cyrilzakka/clinical-trials huggingface dataset:
Care4Today v2.0 Application for Improving Adherence to HIV Medications

Although poor antiretroviral (ART) adherence in HIV does not mean a complete lack of therapeutic results, the benefit of ART increases as adherence improves. Consequences of suboptimal ART adherence are viral rebound, development of drug-resistant HIV strains, and more rapid progression to AIDS. Moreover, HIV-infected persons tend to have numerous co-occurring conditions and therefore take many medications making adherence to multiple drug regimens more difficult. A mobile application capable of improving medication adherence among HIV-infected persons would be highly useful.

The investigators propose an intervention study designed to address these potential mechanisms of nonadherence by utilizing the Care4Today v2.0 smartphone application (app). The current study is a small pilot Randomized Controlled Trial (RCT) comparing the smart phone application titled "Care4Today v2.0" versus standard of care to improve medication adherence to ART over a 4-week period with 60 HIV-infected participants.

The pilot RCT consists of 60 HIV-infected persons who are at risk for ART medication nonadherence. Using random assignment, 30 HIV-infected participants will be assigned to medication adherence improvement via "Care4Today" app as compared to 30 HIV-infected participants assigned standard of care.

The investigators will assess the effectiveness and acceptability of the app in improving objectively measured ART adherence (i.e., via medication event monitoring system caps) over a 4-week period via a pilot RCT with 30 HIV-infected persons assigned to the Care4Today intervention and 30 HIV-infected persons assigned to standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* 18 years or older at the time of enrollment
* HIV-infected
* Taking at least one medication to treat HIV illness
* Indication of medication nonadherence, or having a condition (e.g., active substance use, depression) that puts the individual at risk for medication non adherence
* Willingness to use electronic monitoring caps to track ART medication
* Willingness to respond to application alert messages

Exclusion Criteria:

* Axis I psychiatric diagnosis of psychotic disorder or mood disorder with psychotic features
* Presence of a neurological condition (beyond HIV infection) known to impact cognitive functioning (e.g., Huntington's Disease, Stroke)
* Unwillingness or inability to use electronic medication monitoring technology
* Unwillingness or inability to use daily alert messages
Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial

This trial is being completed to compare two commonly used options to treat pain after surgery. Participants that undergo gallbladder removal, hernia repair, and breast lump removal will be eligible to enroll. Eligible participants will be randomized to 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) plus acetaminophen or low dose opioids plus acetaminophen).

It is anticipated that the NSAID group will have superior clinical outcomes and fewer side effects when compared to the opioid group.


Eligibility Criteria:
Inclusion Criteria:

* No significant analgesic medication use before surgery: For this study, significant analgesic medication use before surgery as use of prescriptions for opioid or NSAID medications in the past 30 days, or over-the-counter NSAID use on greater than 7 of 30 past days, as reported by the patient.
* One of three common low-risk surgical procedures: For this study, the three-common low-risk surgical procedures will include laparoscopic gallbladder removal, inguinal hernia repair, and breast lumpectomy.

Exclusion Criteria:

* Anticipated other surgery within 6 months or anticipated life expectancy of less than 6 months
* Patients with contraindications to NSAID drugs in the NSAID arm, opioid drugs in the OPIOID arm, or acetaminophen will be excluded. There are specific contraindications that will be reviewed per protocol.
Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells

Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells


Eligibility Criteria:
Inclusion Criteria:

* SLE diagnosis (4 of 11 criteria by ACR);
* positive dsDNA;
* SELENA-SLEDAI index ≥6;
* active lupus nephritis;
* patient can read, understand and follow the procedures.

Exclusion Criteria:

* need for dialysis;
* planned renal transplantation;
* any medical condition which can be associated with the high risk for the patient;
* pregnancy/lactation;
* chronic infections, including hepatitis B/C, tuberculosis, HIV;
* any malignant tumor in the last 5 years.
Set-up of a Platform for Personalized Diagnosis of Rare Kidney Diseases (NIKE)

Chronic kidney disease (CKD) is a major health problem, with steadily increasing incidence and prevalence and the threat of a true "epidemic". Converging evidence suggests a high prevalence of genetic etiology in rare kidney diseases and the list of new disease-causing genes is constantly updated. Recent advances in next-generation sequencing (NGS) technologies have prompted a significant improvement in the diagnosis of rare kidney diseases. Notwithstanding this, NGS generates high numbers of information that need to be properly analysed by the joint efforts of geneticists, nephrologists and bioinformatics in order to integrate clinical and genetic information in a personalized manner. In addition, in selected cases, the contribution of researchers proves essential for the development of experimental models of the disease to study and understand the pathogenic features and propose a personalized therapeutic approach. Such an innovative, integrated diagnostic paradigm is currently available in few centers all over the world and cannot be easily translated in daily clinical practice.

The aim of the study is to set-up an integrated diagnostic algorithm to extend the newest personalized diagnostic and treatment strategies for rare kidney diseases to all patients in the Tuscany region, under 40 years of age with kidney disease. This algorithm will be based on a constant cross-talk between participating centers and a dedicated multidisciplinary team. Diagnostic and therapeutic performances will be validated at European level.


Eligibility Criteria:
Inclusion Criteria:

* family history of kidney disease and/or parental consanguinity;
* extra-renal involvement (e.g., sensorineural hearing loss);
* resistance to treatment (e.g., immunosuppressive);
* metabolic acidosis or metabolic alkalosis in the absence of renal failure;
* ultrasound detection of of at least 2 cystic lesions in each kidney or nephrocalcinosis;
* ultrasound detection of congenital abnormalities of the kidney and urinary tract (CAKUT) and CKD stage ≥ 2 according to KDIGO definition
* informed consent form.

Exclusion Criteria:

* age \> 40
* refuse to participate to the study
Study of Blood Samples From Older Patients at High Risk of Developing Prostate Cancer and From Healthy Male Participants

RATIONALE: Studying samples of blood in the laboratory from patients who are at high risk of developing prostate cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples from patients at high risk of developing prostate cancer and from healthy male participants.

OBJECTIVES:

* To determine whether there are any changes in pro-oxidant-antioxidant profiles in patients who are at high risk for developing prostate cancer.
* To compare the profiles of these patients with those of healthy controls.

OUTLINE: Participants undergo blood sample collection. Samples are used to measure levels of antioxidant enzymes (i.e., glutathione, glutathione peroxidase, glutathione reductase, superoxide dismutase, and reduced glutathione) and biomarkers of oxidative stress and DNA damage in leukocytes (i.e., thiobarbituric acid reactive substances \[TBARS\] and 8-hydroxydeoxyguanosine). Samples are analyzed via antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay.

PROJECTED ACCRUAL: A total of 40 participants (20 at high risk for developing prostate cancer and 20 healthy controls) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Patient at high risk for developing prostate cancer, due to 1 of the following risk factors:

    * Histologically confirmed proliferative inflammatory atrophy and/or high-grade prostatic intraepithelial neoplasia lesions accompanied by chronic intraprostatic inflammation
    * Abnormality observed during digital rectal exam or transrectal ultrasonography
    * Continued elevated age-adjusted prostate-specific antigen (PSA) meeting at least 1 of the following criteria:

      * Screening PSA \> 4.0 ng/mL
      * Free PSA \< 18%
      * PSA velocity \> 0.75 ng/mL within the past year
  * Healthy volunteer meeting the following criteria:

    * Age-matched
    * Normal PSA level (≤ 2.1 ng/mL)
    * Normal digital rectal exam
    * No prostatitis or benign prostate hyperplasia
    * No urinary symptoms (diagnosed or undiagnosed)
* No diagnosis of cancer

PATIENT CHARACTERISTICS:

Patients and healthy controls:

* No chronic inflammatory conditions, especially those for which regular use of non-steroidal anti-inflammatory medications (NSAIDs) is prescribed/recommended, including any of the following:

  * Coronary heart disease
  * Chronic obstructive pulmonary disease (COPD)
  * Psoriasis
  * Pelvic inflammatory disease
  * Multiple sclerosis
  * Arthritis
  * Lupus
  * Hashimoto thyroiditis
  * Inflammatory bowel disease (i.e., ulcerative colitis or Crohn disease)

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy or surgery to the prostate (healthy controls)
Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib.

The purpose of this study is to provide continued use of parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib to participants who are currently enrolled in an Incyte-sponsored study and receiving the same treatment, who have at least stable disease, who are obtaining clinical benefit (in the opinion of the investigator) on the current study treatment, as defined by the parent Protocol, and who are unable to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib outside a clinical study. Participants will continue on the same dose and schedule as the ones being administered in the Incyte-sponsored parent Protocol at the time of the rollover. The study will collect and assess safety information with regards to AEs.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of parsaclisib.
* Currently tolerating treatment in the parent Protocol.
* Currently receiving clinical benefit from treatment with parsaclisib as monotherapy or in combination therapy with Itacitinib, ruxolitinib, or ibrutinib as determined by the investigator.
* Has at least stable disease, as determined by the investigator.
* Has demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
* Willingness and ability to comply with scheduled visits, treatment plans, including PJP prophylaxis, and any other study procedures indicated in this Protocol.
* Willingness to avoid pregnancy or fathering children
* Ability to comprehend and willingness to sign an ICF

Exclusion Criteria:

* Has been permanently discontinued from study treatment in the parent Protocol for any reason.
* Able to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib therapy outside a clinical study.
* Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
* Pregnant or breastfeeding women.
Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients

Social psychological research has demonstrated that internalized stereotypes affect people's attitudes and behaviors. Music-based interventions that rely on stereotypes might have promise for keeping participants engaged in health interventions, reducing stress, and improving wellbeing.

Group Assignments

Participants will be randomized into one of four groups.

1. Group 1 (Reggae): Participants in this group will receive the stereotype and listen to the music over the 4 weeks.
2. Group 2 (Preferred): Participants in this group will listen to preferred music over the 4 weeks.
3. Control Group: Participants in this group will serve as a control and will not receive any intervention until the study is completed. They will complete a baseline survey and a follow-up survey at four weeks, as well as similar daily surveys. Some recordings will be sent to this group after the study is completed, without tracking their usage.

Intervention

All groups will complete a baseline and 4-week follow-up survey.

Participants in Group 1 and Group 2 will engage in daily listening 4-week intervention.They will have access to electronic audio recordings, with the order of listening labeled for each day. It is up to them if they want to listen to the daily recordings.

Eligibility Criteria:
Inclusion Criteria:

1. Are 18+
2. Live in the US
3. Are an English-proficient adult with a chronic pain diagnosis (no restrictions placed on type)
4. Have a pain rating of four or greater in average pain on a 0-10 numeric rating scale in the preceding week
5. Have had pain for at least 3 months and for at least 15 days in the preceding 30 days
6. Have moderate to severe anxiety based on GAD-7

Exclusion Criteria:

1. Are currently using or have used prescription opioids in the past 3 months to minimize a known treatment confound and increase sample homogeneity
2. Have a current cancer diagnosis
Serum CD14 and CD88 Mointoring in ICU

The present study will be conducted to determine the dynamic changes of serum soluble CD14 and the corresponding changes of serum CD88 and their correlation in critically ill sepsis and SIRS patients.

A total of ninty four will be included in the study. Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and forty seven patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* The patients staying in ICU for more than 24 hours will be included in the study.

Exclusion Criteria:

* Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation will be excluded from the study.
Evaluation of the Safety and Performance of the NESS L300 Plus System

The study is designed to evaluate the safety and efficacy of using the L300 Plus as a neuroprosthesis device for walking in patients following an UMN injury or disease. The clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study.

This is a prospective, one-center, single group, repeated measures, non inferiority study. Forty-five (45) subjects suffering from foot drop and thigh muscles weakness due to upper motor neuron injury or disease will be evaluated for this study. Each subject will be in the study for six weeks. Clinical benefits will be measured through an assessment of the gait performance. In particular it will test the hypothesis that the NESS L300 Plus System which involves foot drop correction with thigh muscles activation, may achieve walking enhancements not inferior to those gained from using a system that only corrects foot drop (i.e. NESS L300).

Eligibility Criteria:
Inclusion Criteria:

* Upper motor neuron lesion
* Thigh muscle weakness - hamstrings or quadriceps strength of less than 4/5 according to manual muscle testing
* Foot drop - toe drag during walking
* Lower limb spasticity - 0-4 according to the modified Ashworth scale
* Responsible mental state, able to follow multiple step directions
* Between 18 and 80 years old
* Available for participation in the study
* Able to understand and sign the informed consent form
* Able to walk independently or with an assistance device (e.g. cane, walker etc.) / spot guarding for at least 10 meters
* Sufficient response to electrical stimulation (visible muscle contractions in a seated or prone position of each designated muscle separately)

Exclusion Criteria:

* Subjects with a demand-type cardiac pacemaker, defibrillator or any electrical or metallic implant
* Cancerous lesion of lower limb, present or suspected
* Medical condition that prevents participation or would likely lead to inability to comply with the protocol \[e.g.: congestive heart failure, patient receiving chemotherapy, uncontrolled epilepsy, etc\]
* Severe cognitive impairment (MMSE\<21)
* Severe neglect (Star cancellation test\<30)
* Skin lesion at the site of the stimulation electrodes
* Change in bone-joint structures of the lower limb, such as contractures or deformations; fracture or dislocation, which would be adversely affected by motion from the stimulation
* Pregnancy
* Diagnosis of major depression or psychotic disorder
* Participation in another investigation that may directly or indirectly affect the study results
* Unable to tolerate electrical stimulation
It's WeWomen Plus Intervention for Health, Safety and Empowerment

This study evaluates the impact of adaptive technology-based intervention (online, text and phone) "weWomenPlus" on safety, mental health and empowerment of abused immigrant women.

Intimate partner violence (IPV) disproportionately affects immigrant women. However, immigrant women remain an understudied and underserved population in need for evidence-based rigorously evaluated culturally competent interventions that address the health and safety needs of immigrant women. This study uses a sequential, multiple assignment, randomized trial (SMART) design to rigorously evaluate an adaptive culturally informed intervention tailored to needs of immigrant women with IPV experiences. For the first stage randomization, participants will be randomly assigned to an online intervention or the usual care control arm and safety, mental health and empowerment outcomes will be assessed at 3, 6 and 12 months follow up. For the second stage randomization, women who do not report significant improvement in safety (i.e., reduction in IPV) and in empowerment from baseline to follow up points (i.e., non-responders) will be re- randomized to the augmented intervention components (text only or a combination of text and phone) developed in the formative phase. Data on outcomes (safety and empowerment) will be assessed at 6 and 12 months of re- randomization. By re-randomizing participants, the study will assess the relative effectiveness of two strategies for augmentation (text only or a combination of text and phone) on safety and empowerment outcomes among the non-responders of the online intervention. In addition, the study will compare the non-responder group of women to the responder group of the online intervention to determine if the strategies of augmentation brought the non-responders to the level of responders on safety and empowerment. Finally, the study will identify facilitators and barriers to the adoption, implementation and maintenance of use of the original and augmented intervention by programs serving immigrant women and design strategies to decrease barriers and build on strengths.

Eligibility Criteria:
Inclusion Criteria:

* Experiences of intimate partner violence within the past one year
* Foreign born immigrant woman
* 18-64 years of age
* Can access and use internet and phone

Exclusion Criteria:

* No experience of intimate partner violence within the past one year
* US born
* Younger than 18 or older than 64
* Cannot access or use internet or phone
An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease

The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease.

This is a randomized, placebo-controlled, double-blind, repeated-dose study to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease. The primary efficacy outcome of the study is the number of patients with at least a 50% reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits.

Patients will be treated with either anti-TNF chimeric monoclonal antibody (cA2) or matching placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Crohn's disease of at least 3 months duration confirmed by radiography orendoscopy
* Having single or multiple draining enterocutaneous (including perianal) fistulae of at least 3 months duration
* If treated with oral prednisone (or equivalent), the dose must be \<=40 mg/day and must have been stable for at least 3 weeks prior to enrollment. (If currently not treated with oral prednisone, the stop date must have been at least 4 weeks prior to enrollment)
* If treated with 6-mercaptopurine or azathioprine, the start date must have been at least 6 months prior to enrollment. (The dose must have been stable for at least 8 weeks prior to enrollment. If currently not treated with 6-mercaptopurine or azathioprine, the stop date must have been at least 4 weeks prior to enrollment.)

Exclusion Criteria:

* Patients with local complications of Crohn's disease such as strictures or abscesses that might confound the evaluations of the benefit from cA2 treatment
* Having abscesses that should be drained prior to enrollment, with at least 3 weeks between drainage of the abscess and enrollment
* Having a serious infection, such as hepatitis, pneumonia or pyelonephritis, in the previous 3 months or a history of opportunistic infection such as herpes zoster within 2 months prior to screening, or evidence of active cytomegalovirus, active pneumocystis carinii, or drug resistant atypical mycobacterium
* Currently having signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease
* Currently having any known malignancy or any history of malignancy within the past 5 years