cyrilzakka/clinical-trials huggingface dataset:
Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.


Eligibility Criteria:
Inclusion Criteria:

* Liver volume ≥ 4 liter
* ≥ 20 liver cysts
* Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity:

  * Abdominal distention perceived as uncomfortable
  * Frequent abdominal pain
  * Early satiety
  * Nausea (with the inclusion of dyspeptic complaints)
  * Dyspnea
* Diagnosed with ADPKD or ADPLD
* Male and female patients of 18 years and older
* Written informed consent

Exclusion Criteria:

* Creatinine clearance \< 20 ml/min
* Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year
* Hormonal replacement therapy
* Hormonal contraception
* Pregnant or lactating
* Presenting with an uncontrolled disease (other than ADPKD/ADPLD)
* Planned to undergo any surgery of the liver during study participation
* Planned to undergo any surgery of the KIDNEY during study participation (ADPKD patients only)
* Patients with known allergies to somatostatin or its analogues or any of its components
* Patients who received somatostatin analogues in the 6 months preceding study inclusion
Clinical Trial to Analyze the Efficacy of a Supplement Extracted From Persimmon on Overweight / Obesity.

Randomized, controlled, double-blind clinical trial, with two parallel branches depending on the product consumed (experimental product and placebo product) and single-center, to measure the efficacy of a supplement extracted from Persimmon on overweight and obesity grade I in subjects with BMI over 25.

The product to be consumed is a supplement extracted from the Persimmon. Participants will consume the product for 84 days. They will take one capsule before the two main meals.

Subjects will have to make 3 visits to the laboratory. In the initial visit it will be verified if the subject meets the criteria required by the study. Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product or placebo, depending on the group to which they have been assigned).

In the other two visits, the subjects will carry out the appropriate tests for taking of data colletion. These visits will be separated by 84 days of product consumption.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes aged 18-65 years.
* Subjects with a body mass index greater than 25 and less than 35.
* Volunteers able to understand the clinical study and willing to comply with the study procedures and the procedures and requirements of the study.

Exclusion Criteria:

* Subjects undergoing treatment that may affect body weight.
* Subjects with acute diseases.
* Volunteers with a history or presence of chronic pulmonary disorders, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular, or malignant tumor pathology or disease.
* Subjects who have undergone major surgery in the last 3 months.
* Subjects who quit smoking in the last 6 months or who intend to quit during the study.
* Subjects with allergies or eating disorders.
* Volunteers who are participating in another study that involves blood draws or dietary intervention.
* Pregnant or breastfeeding women.
Effect of Acupressure on Constipation in Community-dwelling Spinal Cord Injury Patients: a Randomized Controlled Trial

Spinal cord injury is a multi-sensory, motor and autonomic dysfunction, caused by various types of acute and chronic central nervous system injuries. And it will affect patient's ability to live normally and return to society. Due to lack of physical activity and psychological and environmental factors, the feces remain in the intestine for too long, and there will be excessive water absorption and lead to dryness and difficulty in excretion and it will be constipation. Chinese medicine, acupuncture and acupressure are the treatments of constipation in Traditional Chinese Medicine. Acupressure is a non- invasive intervention which is easy to learn and apply. We have carried out a number of studies on spinal cord injury rehabilitation support and acupressure to solve chronic problems such as constipation and anxiety. And this study aims to investigate the effects of acupressure combined with nursing intervention on constipation and quality of life in community-dwelling spinal cord injury patients.

This study will use an open-label, double-group, randomized controlled trial to compare the effect of the intervention group with the control group. Study participants will be recruited from the "Hong Kong Direction Association for the Handicapped, a non-governmental organization dedicated to serving severely disabled Hong Kong people such as SCI. The sociodemographic data, disease status and outcome indicators of the study subjects were measured before the intervention, after the intervention and one month after the intervention. Research assistants (RA1) were trained to evaluate data and data, blinded to group assignments.

We will have the focus group interviews (semi-structured) with participants after the the intervention (post-intervention). The interviews will be conducted online to further understand the benefits and limitations of the research intervention.

Eligibility Criteria:
Inclusion Criteria:

1. being Hong Kong residents between the ages of 18 or older,
2. having an SCI diagnosis for over 6 months and living in the community,
3. demonstrating the willingness and ability to learn and engage in acupressure (or having a caregiver to assist if self-operating is not feasible),
4. experiencing difficulties with defecation or having concerns related to defecation.

Exclusion Criteria:

1. currently undergoing other TCM treatments or receiving interventions related to defecation or bowel functions,
2. being unable to attend the training sessions due to personal reasons,
3. having a history of gastrointestinal organic disease,
4. having severe metabolic diseases, cardiovascular, cerebrovascular, or mental illnesses
Presentations of Hyperandrogenic Phenotypes in Taiwanese Women

STUDY QUESTION: Which of the four abnormally elevated androgen groups (total testosterone \[TT\], androstenedione \[A4\], free androgen index \[FAI\], or dehydroepiandrosterone-sulfate \[DHEA-S\]) present with an unfavorable metabolic and hormonal profile, appear to be more insulin-resistant and pose additional cardiovascular risk? SUMMARY ANSWER: Subjects with excess free androgen index tend to be obese and face the highest metabolic syndrome risk, adipocytokine alterations, insulin resistance (IR) and cardiovascular risk. The excess TT group presents with a marginal IR risk, while the excess A4 group has the highest antimüllerian hormone (AMH), and may counterbalance obesity; this group and the excess DHEA-S group have a favorable association with IR.

STUDY DESIGN, SIZE, DURATION:A retrospective study in 160 Taiwanese women with HA and 165 women without HA, with medical records reviewed from 2009 up to 2012. The hyperandrogenic women were classified into four groups (TT, A4, FAI, and DHEA-S) according to independent abnormally elevated androgen measures each above its cut-off value, and the groups were compared with each other and with controls.

PARTICIPANTS/MATERIALS, SETTING, METHODS: This study was performed in the Reproductive Endocrinology Clinic at Wan Fang Medical Center in Taipei, Taiwan. Anthropometric, metabolic, endocrine, and IR components as well as lipid accumulation product (LAP) index were compared between the groups. IR was assessed with the following markers: fasting glucose and insulin levels, oral glucose tolerance test, glucose-to-insulin ratio and homeostasis model assessment of IR index (HOMA-IR).

Eligibility Criteria:
Inclusion Criteria:

* Hyperandrogenic women who were classified into four groups:

  * Total testosterone (TT),
  * Androstenedione (A4),
  * Free androgen index (FAI),
  * and Dehydroepiandrosterone sulphate(DHEA-S).
* According to abnormally elevated androgen measures each above its cut-off value, and non hyperandrogenic women (who had all androgens below their cut-off values)

Exclusion Criteria:

* None of the women studied had

  * Hypogonadotropic hypogondism,
  * Hyperprolactinemia,
  * Congenital adrenal hyperplasia,
  * Premature ovarian failure,
  * Androgen-secreting tumors,
  * Cushing's syndrome,
  * or any other endocrine or systemic disease that may affect the reproductive function,
  * or any disorders of the uterus (e.g. Asherman's syndrome and Mullerian genesis) and chromosomal anomalies (e.g. Turner's syndrome).
* In addition, we excluded females who had

  * Experienced menarche less than three years preceding the study start,
  * or who had day 3 FSH \> 15 mIU/ml, as well as women with insufficient clinical/biochemical records,
  * and women with ovarian cysts or tumors in an ultrasonographic examination.
Characterization of Dyslipidemia in Adolescent Obesity

The primary objective of this pilot study is to characterize the profile of lipoprotein, inflammatory, and metabolic markers of cardiovascular disease in obese adolescents as compared to normal-weight age-matched controls.


Eligibility Criteria:
Inclusion Criteria:

* Age 13-19
* BMI ≥25 (obese) or \<25 (normal weight)

Exclusion Criteria:

* Prior diagnosis of any eating disorder (e.g. anorexia or bulimia)
* Prior diagnosis of any congenital lipid disorder (e.g. familial hypercholesterolemia)
* Current use (or within past 6 months) of any lipid altering medications
Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events

This study seeks to determine which Loa loa antigens are released into circulation when infected individuals are treated with ivermectin.

A cohort of up to 50 participants with Loa loa microfilarial levels between 5,000 and 18,000 per ml/blood will be treated with ivermectin in an inpatient setting. Participants will be monitored for treatment-related adverse events for seven days post-treatment, and will have blood drawn on days 0, 1, 2, 3, and 7 post-treatment to assess for microfilarial load, cytokine, and antigen levels.

Eligibility Criteria:
Inclusion Criteria:

* Loa loa blood microfilariae of between 5,000 - 18,000 per mL

Exclusion Criteria:

* known allergy to ivermectin; severe comorbidities
The SEEA (SCI Energy Expenditure and Activity) Study

People with SCI are at higher risk of obesity and chronic diseases, such as hypertension, high cholesterol, diabetes and cardiovascular disease, than the general population. Researchers currently lack data on factors that influence weight gain among people with SCI. During this one-year observational study, study staff will enroll 60 individuals with SCI while they are inpatients at Baylor Scott \& White Institute for Rehabilitation (BSWIR). Data will be collected at 3 time periods (before discharge and 6 and 12 months after discharge) in order to better understand factors that affect weight gain over the first 12 months following discharge from inpatient rehabilitation, such as nutritional intake, environmental access, psychosocial factors, energy requirements and risk factors for metabolic syndrome. These data will be used to inform future interventions for people with SCI.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years with complete or incomplete spinal cord injury (SCI)
* Currently have or are expected to regain enough arm function within 6 months to feed themselves independently.
* Injury occurred within previous 18 months

Exclusion Criteria:

* Unwilling or unable to complete repeat assessments
* Cognitive impairment or brain injury that limits ability to provide data
A Music-Based Mobile App for People Living With Alzheimer's Disease and Related Dementias (ADRD)

The purpose of this pilot is to develop a mobile application that detects physiological measures of individuals with Alzheimer's disease and related dementias and triggers auto-play of personalized songs in a wearable device. The investigators will test the feasibility and acceptability of the app. This app may be an important tool to include in daily caregiving in a home setting by extending established benefits of music therapy for people with Alzheimer's disease and related dementias.


Eligibility Criteria:
Inclusion Criteria for person with dementia

* A person with ADRD exhibits neuropsychiatric symptoms of dementia such as agitation, restlessness, depressed mood, etc.
* Stability with or without psychotropic or anti-depressant medications
* Ability to hear with or without an assistive device

Inclusion Criteria for Caregivers

* Family or close friend caregiver of persons with dementia
* Must be able to read and write in basic English

Exclusion Criteria for all participants

* Inadequate hearing
* History of psychosis or other mental disorders other than depression
* Presence of substance or alcohol abuse
Fibrinolysis Compared to Thoracoscopy for Pleural Infection

The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complex parapneumonic effusion (CPPE) in adults.

Background: Pleural infection (empyema or complex parapneumonic effusion (CPPE)) represents one of the most common clinical diagnoses encountered in clinical practice in the United States (US) It is associated with substantial morbidity and mortality despite advances in medical diagnostic and therapeutic strategies.

Objective: Compare two standard of care treatments: TPA/DNase vs early medical Thoracoscopy

Methods: We will conduct a prospective randomized clinical trial. We plan to enroll a total of 80 patients and randomize them to either Medical Thoracoscopy group or Fibrinolytic Therapy group.

Follow-up will be daily until hospital discharge and at 6 and 12 weeks in the outpatient setting

Primary Outcome: Duration of hospital stay after intervention

Secondary Outcome: Failure rate of assigned treatment and adverse events

Potential Outcome and Benefit: Determine best strategy for treating patients with pleural infection

Eligibility Criteria:
Inclusion Criteria:

* Subjects \>18 years old with:
* Evidence of empyema or complex parapneumonic effusion

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Inability to give informed written consent
* Previous thoracic surgery or thrombolytic therapy for pleural infection
* Medical thoracoscopy cannot be performed within 48 hours
* Hemodynamic instability or severe hypoxemia
* Non corrected coagulopathy
* Homogeneously echogenic effusion on pleural ultrasonography
Studying Genes Associated With Non-Hodgkin Lymphoma in Young Patients

This research studies genes associated with non-Hodgkin lymphoma in young patients. 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

OBJECTIVES:

I. To conduct a preliminary investigation of the effects of loci strongly and consistently associated in prior genome-wide association studies (GWAS) and validation studies of childhood/adolescent acute lymphoblastic leukemia (ALL), adult non-Hodgkin lymphoma (NHL), autoimmune diseases, and atopic diseases on the risk of NHL (lymphoblastic and Burkitt lymphomas) in children and adolescents.

OUTLINE:

DNA samples are analyzed by single nucleotide polymorphism and genotyped by fluorogenic polymerase chain reaction (PCR)-based allelic discrimination (Taqman) assays using the ABI Prism 7900HT reverse transcriptase (RT)-PCR system.

Eligibility Criteria:
Inclusion Criteria:

* Slides and/or other available specimens from patients diagnosed with lymphoblastic lymphoma (LL) or Burkitt lymphoma ( BL) enrolled on the Children Oncology Group (COG) protocols 5961, A5971, and ANHL01P1 collected at the time of diagnosis and currently housed at the Biopathology Center at Nationwide Children's Hospital

  * Samples from non-Hispanic white patients
* DNA samples from 384 healthy, anonymous, non-Hispanic white blood donors used as controls
* See Disease Characteristics
* Not specified
Resilience and Equity in Aging, Cancer, and Health (REACH)

The purpose of this multi-phase research study is to understand how consultation of cancer care with a geriatrician can best improve outcomes for older adults with gastrointestinal malignancies.

This research study will be conducted in three phases:

* Phase 1 - Needs assessment and implementation plan
* Phase 2 - Pilot Intervention
* Phase 3 - Expanded Clinical Trial

  * Please note Phase 2 - Pilot Intervention and Phase 3 - Expanded Clinical Trial will be added to the clinicaltrials.gov record once Institutional Review Board (IRB) approved.

Phase 1 is composed of three aims and will inform the subsequent two phases:.

* Aim 1: To evaluate the perceived needs of Older Adults diagnosed with gastrointestinal malignancies, caregivers, staff, and faculty to characterize the implementation setting for a geriatric consultation.
* Aim 2: To refine the proposed REACH program implementation plan based on qualitative feedback provided by Older Adult (OA) patients, their identified caregivers, staff, and faculty.
* Aim 3: Determine the patient, demographic, social determinants, clinical and disease characteristics of Older Adults (OA) associated with ED visits/hospitalization following initial oncology consultation at DF/BWCC in year 2019.
* Phase 2 intervention has started as of January 2022 following IRB approval. Study team has begun recruiting participants into Phase 2 intervention of REACH study starting in January 2022. Participants approached by REACH coordinator for consenting and enrollment after their initial consult visit at Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC). Participants are then asked to complete an electronic fitness assessment (EFA) that is sent to them via Patient Gateway. Participants complete this questionnaire and receive a score of "Robust", "Pre-frail", or "Frail" - those who score "Pre-frail" or "Frail" will be randomized to meet with a study geriatrician for geriatric co-management intervention alongside their standard oncology care. All enrolled participants will be followed for a duration of 1 year as they are continuing care at DF/BWCC.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are age 70+ at time of initial consult at DF/BWCC
* Diagnosed with a gastrointestinal cancer, including: cancers of the esophagus, stomach, pancreas, liver, bile duct, ampulla, colon, rectum, or anus, as well as neuroendocrine tumors.
* Continuing care at DF/BWCC beyond initial consult visit
* English and Spanish-speaking

Exclusion Criteria:

* Patients less than age 70 at time of initial consultation appointment with DF/BWCC.
* Patients who are not continuing care at DF/BWCC beyond first consult visit.
* Not proficient in English or Spanish
* Patient who are not considered appropriate for enrollment due to complex medical, social, or other situation as determined by their primary oncology team.
* Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms

The purpose of this study is to use technology to improve symptom status and ultimately improve patient centered outcomes in people living with HIV/AIDS (PLWHA). The primary purpose of the intervention (VIP-HANA) is to improve symptom status. The investigators hypothesize that VIP-HANA will improve symptom frequency and intensity.

As PLWHA age, they are developing chronic illnesses and co-morbid conditions that are often seen in older HIV negative patients. HANA conditions (e.g., cardiovascular disease, liver disease, diabetes, and asthma) are becoming more common as PLWHA age.

An individual's ability to identify and self-manage symptoms of HIV illness has been shown to improve patient outcomes and quality of life. The investigators will develop and pilot test the Video Information Provider (VIP), a web application (app) that delivered HIV-related symptom self-care strategies for PLWHA for 13 common (non-HANA) HIV/AIDS symptoms. There is a need to identify the symptom experience of PLWHA with HANA conditions.

The aim is to compare the efficacy of VIP-HANA to a control arm for ameliorating symptom frequency and intensity and secondary health outcomes in 100 PLWHA with HANA conditions over 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. HIV+
2. Age 18 or over
3. Able to read and respond in English
4. Reside within the US
5. Willing to participate in an online survey.

Exclusion Criteria:

1. HIV-negative
2. under age 18
3. Unwilling to provide key data (i.e., age, information about symptoms) on the online survey.
Reducing Opioid Mortality in Illinois

Reducing Opioid Mortality in Illinois (ROMI) is 5-year research study led by the University of Chicago in partnership with the University of Illinois at Chicago's (UIC) Community Outreach Intervention Projects (COIP), the Illinois Criminal Justice Information Authority (ICJIA) and the American Institutes for Research (AIR). ROMI aims to understand and test strategies for linking individuals with a history of opioid use disorder who are released from Illinois jails and prisons to substance use treatment. ROMI is one of twelve grants awarded by the National Institutes of Health (NIH) as part of the Justice Community Opioid Innovation Network (JCOIN) to support research on quality addiction treatment for opioid use disorder in criminal justice settings nationwide.

This NIDA-funded multi-site randomized control trial (RCT) examines the effectiveness of an established, intensive case management model for study participants who are awaiting release from four jails and two prisons across Illinois. The investigators seek to demonstrate that a unified case management approach can improve treatment engagement and retention among individuals who face high risks of opioid use disorders, overdose, and related harms. The investigators will examine the impact of case management and peer recovery coaching on participants' engagement with treatment and harm reduction interventions. The investigators will also study secondary outcomes including insurance enrollment, re-arrest, use of mental health services, and more.

ROMI will enroll at least 300 individuals with opioid disorders in the CMPR group, and at least 300 participants in the naloxone-only across five geographically distinct sites of care. All participants will receive harm reduction resources. The investigators hypothesize that the treatment group will display declines in opioid use, re-arrest, self-reported syringe sharing, and overdose risk behaviors relative to the control groups. The investigators will also examine differences between urban - rural and rural differences in treatment engagement and retention engagement, retention, and downstream outcomes across treatment arms. Aside from demonstrating these treatment impacts, the investigators will guide, document and evaluate ROMI's implementation efforts to ensure consistency across sites across sites and to inform future replication of the model in different settings or for different populations. (Edited 11/27/23 to reflect changes in recruitment from 500 in each treatment arm to 300)

Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years old
* Reside in designated research site county or zip code
* Satisfy criteria for likely OUD based upon nonmedical use of prescription opioids, heroin, or synthetic opioids.

Exclusion Criteria:

* Participants experiencing cognitive impairments that preclude informed consent.
* Reside out of the service area.
* Prior enrollment in a parallel JCOIN study.