cyrilzakka/clinical-trials huggingface dataset:
CCTG 593: Testing and Linkage to Care

This is a CCTG sponsored project to determine if those recently screened for HIV would accept assistance to be linked into appropriate health services. After receiving their HIV results, high-risk individuals who test negative will have an option to be linked into a study that offers them Pre-exposure Prophylaxis (PrEP), and individuals who test positive will have an option to be linked into care.

If they accept, tested individuals will be in contact with an ALERT specialist that will help facilitate their linkage. The study's primary analysis will analyze how many HIV screened individuals accept the ALERT specialist assistance.

Design: CCTG 593 is a project to evaluate the uptake and effectiveness of an ALERT specialist serving to

1. link newly diagnosed, HIV infected persons from HIV testing sites to HIV specialist providers, and
2. link confirmed HIV antibody negative persons with continued high risk behaviors to PrEP centers

Duration: Each subject who agrees to linkage will receive ALERT follow-up until successful linkage or 60 days following enrollment for linkage to care or 90 days following enrollment for linkage to PrEP, whichever comes first. The duration of the 593 project will be for 3.5 years or until all subjects have been enrolled and successfully linked, or 60 days pass for linkage to care or 90 days for linkage to PrEP.

Sample Size: Up to 600 subjects will be tested and offered linkage across all CCTG sites: LA County-USC Medical Center, Harbor-UCLA/City of Long Beach Department of Health and Human Services, UCSD/San Diego Health and Human Services Agency.

Study Population: Eligible subjects will include any persons 18 years of age or older who have been tested for HIV at one of the CCTG testing sites (LA County + USC, Long Beach Department of Health and Human Services, and San Diego Health and Human Services Agency).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Has had an HIV test result form the CCTG Consortium testing site as either positive or negative
* Ability to provide informed consent
* English or Spanish Speaking

Exclusion Criteria:

* Severe active substance abuse or mental illness that the investigator feels will interfere with the ability to provide informed consent
* Acute medical illness that requires transfer to a non CCTG hospital
A Phase 2a, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects

The purpose of this study is to examine the effects of multi-dose regimens of IPI-145 on lung function in mild asthmatic subjects following allergen challenge.

This is a phase 2a, randomized, double-blind, placebo-controlled, multi-dose, 2-way cross-over study designed to examine the effect of IPI-145 on lung function and inflammatory indices in mild, allergen-reactive asthmatic subjects undergoing allergen challenge.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults between 18 and 60 years of age
* Diagnosis of asthma (mild) for at least 6 months prior to Screening
* Forced expiratory volume in one second (FEV1) ≥70% of predicted value at Screening
* A positive skin prick test to test allergen

Exclusion Criteria:

* Any prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor other than IPI-145 in a previous clinical study
* Acute asthma exacerbations within 6 weeks prior to Screening
* Use of any medication for the treatment of asthma other than a short-acting β2 agonist (as needed) within the 4 weeks prior to Screening
* Participation in another clinical study within minimum of 30 days prior to study Screening
* A positive screen result for active or latent tuberculosis
* A history of cardiovascular disease
* The concomitant use of acid-reducing agents and cholinesterase inhibiting medication
* Inadequate hepatic function defined by Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) greater than 1.5 times greater limit of normal (ULN)
* Inadequate renal function defined by serum creatinine greater than 2.0 milligrams/dL
Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout

In this single-blinded randomized controlled clinical trial 290 patients with stress or burnout will be investigated regarding the effectiveness of a digital therapeutic for improvement of stress level, the unguided online intervention reviga.

Inclusion criteria are: age 18-65 years, ICD-10 diagnosis Z73, operationalized as above average general stress level (PSS score \> 21) and increased levels of work-related stress / burnout (OLBI score ≥ 2.18), living in Germany, working a minimum of 20h per week, having a stable treatment for at least 30 days at the time of inclusion, and consent to participation. Exclusion criterion is having plans to change the treatment in the upcoming three months at the time of inclusion.

Patients will be randomized and allocated to either an intervention group, receiving reviga in addition to treatment as usual (TAU), or a control group, receiving only TAU. The control group will be granted access to the program at the end of the study. Primary endpoint will be the perceived stress measured by the PSS score, with three months post-allocation being the primary time point for assessment of effectiveness. Six months post allocation will be used as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be anxiety symptoms, level of functioning, burnout symptoms, health-related quality of life, and sick days.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* living in Germany
* employed (minimum of 20h/week)
* ICD-10 diagnosis Z73, operationalized as above average general stress level (PSS score \> 21) and increased levels of work-related stress / burnout (OLBI score ≥ 2.18)
* stable treatment (psychotherapy, medication, no treatment) for at least 30 days at the time of inclusion
* consent to participation

Exclusion Criteria:

* plans to change treatment (psychotherapy, medication, ...) in the upcoming three months at the time of inclusion
Safety and Efficacy of Lastacaft® for the Prevention of Itching Associated With Allergic Conjunctivitis in Korea

This post-marketing surveillance study will assess the safety and efficacy of Lastacaft® Opthalmic Solution 0.25% (Alcaftadine) for the prevention of itching associated with Allergic Conjunctivitis as prescribed as standard of care in clinical practice in Korea.


Eligibility Criteria:
Inclusion Criteria:

-Patients with itching associated with allergic conjunctivitis.

Exclusion Criteria:

-Patients with hypersensitivity to Lastacaft® or its components.
Computational Mathematical Analysis in Vastus Medialis Between a MTrP and Non Painful Point

With the help of ultrasound, the goal of the study is to asses the differences between MTR points and non painful points, in order to characterize the identification of MTR througought ultrasound. Being a complex process that needs to be standarized for each muscle, the study takes place in the vastus medialis.

Nowadays, myofascial trigger points (MTrP) represent one of the most common musculoskeletal alterations in clinic, being many times diffuse and complex to diagnose and localize. Ultrasound is a therapeutic tool used in physiotherapy for assessment and treatment. Some of its advantages include the quickness and harmlessness. Linking these two concepts, there is no vast evidence regarding the identification of myofascial trigger points through ultrasound. A computational mathematical analysis was performed throughout ultrasound images of the vastus medialis in order to characterize MTrPs, where images of 66 participants vastus medialis were taken. Two investigators made the finger point palpation locating a MTrP and a non-painful point. A third investigator screened the photographs with the ultrasound and a preset for the zone. 3 images were taken from the MTrP, 3 from the non-painful point, and other 3 of a different MTrP, in case the investigators disagreement of the MTrP location. A fourth investigator carried out the histogram analysis using Fiji software. Lastly, stastistical analysis of the study variables was performed.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 year old.
* Presence of pain on palpation along the course of the muscle fibers of the vastus medialis of the quadriceps.
* Painful point and/or localized tense band with or without radiation of pain to the knee area or adductor region.

Exclusion Criteria:

* Serious diseases (neurological, psychiatric, systemic diseases, obesity).
* Knee or hip surgeries.
* Muscle tears in a state of recovery in the vastus medialis of the quadriceps.
* Inability to position yourself in a lateral decubitus position.
Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

Fasting ketoacidosis adds morbidity to children affected by gastrointestinal infections. The investigators investigate oral glucose gel for its effectiveness in rapidly reducing ketoacidosis and for improvements in oral hydration therapy success.

More than 1.7 million children with acute gastroenteritis present for emergency department (ED) care annually in the United States. Gastroenteritis treatment regimens have been outlined in guidelines endorsed by the American Academy of Pediatrics, European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN), and Center for Disease Control (CDC). A fundamental principle included in these guidelines is the administration of oral rehydration therapy (ORT) to the vast majority of children with gastroenteritis; however, surveys have shown that a gap exists between guidelines and practice. Fasting ketoacidosis is an increasingly recognized metabolic derangement for children presenting with symptoms suggestive of gastroenteritis and mild to moderate dehydration. Ketoacidosis frequently occurs and likely adds comorbid symptoms of lethargy, vomiting, and malaise. These symptoms likely impair successful oral rehydration interventions. These symptoms may also lead to overestimations of the severity of dehydration. Rapid recognition of ketoacidosis is now possible with point of care testing beta-hydroxybutyrate. This investigation will determine if an oral glucose gel intervention will improve the Point Of Care (POC) beta-hydroxybutyrate from baseline. Secondary outcomes measured will include net fluid volume intake estimates, need for IV hydration, and need for hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Participants with gastroenteritis presenting to UF Health Shands Emergency Department

Exclusion Criteria:

* hypoglycemic- Blood glucose less than 50 or hyperglycemic- greater than 200
Kyrgyz Asthma Rehabilitation at High Altitude

prospective controlled interventional trial evaluating the efficacy of a 3-weeks asthma rehabilitation program at high altitude (3200m) and low altitude (760m) on lung function and asthma control.

Low altitude baseline measurements will be performed in Bishkek. Participants will then either be assigned to a rehabilitation program in Bishkek (760m) or in Tuja Ashu (3200m).

The rehabilitation programs in high or low altitude will be identically performed and will comprise

* asthma education and awareness
* instruction on inhaled therapies
* smoking cessation counseling
* respiratory and skeletal muscle training in groups
* guided walks / cycle ergometer training
* questionnaires on asthma control, quality of life
* spirometry and peak flow measurements
* echocardiography

Measurement on study subjects will be performed at baseline (Bishkek), during the rehabilitation program, after completion of the rehabilitation program and during a follow-up at week 15.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with atopic or non-atopic Asthma for at least 3 months
* partly controlled on regular or on demand inhaled therapy according to guidelines.
* asthma variability in peak expiratory flow \> 10%/day and/or a reversible airflow obstruction in spirometry
* History of asthma consisting of variable symptoms (cough, dyspnea, wheezing).

Exclusion Criteria:

* Unstable and severely uncontrolled asthma needing systemic corticosteroids.
* Need of continuous oral steroids for their asthma control
* Heavy smokers (\>20 cigarettes per day)
* Severe concomitant diseases preventing patients to adhere to the protocol and/or altitude exposure (severe metabolic, kidney- or liver disease, heart failure (ejection fracture \<50%).
* Chronic lung diseases with a persistent FVC \< 60% an/or arterial oxygen saturation \<92%).
* Severe mental- or musculoskeletal disorders
* Pregnant or breast feeding women
* Patient which are unable to comply with the study procedure.
Acupressure in Preventing Nausea and Vomiting in Young Cancer Patients Receiving Chemotherapy

RATIONALE: Using acupressure wrist bands to press and stimulate nerves at an acupressure point on the inside of the wrist may help control nausea and vomiting caused by chemotherapy.

PURPOSE: This randomized clinical trial is studying how well acupressure works in preventing nausea and vomiting in young cancer patients receiving chemotherapy.

OBJECTIVES:

* Determine the feasibility of implementing an acupressure therapy for the prevention of chemotherapy-associated nausea in children with cancer.
* Test the hypothesis that acupressure bands will prevent chemotherapy-associated nausea and vomiting in children, when compared to placebo acupressure (wrist bands without acupressure).
* Develop a competitive grant application for a large, multi-institutional randomized controlled trial of the efficacy of acupressure in preventing chemotherapy-associated nausea in children.

OUTLINE: This is a prospective, randomized, placebo-controlled, crossover, pilot study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients wear Sea-Band elastic acupressure wristbands on each wrist beginning approximately 1 hour before beginning their first inpatient chemotherapy session and continuing for at least 24 hours after completing chemotherapy. Patients do not wear wristbands for their second chemotherapy session. Patients wear placebo wristbands on each wrist beginning approximately 1 hour before their third chemotherapy session and continuing for at least 24 hours after completing chemotherapy.
* Arm II: Patients wear placebo wristbands on each wrist beginning approximately 1 hour before their first chemotherapy session and continuing for at least 24 hours after completing chemotherapy. Patients do not wear wristbands for their second chemotherapy session. Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 1 hour before their third chemotherapy session and continuing for at least 24 hours after completing chemotherapy.

All patients also receive standard antiemetic therapy.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients must receive in-patient primary oncology care at least monthly at Brenner Children's Hospital

  * Patients may have any type of cancer
* Must be receiving at least 1 of the following chemotherapy agents as an inpatient:

  * An alkylating agent (e.g., cisplatin, cyclophosphamide, or ifosfamide)
  * An antitumor antibiotic (e.g., doxorubicin, daunomycin, dactinomycin, or mitoxantrone)
  * High-dose cytarabine

PATIENT CHARACTERISTICS:

* Patient's primary caregiver must speak English

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Impact of a Printed Decision Aid on Patients' Intent to Undertake Prostate Cancer Screening

Although the number of recommendations against systematic screening of prostate cancer, 70% of patients still request testing because they overestimate the benefits and are unaware of the limitations.

The investigators aim is to assess the impact of a short printed decision aid presenting benefits and limits of screening, on patients' intent to undergo prostate cancer screening.

A Cochrane systematic review of 5 randomized controlled trials showed that screening for prostate cancer, using digital rectal examination and dosage of prostate specific antigen (PSA), did not significantly decrease prostate cancer specific mortality. Rather, screening for prostate cancer often led to over-diagnosis by detecting tumors that would not otherwise have become symptomatic or by producing false positive results. It could therefore result in unnecessary supplementary testing (including prostate biopsies), inadequate and/or harmful treatment, and negative psychological outcomes among patients.

Although the growing number of recommendations against PSA testing for screening of prostate cancer, 70% of patients still request testing prior to any information because they overestimate the benefits and are unaware of the limitations. As a result, about 55% of patients between 50 and 74 years old, undergo prostate cancer screening in the USA every year, despite recommendations against it.

To help patients understand the complexities about PSA testing for prostate cancer screening, professional organizations encourage physicians and patients to use decision aids to make informed decisions.

The aim of this study was to evaluate the impact of a decision aid, usable in daily practice by general practitioners, presenting harms and benefits of prostate cancer screening on patients' intent to undergo screening.

Eligibility Criteria:
Inclusion Criteria:

* male patients from 50 to 75 years old

Exclusion Criteria:

* personal history of prostate cancer
* any urinary tract symptoms
* history of prostate cancer in a first degree relative
* known exposition to chlordecone
Evidence-Based Tobacco Cessation Strategies in Patients With Cancer

This pilot clinical trial studies evidence-based tobacco cessation strategies in patients with cancer. Stop-smoking plans suggested by doctors may help patients with cancer quit smoking.

PRIMARY OBJECTIVES:

I. To assess oncology providers' self-reported need for training on evidence-based tobacco cessation strategies and assess their level of interest in future training on evidence-based tobacco cessation strategies.

II. To test the feasibility of the implementation of evidence-based tobacco cessation strategies in community oncology clinics.

III. To test the feasibility of surveying community oncology patients after a clinic visit to assess provider behavior regarding screening and brief intervention for tobacco use.

OUTLINE:

Patients complete a survey over approximately 10-15 minutes related to their provider's cessation advice and assistance with quitting.

After completion of study, patients are followed up at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* All patients with cancer who saw a provider will be eligible

Exclusion Criteria:

* Having a nurse or lab visit only
Nociplastic Pain in Patients With Chronic Shoulder Pain

The aim of this study was to investigate predictors of nociplastic shoulder pain. Factors of psychological distress, functionality, fitness, quality of life, quality of sleep, functioning of the parasympathetic system, and lifestyle will be examined. Patients with nociplastic pain will be identified using the classification system proposed by the IASP.

The main part of the study will include patients with chronic shoulder pain who visit the Hand Surgery-Upper Limb and Microsurgery Department of the General Hospital KAT. The measurements will be performed in one session. Once participants have been informed of the purpose and procedure of the study and given written consent, they will complete their demographics and a series of questionnaires and questions about their pain history. They will then be examined by a doctor and finally subjected to dynamometry, a functional test and two quantitative sensory tests.

Eligibility Criteria:
Inclusion Criteria:

* patients (men and women) with chronic shoulder pain (lasting more than 3 months, 3/10 Numeric Pain Rating Scale),
* aged 18-65 years
* mentally able to follow instructions or
* healthy volunteers
* aged 18-65
* who do not experience pain and have not received analgesic medication in the last trimester.

Exclusion Criteria:

* referred shoulder pain from different primary sources of pain (eg shoulder pain in women with mastectomy or stroke),
* pain manifested by movements in the neck,
* shoulder arthroplasty or fractures or dislocation of the shoulder, -
* diagnosis of chronic pain syndrome such as fibromyalgia, chronic fatigue syndrome, chronic regional pain syndrome, cancer diagnosis, osteoporosis, rheumatic inflammatory diseases,
* use of medication for neurological/psychiatric disorders,
* the presence of gastrointestinal or renal disease
* taking medication that may affect the assessment results, such as calcium channel blockers that could alter HRV,
* pregnancy or childbirth before 1 year will be excluded from the study.
iCare 2: Personalized Genomic Mutation Informed Treatment of Patients With Myelodysplastic Syndromes

This open-label, randomized, parallel group phase II study will investigate the efficacy of computational biology-informed treatment vs. standard of care treatment for patients with relapsed or refractory myelodysplastic syndromes (MDS).

It is hypothesized that personalized treatment informed by computational biology simulation technology will improve treatment outcomes for patients with relapsed or refractory MDS.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Must be at least 18 years of age
* Diagnosis of MDS, as defined by World Health Organization (WHO) 2008, that has relapsed after any duration of time from last best response or is refractory to induction therapy (defined as 4 cycles of treatment with a hypomethylating agent, 2 cycles of lenalidomide, 1 cycle of low intensity chemotherapy, or 1 cycle of high intensity chemotherapy)
* ECOG performance status of 0-2
* Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) may participate, provided they meet the following conditions:

  1. Must agree to use physician-approved contraceptive methods (e.g., abstinence, intrauterine device, oral contraceptive, double barrier device) throughout the study and for 3 months following the last dose of study treatment; and
  2. Must have a negative serum or urine pregnancy test within 7 days prior to beginning treatment on this trial
* Males with female partners of child-bearing potential must agree to use physician approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 6 months following the last dose of study treatment.

Exclusion Criteria:

* Must not have acute myeloid leukemia (AML), as defined by WHO 2008
* Pregnant and nursing subjects are excluded because the effects of study treatments on a fetus or nursing child are unknown
* Must not have had treatment with any anti-cancer therapy (investigational or standard) within the previous 21 days prior to the first dose of study drug or less than full recovery (no worse than CTCAE v4.0 grade 1) from the clinically significant toxic effects of that treatment.