cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of Venetoclax Combined With Azacytiside in the Treatment of Myelodysplastic/Myeloproliferative Neoplasms in Adults

To explore the efficacy of venetoclax combined with azacytidine in Myelodysplastic / myeloproliferative neoplasms（MDS/MPN）, so as to improve the overall survival and treatment status of MDS/MPN patients.

At present, there is no standardized treatment strategy for MDS/MPN. The purpose of our study is to explore the efficacy of venetoclax combined with azacytidine in the treatment of MDS/MPN, so as to improve the overall survival and treatment status of patients with MDS/MPN. After the participants were treated with four cycles of venetoclax combined with azacytidine, the efficacy was evaluated according to the 2015 adult MDS/MPN response criteria to determine the disease status. Participants with disease progression and intolerance withdrew from the study during treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, Age (years) \>= 18；
2. Patients newly diagnosed or previously treated with MDS/MPNs (CMML, MDS/MPN-U, aCML) according to 2016 WHO diagnostic criteria:

   Initial diagnosis: CMML: CPSS-mol intermediate risk 2 and above; aCML; MDS/MPN-U.

   Previous treatment: HMA treatment failed.
3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ;
4. Liver function: Total bilirubin ≤3 upper limit of normal (ULN); aspartate aminotransferase (AST) ≤3 ULN; alanine aminotransferase (ALT)≤3 ULN；
5. Renal function#Ccr ≥30 ml/min;
6. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Acute myeloid leukemia
2. Myelodysplastic syndrome
3. Subjects who had previously been treated with Venetoclax
4. Subjects who are known to be allergic to ingredients of the study drug or their analogues
5. HIV infection
6. HBV-DNA or HCV-RNA positive
7. Subjects with grade 2 or above cardiac failure and those considered unsuitable for inclusion by the investigator
8. Subjects who are pregnant or breastfeeding
9. Subjects reject to participate in the study
Auditory Brainstem Response as a Diagnostic Tool in Schizophrenia and Bipolar Disorder

The purpose of this study is to study the predictive value of SensoDetect-BERA as a diagnostic tool in clinical practice for schizophrenia and bipolar disorder.

Background:

Within the daily clinical work of all medical specialties, objective diagnostic tools are paramount. However, in the psychiatric field such measures are lacking. Since 1983 the method of psychoacoustics has been under development in hope to serve this purpose. A recent development of auditory brainstem response (ABR/SD-BERA), has been proposed as a potential diagnostic tool within psychiatry.

The ABR is a diagnostic tool used primarily to diagnose sensorineural hearing loss. It detects evoked potentials, generated by neuronal activity in the auditory pathways in the brainstem, within the first 10 ms following acoustic stimulation. The potentials are recorded by surface electrodes placed on the forehead and on the mastoid processes. The wave pattern recorded consists of seven peaks, which are interpreted with respect to latencies and amplitudes.

Previous studies have aimed to associate the peaks with specific anatomical structures. The method SD-BERA is a further development of the standard ABR. It uses a wider array of acoustic stimuli, including complex sounds, for instance masking noises. The measuring procedure will roughly take 25 minutes. Previous studies using these complex sounds to compare mentally healthy subjects with patients suffering from schizophrenia, ADHD and bipolar disorder have shown that the different psychiatric groups exhibit specific wave patterns.

Aims

The aim of the first study is to validate previous results and identify five (n=5) patients with diagnosed ADHD, schizophrenia and bipolar disorder, and to compare these patients (n=15) with healthy, age-matched controls.

The aim of the second study is to present a blinded study where 12 patients with schizophrenia and 12 patients with bipolar disorder (total n=24) are compared to each other and to healthy controls (n=12) in order to evaluate the method as a diagnostic tool in clinical healthcare practice.

Eligibility Criteria:
Inclusion Criteria:

* Best-practise diagnosed schizophrenia, bipolar disorder or ADHD
* Diagnosed since at least one year prior to enrollment.

Exclusion Criteria:

* Serious hearing loss
* Severe ongoing alcohol abuse or drug abuse
* Diagnosed psychiatric comorbidity
* Brain injury following cranial trauma
Evaluation of Hospitalization for Anorexia Nervosa (EVALuation de l'Apport de l'HOSPITalisation Pour Anorexie Mentale : EVALHOSPITAM)

The objective of this research is to evaluate the efficacy of five different in-patient treatment modalities and predictive factors of outcome for anorexia nervosa. The primary hypothesis is that the different treatment types impact outcome of patients at discharge from inpatient treatment and at one year follow-up, even after adjustment for confounding factors (age, length of illness, number of previous hospitalizations, clinical state at intake).

This study will evaluate global, psychiatric, somatic and psychosocial outcome for inpatients with anorexia nervosa through three evaluations (intake, discharge and one-year follow-up). The study will also consider five types of in-patient treatment in a naturalistic setting (i.e., patients will not be assigned to different treatment conditions; rather, we will study inpatient care as it exists today). The five treatment modalities to be studied are:

1. Discharge weight objectives.
2. The practice of a separation period.
3. The use of clear nutritional and dietary objectives (cognitive/behavioural).
4. The intensity of family involvement in treatment.
5. Stabilisation phase before ending inpatient treatment.

Eligibility Criteria:
Inclusion Criteria:

* All patients who accept participation between 8 and 50 years old, consecutively hospitalized for a DSM IV diagnosis of Anorexia Nervosa in one of the departments participating in this research by necessity of physical condition (BMI \< 15, rapid weight loss) or psychological condition
* Parents of participating patients still living with their parents who accept participation

Exclusion Criteria:

* Refusal of research
* Patients who do not speak French
* Patients with a related somatic illness (diabetes, Crohn's disease, metabolic illness)
* Patients not covered by social security health insurance
Effects of Blueberry Juice Consumption on Cognitive Function in Healthy Older People

Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory properties, which in rodent models are neuro-protective. The risk of developing dementia is reduced in people habitually consuming high flavonoid intakes, but data from human intervention studies is sparse. We therefore investigated whether 12 weeks of blueberry concentrate supplementation improved cognitive function in healthy elderly via increased brain activation and perfusion.


Eligibility Criteria:
Inclusion Criteria:

* aged 60-80y
* Addenbrooke's Cognitive Examination III questionnaire \> 88
* Consuming 5 or less portions of fruit per day

Exclusion Criteria:

Addenbrooke's Cognitive Examination III questionnaire \< 88 Contraindications for MRI Consuming more than 5 portions of fruit per day
Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients

The purpose of this study is to investigate whether the anabolic potentials of insulin may be used to reverse the catabolic effects of hemodialysis in non-diabetic patients with end-stage renal failure.

Nutritional markers such as lean body mass and serum albumin are strong predictors of the mortality and morbidity in patients with end-stage renal failure (ESRF) on maintenance hemodialysis (HD). Maintenance HD is considered to contribute to the malnutrition of patients with ESRF, but the exact mechanism has remained unknown. However, we have recently shown that the bioactivity of insulin-like growth factor-I (IGF-I) is reduced by 50% during HD. Furthermore, we showed that the reduction in the bioactivity of IGF-I is directly linked to an up-regulation of IGF-binding protein-1 (IGFBP-1), the only acutely regulated IGFBP, which increased by 6-fold during HD. IGFBP-1 is produced in the liver, primarily under the control of insulin, which promptly inhibits the hepatic production of IGFBP-1. As plasma insulin remains fairly low during a maintenance HD, the increase in IGFBP-1 may be explained by the absence of insulin.

The finding that HD acutely down-regulates the bioactivity of IGF-I by an up-regulation of IGFBP-1 may not only explain the catabolic mechanisms of HD per se, it also opens for a new treatment strategy of ESRF patients undergoing maintenance HD. Thus, on the basis of our previous study we hypothesize that treatment of ERSF patients with high doses of insulin during maintenance HD may counter-act the HD-induced stimulation of IGFBP-1, making it possible to preserve the bioactivity of IGF-I, and thereby abolishing the catabolic impact of HD.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* stable patients on maintenance hemodialysis for \> 3 months
* well-functioning arteriovenous (AV) shunt with recirculation \< 5%
* informed consent

Exclusion Criteria:

* diabetes mellitus
* body mass index \< 18.5 kg/m2 or \> 30 kg/m2
* malnutrition (subjective global assessment (SGA) score C)
* malignancy
* use of immunosuppressive drugs including glucocorticosteroids
* severe infectious disease \< 4 weeks
* pregnancy

Exclusion Criteria during the study:

* myocardial infarction or arrythmia with hemodynamic derangements
* permanent thrombosis in the arteriovenous (AV) shunt
* severe infectious disease
* renal transplantation
Intensive Music Therapy on Cognitive Function in Subacute Stroke Rehabilitation in Malaysia

The purpose of this study is to explore whether intensive music therapy can help improve cognitive functions like memory, attention, and decision-making skills in stroke patients who are undergoing rehabilitation.

This is a feasibility study, meaning it's also designed to see how practical it is to include music therapy as part of stroke rehabilitation. The investigators want to learn how well patients can participate in and stick with this type of therapy, and whether it fits well with other treatments that stroke patients usually receive. By understanding this, the investigators can assess the resources, staff training, and planning needed for music therapy to be part of stroke recovery in the future.

The study will also help the investigators estimate the effects of music therapy, which will be used to design a larger, more detailed study in the future.

This study will be a feasibility randomised controlled trial (RCT) in one centre, with two parallel groups: an intervention group receiving intensive music therapy in addition to standard neurorehabilitation, and a control group receiving only standard neurorehabilitation. A certified music therapist will conduct the intervention and a trained assessor will evaluate the outcome. The assessor is blinded to the patients' allocation group and will evaluate the cognitive outcomes at baseline, at two weeks (after 8 sessions) and at 1 month post intervention. All patients whoare admitted to the rehabilitation ward for stroke rehabilitation will be screened and approached. Informed consent will be obtained from eligible patients before randomisation. To ensure that there are exactly 15 patients in both the control and intervention groups, block randomization will be used using a random number generator. After randomization, the group assignments will be kept in a password-protected file that only the study coordinator can access. The assessor will not have access to this information because the patients will be labelled with anonymous codes that do not reveal whether they are in the control or intervention group. The assessor will only know the code, not the group assignment, ensuring unbiased evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ischemic or haemorrhagic stroke confirmed by CT scan
* Duration of stroke within the first 3 months
* Aged 18 - 75 years old
* Ability to provide informed consent
* Understands Bahasa Melayu or English with basic communication abilities to follow instructions during therapy sessions
* Mild to moderate cognitive impairments with MoCA score of 10-25.

Exclusion Criteria:

* Severe aphasia
* Significant uncorrected hearing or visual impairments preventing engagement in music therapy.
* Severe or unstable medical conditions (e.g., uncontrolled hypertension or diabetes).
* Medications that significantly impair cognition or motor function (e.g., high dose sedatives).
* History of neurological diseases other than stroke (eg, Parkinson's disease).
Evaluation of a Novel Nasal Conformer in Pediatric Patients

This study compares the current commercially available nasal conformer available for use in cleft lip repair and nasal scar release to a novel, anatomically shaped conformer based upon typical nasal airspace shape. This will follow patients using both of these types of splints during the post-operative healing process with one group starting with the standard splint and then moving to the anatomic conformer and the second group beginning with the anatomic and them moving to the standard conformer. This study will evaluate the patient experience and outcomes of the 2 types of conformers, looking at the discomfort, device dislodgements, ease of use and occurrence of complications such as skin irritation and rashes or skin breakdown.


Eligibility Criteria:
Inclusion Criteria:

* Patient's undergoing primary cleft lip repair or release of nasal scarring

Exclusion Criteria:

* patient or parents declined participation postoperative nasal stenting is judged clinically inappropriate
A Study to Compare Genetic Variations of IGF-I and IGF-II

The purpose of this study is to determine if insulin-like growth factors (IGF) play a role in the development of dementia, specifically Alzheimer's disease (AD). The study will compare results from genetic testing between patients with AD and two other groups: younger biological family members of the AD patients and individuals without AD matched by age to the AD patients.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 50 and 81 years old who have a diagnosis of dementia
* Men and women who are at least 18 years old and are biologically related to the study subject with dementia
* Control subjects must not have a diagnosis of dementia and must be matched in age to the study subjects with dementia

Exclusion Criteria:

* Biological family members of the dementia patient who are either younger than 17 years of age or older than the patient with dementia
* Biological family members with a diagnosis of dementia
* Age-matched control subjects with a diagnosis of dementia
The Effects of Palmar Cooling on Repeated Sprinting Ability

Repeated sprinting ability is key for athletic performance in a variety of sport settings. Significant degradations in work output (i.e. fatigue) have been shown to develop after just one sprinting bout1. This pilot study aims to investigate the effects that noninvasive transient temperature manipulation has on an individual's ability to perform repeated sprints. The investigators aim to enroll 90 healthy individuals, 18-30 years of age. Participants will be randomized into two groups (Group A, and B). All groups will perform a ten-minute warm-up followed by two minutes of rest. Following the warm-up and rest period, all groups will participate in a series of five sprints, 60 meters in total length with two 180 degree changes in direction. Between sprints, participants will have 10 seconds rest. After the first series of five sprints participants will be given a 2-minute rest interval. Then participants will perform another series of five sprints followed by another 2-minute rest interval. During each rest interval, Group A will utilize a palmar cooling device. Group B will utilize a placebo version of the palmar cooling device. All sprints will be timed. Heart rate recovery will be measured during all rest breaks, and a rating of perceived exertion will be measured at the beginning and end of each resting interval. Delayed onset muscle soreness will be assessed 48 hours post sprinting, utilizing a visual analog scale.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals 18-30 years of age

Exclusion Criteria:

* Participant self-reporting injury or illness that will prevent them from exercising at maximal capacity
* If participant has been told by their healthcare provider that they should avoid exercising at maximal capacity
* Has previously used the palmar cooling device
Evaluation of Fluid-Filled Expression Core Technology Study - I

A functional model of a fluid-filled, smaller dead volume breast pump has been developed in order to more closely mimic the breastfeeding infant. The technology of fluid-filled pumping has been tested in one prior clinical study and has now progressed to a complete prototype with which the user can assemble, pump, disassemble, clean and reuse.

Current breast pumps function in a way that is different to breastfeeding. These include the seal to the breast, the movement of the nipple, the sensations of warmth and moisture, the variability in frequency, and the strength of the applied vacuum. During breastfeeding the mother's nipple and the infant's mouth form a chamber that is a fluid-filled, no dead volume system, which is needed to create a working vacuum to remove milk from the breast. There is no air visible in the natural system according to ultrasound measurements. This is unlike breast pumps which use an air-filled, large dead volume system, to create a working vacuum. Therefore, a functional model of a fluid-filled, smaller dead volume breast pump has been developed in order to more closely mimic the breastfeeding infant. The technology of fluid-filled pumping has been tested in one prior clinical study and has now progressed to a complete prototype with which the user can assemble, pump, disassemble, clean and reuse.

Eligibility Criteria:
Inclusion Criteria:

1. Subject ≥ 18 years old
2. Infant is ≥1 and ≤6 month old
3. Subject and baby are healthy according to self-declaration in the "Mother and infant health questionnaire"
4. Subject is predominantly breastfeeding (80% of all feeds, i.e. ≤150 ml formula/day or equal representative amount of solid food)
5. The subject agrees to pump or feed the last time a minimum of 2 hours (hr) before the start of the pumping session at the study site
6. The subject agrees to photographs/3 D scan of the breast and upper body (no face),
7. The subject agrees to a video while pumping
8. The subject signs the informed consent documentation
9. Subject agrees that a maximum of 2 male team members can be present in the room to conduct the usability part of the study
10. The mother accepts that the pumped milk in visit 2 must be donated to the study i.e. cannot be fed to the baby

Exclusion Criteria:

1. The subject has a nipple size ≥ 21 mm
2. Mastitis (any breast within two weeks prior to enrolment)
3. Engorgement (any breast within two weeks prior to enrolment).
4. Case of current infection as self-declared in the Mother and infant health questionnaire
Colonisation Efficacy of a Probiotic Chewing Gum.

To evaluate the colonization efficacy (the ability of a probiotic bacteria to remain in the mouth) delivered in a chewing gum format. The chewing gum contains Streptococcus salivarius probiotic and the study is to be done in health adults.

This is a single blind, randomized controlled study to evaluate the colonization effectiveness of a chewing gum containing a commercially available probiotic bacterium. Participants will be randomly assigned to one of the two groups consuming chewing gum containing Streptococcus salivarius M18 over a 7-day period. Saliva samples will be collected at pre determined points (pre and post intervention). Colonization efficacy will be determined by enumerating the probiotic from the saliva samples using standard microbiological techniques.

Eligibility Criteria:
Inclusion Criteria:

* In general, good health
* Practice good oral hygiene

Exclusion Criteria:

* Have a history of autoimmune disease or are immune compromised.
* Are on concurrent antibiotic therapy, or regular antibiotic use within last one week
* People with allergies or sensitivities to dairy.
Intervention for Medical Student to Promote Cervical Cancer Screening Among Latinx Transmasculine Individuals

The team aims to test the effectiveness of an intervention to increase gender-affirming cervical cancer prevention behaviors targeted at medical students studying in Puerto Rico and Florida. The team expects that after exposure to the intervention, relative to the control group, participants in the experimental condition will manifest more favorable changes in knowledge, attitudes, and behaviors of adequate care towards Latinx transmasculine and non-binary people.

Transmen (TM) and non-binary individuals (NB; individuals assigned female sex at birth who identify as a man, male, or another diverse non-binary gender identity on the masculine spectrum) are at higher risk of screening-detectable cancers. Latinx TM-NB (LTM-NB) are at a higher risk for cervical cancer (CC) as they intersect two health disparity populations with high risk for this type of cancer (gender identity and ethnic minorities). Despite CC being highly preventable, LTM-NB individuals have been found to have lower rates of CC screening than cisgender female patients (persons who are not transgender). Unfortunately, findings from the team's previous funded studies with LTM-NB individuals in Puerto Rico (PR) and Florida evidence that providers lack knowledge regarding LTM-NB individual's healthcare needs, have negative stigmatizing attitudes, and manifest discriminatory behaviors in clinical interactions with LTM-NB individuals; which greatly limits their ability for engaging in recommended education and prevention guidelines of care for CC screening and prevention. In light of this, the research team (community stakeholders from PR and Mainland US, researchers, and providers) has developed a brief online intervention to improve medical students' competencies for cervical cancer education and screening promotion among LTM-NB individuals.

The proposed study aims to: 1) Test the effectiveness of the intervention in increasing medical students' knowledge, attitudes, and skills for providing healthcare to LTM-NB. , 2) Determine the acceptability, appropriateness, and feasibility of implementing the interventions in real-world medical educational settings.

While the team has preliminary data regarding the efficacy of the intervention, this pilot is proposing a rigorous study design: Aim 1 will measure the magnitude of effect of the intervention, and Aim 2 measures the implementation. This study will address cervical cancer disparities among LTM-NB individuals. The impact of this study will reveal new effective interventions and implementation strategies. The translational implications of this work will result in providing medical schools with a cross-cultural tool to train students on cervical cancer prevention for LTM-NB individuals.

Eligibility Criteria:
Inclusion Criteria:

* Medical student currently in third year of medical school training

Exclusion Criteria:

* Do not speak English