cyrilzakka/clinical-trials huggingface dataset:
Adverse Events and Genomics in Schizophrenia

The purpose of this study is to find genes that predict whether or not a person will develop side effects to antipsychotic medications, such as weight gain, blood sugar dysregulation, or immune cell abnormalities. We will be collecting blood samples from participants who are taking second-generation antipsychotic medications. These blood samples will be stored over the long-term in a biobank, and will be used for later genetic testing and other cell-based studies.

All data (including blood samples and medical information gathered from participants) will be labelled with each participant's unique coded identifier. Participants' identities will be matched with their coded identifier in a single, hard-copy of a Master Coding List. The maintenance and security of this list is the responsibility of the Principal Investigator.

All processing steps of the blood samples, including details of the blood draw, nucleic acid extraction, sequence library preparation, and sequence analysis will be documented in a Microsoft Excel worksheet. This worksheet will be encrypted for privacy.

Anonymized aliquots of blood samples (as well as any derived cell cultures) will be barcoded before long-term storage in a surveillance-monitored, secured freezer at -80 degrees Celsius. Samples within the freezer will be maintained via a positional numbered grid within the Laboratory Information Management System. This grid will also allow the study team to link each barcoded sample to a participant's coded identifier.

Mapped genomic sequences and other data collected from participants will be saved in password-protected folders on the UBC server. The coded sequence data will be transferred to the Department of Genetics and Genomic Sciences at Mount Sinai School of Medicine (MSSM) for further analyses. Data transfer will occur by Two Factor Identification. The MSSM secure network is Clinical Laboratory Improvement Amendments (CLIA) certified for secure handling of patient sequence data. The transfer of sequence data between UBC and MSSM will be performed under a material transfer agreement which requires that 1) all data and analysis be confined within the secure, password-protected database defined by UBC, 2) not distributed to any third party, and 3) both raw and analyzed data be destroyed from the MSSM monthly. This study is not required to comply with any U.S. federal regulations, as the group in MSSM will not have access to any identifying information about our participants.

Eligibility Criteria:
Inclusion Criteria:

* Must be taking an antipsychotic medication (no limit on treatment duration)

Exclusion Criteria:

* None
The Effect of Remote Ischemic Conditioning on the Microcirculation in Sepsis

This study is an evaluation of the effect of Remote ischemic conditioning on sublingual microcirculation in patients with sepsis.

This prospective open-label trial is performed in mixed ICU in a tertiary teaching hospital. Investigators include patients with sepsis or septic shock within the first 24 h after ICU admission. Remote ischemic conditioning (RIC) procedure comprise three repetitions of brachial cuff inflation to 200 mmHg for five minutes following deflation to 0 mmHg for another five minutes. The procedure overall took 30 minutes. RIC is performed at inclusion and repeated 12 h and 24 h later. Sublingual microcirculatory measurements are obtained before and after each RIC procedure, using incidence dark field (IDF) device.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sepsis or septic shock within the first 24 h after ICU admission.

Exclusion Criteria:

* age \< 18 years,
* pregnancy,
* advanced malignancy,
* peripheral artery disease affecting both arms,
* oral mucosal inflammation or injury or technical difficulties in obtaining sublingual images.
Adherence in Chronic Adrenal Insufficiency

Adherence, concerns and satisfaction with information in German patients with adrenal insufficiency as well as the influence of a standardized education program will be assessed by a compared cross-sectional and longitudinal study.

Patients with adrenal insufficiency (AI) require a lifelong replacement therapy with glucocorticoids (GC). To avoid over- and under- replacement, an individual daily dose scheme and adequate dose adjustment during stressful events is essential. Recent patient surveys revealed nonadherence to treatment, concerns about GC and dissatisfaction with the provided information.

The aim of this trial is to evaluate the adherence, concerns and satisfaction with information in German patients with primary and secondary AI (PAI/SAI) and the influence of a standardized education program.

Patients with AI on GC therapy will be assessed by questionnaire, including the Medication Adherence Report Scale\* (MARS), Beliefs about Medicines Questionnaire\* (BMQ, adapted for AI) and Satisfaction with Information about Medicines Scale\* (SIMS).\*©Professor Rob Horne.

The study includes one cross-sectional-analysis and one longitudinal study (patient survey before and after participation at the standardized education program in Germany).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patient's written informed consent
* Ability to comply with the protocol procedures
* Patients with chronic adrenal insufficiency under established stable replacement therapy

Exclusion Criteria:

* Age \< 18 years
Water, Sanitation, and Hygiene Mobile Health Messages as an Innovative Tool to Facilitate Behavior Change

Develop a scalable approach for delivering water, sanitation, and hygiene (WASH) messages to households in areas with confirmed cholera patients in Dhaka, Bangladesh. This will be done by conducting formative research through in-depth interviews, focus group discussions, and intervention planning workshops with households in areas with confirmed cholera patients and government officials to identify perceptions of WASH behaviors and to inform the development of a mobile health intervention (mHealth) for this population. This intervention approach will then be piloted in a subset of households, and revised according to feedback. Then the investigators will conduct a randomized controlled of the refined mHealth intervention.

Aim 1. Develop an evidence and theory based WASH mHealth intervention for households in areas with confirmed cholera patients in Dhaka, Bangladesh through formative research

1. Conduct formative research through in-depth interviews, focus group discussions, and intervention planning workshops with caregivers and household members of young children, and government officials to identify perceptions of WASH behaviors and to inform the development of intervention materials.
2. Pilot the WASH mHealth intervention in a subset of households, and revise according to feedback.

Aim 2: Evaluate the effectiveness of the developed WASH mHealth intervention in increasing WASH behaviors and reducing fecal contamination on hands and in stored drinking water by conducting a RCT

1. Recruit and prospectively follow for 12 months 120 households (600 participants, 4 per household) with a child under five years of age assigned to one of two study arms (60 households per arm). The first arm will receive the CHoBI7 mHealth program (CHoBI7 mHealth program Arm) and the second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS).
2. Compare the 2 study arms using structured observation of handwashing with soap at stool and food related events, unannounced spot checks of the presence of soap in the cooking and latrine areas of the household, and fecal coliform counts on caregiver hands and in stored drinking water.

Eligibility Criteria:
Inclusion Criteria:

* At least one household member must report ownership of an active mobile phone in their possession on the day of enrollment

Exclusion Criteria:

* Household has a tap or basin with running water inside their home.
UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy

The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer \[C-11\]PiB in participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with \[C-11\]PiB-PET, and cognitive status will be the primary outcome of this imaging study.

The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer \[C-11\]PiB in participants in the UAB-ADC cohort. The amount and distribution of \[C-11\]PiB in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with \[C-11\]PiB-PET, and cognitive status will be the primary outcome of this imaging study. As a secondary aim, the investigators will assess the ability of the early flow frames from \[C-11\]PiB-PET and brain volumetric measurements with MRI to serve as a marker of neuronal injury and to predict cognitive status in conjunction with the amyloid-PET results.

Eligibility Criteria:
Inclusion Criteria:

- 1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol (IRB-300000169).

2. Negative urine or serum B-hCG test within 2 days of \[C-11\]PiB administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

Exclusion Criteria:

1. Meets any exclusion criteria for the UAB-ADC study (IRB-300000169).
2. Inability or contraindication for undergoing MRI and/or PET imaging
3. Inability to participate in the imaging studies due to severity of dementia
Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue

This research aims at describing the relationship between white adipose tissue inflammation and post-operative cognitive dysfunctions.The possible link between inflammatory cytokines secretions of the white adipose tissue of a surgical wound and the arising of patient's cognitive dysfunction in the post-operative course will be investigated. The hypothesis is that obese patient's inflammation of the white adipose tissue leads to cognitive dysfunction.

The postoperative cognitive dysfunctions (POCD) are characterized by delirium and cognitive impairment. The delirium is defined by an acute altered attention with a fluctuating course. The post-operative cognitive impairment involves the early alteration of different functions including memory, attention and cognitive flexibility. POCD have a major impact in patient's morbidity. They are linked to the systemic inflammation induced by the surgical wound. The systemic inflammation leads to the rupture of the brain-blood barrier and to hippocampal inflammation. As hippocampus mediates the principal cognitive functions, hippocampal inflammation leads to POCD. Orthopedic and cardiac surgery are particularly concerned. Obesity is growing condition in the French population. It is linked to chronic systemic inflammation and altered cognitive functions. We think that obese people may present a susceptibility to POCD because of the pre-operative systemic inflammation.

Eligibility Criteria:
Inclusion Criteria:

* patient about to receive a hip arthroplasty under general anesthesia, elective cardiac surgery with cardiopulmonary bypass,
* patient with a MMSE score \> or = 20(/30),
* patient able to give informed consent

Exclusion Criteria:

* emergency surgery, or surgery in a septic context,
* patient with a known dementia or altered MMSE score (under 20)
EndeavorOTC® Research Study in College Students

The objective of this study is to evaluate the impact of a digital therapeutic (EndeavorOTC®, also known as AKL-T01A) on clinical symptoms of executive and cognitive functioning in a real-world sample of university students. This study aims to answer whether EndeavorOTC represents a useful intervention for targeting broad cognitive and emotional health among university students.

University students face an increased risk of mental health challenges, as well as elevated stress due to the demands of managing coursework and social stress during a formative developmental period with increased independence. Consequently, there is a need for scalable, evidence-based interventions that can help university students manage their cognitive and emotional health. Through a partnership between Akili Interactive Labs and participating colleges, free 12-week access to AKL-T01 will be provided to any student interested in treatment for the duration of an academic semester, up to an N of 500 per site. This study will evaluate changes in participants across a range of clinical and functional outcomes, including cognitive functioning, academic outcomes, social functioning, attention and associated symptoms, and quality of life. The study will also evaluate user feedback and information on the usability of AKL-T01 through both quantitative and qualitative methods.

Eligibility Criteria:
Inclusion Criteria:

* Owns a personal Android or iOS device to access AKL-T01 treatment
* Provides informed consent to participate in this study
* Is 18 years of age or older

Exclusion Criteria:

* Known photosensitive epilepsy, color blindness, and any physical limitation that would make engagement with an app-based digital intervention difficult
* Has participated in the same study in previous semesters

Pregnant and nursing people are eligible to participate.
Microbiome of Donor Iron Deficient Study

The goal of this pilot study is to test whether the microbiome is affected by intravenous iron repletion.

The colonic microbiome, the community of bacteria living in our gut, is essential in human health and disease. Iron is an essential nutrient for both bacteria and humans. In the United States, of the donors who provided the \~15 million units of red blood cells that were collected for transfusion, 69% were repeat donors. Although iron deficiency is surprisingly prevalent in first-time donors, its prevalence is even higher in these particularly altruistic frequent donors, (i.e., up to 49% and 66% of male and female repeat donors, respectively), manifested as iron depletion or iron-deficient erythropoiesis. Iron deficiency from blood donation is associated with fatigue, restless leg syndrome, decreased physical endurance and work capacity, and impaired concentration, attention, and other neurocognitive functions; however, these conclusions are not based on definitive studies and have not yet changed blood donation policy. The goal is to conduct a prospective, double-blind, randomized controlled trial, recruiting 60 healthy regular donors who meet donation standards, while exhibiting iron-deficient erythropoiesis by laboratory test criteria. In this ancillary study, we will determine what effect donor iron deficiency and IV iron repletion have on the gut microbiome.

Eligibility Criteria:
Inclusion Criteria:

* Current participant of the associated randomized controlled trial conducted at Columbia University Medical Center (therefore invited to participate in this optional ancillary study).

Exclusion Criteria:

* Not a current participant of the associated randomized controlled trial conducted at Columbia University Medical Center.
Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation

Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. This was a prospective randomized trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed (\<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to one of two interventions or to control. The interventions consisted in the daily administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal Group). The control group received complementary foods chosen by he parents but no source of iron provided by the investigators. The interventions took place from 4 to 9 months. All infants were subsequently followed to 2 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Predominantly breastfed (at 4 months) term infants

Exclusion Criteria:

* Not predominantly breastfed at 4 months
* Premature infants
Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1

To investigate the effects of rhIGF-I/rhIGFBP-3 treatment for 24 weeks on endurance, ambulation, cognitive functioning, insulin resistance, lipid levels, muscle function and strength, pain, gastrointestinal functioning, and quality of life endpoints in DM1 patients

Efficacy Measures:

Endurance, Ambulation, Cognitive function, Insulin resistance, Cholesterol and triglycerides, Muscle function and strength, Pain, Gastrointestinal function, Quality of life

MINIMUM INCLUSION CRITERIA

1. A diagnosis of DM1, confirmed by DM1 genetic mutation
2. Age 21 to 65 years (inclusive)
3. Ability to walk 30 feet - assistance with cane and/or leg bracing permitted
4. Able to self-administer study medication by subcutaneous injection or caregiver is available to administer study medication

Eligibility Criteria:
Inclusion Criteria (list is not inclusive):

* A diagnosis of DM1, confirmed by DM1 genetic mutation
* Ability to walk 30 feet - assistance with cane and/or leg bracing permitted
* Able to self-administer study medication by subcutaneous injection or caregiver is available to administer study medication

Exclusion Criteria (list is not inclusive):

* Congenital DM1
* Weight greater than 100 kg or body mass index greater than 30 kg/m2
* Prior treatment with glucocorticoids, anabolic steroids, testosterone, growth hormone, investigational agent within 60 days of screening
* Current diagnosis or history of malignancy expect for surgically cured skin cancer or pilomatricoma
* Changes in lipid lowering medications during the 3 months prior to screening
* Diaphragmatic weakness such that patients are unable to tolerate the supine position, or swallowing impairment such that patients are unable to maintain nutrition without use of gastrostomy.
* Major psychiatric illness (major depression, bipolar disorder or schizophrenia) within twelve months of screening
* History of non-compliance with other therapies
Reliability and Validity of the Turkish Version of the Sensory Eating Problems Scale

The aim of this study was to adapt to the Sensory Eating Problems Scale to Turkish. Within the scope of the study, firstly the Turkish version of the scale will be developed and then its reliability and validity will be examined.

The etiology of childhood feeding problems is often complex and likely due to multiple factors, such as biological issues, oral motor deficits, and environmental contingencies. Sensory processing, or the ability to receive, integrate, and process sensory input, such as visual, olfactory, or gustatory information, has also been speculated to influence eating. A growing literature has examined the association between sensory processing and eating behavior in several populations of children.

While child feeding problems have been found to be associated with withsensory processing problems, clinicians could benefit from more specifics about the types of oral sensory problems most associated with feeding problems. For example, the Oral Sensory Processing subscale of the Sensory Profile includes a collection of sensory problems associated with feeding difficulties such as gagging easily to food or utensils in the mouth, rejecting certain food tastes or smells, accepting limited food textures, biting the tongue or lips , but without documentation that identifies the separate dimensions of oral sensitivity problems relevant to children's feeding problems. Further, along theOral Sensory Processing Subscale of the SP, a particular oral sensory problems, such as sensitivity to texture, may be measured by only one or two items.

Sensory Eating Problems Scale is a newly developed scale and can measure specific oral sensory problems in children. SEPS can also provide a more detailed assessment of sensory eating behavior than provided in previous studies by developing the Sensory Eating Problems Scale (SEPS) to identify specific dimensions of oral sensitivity children show during feeding. However; there is no short, easy to use and easy to understand sensory eating problems scale with the Turkish version.

Eligibility Criteria:
Inclusion Criteria:

* The children had been referred to the clinics for eating problems that included failure to gain weight, dependence on tube feeding or oral supplements, difficulties with texture or learning to chew, limited diet variety, and mealtime behavior problems.

Exclusion Criteria:

-
Compare Bioavailability of RO7239361 After Subcutaneous Injection

Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participant as determined by no significant deviations in normal medical and surgical history and assessments
* Body Mass Index 18 kg/m2 to 32 kg/m2
* females must be of non-childbearing potential

Exclusion Criteria:

* tattoos or other skin findings on any of the potential injection sites
* history of chronic muscle pain within 30 days prior to study treatment
* prior history of IgG1 therapy

Other protocol defined inclusion and exclusion criteria apply
ARQ 501 in Subjects With Cancer

ARQ 501, an investigational anticancer drug, is intended to selectively kill cancer cells and spare normal cells by restoring and activating cellular checkpoints known to be defective in cancer using the Company's unique biology platform, Activated Checkpoint Therapy™ (ACT).

ARQ 501 has the potential for improved activity and reduced toxicity over other molecular approaches and traditional cancer chemotherapy.


Eligibility Criteria:
Inclusion Criteria

* Histologically or cytologically confirmed solid tumor that is metastatic, unresectable or recurrent and for which standard curative or palliative measures do not exist or are no longer effective.
* ECOG performance status greater than or equal to 1
* Life expectancy greater than three months
* Acceptable pretreatment clinical laboratory results

Exclusion Criteria

* Subjects who have had chemotherapy or radiotherapy within 4 weeks
* Subjects receiving any other investigational agents
* Subjects with known untreated brain metastases
* Subjects receiving hepatic enzyme-inducing antiseizure drugs ("EIASD")
* Subjects with uncontrolled intercurrent illnesses
* Pregnant women