cyrilzakka/clinical-trials huggingface dataset:
RISE With Veteran Service Providers

Veterans and their families are more likely to experience forms of family violence like intimate-partner violence and child maltreatment. Evidence suggests that healthcare and social service providers (HSSPs) need more training to effectively and confidently recognize and respond to these situations. The Violence, Evidence, Guidance, Action (VEGA) Educational Intervention is a novel education intervention aimed at improving provider's preparation for these clinical encounters. The goal of this project is to determine the acceptability and feasibility of a future randomized-controlled trial comparing two approaches (facilitator-led VEGA or self-directed VEGA) to administering the VEGA training to understand whether/how these approaches can support HSSPs continued care of veterans and their families. The investigators aim to generate initial estimates of the effectiveness of both approaches in improving HSSPs knowledge and skills to effectively recognize and respond to intimate-partner violence and related forms of family violence, including child maltreatment. As well, the investigators aim to contribute to the knowledge base regarding optimal educational approaches for HSSP education in family violence.

The investigators hypothesize that there will be significant increases in preparedness, knowledge and skills, and self-efficacy to recognize and respond to both CM and IPV in both the experimental and AC arms from Time 1 (baseline) to Time 2 (immediately after the intervention) and Time 1 (baseline) to Time 3 (3 month follow-up). These improvements will be slightly attenuated in the experimental arm. Qualitative data pertaining to perceived value and impact will corroborate the quantitative findings.


Eligibility Criteria:
Inclusion Criteria:

* Participant is a regulated healthcare or social service provider that is an active member in good standing with the associated regulatory college.
* Participant is fluent in written and spoken English.
* We are looking for participants who are currently working with or have previous experience working with military and/or RCMP veterans or their family members. Participants must meet one of the following criteria:

  1. Participant works with military and/or RCMP veterans or family members of military and/or RCMP veterans in a direct service capacity at least one day per week OR
  2. Participant has two years or more of experience working with military and/or RCMP veterans or family members of military and/or RCMP veterans in a direct service capacity OR
  3. Participant has worked with 15 or more patients that were either military and/or RCMP veterans or family members of military and/or RCMP veterans in a direct service capacity.

Exclusion Criteria:

* Participant has previously accessed VEGA intervention materials.
* Participant is currently enrolled in or plans to enroll in any other educational intervention focused on family violence within the study time period (approximately next 3 months).
Improving Medication Self-Administration and Health After Brain Injury

The purpose of this research study is to assess medication self-administration (MSA) and the impact of three different interventions on improving medication adherence. The findings for this study may help develop evidence-based reminder protocols to reduce medication self-administration errors after brain injury.

The investigators are interested in studying how brain injury (TBI, stroke, etc.) survivors manage self-administering their medication once they return home, and are aiming to improve their medication adherence. In this six month long study, patients will be placed into one of three intervention groups 1) standard care received (usual care, no reminder provided), 2) receive a video call at time medication is to be taken, 3) receive an automated text message when medication is to be taken. The investigators aim to identify which intervention is best at helping brain injury survivors adhere to their medication schedule, with the future goal of implementing this type of reminder protocol into standard care.

Hypothesis: The investigators hypothesize that automated reminder text messages will result in MSA improvement comparable to video calls, maintained over the six month period.

Allocation to groups: Patients will be randomized to receive video calls, automated text messages, or no intervention (standard care). The randomization schedule is by computer-generated number list.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18
* Less than three months post Brain Injury event
* English speaking (learned English at age 10 or younger, and use it daily)
* Currently taking up to eight medications on a daily basis

Exclusion Criteria:

* Legally blind
* Unable to give informed consent due to comprehension deficits
* Severe memory or cognitive impairments that would not allow for formal testing, as determined by the investigator
* History of psychiatric hospitalization for attempted overdose of pills
Concomitant Posterior Colporrhaphy on Bowel Functions in Pelvic Organ Prolapse Repair

Compare the changes of preoperative and postoperative posterior colporrhaphy.

Introduction:

Concomitant posterior colporrhaphy was frequently used during pelvic organ prolapse repair.

Objectives:

To evaluate the correlation between the presence of bowel symptoms and s rectocele severity and elucidate the impact of posterior colporrhaphy on bowel functions.

Methods:

Medical records of all consecutive women who received concomitant posterior colporrhaphy for their pelvic organ prolapse repairs were reviewed. In general, all women were requested to answer bowel incontinence assessment questionnaires before and after surgery.

Possible results:

Differences in rectocele severities between the presence or absence of fecal incontinence, flatus incontinence, constipation, diarrhea or sensation of residual stool will be shown.

Eligibility Criteria:
Inclusion Criteria:

* women with pelvic organ prolapse planned to receive concomitant posterior colporrhaphy

Exclusion Criteria:

* Pregnancy
Calquence CLL rr Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - All Patient Investigation

To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting

To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting.

This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law. In addition, after launch, the data for a certain number of all cases are collected and the survey is required to be conducted for all cases as conditions of approval.

Eligibility Criteria:
Inclusion Criteria:

Patients with relapsed or refractory chronic lymphocytic leukemia (small lymphocytic lymphoma) who are treated with the product -

Exclusion Criteria:

None

-
Studying Biomarkers in Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on E1302 Trial

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers in samples from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1302 trial.

OBJECTIVES:

* To evaluate the frequency of ATP-binding cassette, sub-family G (WHITE), member 2 (ABCG2), met proto-oncogene (hepatocyte growth factor receptor) (c-MET), and v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras) polymorphisms or mutations in this study population and the predictiveness of these polymorphisms on survival, time to progression, response rate, and toxicities.

OUTLINE: Archived tumor tissue and peripheral blood mononuclear cells are analyzed for the frequency of ABCG2, c-MET, and K-ras polymorphisms or mutations by polymerase chain reaction (PCR). Results are then correlated with patients' clinical outcomes and toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients diagnosed with recurrent or metastatic head and neck cancer treated on Eastern Cooperative Oncology Group (ECOG)-E1302 trial

  * Patients treated with docetaxel with versus without gefitinib
* Existing paraffin blocks and peripheral blood mononuclear cells

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Exercise Training in Children With Congenital Heart Defect

The purpose of this study was to investigate the effects of exercise training on exercise capacity, physical activity (PA), health-related quality of life (HRQoL), and the psychosocial factors affecting PA in sedentary congenital heart defect (CHD) children and healthy sedentary children. The degree of improvement after exercise training were compared between CHD children and healthy sedentary children.

Exercise groups took 12-week exercise training, twice in hospital and once at home, using a video game so-called Dance Dance Revolution (DDR), while the control group kept their daily routines.

Eligibility Criteria:
Inclusion Criteria:

* Children with congenital heart defect s/p repair \> 6 months
* Sedentary lifestyle

Exclusion Criteria:

* Unstable hemodynamics
* Impaired mental and cognition
* Systemic disease
Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula

This study is a cross-sectional study of 110 Malawian women to compare the ultrasonographic and hormonal characteristics of women and without obstetric fistula.

Hypothesis #1: Women with obstetric fistula have a mean cervical length measurement that is at least 10 mm shorter than the mean cervical length measurement of similar women without obstetric fistula.

Hypothesis #2: Evaluation of the hormonal and ultrasonographic characteristics of women with obstetric fistula will allow us to assess the cause of amenorrhea in these women.

This study is a cross-sectional study of 110 Malawian women who present for medical evaluation at the Fistula Care Centre in Lilongwe, Malawi. If a woman enrolls in the study, her demographic, medical history, physical exam, and lab data will be abstracted from her medical records at the Fistula Centre. She will also a pelvic ultrasound on each participant so that the characteristics of her cervix, uterus, and ovaries (such as the cervical length, endometrial thickness and ovarian volume) can be evaluated. If the participant has an obstetric fistula, she will also complete an additional blood draw for lab testing. The laboratory tests will evaluate three hormones that are associated with amenorrhea and infertility: follicle stimulating hormone, estradiol, and antimullerian hormone.

Eligibility Criteria:
Inclusion Criteria:

1. Presentation to the Fistula Care Centre in Lilongwe for medical evaluation
2. Ability to consent for study participation in Chichewa
3. Female aged 18-45 years
4. Willingness to undergo pelvic ultrasound for assessment of pelvic organs

Exclusion Criteria:

1. No history of pregnancy
2. History of hysterectomy
3. Current pregnancy or pregnancy within the past six weeks
4. Seriously or terminally ill
Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis

OBJECTIVES: I. Compare the effects of ursodiol (ursodeoxycholic acid), with and without methotrexate, on pruritus, incapacitation index, and serum markers of activity and severity in patients with primary biliary cirrhosis.

II. Compare the effects of these regimens on the development of ascites, encephalopathy, varices (or bleeding from pre-existing varices), histologic liver changes, transplantation, and survival.

III. Compare the toxicity and safety of each regimen.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and Ludwig histologic stage.

All patients are treated with ursodiol (ursodeoxycholic acid, UDCA) for 6 months. If entry criteria continue to be met, patients are randomly assigned to UDCA/methotrexate or UDCA/placebo.

Combination therapy continues for at least 5 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- The following criteria must be met prior to study entry and ursodiol treatment: Bilirubin less than 3 mg/dL Alkaline phosphatase at least 1.5 times normal limits Albumin at least 3 g/dL The following criteria must be met prior to randomization to Arms I and II: Primary biliary cirrhosis (PBC), i.e.: Cholestatic liver disease for at least 6 months prior to randomization Liver biopsy compatible with PBC within 6 months prior to randomization No biliary obstruction on ultrasound, computerized tomography, or cholangiography The following exclude: Asymptomatic and stage I liver histology (Ludwig classification) Hepatic encephalopathy Ascites Variceal bleeding No liver disease of other etiology, e.g.: Chronic hepatitis B or C Autoimmune chronic active hepatitis Alcoholic liver disease Sclerosing cholangitis Drug-induced liver disease Symptomatic or obstructive gallstones --Prior/Concurrent Therapy-- At least 6 months since the following immunosuppressives: Cyclosporine Tacrolimus Methotrexate At least 3 months since other immunosuppressives, e.g.: Azathioprine Chlorambucil Colchicine Corticosteroids Penicillamine At least 3 months since rifampin --Patient Characteristics-- Life expectancy: No major illness limiting life span Hematopoietic: WBC at least 2500/mm3 Absolute granulocyte count at least 1500/mm3 Platelet count at least 80,000/mm3 Hepatic: See Disease Characteristics Renal: Creatinine clearance at least 60 mL/min Pulmonary: No diffusion capacity or vital capacity less than 50% of predicted Other: Antimitochondrial antibody positive HIV antibody negative No alcoholism within the past 2 years No epilepsy requiring phenytoin No malignancy within the past 5 years other than skin cancer No pregnant women Adequate contraception required of fertile patients
Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects

This is a single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to determine the effect of CTP-543 on the pharmacokinetics (PK) of midazolam in healthy adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female, aged 18-60
* Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening
* If of reproductive age, willing and able to use a medically highly effective form of birth control 4 weeks prior to first dose, during the study and for 30 days following last dose of study medication
* Capable of giving informed consent and complying with study procedures

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease
* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
* Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
* History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) \> 450 msec for males or QTcF \> 470 msec for females at screening visit or prior to the first dosing
* Abnormal liver function at screening
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
* Positive results for coronavirus infection (COVID-19) at screening or check-in
* Positive drug or alcohol results at screening or check-in
* Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
* Participation in another clinical study within 30 days prior to, and 30 days after the first dosing.
Spine Registration Using 3D Scanning - Arise

The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.


Eligibility Criteria:
Inclusion Criteria:

1. Patients that require exposure of bony posterior spine anatomy for localization as standard of care.
2. Have had a CT scan performed prior to the procedure.
3. Clinically planned for spine surgery.
4. Able to provide written informed consent from subject, using IRB approved consent form, and agrees to comply with protocol requirements.

Exclusion Criteria:

1. Language problems that would prevent from properly understanding instructions.
2. Patients less than 18 years of age.
3. Requirement of an interpreter.
4. Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.
5. Special populations: pregnant women, prisoners.
6. Minimally invasive spine surgery that does not expose the necessary bone/s.
7. Spine surgery without posterior exposure.
Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease

The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at screening.

WONCBP may be included if they are either surgically sterile (hysterectomy or oophorectomy) or postmenopausal for =1 year (with follicle-stimulating hormone \[FSH\] level =38 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. 2-Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay. 3-Have a high probability for compliance with and completion of the study

Exclusion Criteria:

* Family history of QT prolongation, syncope, seizure, or unexplained cardiac-related death. 2-Presence or history of any disorder that may prevent the successful completion of the study. 3-History of drug abuse within 1 year before study day 1.
fMRI Study Examining Effects of D-cycloserine in Specific Phobia

The research team hopes to use brain imaging and mental testing to learn more about specific phobias and the treatment of phobia. When given directly prior to therapy sessions, D-cycloserine has been shown to enhance the effects of therapy. This study hopes to identify reasons why D-cycloserine has this effect by measuring brain activity.

Exposure and Response Prevention (ERP) therapy has become the treatment of choice for specific phobias. ERP involves systematic and repeated exposure to a feared or anxiety-provoking stimulus, leading to habituation and extinction of the fear response. Animal models of fear extinction have shown that acute administration of D-cycloserine (DCS) prior to exposure to a feared stimulus enhances extinction of that fear. A recent study in human subjects with height phobia (a specific phobia) has also demonstrated that DCS facilitates the effects of ERP therapy. Current theories postulate that DCS facilitates fear extinction by enhancing the learning process and increasing consolidation of memories, but the neural mechanisms underlying this process are not understood. The proposed research aims to elucidate these mechanisms by using fMRI to measure brain activation during 1) symptom provocation and verbal learning two hours post-medication, and 2)repeated symptom provocation and verbal recognition one week post-medication. This research will also examine the effects of DCS on cognitive functioning using neuropsychological testing both two house and one week post-medication.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* Adults between 18 and 55 years of age
* Subjects in the phobic group will additionally meet diagnostic (DSM-IV) criteria for spider phobia.
* Individuals of both genders and all races will be included

Exclusion Criteria:

* Women who are breastfeeding or pregnant
* Individuals with medical conditions unsuitable for MR scanning
* Individuals reporting a history of epilepsy or seizures
* Individuals reporting an allergy to cycloserine
* Individuals diagnosed with asthma or who report previous anaphylactic reaction to insect stings/bites, medication, food, or other material and/or event
* Individuals reporting present or past diagnosis of a developmental disorder, neurological disorder, or head injury \*Individuals found to have Axis I psychopathology as defined by the DSM-IV (other than spider phobia)
* Individuals currently taking any psychotropic medication
Use of Baxter Animated Retching Faces (BARF) Scale to Measure Nausea in Children Who Speak Spanish

Pediatric research in the management of nausea has been limited by the absence of a reliable method to quantify the intensity of this subjective symptom. In adults, the visual analog scale (VAS) is an accurate tool, but this has not been shown to be reliable in young children. A scale is a series of points made on a line that will be used for measurement; a mark on the far left of the line shows little pain and the mark on the far right means alot of pain.

By default the most common objective outcome measure used in pediatric studies has been the incidence and number of emetic episodes. This measure, however, correlates poorly with the somatic subjective symptom of nausea. Apfel et al have shown that 30-40% of adult patients undergoing surgery have post discharge nausea and / or vomiting while 12% have vomiting. These data on nausea in adults were based on a visual analog scale for nausea. There are no data on the incidence of postoperative nausea in children since the severity of symptoms are difficult to measure as younger children are known to be unable to use the VAS reliably. Recently a pictorial scale for measuring nausea, the Baxter Animated Retching Faces (BARF) scale, has been developed and shown to have construct, content and convergent validity as an instrument to measure nausea in children. This was a two center study that was limited to children who could speak English. The clinical usefulness of this scale in determining the incidence of postoperative and post-discharge nausea in children has yet to be determined including the lowest age where it can be used reliably, the score associated with a patient's perception of a need for treatment, the minimum change in the scores of clinical relevance and the test-retest reliability when nausea is rated as not having changed. The score has also not been validated in children who speak Spanish. This study is designed to provide the missing information and will specifically look at the Spanish speaking population.

Eligibility Criteria:
Inclusion Criteria:

* (1) Spanish speaking children (2) Age \> 7 years but below 18 years (3) Elective surgery (4) American Society of Anesthesiologists physical status 1-3 (Free from major concurrent disorders) (5) Free from nausea and / or vomiting in the previous 24 hours (6) Cognitive and communicative ability to rate the intensity of symptoms as described below.

Exclusion Criteria:

* (1) Inability to understand or speak Spanish (2) Developmental delay (3) Blindness (4) Impaired cognitive or communicative abilities including inability to rate the intensity of symptoms (5) Surgical procedure where vision or hearing is anticipated to be impaired in the immediate postoperative period (6) Nausea and /or vomiting within 24 hours of procedure, (7) Patient or parental refusal to participate (8) Pregnant females