cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety, Tolerability, and Drug Levels of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity

The purpose of this study is to evaluate the safety, tolerability, and drug levels of orally administered BMS-986368 in healthy participants, healthy elderly participants, and healthy participants of japanese ethnicity.


Eligibility Criteria:
Inclusion Criteria

* Participants must be healthy male or non-pregnant and non-nursing female individuals.
* For Part 2 only, participants must be of Japanese ethnicity (both biological parents are ethnically Japanese).
* Participants must have a body mass index (BMI) of 18.0 kg/m2 to 33.0 kg/m2, inclusive.
* Participants must have normal renal function at screening.

Exclusion Criteria

* Participants must not have a personal or first-degree family (individual's parents, siblings, and children) history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, panic disorder, generalized anxiety disorder, and obsessive-compulsive disorder.
* Participants must not have any significant acute or chronic neurological illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etc) as determined by the investigator.
* Participants must not have a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases including but not limited to peptic ulcer disease, or significant GI bleeding, pancreatitis, hypokalemia.
* Participants must not have had a SARS-CoV-2 infection within 2 weeks prior to screening.
* Participants must not have a history of any significant drug allergy or hypersensitivity (such as anaphylaxis or hepatotoxicity).
* Other protocol-defined Inclusion/Exclusion criteria apply.
Peripheral Arterial Disease Biomarkers

The study aims to determine how expression levels of biomarkers for peripheral arterial disease change over time in response to exercise therapy, surgical or endovascular intervention, and whether they can be used to predict disease progression.

Several studies have identified markers in the blood (called biomarkers) that are associated with peripheral arterial disease, or clogging up of the blood supply to the leg. There is little understanding however regarding how these respond to intervention, and how they are related to walking distance.

This study will increase the understanding of the relationship between peripheral arterial disease state and biomarker expression and enable us to work towards the development of new targets for treatment.

Participants will be invited to undertake questionnaires and dedicated walking tests alongside regular blood tests to check their biomarker levels. These will be undertaken on a regular basis so the investigators can see what happens over time, such as after a surgical procedure, and see if these markers go back towards normal following intervention.

Eligibility Criteria:
Inclusion Criteria:

* Aged \> 50 years
* Symptomatic PAD
* ABPI \<0.8 or TBPI \<0.7

Exclusion Criteria:

* Aged \<50 years
* Current Malignancy
* Rheumatological Condition
* Previous surgical or endovascular intervention for PAD
* ABPI \>0.8 or TBPI \>0.7
Skin Rejuvenation Using Stem Cell Secretome

This clinical trial aims to investigate the effect of umbilical cord explants (UC)-explants and UC-mesenchymal stem cells (MSCs) secretome on skin rejuvenation, to provide future reference or standard in the application of cell free-based therapy in skin aging.

This trial is a pilot clinical trial evaluating the effect of the secretions of umbilical cord explants and mesenchymal stem cells on skin rejuvenation. Also the concentration of selected growth factors was assessed in the secretome derived from UC-explants and UC-MSCs.

Healthy women participants, after their consent, received secretome injections in their hands, face, and neck. Outcomes were assessed on the Hand Volume Rating Scale, Wrinkle Severity Rating Scale, and through histologic examination of skin biopsy at two different times: before treatment and after 12 months. A digital camera was used to obtain photographs of hands, face, and Neck at each visit. These were assessed by a single-blinded dermatologist. SPSS software version 26 (64-bit) was used for all analyses.

Participants provided written informed consent and were asked not to change their routine skin care habits during the study.

Eligibility Criteria:
Inclusion Criteria:

* women participants aged \> 25 years
* any skin type according to the Glogau scale
* Willing to be a research subject, sign a consent form, and commit to follow-up visits

Exclusion Criteria:

* patients with active skin diseases (e.g. atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis)
* patients using other anti-aging treatments within 1 month
Effect of Debridement-scaling on the Relief of Dry Eye Signs and Symptoms in Sjogren's Syndrome

Sjogren's Syndrome is an autoimmune condition in which the body attacks its own glands in the body. Some of these glands are responsible for providing lubrication for the eye. As a result, individuals with Sjogren's Syndrome often experience dry eye. Recently, a study had shown that dry eye symptoms were improved by removing debris and old skin cells along the eyelid margin. This technique is called eyelid debridement-scaling. The purpose of this study is to determine how well this technique works in improving dry eye signs and symptoms in individuals with Sjogren's Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Is diagnosed with Sjogren's Syndrome;
* Meibomian gland score of ≤ 9 (out of 15);
* OSDI ≥ 23;
* Willing to maintain the use of OTC medications throughout the course of the study
* Have not worn contact lenses within the past 3 years

Exclusion Criteria:

* Is participating in any concurrent clinical or research study;
* Has any known active\* ocular disease and/or infection;
* Has a systemic condition, other than Sjogren's Syndrome and its associated conditions, that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications, other than those indicated for Sjogren's Syndrome and its associated conditions, that in the opinion of the investigator may affect a study outcome variable;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Is pregnant, lactating or planning a pregnancy at the time of enrolment;
* Is aphakic;
* Has undergone refractive error surgery; \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Immersive Virtual Reality Bicycling for Healthy Adults

This study has four objectives about healthy younger and older adults during immersive virtual reality bicycling:

Determine the effect of visual feedback and competition for younger healthy adults during virtual bicycling on user experience, motivation, enjoyment, perception of effort, and neuromuscular and cardiovascular intensity

Determine the effect of visual feedback and competition for older healthy adults during virtual bicycling on user experience, motivation, enjoyment, perception of effort, and neuromuscular and cardiovascular intensity

Compare younger and older during visual feedback and competition bicycling in terms of: user experience, motivation, enjoyment, perception of effort, neuromuscular and cardiovascular intensity

Determine if attention differs in visual feedback bicycling compared to competition bicycling for younger and older healthy adults

Participants will attend one session lasting about 1.5 hours. They will complete a competitiveness assessment and a questionnaire about physical activity. They will then exercise in three different virtual reality augmented bicycling conditions while wearing a head mounted display (goggles). Each of the three conditions will last approximately 5 minutes and will be followed by questionnaires about the participant's experience.

Eligibility Criteria:
Inclusion Criteria:

* 21-75 years old,
* Able to ride a stationary upright bicycle,
* Able to sign informed consent.

Exclusion Criteria:

* Have a recent history of severe heart disease, severe lung disease, uncontrolled diabetes, traumatic brain injury or any other neurological disorder
* Are unable to follow directions or sign a consent form,
* Do not have adequate vision or hearing ability to see or hear a television,
* Have unstable medical condition or musculoskeletal disorder such as severe arthritis, recent knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to ride the bicycle,
* Have any other medical condition that prevents bicycling,
* Have moderate depression (score of 10 or more on PHQ-9 screening tool)
Combined Prostate-specific Antigen, Multi-parametric MRI and Targeted Prostate Biopsy for Prostate Cancer Screening

The study aims to investigate the incidence of prostate cancer among males in Nanjing and whether a combination of PSA, multi-parametric MRI and targeted biopsy is a feasible approach for screening prostate cancer in China.

The investigators are going to collect serum samples and clinical information from men aged ≥50 years taking physical examination in community health service centers in Nanjing. The investigators will propose mpMRI for those with serum PSA ≥4 ng/mL. Transperineal systematic biopsy (TPSB) combined with MRI /ultrasound fusion targeted biopsy (TB) will be offered for those scored ≥3 on the Prostate Imaging-Reporting and Data System Version 2 (PI-RADS v2). TPSB alone will be offered for those scored \<3 and serum PSA ≥10 ng/mL. Subjects with serum PSA between 4 ng/mL and 10 ng/mL and PI-RADS score \<3 points will be referred to follow-up examinations every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50
* (Eastern Cooperative Oncology Group)ECOG grade: 0-1
* Normal organic function indexes:
* (absolute neutrophil count)ANC ≧1.5×109/L
* (platelet count)PLT ≧100×109/L
* Hb ≧90 g/L
* (total bilirubin)TBIL ≦1.5×ULN
* (aspartate aminotransferase)ALT≦2.5×ULN
* (alanine aminotransferase)AST ≦2.5×ULN
* (blood urea nitrogen)BUN (orUREA) and Cr ≦1.5×ULN

Exclusion Criteria:

* Former serum PSA detection
* Having took Proscar in the past 3 months
* Suffered from any other malignant tumor in the past 5 years
* History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system
* Having took Proscar in the past 3 months
* Suffered from any other malignant tumor in the past 5 years
* History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system
Novel Augmentation of DAOIB and Antioxidant for Early Dementia

Previous studies found that some NMDA-enhancing agents were able to improve cognitive function of patients with early-phase dementia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of dementia too. Whether combined treatment of an NMDA-enhancing agent and a drug with antioxidant property can be better than an NMDA-enhancing agent alone deserves study.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
* MMSE between 10-26
* CDR 1 or 0.5

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* Substance abuse/dependence
* Parkinson disease, epilepsy, dementia with psychotic features
* Major depressive disorder
* Major physical illnesses
* Severe visual or hearing impairment
The Use of Transcranial Direct Current Stimulation (tDCS) in Adults with Developmental Disabilities

Aggressive behaviours are highly prevalent among people with developmental disabilities, both in community and inpatient or residential settings, with adverse consequences for the individuals involved and others. Some predictive factors, particularly impulsivity, are dynamic with neurobiological underpinnings, and as such amenable to change or neuromodulation using non-invasive brain stimulation techniques. With this in mind, we designed an experimental protocol to determine the efficacy of transcranial Direct Current Stimulation (tDCS) as a non-invasive brain stimulation technique to reduce impulsivity and aggression associated with developmental disability.

This study aims to assess the efficacy of anodal tDCS in modulating Rapid Response Impulsivity (RRI) and reducing incidents of aggression in people with developmental disabilities is residential or hospital settings. Using a single blind, parallel arms, randomized controlled trial design, adults (n=60) aged 18 to 65 with developmental disabilities, who have a history of impulsivity leading to aggression, will be randomised to receive either repetitive anodal or sham tDCS. Enrolled participants will receive either three treatment sessions of tDCS or sham tDCS. Behavioural and impulsivity will be measured before and immediately after treatment, one week, and one month after treatment end. Data will be analysed in SPSS using repeated measures ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-64 years
* Diagnosis of a developmental disability
* History of one or more incidents of aggression in the last month
* Consent to participate in the trial by the individual or their Substitute Decision Maker

Exclusion Criteria:

* History of epilepsy or seizures
* History of acquired brain injury
* Having metal in the brain/skull, e.g. splinters, fragments or clips
* Having a cochlear implant
* Having an implanted neuro-stimulator (e.g. direct brain stimulation, epidural/subdural stimulation, vagal nerve stimulation)
* History of brain surgery of procedure
* History of severe adverse reaction to tDCS
* Having a cardiac pacemaker or intracardiac lines
* Current alcohol or drug misuse
* Having a sensitive scalp
Participant Reported Outcomes and Treatment Experiences in Kidney Cancer

The purpose of this observational study is to collect contemporary real-world treatment patterns, clinical outcomes, humanistic burden (including patient-reported disease-specific Health-related Quality of Life (HRQoL), and treatment- related adverse events (AEs) or adverse reactions (ARs) among Advanced Renal Cell Carcinoma (aRCC) patients initiating first-line systemic therapy.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Cohort 1

* Primary diagnosis of aRCC (advanced Renal Cell Carcinoma) or metastatic RCC
* Medical history must be available from date of aRCC diagnosis
* Initiated 1LOT between April 2018 - March 2020

Cohort 2:

* Primary diagnosis of aRCC (not amenable to curative surgery or radiation therapy/ AJCC Stage III unresectable) or metastatic RCC (AJCC Stage IV).
* Medical history must be available from date of aRCC diagnosis.
* Initiate 1LOT.

Exclusion Criteria:

* Currently enrolled in a clinical trial for treatment of aRCC
* Any prior malignancy active within the previous 3 year, except for locally curable cancers that have been cured
* Any prior systemic therapy for aRCC, with the exception of neoadjuvant or adjuvant therapy (Cohort 2 only)

Other protocol-defined inclusion/exclusion criteria apply
Comparison of Lung Ultrasound Scores With Clinical Models for Predicting Bronchopulmonary Dysplasia：A Multi-center Prospective Cohort Study

This study aimed to fill this knowledge gap and designed a multicentre cohort study to verify the hypothesis that LUS has good reliability to predict BPD in China and to compare the predictive value of LUS and clinical models for the development of BPD at different time points in infants born before and after 28 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Preterm infants with GA \<32 weeks.
2. Infants with enrollment within 24 hours from birth
3. Parental written consent is obtained.

Exclusion Criteria:

1. Complex congenital malformations or chromosomal abnormalities
2. Congenital lung diseases or congenital heart defects
3. Infants with enrollment after 24 hours from birth
Couple-based Interpersonal Psychotherapy on Postnatal Depression and Family Sense of Coherence

Postnatal depression is a common public health problem which has long-term sequelae on the family and the infant's psychosocial development. Interpersonal psychotherapy has demonstrated its value as one of the most effective interventions for postnatal depression. The aim of this study is to examine the effect of a couple-based interpersonal psychotherapy for first-time Chinese mothers and fathers on depressive symptoms, family sense of coherence, and marital relationships immediately after intervention and at 6 weeks and 6 months postpartum.

Background: Postnatal depression is a common public health problem which has long-term sequelae on the family and the infant's psychosocial development. Interpersonal psychotherapy has demonstrated its value as one of the most effective interventions for postnatal depression. Enhancement of family sense of coherence may be helpful for women who are at risk for postnatal depression. However, few studies in the context of Chinese parenthood have evaluated the effect of interpersonal psychotherapy on postnatal depression and the underlying mechanisms.

Aim: To examine the effect of a couple-based interpersonal psychotherapy for first-time Chinese mothers and fathers on depressive symptoms (primary outcome), family sense of coherence (secondary outcome), and marital relationships (secondary outcome) immediately after intervention and at 6 weeks and 6 months postpartum.

Method: A randomized controlled trial will be used to evaluate the effect of a couple-based interpersonal psychotherapy on depressive symptoms (primary outcome), family sense of coherence (secondary outcome), and marital relationships (secondary outcome) immediately after intervention and at 6 weeks and 6 months postpartum. A convenience sample of 125 couples will be recruited at the antenatal clinics and randomly assigned to either experimental or control group. The experimental group will receive the intervention in addition to the standard perinatal care, while the control group will only receive the standard perinatal care.

Intervention: The intervention consists of three weekly 2-hour antenatal sessions using an interpersonal psychotherapy approach that focused on enhancement of family sense of coherence and two telephone follow-ups within the first four weeks after delivery.

Outcome measures: The primary outcome measure of postnatal depression will be assessed by the Edinburgh Postnatal Depression Scale. Secondary outcome measures of family sense of coherence and the marital relationship, will be assessed by the Family Sense of Coherence Scale and Dyadic Adjustment, respectively, at baseline, immediately post-intervention, 6 weeks and 6 months postpartum.

Data analysis: Linear mixed models will be used to test for significant differences between the groups on outcome variables.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 or above;
* married, first-time parents, live together;
* able to speak and read Chinese; and Hong Kong residents.

Exclusion Criteria:

* a present history of psychiatric illness
Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma

This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 to 65 years old (inclusive)
* Patients with mild to moderate persistent asthma
* BMI must be within the range of 18-32 kg/m2 inclusive
* Female subjects must:

  1. have been sterilized at least 6 months prior to screening
  2. be post-menopausal with no regular bleeding for at least a year prior to inclusion

Exclusion Criteria:

* Patients with life-threatening arrhythmias
* Patients with COPD or diabetes mellitus
* History of immunocompromise, including a positive HIV
* A positive Hepatitis B surface antigen (HBsAg) of Hepatitis C test result

Other protocol-defined inclusion/exclusion criteria may apply.
HOPE from the Cerebellum: TMS-Induced Cognitive Recovery After Stroke

The objective of this clinical trial is to investigate the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. Participants will undergo rTMS in the cerebellar hemisphere opposite the lesion site, once daily for a total of five days.

The primary objective of this clinical trial is to investigate the effectiveness and safety of intermittent theta burst stimulation ( iTBS) in the cerebellum for individuals with post-stroke cognitive impairment. The trial aims to answer two main questions: (1) What is the effectiveness of iTBS in improving post-stroke cognitive impairment? (2) Is iTBS in the cerebellum safe for individuals with post-stroke cognitive impairment? Participants will undergo iTBS in the cerebellar opposite the lesion site, twice daily for five days. The control group will receive sham rTMS with the same parameters and positions.

Eligibility Criteria:
Key inclusion criteria:

(1)ischemic stroke, with an initial incident occurring within 2 weeks;(2)MoCA\<26;

Key exclusion criteria:

(1)Cerebral hemorrhage or subarachnoid hemorrhage;(2)A pre-existing history of epilepsy;