cyrilzakka/clinical-trials huggingface dataset:
A Geriatric Assessment Electronic Platform for Older Patients With Cancer (eGAP - Electronic Geriatric Assessment Platform)

This project assesses the feasibility and usability of the geriatric assessment platform (electronic Geriatric Assessment Platform or eGAP in 50 older patients with cancer, their caregivers, and their oncology team. Using an iterative process, we will refine the eGAP based on input from stakeholders.

A geriatric assessment is a multidisciplinary diagnostic process that can detect medical, psychosocial and functional problems not identified by routine evaluation. This can subsequently guide management of the identified problems. However, the time and resources required to incorporate a geriatric assessment into clinic visits remain the primary barriers for implementation. There is a need to increase the adoption of the geriatric assessment among general oncologists and to address the associated resource limitations. Our long-term goal is to utilize an electronic platform to facilitate completion of the geriatric assessment. This project assesses the feasibility and usability of the geriatric assessment platform (electronic Geriatric Assessment Platform or eGAP) in 50 older patients with cancer, their caregivers, and oncology providers. Using an iterative process, we will refine the eGAP based on input from stakeholders (patients, caregivers, oncologists, nurses, advanced practitioners)

Eligibility Criteria:
Inclusion Criteria for patients:

* Age ≥65 years
* Have a diagnosis of cancer
* Able to provide informed consent
* English-speaking (because the platform is currently in English)

Inclusion criteria for caregivers:

* Age ≥21 years
* Selected by patient when asked if there is a "family member, partner, friend, or caregiver with whom you discuss or who can be helpful in health-related matters".
* Able to provide informed consent
* English-speaking

Inclusion criteria for oncologists:

* Oncologists, APPs, and nurses who care for the patient

Exclusion Criteria:

* N/A
Medication Use Among American Indians Adults

The goal of this study is to explore facilitators of and barriers to medication adherence within the context of local social determinants of health (SDOH) that are not available in the EHR.

for American Indians with type 2 diabetes. The main aim is:

Identify facilitators of and barriers to medication adherence within the context of SDOH, Electronic Health Record (EHR) derived medication adherence \[HbA1c \< 7 (at target); HbA1c \>7% to ≤9% (above target); and HbA1c \> 9% (uncontrolled)\].

The investigators will identify potential participants by drawing a sub sample of 90 patients from the larger sample (based on findings from aims 1 and 2).

Once patients are identified University of Florida (UF) study team members will provide a coded list of eligible patients, from the limited dataset, to the Choctaw Nation of Oklahoma (CNO) Information Management team. The CNO Information Management team will provide the contact information for 135 individuals directly to the CNO community health worker who will then contact patients. UF study team members will not have access to the identifiable data.

The CNO community health worker (not UF study team members) will contact by telephone or in person at a scheduled visit the identified patients within each of the sampling groups (labeled 1-6) to introduce the study and screen for eligibility.

After reviewing the consent, answering any questions, and obtaining written consent for the study, the CNO community health worker will use a structured interview guide containing semi-structured and open-ended questions with probes to collect in-depth information from the patient. As part of the interview session patients will be asked to complete 3 sets of questionnaire items: demographic, SDOH, and medication and utilization.

All interviews will be audio recorded and professionally transcribed and validated for accuracy. Instead of using patient names CNO will link each transcript back to the code number provided by the UF study team. The UF study team will not have access to the link of the code number to the patient identifier. The de-identified transcripts will be sent to UF Study team members for analysis. A UF study team member will use a qualitative data management program to aid in analyzing and managing the data.

Eligibility Criteria:
Inclusion Criteria:

1. enrolled tribal member
2. 18 years and older
3. have been diagnosed with type 2 diabetes
4. live within CNOs 10.5 county service area
5. use CNO Tribal Health Services
6. for whom cardiometabolic levels and medication adherence level will have been generated from the aim 1 analysis of CNO data
7. willing and able to participant in a 60-90-minute interview focused on facilitators of and barriers to medication adherence.

Exclusion Criteria:

(1) has end-stage renal disease
Long Term Hemodialysis Catheters (LTHD) Post Market Clinical Follow up (PMCF)

The primary objective of this observational PMCF study is to collect clinical data on the safety and efficacy of Medcomp Long Term Hemodialysis (LTHD) Catheter Kits in compliance with MDR 2017/745.

The Observational Study will enroll a target of 198 subjects across two cohorts of 89 patients per cohort, with each cohort representing one catheter type. Retrospective patients previously treated with either a Hemo-Flow or Titan HD catheter will be enrolled. The primary endpoint of this study for all device families is insertion success. For the purposes of this data, a successful insertion will be defined as the successful initiation of vascular access device insertion, as determined by the investigator.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age at the time of enrollment
2. Patients who have previously received the Medcomp subject device or patients currently receiving hemodialysis treatment, who have had a Medcomp subject device implanted for \>90 days
3. Health records relevant to this study are complete and accessible by Study team at the hemodialysis center, implantation center, medical facilities where complications are treated, and by the participating Principal Investigator (PI)
4. Subject or authorized representative participated in the Informed Consent process and signed/dated the relevant institutional ethics committee approved Informed Consent form

Exclusion Criteria:

1. Meet any of the contraindications listed on the Medcomp Long Term Hemodialysis Catheter Instructions for Use
2. Participation in any other drug, device, or biologic study concomitantly, or within the last 30 days (which may clinically interfere with this Study in the opinion of the sponsor in consultation with the Principal Investigator)
Anlotinib Retrospective Study for Esophageal Cancer

The efficacy of anlotinib in the treatment of esophageal cancer has been confirmed. The purpose of this study was to retrospectively observe the efficacy and safety of anlotinib in the first and second line of advanced esophageal cancer in the real world.


Eligibility Criteria:
Inclusion Criteria:

* Esophageal cancer diagnosed pathologically or clinically
* Patients who use anlotinib alone, or combined with chemoradiotherapy, or plus PD-1 inhibitors in first-line or second-line treatment

Exclusion Criteria:

None
COMPARISON OF OBSTETRIC AND NEONATAL OUTCOMES OF ADOLESCENT PREGNANCİES

ABSTRACT

Adolescent pregnancy rates are gradually increasing in the recent decades. As a reason of war nutritional difficulties, language differences and difficulty in applying to the health institution causes lack of prenatal care. As a reason of absence of prenatal care, associated medical complications can occur. 525 adolescent women who gave birth to singletons agreed to participate in this study. Data on maternal demographic and obstetric characteristics as well as neonatal outcomes were analyzed. In conclusion, adolescent pregnancy continues to be an important social problem due to the health support needs. However, the results of our present study are important in terms of showing that the perinatal care is quietly improved in Turkey.


Eligibility Criteria:
Inclusion Criteria:

* 14-16 y Age

Exclusion Criteria:

* over 16 years
Control of Unsupported Paraplegic Standing

The study will investigate the feasibility of using functional electrical stimulation (FES) of the calf muscles of paraplegic subjects to assist in posture stabilisation during standing. We aim to achieve postural stability by combining controlled FES of the lower-limb muscles with the voluntary motor control skills of the intact upper body.

Aim:

The study will investigate the feasibility of using functional electrical stimulation (FES) of the calf muscles of paraplegic subjects to assist in posture stabilisation during standing. We aim to achieve postural stability by combining controlled FES of the lower-limb muscles with the voluntary motor control skills of the intact upper body.

Background:

In spinal cord injury (SCI), the paralysed muscles generally retain their ability to contract and electrical stimulation can be used in rehabilitation as a therapy. With functional electrical stimulation (FES) the aim is to restore some normal motor functions such as standing, stepping or cycling. A number of studies have investigated the physiological effects and potential therapeutic benefits of lower-limb FES exercise. These studies have shown that the benefits include restoration of muscle bulk and strength, a reduction in the rate of bone demineralisation, improvements in the range of joint motion, and relaxation of spasm. Standing is an important part of rehabilitation therapy for paraplegic patients, and helps to alleviate some of the secondary effects of paralysis.

Eligibility Criteria:
Inclusion Criteria:

* Neurologically intact, healthy individuals individuals with complete spinal cord lesion between T6 and T12

Exclusion Criteria:

* Incomplete SCI
Mindfulness Intervention for Overweight Primary Care Patients

Mindfulness has been applied in the United States and Europe to improve both physical and psychological health, however, it is still poorly studied in Brazil. Mindfulness, or its lack, may also have particular relevance to obesity and eating disorders, reducing the episodes of "binge eating", which are partly responsible for weight regain for many people, and improving the eating behavior in order to promote awareness of emotional states which distort the physiological signals generated by the process. The hypothesis is that Mindfulness-based Interventions (MBI) as well as specific programmes focused on conscious eating, as Mindfulness Based Eating Awareness Training (MB-EAT) can, in short time, and in a sustainable fashion, improve biochemical, psychometric and anthropometric parameters in primary care patients with overweight.

A randomized-controlled trial will be conducted to compare treatment-as-usual (TAU) in Primary Care combined a generic MBI (with 8 sessions) developed by our research group, called "Mindfulness-Based Health Promotion" (MBHP) program versus TAU plus MB-EAT. It will be included women aged ≥18 and \< 60, literate , with a BMI (body mass index) ≥ 25 kg/m2. The primary outcome is the improvement of the eating behaviour measured by DEBQ. Secondary outcomes are: It is expected improvement of nutritional status (reduction of body weight by at least 5% of the weight) along the intervention, as well as maintenance of this (without weight regain) which could lead to the prevention of multiple morbidities related to excess body weight. Will be assessed the levels of Mindfulness, stress, anxiety (psychometric scale and serum cortisol) and self-compassion. There will be performed basal (baseline), at post-intervention, 3 and 6 months follow-up measurements. The control group will receive the intervention that has been shown to be more effective at the end of the study (MBHP or MB-EAT).

Eligibility Criteria:
Inclusion Criteria:

* women aged 18-59 years old, literate;
* Primary Care patients who have the body mass index (BMI) ≥25kgm2 and \< 40kg/m2
* People who have an interest in the objectives of this study and consented to be randomized to one of three arms.
* Those who have participated in 75% of sessions or only two absences in the program

Exclusion Criteria:

* those who are under pharmacological treatment for overweight;
* pregnant women;
* those who have problems with substance use (drugs and alcohol);
* untreated hypothyroidism or hyperthyroidism;
* those who are in acute phase of depression (less than 6 months in depression); schizophrenia or psychotic disorders or who are using drugs that cause cognitive attentional and concentration losses (such as powerful anti-anxiety drugs);
* current practitioners of Mindfulness, meditation, yoga, or the like, in the last 6 months (with formal practice at least once a week);
* those who have undergone any type of Bariatric Surgery.
Haplo HCT vs Haplo-cord HCT for Patients With AML

Patients who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic cell transplantation (haplo HCT) are potential candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an coinfusion of an unrelated cord blood unit (haplo-cord HCT) in addition to Arm A. Progression-free survival, overall survival, cumulative incidence of relapse and nonrelapse mortality will be recorded as endpoints.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 60 years old;
2. Patients with AML;
3. With available minimal residual disease (MRD) parameters assessed by flow cytometry (FCM) and/or quantitative real-time PCR (qPCR)
4. Having no available HLA-matched donor, and willing to undergo haplo-HCT and having a suitable haploidentical donor
5. With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
6. Signing informed consent form, having the ability to comply with study and follow-up procedures

Exclusion Criteria:

1. Acute promyelocytic leukaemia (AML subtype M3)
2. With other malignances
3. Failing to acquire a suitable UCB unit
4. With previous history of autologous haematopoietic cell transplantation (auto-HCT), allogeneic haematopoietic cell transplantation (allo-HCT) or chimaeric antigen receptor T-cell therapy
5. With uncontrolled infection intolerant to haplo-HCT
6. With severe organ dysfunction

   * Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
   * Respiratory failure (PaO2≤60 mmHg)
   * Hepatic abnormalities (total bilirubin≥2×upper limit of normal \[ULN\], alanine aminotransferase or aspartate aminotransferase≥2×ULN)
   * Renal dysfunction (creatinine≥2 mg/dL creatinine clearance rate \< 30 mL/min)
7. In pregnancy or lactation period
8. With any conditions not suitable for the trial (investigators' decision)
Interstitial Cystitis: Monitoring of the Psychic State and Counseling Intervention in the COVID-19 Era

The target population of this observational study is made up of all patients belonging to the Interstitial Cystitis pathway of the Gemelli University Hospital Foundation - IRCCS, who have accepted to be subjected to remote monitoring and diagnostic investigation. The aim of the study is the evaluation of some outcome parameters at the time of enrollment (T0), and at the end (T1) of subjects affected by Intersitial Cystitis who have carried out a monitoring of the dimensions of the psychic sphere concerning: depression, trait anxiety, state anxiety , well-being, self-efficacy, resilience.The objective is also to evaluate the presence of evolutionary and maturational trends in the mental set-up of the people who participated in the individual counseling intervention.


Eligibility Criteria:
Inclusion Criteria:

* Recruited subjects have a diagnosis of Interstitial Cystitis and are 18 years of age or older.

Exclusion Criteria:

* Previous or current intellectual disability in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5.
* Patients who are unable to express consent and who do not have a caregiver who can give it for them.
A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.

The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence.

This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.

Eligibility Criteria:
Inclusion Criteria:

* All subjects vaccinated at least one injection of EV71 vaccine or the placebo in the phase III efficacy trial.

Exclusion Criteria:

* subjects who refuse to continue in the study.
EEG and TMS-based Biomarkers of ALS, MS and FTD

The purpose of this observational study is to improve understanding of the biology of why ALS, MS and FTD have different effects on different people and facilitate better measurement of the disease in future drug testing. To do this, brain and spinal cord neural network functionality will be measured over time, in addition to profiling of movement and non-movement symptoms, in large groups of patients, as well as in a population-based sample of the healthy population. Patterns of dysfunction which relate to patients' diagnosis and coinciding and future symptoms which align with categories of patients with similar prognoses will be investigated and their ability to predict incident patients' symptoms in future will be measured.

The aim of this project is to characterize spatiotemporal patterns of central nervous system dysfunction that correlate with clinical features of ALS, MS and FTD, to provide non-invasive electrophysiological measurements that can be used in a clinical setting to inform stratification of patients in clinical trials, and to provide data driven diagnostic and prognostic biomarkers and objective clinical trial outcome measures. Such dysfunction will be investigated by recording single- and paired-pulse transcranial magnetic stimulation (TMS)-associated electromyography (EMG) during rest and by recording electroencephalography (EEG) during rest and during cognitive-motor tasks.

Eligibility Criteria:
Inclusion criteria:

* Age \>18 years and able to give informed written or verbal (in the presence of two witnesses) consent.
* In the case of non-control subjects, a clinical diagnosis of:

  (i) Probable frontotemporal dementia (FTD) including behavioural variant FTD, semantic dementia or primary progressive aphasia) with supportive brain imaging or known FTD causing genetic mutation (ii) Multiple sclerosis (MS) according to the McDonald criteria (Polman et al., 2011) or (iii) Possible, probable or definite amyotrophic lateral sclerosis (ALS) according to the El Escorial Criteria Revised (Brooks et al. 2000)

Exclusion criteria:

* Any diagnosed neurological/muscular disease other than ALS, MS or FTD
* Use of neuro- or myo-modulatory medications except riluzole
* Inability to participate due to disease-related motor symptoms (e.g. inability to sit for the required time or click the mouse to respond)
* Upper body metallic implants
* History of seizure disorders in the participant or immediate family members
* Anxiety-induced fainting
* Regular migraine
* Evidence of significant respiratory insufficiency
* Sleep time \>2 hours below normal and/or alcohol consumption the night before data collection (in which case, recording session will be rescheduled).
Responsiveness of the German Version of the Neck Disability Index (NDI-G)

This study evaluates if the German Version of the NDI is sensitive to change over time.

Chronic neck pain patients will be asked to participate in the study.

The participants are asked to fill out the NDI at the beginning of the study and after seven weeks. Additionally the participants will fill out the PGIC.

Eligibility Criteria:
Inclusion Criteria:

* Chronic neck pain
* over 18 years old
* informed consent
* able to speak, write and read German.

Exclusion Criteria:

* Any problems that may exclude Manual Therapy treatment of the cervical spine e.g fractures
Delivering Church-based Interventions to Reduce Stigma and Mental Health Treatment Disparities Among Latinos

This study is a cluster randomized controlled trial of a Latino church-based intervention in Los Angeles and Riverside Counties. This study aims to leverage the collective resources of Latino religious congregations and the National Alliance on Mental Illness to test the effectiveness of a multi-component intervention directed at reducing stigma, increasing mental health literacy, and improving access to mental health services.

This study is a cluster randomized controlled trial of a Latino church-based intervention in Los Angeles and Riverside Counties. This study aims to leverage the collective resources of Latino religious congregations and the National Alliance on Mental Illness to test the effectiveness of a multi-component intervention directed at reducing stigma, increasing mental health literacy, and improving access to mental health services. A total of 12 churches (6 intervention and 6 wait-list control) will be enrolled in the study. Churches within each study site, the Riverside County parishes and the Archdiocese of Los Angeles, will be matched in pairs based on size and geography. Three matched pairs from each study site will be randomly selected and then randomly assigned within each pair to intervention or control. The planned study will involve 2400 participants (1200 intervention and 1200 control) who will be part of congregations that are randomly assigned to receive the church-based intervention immediately or a wait list control condition. Participants will be assessed at baseline, 6-month follow-up, and 12-month follow-up to evaluate intervention effects on mental health service use and potential mediators (i.e., mental health literacy, stigma).

Eligibility Criteria:
Inclusion Criteria:

* Congregant of selected intervention and control churches

Exclusion Criteria:

* Does not meet criteria above
Efficacy Evaluation of Using Finger Stick Peripheral Blood for Point of Care Pregnancy Testing

To evaluate the efficacy of using peripheral blood for POC pregnancy testing in known pregnant participants.

Point of care (POC) pregnancy tests are designed for use with a urine specimen. However, the timely collection of a urine specimen is solely dependent on the patient's need to urinate which can delay the initiation of subsequent care activities. Furthermore, when considering the limitations of urine POC testing in wilderness scenarios, collecting a urine specimen from an injured person may not be a viable option. The literature has demonstrated blood as a viable alternative specimen for use with POC pregnancy testing with a sensitivity of 95.8%. Based on a literature review, these studies used blood specimen that were pre-collected into a serum collection vial. The study postulates the use of peripheral blood via a finger stick has multiple benefits such as 1) eliminating the need to wait for urine, 2) expedite the serum collection process as compared to a venipucture, 3) allow for testing in non-traditional scenarios such as wilderness medicine or mass casualty/gathering scenarios, and 4) minimizing the amount of blood required as compared to a traditional 3-5 ml serum collection vial. Data from this pilot study will provide valuable insight on the potential use of this testing method to inform future studies and treatment protocols for the above mentioned scenarios.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant female, 19 years or older, being seen at the Nebraska Medicine OB/GYN clinic

Exclusion Criteria:

* Does not meet inclusion criteria