cyrilzakka/clinical-trials huggingface dataset:
Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009

Primary objectives:

* To evaluate the safety and tolerability of BAT8009 in patients with advanced solid tumours.
* To determine the maximum tolerated dose (MTD) and recommended dose for Phase 2 (RP2D).

This is a first-in-human (FIH), multicentre, open-label, Phase 1 dose escalation and dose expansion study of BAT8009 (a B7H3-targeting antibody-drug conjugate) in patients with advanced solid tumours.

Eligibility Criteria:
Inclusion Criteria:

1. Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.
2. Aged ≥ 18 years and ≤ 75 years.
3. Life expectancy ≥ 3 months.
4. ECOG performance status ≤ 1.
5. Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumours that are refractory to standard therapy.
6. Has measurable or evaluable disease per RECIST v1.1.
7. Adequate haematological, liver, kidney, cardiac and coagulation function.
8. Is willing to provide pre-existing diagnostic or resected tumour samples (if available).
9. Female patients must: Be of non-child-bearing potential; Male patients must: be willing not to donate sperm.
10. Must agree to adhere to the current state and national advice regarding minimising exposure to COVID-19 from the first Screening visit until the end of study (28-day Safety Follow-up Visit).

Exclusion Criteria:

1. Females who are pregnant or nursing.
2. Receiving concurrent anticancer therapy or investigational therapy.
3. Persisting AEs that are \> Grade 1 from prior antitumour treatment as per CTCAE v5.0.
4. Patients with primacy central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed.
5. Had major surgery within 28 days of the Screening visit.
6. History of autologous transplantation ≤ 3 months.
7. History of severe infection deemed clinically significant by the PI or designee within 4 weeks.
8. History of human immunodeficiency virus (HIV) infection.
9. Active hepatitis B or C.
10. History of a Grade 3 or Grade 4 allergic reaction to treatment with other antibodies.
Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome

This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome.


Eligibility Criteria:
Inclusion criteria:

* Signed informed consent.
* Subjects who have participated in Study MHE100185 and have been administered at least 2 doses of study medication.
* Not pregnant or nursing
* Of non-childbearing potential (i.e., women who had a hysterectomy, are post-menopausal which is defined as 1 year without menses, have both ovaries surgically removed, or have current documented tubule ligation); or
* Of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea \[even severe\], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at the Screening Visit, and agree to one of the following:1). Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of investigational product until 3 months after the last dose of investigational product; Or 2). Consistent and correct use of one of the following acceptable methods of birth control for one month prior to the start of the investigation product and three months after the last dose:Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subjects; Implants of levonorgestrel;Injectable progestogen;Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; Oral contraceptives (either combined or progestogen only)

Exclusion criteria:

* Has developed life-threatening or other serious illness or clinical manifestation deemed inappropriate for inclusion in study per the principal investigator
* Has any of the following abnormal laboratory values at the Week36/EW Visit of Study MHE100185: • Serum creatinine ≥3 times institutional upper limit normal (ULN); • AST or/ALT ≥5 times institutional ULN; • Platelet count \< 50,000/uL
* Has developed abnormal cardiac functions, as the following, within past 3 months:• Left ventricular ejection fraction (LVEF) \< 20%; • NYHA class IIIb or IV; • Angina or acute myocardial infarction
* Has developed allergic reaction to Study MHE100185 investigational product Use of an investigational drug as concurrent medication
* Does not complete Week36/EW Visit assessments required in Study MHE100185
* Has completed or been terminated from Study MHE100185 for more than 1 month
* Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months
* Positive pregnancy test at the Week36/EW Visit of Study MHE100185
Sun Protection Factor Assay (SPF Assay 105/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Functional Role of RUNX1 Mutations in the Etiology of Acute Myeloid Leukemia (AML)

The purpose of this study is to elucidate the role of RUNX1 in Acute Myeloid Leukemia (AML), in particular, the transcriptional regulation of genes by mutated forms of this protein. This research will study the effect of mutations found in AML patients

The RUNX1 gene, located at chromosomal band 21q22, is a transcription factor, crucial for hematopoiesis and the generation of hematopoietic stem cells in the embryo. RUNX1 is the most frequent target for chromosomal translocation in leukemia. In addition, point mutations in the RUNX1 gene have been found to constitute an important mode of genetic alteration in development of leukemia. Recent publications stressing the clinical need for implementing RUNX1 point mutations as both a diagnostic and unfavorable prognostic marker of AML, have aroused particular interest in the functional role of RUNX1 in this disease.

In order to pinpoint specific RUNX1 target genes involved in pre-leukemic transformation or exacerbation of existing leukemia, the investigators plan to compare expression profiles from human hematopoietic progenitors overexpressing a mutated form of RUNX1with controls (RUNX1 wild-type and knocked-down). In this study the investigators intend to collect blood, after receiving informed consent, from umbilical cords of neonates born vaginally, in order to isolate CD34+ hematopoietic progenitors. Human umbilical cord blood contains relatively high numbers of CD34+ cells, which may be frozen directly after collection and used as a source of progenitor cells for further culture or direct analysis.

Eligibility Criteria:
Inclusion Criteria:

* Consenting women who have had full-term birth

Exclusion Criteria:

* Systemic disease
Postcards to Improve Remote Monitoring Adherence Among Veterans

We tested the effect of informational postcards on improving remote monitoring adherence among Veterans with pacemakers and implantable cardioverter-defibrillators in a stepped-wedge randomized controlled trial.

Objective: To test the effect of informational postcards on remote monitoring adherence among Veterans with pacemakers and implantable cardioverter-defibrillators (ICDs).

Design/Patients: Stepped-wedge randomized controlled trial among Veterans with pacemakers and ICDs.

Intervention: In wave 1, Veterans who had sent at least 1 transmission within the past 2 years but had become non-adherent were randomly assigned to receive a postcard or no postcard. Those receiving postcards were randomized to 1 of 2 messages: 1) a "warning" postcard describing risks of non-adherence or 2) an "encouraging" postcard describing benefits of adherence. In wave 2, Veterans who had either not received a postcard in wave 1 or had since become non-adherent were mailed a postcard (again, randomized to 1 of 2 messages). Patients who did not send a remote monitoring transmission within 1 month were mailed a second, identical postcard.

Main Measures: Proportion of patients who sent a transmission within 70 days.

Eligibility Criteria:
Inclusion Criteria:

* Veteran patients with wireless RM-capable pacemakers and ICDs followed by the VA National Cardiac Device Surveillance Program (VANCDSP)
* Sent at least 1 remote transmission within the past 2 years but had become non-adherent (defined as missing their last scheduled transmission by at least 10 days)

Exclusion Criteria:

* Veteran patients without a wireless RM-capable device
* Had not sent a remote transmission in the past 2 years
Cognitive Behavioral Group Therapy for University Students

This study developed a culturally appropriate cognitive behavioral group prevention program for Mainland Chinese university students in Hong Kong. The effects of the group prevention program on psychological distress, acculturative stress, cognitions, emotions, and post-migration growth were examined.

Detailed description:

Previous research has found the effectiveness of group cognitive behavioral therapy in improving international students' mental health and facilitating their psychological adaptation. However, this kind of research in Chinese societies is scant and previous studies lack control group in study design. This study developed an 8-session culturally appropriate cognitive behavioral group prevention program for Mainland Chinese university students in Hong Kong. Research design of randomized controlled trial was adopted. Program effectiveness was evaluated at both cognitive and emotional levels, including psychological distress, acculturative stress, emotions, automatic thoughts, sense-making coping, core belief re-examination and post-migration growth.

Eligibility Criteria:
Inclusion Criteria:

* Chinese students from Mainland China who were studying at local universities in Hong Kong
* GHQ-12 score of 2 or above (0-0-1-1)
* Willingness to participate in the study

Exclusion Criteria:

* GHQ-12 score of 11 or above (0-0-1-1)
* One or more psychotic disorders
* Severe depression diagnosed by professionals with suicidal attempts/ideation in the past 3 months
JOYof ART - an Intervention Study

Music, dance and visual arts are suggested to support health and well-being of older people. Intervention studies, however, are scarce. JOY of ART study investigates the effects of multicomponent art intervention among older people and ther family caregivers.

JOY of ART study investigates the effects of group based intervention including music, dance and visual arts. Art sessions are provided once a week in three months period each session takes 60 minutes. Eligible participants are recruited from the City of Kuopio, Finland, total 60 dyads, 30 to intervention group and 30 to control group. Health, physical performance and quality of life assessments are conducted at the baseline and in the end of the intervention. In addition, participants are contacted by phone and interviewed six months after the intervention has completed. For family caregivers qualitative interviews are conducted at the baseline and in the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* 65+ age, family caregiving dyad, ability to walk independently or assisted, home dwelling

Exclusion Criteria:

* severe dementia, severe aphasia
Effect of 4-session Metacognitive Training in Chinese Adult Outpatients With Schizophrenia Spectrum Disorders and Major Depressive Disorder

Psychological studies have shown that individuals tend to attribute causes of positive and negative events differently. Specifically, individuals hold an internalising or externalising bias of attribution which, in the case of particular patient groups, was found to polarize to the extreme. Such extreme attributional styles have found to have a direct impact on emotions, leading to a waning course of psychiatric disorders. This project aims to further examine the theoretical links between attributions and emotions using a transdiagnostic approach, and the effect of a 4-session process-based intervention on attributional biases.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* Clinical diagnosis of non-organic psychosis or major depressive disorder
* Presentation of delusions/a moderate level of depression

Exclusion Criteria:

* Clinical diagnosis of psychotic depression or depression with psychotic features
* Primary diagnosis of substance misuse or learning disability
* Participation of any cognitive/reasoning training program
Activation of Brown Adipose Tissue Thermogenesis in Humans Using Formoterol Fumarate (GB10)

One emerging, highly modifiable homeostatic mechanism for energy expenditure in humans is brown adipose tissue (BAT) thermogenesis. BAT is currently considered a prime target for the treatment of obesity and Type 2 diabetes (T2D).

Using acetate and fluorodeoxyglucose (FDG) positron emission tomography (PET) , It has been demonstrated that BAT thermogenesis is inducible by chronic cold exposure.

BAT activation through cold exposure is associated with improved glucose homeostasis and insulin sensitivity.

A pharmaceutical approach, which seemed to be very promising to stimulate the activation of BAT, was the use of a selective beta 3-adrenergic receptor agonist, mirabegron. Nevertheless, in a later study, It has been demonstrated that human BAT thermogenesis is under the control of beta-2, not beta-3, adrenergic receptor. The most selective beta-2 adrenergic receptor agonist approved for clinical use in Canada is formoterol fumarate, given in inhalation for the treatment of asthma (Oxeze®).

In summary, BAT contributes to cold-induced thermogenesis and is recruited by chronic cold exposure as well as by a growing number of food supplements and drugs. Intracellular triglyceride (TG) is the primary source of fuel for BAT thermogenesis under normal physiological conditions, as blocking intracellular TG lipolysis using nicotinic acid abolishes BAT thermogenesis. Beta-2 adrenergic stimulation is the pharmacological target to activate BAT thermogenesis in humans and may also lead to white adipose tissue lipolysis. Using a highly-selective beta-2 receptor agonist with and without administration of nicotinic acid would thus give the opportunity to quantify more precisely energy expenditure accounted by BAT thermogenesis and white adipose tissue metabolism in humans.

Each participant will undergo three metabolic sessions with PET imaging using \[11C\]-palmitate, \[11C\]-acetate and \[18F\]-FDG:

1. during a 3-h cold exposure (Study A, control condition)
2. after inhalation of Formoterol with oral nicotinic acid (Study B)
3. after inhalation of Formoterol only (Study C).

Eligibility Criteria:
Inclusion Criteria:

* BMI of 18 to 30 kg/m2.

Exclusion Criteria:

* Change in weight of more than 2 kg over the past 3 months or recent changes in lifestyle;
* The presence of any chronic medical condition requiring any pharmacological treatment;
* Previous intolerance or allergy to lactose, formoterol, nicotinic acid or local anesthetic agent;
* Any previous cardiac arrhythmia, long QT syndrome or hypokalemia;
* Chronic treatment with any medication other than contraceptives;
* Acute use of any drug other that acetaminophen or non-steroidal anti-inflammatory without decongestant or other stimulants;
* Smoking or consumption of more than 2 alcoholic beverages per day;
* Having participated to a research study with exposure to radiation in the last two years before the start of the study.
Low Add Multifocal Versus Extended Depth of Focus Intraocular Lens

The innovations in phacoemulsification surgery and advances in surgical equipment ensure a safe extraction of the crystalline lens and implantation of intraocular lenses (IOL). As a result of developing intraocular lens technologies and changing patient demands, many multifocal, accommodative, toric, toric-multifocal, and extended depth of focus (EDOF) IOLs have been introduced and the original aim of restoration of far vision with implanted monocular IOLs has been evolved to an objective of improved vision at different distances with total spectacle independence. This study aimed to compare the visual acuity at different distances, contrast sensitivity, spectacle needs, photic phenomena, and quality of life parameters of patients bilaterally implanted with a low add bifocal (Tecnis ZKB00) or an EDOF IOL (Tecnis Symfony), both with planned mini-monovision to improve near vision.

The innovations in phacoemulsification surgery and advances in surgical equipment ensure a safe extraction of the crystalline lens and implantation of intraocular lenses (IOL). As a result of developing intraocular lens technologies and changing patient demands, many multifocal, accommodative, toric, toric-multifocal, and extended depth of focus (EDOF) IOLs have been introduced and the original aim of restoration of far vision with implanted monocular IOLs has been evolved to an objective of improved vision at different distances with total spectacle independence. This study aimed to compare the visual acuity at different distances, contrast sensitivity, spectacle needs, photic phenomena, and quality of life parameters of patients bilaterally implanted with a low add bifocal (Tecnis ZKB00) or an EDOF IOL (Tecnis Symfony), both with planned mini-monovision to improve near vision. In this regard, binocular logMAR uncorrected visual acuities (UVA), monocular defocus curves, CS with CSV 1000-E and Pelli-Robson Test (PRT), spectacle needs and quality of life parameters with NEI RQL-42 questionnaire were evaluated at postoperative 1, 3, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria were patients with bilateral visually significant cataract seeking spectacle independence, especially at far and intermediate distances, age of ≥18 years, preoperative corneal astigmatism less than 1.00 D, axial length (AL) between 21 - 26.5 mm, and availability to attend all follow-up visits.

Exclusion Criteria:

Patients were excluded from the study if any of the following conditions were present: high visual demand for near vision, amblyopia, glaucoma, corneal opacity, severe/moderate to severe dry eye, pupillary abnormalities and dysfunction, corneal astigmatism ≥1.00 D, AL \<21 mm or ≥26.5 mm, diabetes mellitus with retinal changes, active uveitis or history of uveitis, previous ocular surgery and lack of attendance to any follow-up visit.
Functional Evaluation of Brain Pain Centers in Endometriosis-Associated Chronic Pelvic Pain Exploring the Impact of Central Sensitization Using a Novel MRI Technique

Endometriosis is a chronic inflammatory disease characterized by the presence of endometrial tissue outside the uterus, affecting about 10% of reproductive-age women. It is commonly associated with chronic pelvic pain, present in 40-50% of women with persistent pelvic pain and 30-40% of infertile women. The condition contributes to chronic pain through mechanisms like inflammation, neurogenic inflammation, neuroangiogenesis, and central sensitization.

Central sensitization involves changes in brain function and can be assessed using magnetic resonance imaging (MRI). While studies have shown the role of brain changes in chronic pain for conditions like migraine and fibromyalgia, research on pain chronicization in endometriosis is limited.

This study focuses on evaluating functional changes in brain pain centers associated with endometriosis-related chronic pelvic pain using neuroimaging. The goal is to enhance understanding of the pathophysiology of chronic pain and emphasize the potential of MRI in guiding more effective management strategies for endometriosis.

Endometriosis is a chronic disease defined by the presence of endometrial stroma and glands outside the uterus. It affects approximately 10% of women of reproductive age and is detected in 40-50% of women experiencing persistent pelvic pain and 30-40% of infertile women. Clinically classified as an inflammatory and systemic disease, endometriosis often manifests as pelvic pain. It is believed that endometriosis contributes to chronic pelvic pain through mechanisms such as inflammation, neurogenic inflammation, neuroangiogenesis, peripheral sensitization, central sensitization, and cross-organ sensitization.

Central sensitization can be identified by evaluating functional changes in the brain using magnetic resonance imaging (MRI). Numerous studies have demonstrated the importance of brain functional changes in the chronicization of pain in various conditions, including migraine, fibromyalgia, trigeminal neuralgia, and chronic lower back pain. However, there are limited MRI studies investigating the chronicization of pain associated with endometriosis.

In this study, we aim to highlight the benefits of neuroimaging in elucidating the pathophysiology of chronic pain by examining the functional changes in brain pain centers in chronic pelvic pain associated with endometriosis.

Eligibility Criteria:
Inclusion Criteria:

Women aged 18-45 who underwent brain magnetic resonance imaging, including those with endometriosis and those without gynecological pathology, matched for age and body mass index

Exclusion Criteria:

patients who were pregnant patients in the postmenopausal period patients who had detected pathologies in brain imaging