
Inclusion Criteria:

* Imaging+/- Clinical +/- laparoscopic e/o pelvic mass and metastatic disease (FIGO III/IV disease) at presentation.
* Confirmation of malignancy on histological/cytological criteria.
* All women aged 18 or over with newly diagnosed FIGO stage III to Stage IV EOC undergoing surgical treatment.
* All women fit to undergo treatment.
* No synchronous malignancy likely to interfere with comparisons.
* Written and informed patient consent

Exclusion Criteria:

* Patient choice
* Patient unfit for any treatment modality
* Patients who are medically unfit for surgery and would only be suitable for chemotherapy.

WITHDRAWAL CRITERIA

* Unforeseen complications in the individual patient will be recorded and then analysed.
* Life threatening situation to the patient, due to any other unrelated complication.
* Patients are free to withdraw from the study at any time with no impact on their care whatsoever.
HKCFP-HKU Primary Care Morbidity Survey in Hong Kong

Background:

Information about the health problems of patients presenting in primary care is crucial to understanding the health of the general community for the planning and allocation of health care resources. Practice-based morbidity studies conducted in primary care settings have proven to be helpful in documentation of disease prevalence and for service planning. With the change in morbidity pattern and the aging population, our study will help to inform primary health care policy and guide work force and service planning.

Method:

This is a prospective practice-based study of health problems presenting in primary care. Doctors who agree to participate in the study will record the health problem and type of management performed in consecutive patient encounters for one of the designated weeks during each season over the course of one year.

Analysis:

Data collected will be analysed by descriptive statistics, comparison with data from previous morbidity study, and by non-linear mixed effects for factors associated with morbidity and management patterns in primary care.

Results:

Findings will will 1) provide evidence to support the allocation of resources to continue and to expand primary care initiatives that support the provision of quality chronic disease care in private sector, 2) enable continued surveillance of the morbidity trends in Hong Kong by providing data for comparison with past and future studies, and 3) inform the content of educational curricula for medical and health care students and practitioners to prepare them to better meet the needs of the community.


Eligibility Criteria:
Inclusion Criteria:

* Consented primary care doctors in Hong Kong who are working in:
* the public sector (GOPC), or
* Department of Health Clinic, or
* private solo or group practices, or
* university health services, or
* non-profit organizations, or
* private hospital family medicine clinics

Exclusion Criteria:

* Doctors who do not consent
* Doctors who are not working as primary care doctors
Strategy for Cardiovascular Disease Prevention Through Tailored Health Management in Individuals With Elevated Risk

The China PEACE SMARTER trial is a cluster ramdomized trial aiming to assess the effectiveness of village doctor-led tailored health management on risk reduction of high-risk individuals for cardiovascular disease.

In this study, investigators aim to develop a series of intervention strategies for cardiovascular disease (CVD) prevention through village doctor-led tailored health management in individuals with elevated risk, then assess their effectiveness through a cluster randomized trial. Investigators hypothesize that the village doctor-led tailored health management can reduce the CVD risk and improve risk factor control of the high-risk subjects through 12 months of follow-up. Around 4200 subjects from 120 villages in mainland China who are considered to be eligible according to inclusion and exclusion criteria will be enrolled to the study. The eligibility criteria is: Individuals aged 35 or above who are in high risk for CVD (10-year ASCVD risk ≥10%), able to use smart phone, and contracted with the local family doctor. Patients with history of CVD or severe illnesses, pregnancy, cognition or communication problems are excluded from the study. The selected villages will be assigned (1:1) to either control group (usual care) or intervention group (village doctor-led tailored health management). The primary outcome is the change in 10-year ASCVD risk from baseline to 12 months. Follow up visits will be conducted every 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Aged 35 or above;
* High CVD risk which defined as 10-year ASCVD risk ≥10% based on China-PAR prediction model;
* Ownership of a smart phone and being able to use apps;
* Being contracted with the local family doctor (village doctor);
* Willing to participate and able to sign informed consent.

Exclusion Criteria:

* CVD history, including myocardial infarction (MI), stroke, heart failure, severe arrhythmia, or peripheral artery disease, or having received percutaneous coronary intervention (PCI) or coronary artery by-pass grafting operation (CABG);
* Severe illnesses, such as cancer, or severe hepatic and renal dysfunction;
* Women during pregnancy, lactation, or plan to have children in the next year;
* Having problems in cognition or communication, or limited daily activities.
Curcumin Supplementation for Gynecological Diseases

To use curcumin supplementation as an additive treatment to induce clinical, biochemical response and remission in patients with suspected Pelvic inflammatory disease, Tubo ovarian abcess, Endometritis, wound infection.

Hypothesis: An addition of oral curcumin to highly suspected PID/Endometritis/Wound infection patients may augment clinical and biochemical response and accelerates the improvements of the sign symptoms and reported outcomes of those diseases.

Pelvic inflammatory disease (PID), Endometritis, Wound infection are infections of the female reproductive system. Although PID is a well known pathophysiology the diagnosis method I not well established and its true magnitude is unknown. Many women report that they have been treated for PID when they did not suffer from it and vice versa. Hence the main way to diagnose remains clinical and currently there is no well-established biochemical marker. In endometritis and wound infection the cause may be known but the pathogens involved in the disease formation vary as for this broad spectrum antibiotic is needed.

Aims: To use curcumin supplementation as an additive treatment to induce clinical, biochemical response and remission in patients with suspected PID, Tubo ovarian abcess, Endometritis, wound infection.

Hypothesis: An addition of oral curcumin to highly suspected PID/Endometritis/Wound infection patients may augment clinical and biochemical response and accelerates the improvements of the sign symptoms and reported outcomes of those diseases.

Rational: Curcumin treatment has been shown to safe and efficient in inflammatory states such as in mild-moderate Ulcerative colitis (UC), obesity, and type II diabetes mellitus when used as an add-on to conventional treatment.

In the gynecology and especially in the PID/Tubo ovarian abcess diseases the use of Curcumin as a supplement has never been studied.

In the future it is necessary to study the use of curcumin in different gynecological diseases (e.g Endometriosis/Premenstrual syndrome (PMS) and also in gynecology oncology) in which inflammatory and immune response are involve in the disease.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18
* The patient was admitted with a diagnosis of Pelvic inflammatory disease / Tubo ovarian abcess, surgical wound infection, Endometritis
* No Antibiotic treatment was given prior to her recruitment for the study
* The women is not in menopause

Exclusion Criteria:

* Age below 18 and above 52
* Antibiotic treatment was given prior to her recruitment for the study
* The women is in menopause
* Pregnant women. Known other inflammatory disease.