cyrilzakka/clinical-trials huggingface dataset:
Identifying the Neural Basis of Capability for Suicide

Since capability for suicide involves overriding potential pain, and the opioid system plays a strong role in controlling pain perception, it follows that capability for suicide may be impacted by the opioid system. The goal of the proposed research is to identify the neural network underlying capability for suicide in order to determine if it can be a target for identifying high-risk individuals and for intervention.

Little evidence exists distinguishing individuals with suicidal ideation (SI) from those at risk for suicidal behaviour, illustrating the need for more comprehensive biomarkers for clinicians to guide their treatment approach and for new treatment avenues. Current theories of suicide have suggested the importance of an individual's capability for suicide in predicting suicide attempt or death. Building on this, Yovell and colleagues (2016) provided important preliminary data that the opioid system affects suicide risk, but the neural mechanisms and their relationship to capability for suicide are unclear. The goal of the proposed research is to identify the neural network underlying capability for suicide using functional magnetic resonance imaging (fMRI) in order to determine if it can be a target for identifying high-risk individuals and for intervention.

Eligibility Criteria:
Inclusion criteria for patients:

* Age between 18-70
* Capability of giving informed consent
* Not currently pregnant or lactating (due to potential confounding of brain activity as a result of differing hormone levels)

Exclusion criteria for patients:

* Lifetime history of any substance abuse, psychosis
* Current use of any opioid acting drugs
* Current use of any prescription pain medication
* Use of over the counter pain medications within 15 hours of brain scan
* For daily users of a benzodiazepine, stimulant or atypical antipsychotic, dose within 12 hours of brain scan
* For as needed users of a benzodiazepine, stimulant or atypical antipsychotic, dose within 2 weeks of brain scan. This is because non-daily use will have more unpredictable effects on brain imaging results than those who are using these medications on a regular basis. The 2 weeks will ensure the drug is not in the system.
* Medical condition requiring immediate investigation or treatment
* Participation in experimental treatment trials for the study duration.

Healthy control inclusion criteria: Ages between 18 and 70 years, capable of giving informed consent, not pregnant or lactating, no lifetime history of Axis I/II disorders, no history of antidepressant or mood stabilizer use, no treatment for acute or ongoing medical condition, no use of any over the counter pain medication for at least 15 hours prior to the brain scan.
Biodiversity Intervention and Atopic Sensitization

Children will receive biodiversity intervention or placebo. The proof of concept trial is double blind. Intervention will start at the age of 2 months and last 10 months. Children will be randomized to arms. IgE sensitization is the primary outcome.

Newborns will start to be exposed to biodiversity intervention or placebo at the age of two months. The proof of concept trial will be double blind. Intervention will start at the age of 2 months and it will end when children become 12 months old. Children will be randomized to the two arms. IgE sensitization is the primary outcome at the age of two and three years.

Eligibility Criteria:
Inclusion Criteria:

* both parents have atopy
* newborn

Exclusion Criteria:

* severe disease, particularly immune system deficiency or down syndrome or cancer
* medication affecting immune system
* birth before week 35 in pregnancy
* being a twin
* only one of the parents have atopy
* none of the parents have atopy
* children have passed the age of two months
* immune system disorder such as rheumatoid disease, colitis ulcerosa, Crohn disease, diabetes or genetic risk to type 1 diabetes
* no participation in national vaccination programme
Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers

This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is a randomized single ascending dose study of indoximod salt formulation to characterize the PK profile and determine the safety and tolerability of each dose in healthy male volunteers. Part 2 is an open-label, randomized, 3-period, 3-way crossover study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoker for at least 3 months
* BMI within 18 to 30 kg/m2
* Able to speak, read, and understand English or Spanish

Exclusion Criteria:

* Clinically significant cardiac, pulmonary, hepatic or renal disease
* History of substance abuse or alcohol dependence within past 2 years
* Inability to fast for a minimum of 14 hours
* Inability to swallow large capsules/tablets
* Pending legal charges or is on probation
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)

This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD
* Age from 50 to less than 89
* Mini-Mental Status Exam score of 16-26 inclusive
* Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
* Stable doses of medications (cholinesterase inhibitors and memantine allowed)
* Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

* Significant neurological disease other than AD
* Major psychiatric disorder
* Significant systemic illness
* History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years
* Smoking greater than 20 cigarettes per day
* Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
* Prior treatment experimental immunotherapeutics or vaccines for AD
* Women of childbearing potential
* Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body
The Effect of Developing Psychological Resilience on Functionality in Schizophrenia Patients

People with schizophrenia have low functionality and psychological resilience. Psychological resilience of individuals can be improved. The funcionality of individual with improved psychological resilience can also be improved. Therefore, both resilience and functionality can be increased by appliying resilience programs to patients with schizophrenia.

The aim of study is to determine the effect of the resilience development program applied to schizophrenia patients on the resilience and functionality of the patients. Experimental research design with pretest posttest control group will be used in the study. 36 patients receiving service from a community mental health center will be included in the study (determined by "power analysis"). 18 people will be included in the experimental group and 18 people in the control group (Random appointment will be made by drawing lots). The data of the study will bu collected with "Personal Information Form", "Adult Resilience Scale", "Short Functionality Assessment Scale" and "Beck Cognitive Insight Scale - for Schizophrenic Patients". Consent will be obtained from the individuals participating in the study before the study. An "ethics commitee approval certificate" will also be obtained before starting the study. "Resilience Development Program" based on cognitive behavioral approach developed by the researcher will be applied to the experimental group. SPSS 28.0 program will be used in the analysis of the data. Mean, standard deviation, median, minimum and maximum values will be used in the descriptive statistics of the data. Mann whitney u test, chi-square test and wilcoxon test will be used in the analysis of quantitative independent data.

Eligibility Criteria:
Inclusion Criteria:

* Be at least literate
* Be in remision
* Not have mental retardation, hearing and speech problem

Exclusion Criteria:

* Those in acute exacerbation
* Those with other psychiatric illnesses
* Those who are / have attended a similar training program
Calcium Concentration in Bicarbonate Hemodialysis (HD)

The study was designed in order to investigate the effects of 3 different dialysate calcium concentrations may exert on mineral metabolism and hemodynamic stability in standard hemodialysis (hd).


Eligibility Criteria:
Inclusion Criteria:

* bicarbonate hd since 6 months
* uncomplicated hd sessions

Exclusion Criteria:

* Incident patients
* unstable hd patients
* patients aged less than 18 years
Study Buddy (an ECA Oncology Trial Advisor) for Cancer Trials

The Study Buddy ECA acts as an advisor to patients on chemotherapy regimens, promoting protocol adherence and retention, providing anticipatory guidance and answering questions, serving as a conduit to capture information about complaints or adverse events, providing a venue for communicating about updates. The Study Buddy will use the web-based ECA infrastructure developed for use on another project. We will use web browsers on tablets provided to study participants to access the Study Buddy, providing anywhere, anytime access to its functions. Usability metrics will include session time, satisfaction, and error rates.

Subjects will be identified from among patients on chemotherapy regimens at BMC. With the provider's approval, we will recruit patients for this study.

All subjects will be enrolled for 2 months. After consent, we will collect baseline data. Baseline data is collected after enrollment and before randomization. Baseline data includes:

sociodemographic data PROMIS Mental and Social health the PHQ-9 clinical factors such as medical diagnosis (cancer type and stage) the Short Assessment of Health Literacy-English the Short Portable Mental Status Questionnaire (SPMSQ) for cognitive impairment the Need For Cognition scale contact numbers of two friends or family members who will assist us in establishing contact, if necessary.

The exit interview will be conducted 2 months after the baseline interview, with windows of 2 weeks plus or minus that date. Study staff will attempt to coincide this interview with a clinical visit, to minimize inconvenience for the subject.

Data collected at the exit interview will include:

PROMIS Mental and Social health the PHQ-9 Satisfaction with ECA

Review of the subject's medical chart will be performed bi-weekly while the subject is enrolled. Chart review will be performed by a staff member who is blinded to the subject's group (intervention vs control).

Eligibility Criteria:
Inclusion Criteria:

1. speaks English fluently
2. is able to independently consent into this study and parent cancer study
3. has adequate corrected vision to use the ECA system (based on a 1-minute functional screener)
4. has adequate hearing to use the ECA system

Exclusion Criteria:

1. suicidal or homicidal
2. currently in police custody
3. do not live in the Boston area
4. plan on leaving the Boston area for more than 4 weeks in the next 6 months
5. score 6 or less on the SPMSQ screening test
Vascular Disease--Structure/Function

To investigate the relationship of non-invasively measured flow-mediated brachial artery dilation with coronary artery disease (CAD).

BACKGROUND:

This study meshed with a longitudinal case-control study, HL-35333, Carotid Atherosclerosis Follow-Up Study. HL-35333 comprised 280 individuals older than 45 equally divided between men and women, half with and half without CAD evaluated for risk factors at baseline and with completed follow-up with yearly B-mode for three years. The Carotid Atherosclerosis Follow-Up Study quantified the interassociations of angiographically defined coronary artery disease and CAD risk factors with progression. The NIH funded a continuation of this effort to review existing ultrasound tapes from this study in order to additionally evaluate the associations of all these factors with extracranial carotid arterial dimensions (ECAD: interadventitial and lumen diameters) and change in ECAD over time.

DESIGN NARRATIVE:

The study assessed brachial artery reactivity among 100 CAD subjects and 100 controls who had been previously enrolled in a study of the relationship between extracranial intima media thickness (ECIMT) as assessed by B mode ultrasonographic measurements and CAD status. Most subjects had three consecutive B mode measurements at 12 month intervals. These subjects had brachial artery reactivity measurements according to a standardized protocol. Linear regression analysis was used to relate brachial artery reactivity to CAD status, gender and risk factors as predictors. Interaction effects were also assessed between CAD status and other risk factors and also between gender and other risk factors. Similar analyses were performed to relate percent dilation to ECIMT measurements.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners

This is a prospective, randomised, multi-site clinical trial testing the non-inferiority of community optometry follow-up of participants with QnAMD over 12 months

Neovascular Age-Related Macular Degeneration (nAMD) is a common vision threatening condition affecting mainly patients over the age of 65. At some point during follow-up the disease becomes inactive in many cases and does not need more injections. The risk of a flare-up is high, however, and patients need to continue to be seen every month for a significant period of time.

Hospital-based eye clinics are struggling to cope with current and expected workload for assessing and treating patients with nAMD. Transferring care of these patients to the community closer to home would ease the workload for hospital based clinics and offer a better experience of care to patients.

This study will recruit 742 patients with nAMD who have reached this inactive phase of the disease. Half of the patients that want to take part will continue to have their follow-up appointments in the hospital eye clinics as usual. The other half, chosen by chance, will have follow-up visits every month in a community optometrist practice by trained optometrists. The research team will provide the training for community optometrists.

The study will seek to show that the community based care is no less safe than hospital-based care.

The study will also check what is the impact of this different way of offering care on the NHS budget and how the patients and practitioners perceive this. The study will involve several hospital eye clinics across the country and several community optometrist practices. Meetings will also be held with patients to discuss their priorities and needs when looking at how to set up the community based eye clinics.

During meetings with patients in preparation for this research, they felt positively about the possibility to receive care closer to home.

Eligibility Criteria:
Inclusion Criteria:

* Participants receiving treatment in nAMD injection clinics, who have reached the agreed definition of disease quiescence
* Informed consent
* Aged \> 55 years
* Ability to perform study specific procedures

Exclusion Criteria:

* Significant media opacities (cataract, vitreous opacities) that would not allow good quality fundus imaging.
* Diabetic retinopathy of severity worse than mild non-proliferative stage and with any degree of diabetic maculopathy
* History of other causes of Choroidal Neovascularisation (myopic, angioid streaks, inflammatory, retinal dystrophies, secondary to Central Serous Chorioretinopathy, idiopathic).
The Women's Screening and Self-Testing Program (PROMETA) Study

This proposal directly addresses the ability to safely scale-up a Screen-Triage-Treat approach to cervical cancer screening. The investigators propose to capitalize on a pool of screen-eligible women accessing routine care within targeted human immunodeficiency virus (HIV) care and treatment services. The primary outcome of interest is the number of women screened and the proportion of screen-positive women undergoing treatment. Secondary outcomes will focus on other implementation outcomes, and if successful, will be utilized to inform future research to take this approach to scale across Mozambique.

This study will use a hybrid type III effectiveness-implementation design. In a hybrid type III design, the primary focus is on testing of an implementation strategy, while simultaneously continuing to observe and gather information on the effectiveness of a clinical intervention, under real world conditions, for which effectiveness data has already largely been determined. Best practices for deploying the Screen-Triage-Treat approach to cervical cancer screening utilizing self-collected human papilloma virus (HPV) deoxyribonucleic acid (DNA) testing within Mozambique´s HIV care and treatment services will be evaluated. The study will employ a mixed-methods approach, collecting both quantitative and qualitative data. The primary outcome of interest is the number of women screened and the proportion of HPV screen-positive women undergoing treatment, while secondary outcomes will focus on other implementation outcomes, and if successful, will be utilized to inform future research to take this approach to scale across Mozambique.

Eligibility Criteria:
Inclusion Criteria:

* Women 25-49 years
* Accessing HIV care and treatment services
* Not being pregnant
* Patients with a cervix

Exclusion Criteria:

* Physical or mental impairment that inhibits participation in the study
* Pregnant women or \<6 weeks post-partum
* Women who have undergone a total hysterectomy with removal of the cervix
Reliability of Point-of-care INR Measurements in Patients With Antiphospholipid-antibody Syndrome Treated With Warfarin

The antiphospholipid-antibody syndrome (APLA), which includes lupus anticoagulant, anticardiolipin, and anti-beta-2-glycoproteinI antibodies, is a thrombophilic disorder associated with arterial thrombosis, venous thrombosis or both. Patients diagnosed with APLA have a higher risk of recurrent thrombosis than do patients without known antibodies. Currently, warfarin is considered the anticoagulant of choice for prophylactic antithrombotic treatment for APLA patients after their first episode of thrombosis. In some patients with APLA who are treated with warfarin, the INR values determined on plasma are unreliable due to an influence of the APLA on the INR. In these individuals, alternative monitoring methods, such as factor II activity, chromogenic factor X activity or prothrombin-proconvertin time should be used to assess adequate anticoagulation. These tests are expensive and not widely available to some clinicians. Point-of-care (POC) instruments, on the other hand, are readily accessible to clinicians. Previous research has shown that INR values from 3 older point-of-care (POC) instruments are unreliable in 1/3 of APLA patients (CoaguChekTM, ProTimeTM, INRatioTM). However, there are now newer versions of these POC instruments available (CoaguChek XSTM, an investigational ProTime device, and a newer INRatioTM device) and it is unknown if these newer POC instruments are reliable in patients with APLA. The purpose of this study is to determine whether newer POC instruments are reliable in patients with APLA.


Eligibility Criteria:
APLA Inclusion Criteria:

* Prolongation of a phospholipid-dependent screening assay, 2) lack of correction of a prolonged screening assay after a 1:1 mix with pooled normal plasma, and 3) correction of a prolonged screening assay by the addition of excess phospholipid. Two positive lupus anticoagulant confirmations at least 3 months apart will be required.
* Diagnosis of anticardiolipin antibodies defined as elevated levels of ACA-IgG (\>30) and/or ACA-IgM (\>15) on two separate occasions at least 3 months apart.
* Stable warfarin therapy, defined as the maintenance of a warfarin dose for a minimal of 2 weeks regardless of INR.

APLA Exclusion Criteria:

* Patients whose warfarin dose has changed within the past 2 weeks.

Control Inclusion Criteria:

* No evidence of either a positive LA or ACA diagnosis by confirmation of negative laboratory values and/or documentation of no clinical signs and symptoms concurrent with these conditions.
* Stable warfarin therapy, defined as the maintenance of a warfarin dose for a minimal of 2 weeks regardless of INR.

Control Exclusion Criteria:

* Patients whose warfarin dose has changed within the past 2 weeks.
A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler and Berotec N® Metered Aerosol in Mild to Moderate Stable Asthma Patients

This is an open-label, randomized, cross-over, active-controlled study to evaluate the efficacy and safety effects using Meptin® Swinghaler and Berotec N® Metered Aerosol in stable asthma patients


Eligibility Criteria:
Inclusion Criteria:

* Male or females outpatients aged ≥18 years old with uncontrolled or partly controlled asthma; Stability was assessed during the past 14 days the patients remained in the same severity class by 2006 GINA guideline (uncontrolled, partly controlled) and had no acute exacerbations by investigator judgment;
* Pulmonary function test: Improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist before the study or ; Positive result of Brocho-provocation test;

Exclusion Criteria:

* Hypersensitivity to β2-agonist or lactose;
* Hospitalization due to asthma during the previous 3 months;
* Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
* Oral or systemic corticosteroids in the previous 4 weeks;
* Inadequately controlled hyperthyroidism;
* Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system or respiratory disease other than asthma(e.g. COPD), or any other disorder which may interfere wth the study evaluations or affect subject safety;
* Patients receive an investigational drug within 30 days prior to admission to the study;
* Patients with significant alcohol, drug or medication abuse as judged by the investigator;
* Females who are pregnant or breast-feeding; (exception: Females of child-bearing age might be included, if in the opinion of the investigator, they are using adequate contraceptive precautions);
* Subjects who are heavy smoker (more than 10 packs year) or who are smoking within previous 6 months.
Comparison of Two Pulse Oximeters in Delivery Room

Time to stable reading of oxygen saturation at the delivery room will be compared between two different devices.

After delivery babies will be located in the radiant warmer. The probe of each pulse oximeter will be applied to one of the feet. Both probes will be simultaneously connected to the female plug of the pulse oximeter.

Heart rate will be checked

Time to get a stable reading in each device (by observation on the devices' display) will be recorded; this will be the primary study outcome. Other vital signs (oxygen saturation, heart rate) and demographics) will be recorded as well.

Paired students T test will be used for the statistical analyzes.

Eligibility Criteria:
Inclusion Criteria:

* Neonates in the operation or delivery room immediately after delivery whose parents agreed to enter the study

Exclusion Criteria:

* Malformation of one of the legs, not allowing sensor application. Any situation in which the study might interfere with the treatment of the newborn