cyrilzakka/clinical-trials huggingface dataset:
PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis

Isolation of nontuberculous mycobacteria (NTM) from the sputum of individuals with CF is an increasingly common finding, and the lack of an evidenced-based approach to the diagnosis of NTM disease has been identified as one of the greatest unmet needs within the CF community. Current evidence predicts that the prevalence of NTM will remain relatively high in the CF population. Approaches to NTM disease diagnosis differ widely between centers. This study is observational and follows current best practices. The study will help standardize the diagnosis and collect relevant data associated with the diagnosis of NTM disease to build a framework for future therapeutic trials.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent (and assent when applicable) obtained from participant or participant's legal representative
2. Enrolled in the CFF Patient Registry (CFF PR)
3. Be willing and able to adhere to study procedures in the context of clinical care, and other protocol requirements
4. Male or female participant ≥ 6 years of age at enrollment
5. Diagnosis of CF consistent with the 2017 CFF Guidelines
6. NTM positive for a species or sub-species in the 2 years prior to enrollment that has never been treated.
7. Willing to discontinue chronic azithromycin use for the duration of the study

Exclusion Criteria:

1. Prior or ongoing antibiotic treatment of the same NTM species or sub-species for which the patient is being considered for this study
2. History of solid organ or hematological transplantation
3. Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Comparative Analysis of Phase Lag Entropy (PLE) and Bispectral Index (BIS) as an Anesthetic Depth Indicator

The aim of this comparative analysis is to evaluate the reliability of PLE value as an anesthetic depth indicator

1. To evaluate the reliability of PLE value as an anesthetic depth indicator, the investigators compare PLE value with BIS score during induction and emergence of general anesthesia using propofol target controlled infusion.
2. In addition, the investigators verify whether or not the facial nerve integrity monitoring affects the efficacy for PLE and BIS values as an anesthetic depth indicator.

Eligibility Criteria:
Inclusion Criteria:

* Patients who scheduled for otopharyngeal surgery under facial nerve integrity monitoring requiring general anesthesia and American Society of Anesthesiology (ASA) physical status 1 or 2

Exclusion Criteria:

* Patient who has been taken anticonvulsant agents, sedatives, and hypnotics
* Patient who has central nerve system disease, neurological disorder
* Patient with hypersensitivity to anesthetics
Diabetes Homeless Medication Support Single Arm Treatment Development Trial

This single-arm trial of the Diabetes Homeless Medication Support intervention alone (n=15) will test the perception and feasibility of anticipated study procedures.

This study is of a set of studies with an overall goal to develop and pilot test a collaborative care intervention using motivational interviewing and behavioral activation alongside education and psychosocial support to improve medication adherence tailored to the experiences of people experiencing homelessness and diabetes (DH). Our team's central hypothesis is that medication adherence and diabetes self-care (and eventual glycemic control, health care use/cost) will improve with an intervention tailored to the unique context of DH.

This protocol addresses a pilot study to test patient perceptions of the feasibility and acceptability of study procedures and refine the D-Homes treatment manual through test cases (n=15). With a hypothesis that the D-Homes manual and study procedures will be feasible and acceptable to DH as measured by self-report and post-treatment interview.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 yrs. or older
2. English-speaking
3. Homelessness by federal definition in the last 12 mo.
4. Self-reported diagnosis of type 2 diabetes, later verified in medical record
5. Plan to stay in local area or be reachable by phone for the next 16 weeks
6. Willingness to work on medication adherence and diabetes self-care
7. HbA1c \>/= 7.5%

Exclusion Criteria:

1. Inability to provide informed consent (e.g., presence of a legal guardian, prisoners)
2. Active psychosis or intoxication precluding ability to give informed consent
3. Pregnant or lactating females.
4. Patients who choose to opt out of research.
A Video-Based HCV Curriculum for Drug Users

The investigators hypothesize that a well-designed hepatitis C (HCV)video education curriculum for high-risk drug users will show measurable benefits in improving HCV testing, hepatitis A and B vaccinations, and HCV knowledge, attitudes, and motivations toward transmission behavior change. The investigators will use a 4-part modular video series designed for at-risk drug users, and in this 12 week study will assess its impact on testing/vaccinations as well as knowledge, attitudes, and motivations in methadone-maintained drug users as compared to a usual-care intervention.

Injection drug users are at high risk for contracting hepatitis C (HCV). Very few culturally-specific educational tools have been developed to improve outcomes in this population. We hypothesize that measurable improvements in HCV testing, hepatitis A and B vaccinations, and testable knowledge, attitudes, and motivations may be elicited by such a curriculum.

In this study, we will investigate the impact of a 4-module short video educational series on these measures in in-treatment drug users maintained on methadone. Subjects will be enrolled in 3 sequential cohorts of 150 each: usual care, a 4 weekly sequential video cohort, and a single-session intervention in which the 4 videos are viewed at once. Subjects will undergo written testing for knowledge, attitudes about transmission behaviors, and motivations toward behavior change before the intervention, 4 weeks after the intervention, and 12 weeks after the intervention. Additionally, we will measure and compare the rates of HCV testing and HAV/HBV vaccinations before and at the 12-week time point in all cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Enrolled on methadone maintenance within last 30 days

Exclusion Criteria:

* Unable to provide informed consent
* Not interested in study
* Not able to speak or understand English
Dialysis Clinical Outcomes Revisited (DCOR) Trial

This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients. Informed consent will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be randomized to receive either Renagel or a calcium-based binder.

Starting from the randomization date, mortality data including survival, death date and cause of death (vital status information) and morbidity data including hospitalization date will be recorded for all patients. These data will be collected until the end of the study (December 31, 2004, ± 2 weeks). Patients completing or terminating from the study will return to the phosphate binder prescribed by their usual healthcare provider.


Eligibility Criteria:
Inclusion Criteria:

* patients must be 18 years of age or older,
* on dialysis for more than 3 months,
* require phosphate binder therapy,
* have Medicare as their primary insurance.

Exclusion Criteria:

* dysphagia,
* swallowing disorders,
* severe gastrointestinal motility disorders,
* bowel obstruction.
WINROP Algorithm Validation for Retinopathy Screening in a Cohort of Premature Infants

When a child was born too early, it is more likely to develop an alteration of its visual function than in the case of term birth. Significant visual disturbances are found in 3% of children born prematurely, but visual impairment can be very severe, up to the loss of vision in case of retinopathy of prematurity (ROP) in the most immature infants. The introduction of screening surveillance systems, such as WINROP software, might reduce the need for stressful eye examination in low risk neonates. This retrospective study aimed at validating the WINROP algorithm in a cohort of premature infants, born below 32 weeks of gestation, who had systematic eye examination for ROP screening over 4 year period.


Eligibility Criteria:
Inclusion Criteria:

* All infants born below 32 weeks gestation within the study period
* At least one eye examination recorded by Retcam

Exclusion Criteria:

* Any ophthalmic abnormality
* Any genetic abnormality
From Clinic to Community: An Information and Communication Technology (ICT) Home-Based Exercise Training System for Translating Clinical Findings

The specific aim of the study in our example is to conduct a feasibility translational home-based exercise trial established in the LEADERS (R2) project with the TExt-ME tele-exercise training system for participants with neurologic disability. We hypothesize that participants in this home-based tele-exercise training program will achieve similar gains in health and function outcomes as the onsite exercise training program. Further, there will be no difference in adverse side effects (safety) between the home-based and onsite exercise treatment groups.

TExT-ME is a home-based tele-exercise study providing a novel exercise program to participants with neurologic disabilities. The exercise curriculum is a Movement 2 Music (M2M) program developed during phase 2 of the grant (clinicaltrials.gov identifier NCT02533882). The exercise exercise classes are taught by trained dance instructors and are composed of a set of exercises tailored to the specific needs and capabilities of adults with neurologic disability. Each set of exercises is performed to high and low tempo music based on the individual's baseline level of function, with adjustments made to increase or decrease intensity if needed. The class consists of several training components: a) warmup (10 min.) to increase range of motion; strength/balance (15-20 min), aerobics (25-30 min. with rest periods as necessary); cool down (5 min).

The TExT-ME training and monitoring system is a user-centered design (UCD) involving a tele-exercise coach (e.g., a trained research staff person) interacting remotely with a participant in their home using video conferencing programs. Participants wear monitors to maintain safe levels of exercise and provide feedback regarding exercise intensity to the instructors. Self-reported indicators of exercise intensity are also collected using rating of perceived exertion.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with stroke
* MS - mild to moderate disability (Patient Determined Disease Steps Score 0-6)
* Able to use arms or arm/legs for exercise
* Ambulatory or use manual wheelchair

Exclusion Criteria:

* Cognitive impairment (Mini-Mental State Exam score \< 24)
* Recent weight change (+/- 25 pounds in 1 year)
* Poorly controlled blood pressure
* Cardiovascular disease event within the past six months
* Severe pulmonary disease
* Renal failure
* Current tobacco user or quit within the last six months
* Current use of medications for psychosis
* Active pressure ulcers
KN026 in Patients With HER2 Expressing Gastric/Gastroesophageal Junction Cancer

This is an open-label, phase 2 study of KN026 in subjects with HER2 expressing gastric/gastroesophageal junction cancer to evaluate efficacy and safety. The subjects will receive KN026 10 mg/kg QW or 20 mg/kg Q2W or 30mg/kg Q3W until progressive disease, unacceptable toxicity or death.

The study consists of two arms as HER2 overexpression arm and HER2 expression arm and both arms will receive KN026 treatment.

Eligibility Criteria:
Inclusion Criteria:

* Signed inform consent form(ICF)
* Age ≥ 18 years and ≤ 75 years, male or female
* Histologically or cytologically documented advanced gastric/gastroesophageal junction cancer HER2 overexpressing: IHC 3+ or IHC 2+ \& ISH+ HER2 expressing: IHC2+ \& ISH- or IHC 1+ \& ISH+
* Received at least one prior standard therapy
* At least one evaluable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function
* LVEF≥ 50% (ECHO)
* Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
* Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures

Exclusion Criteria:

* Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
* Accepted radiotherapy within 4 weeks before enrollment
* An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines
* Subjects are eligible with clinically controlled and stable neurologic function \>= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
* Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
* History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
* Severe chronic and active infection, need to system antibiosis/antiviral treatment
* Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
* Even with peripheral or central venous nutritional support, unintentional weight loss ≥5% within 1 month before the first medication
Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases

This trial is multicenter prospective study to evaluate clinical efficacy of respiratory rehabilitation personalized mobile services for respiratory disease.

Patients with Lung Cancer or COPD who need respiratory rehabilitation were enrolled in this trial. The subjets were randomized to 3 group(A: Fixed respiratory rehabilitation program group, B: Mixed respiratory rehabilitation program group(Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks) and C: Control group(Ordinary rehabilitation service of the site)).

Patients in Group A\&B were provided with mobile application and wearable O2 saturation machine and mobile application monitors physical activity and provides

1. how to do stretching, weight training with The-ra Band
2. daily and weekly target of exercise
3. alarm algorithms depending on patient's respiratory status(purse rate and O2 saturation)

Eligibility Criteria:
Inclusion Criteria:

* Patients with Lung cancer or COPD
* Patients with FEV1\<80% or FVC\<80% in Pulmonary function test

  * In case of COPD, post-bronchodilator FEV1 or FVC will be used.
  * Exceptionally Lung Cancer patients with operation, FEV1\>80% or FVC\>80% will be permitted
* The distance walked for 6 minutes in 6-minute walk test ≥ 150 m
* Patients with android phone
* Patients who voluntarily agree to study participation and provide written informed consent form

Exclusion Criteria:

* Patients with diseases which could be cause of death or significant disability for 1 year after study enrollment.
* Patients with diseases that are difficult to walk or improve walking at screening
* Patients with significant diseases which are difficult to include in this study in accordance with the investigator's judgment
* Patients who are illiterate or have communication limitations
* Patients who have a difficulty to complete a questionnaire or are uncooperative due to deterioration of recognition function
Study to Evaluate of EXG34217 in Patients With Telomere Biology Disorders With Bone Marrow Failure

This is a Phase I/II, open label, single center study to assess the safety and tolerability of EXG34217 in bone marrow failure patients with telomere biology disorders.

This is a Phase I/II, open label study in up to 12 subjects with telomere biology disorders with bone marrow failure. The study is open to all participants regardless of gender or ethnicity. Subjects who are enrolled but not evaluable will be replaced.

Subjects will sign a consent form prior to any study related procedure and will complete baseline screening assessments. Subjects for this study will not require any preparative regimen such as chemotherapy or radiation.

The study will be conducted in three parts

* Peripheral blood mononuclear cells (PBMNCs) collection; mobilization and apheresis,
* Ex vivo cell processing
* Processed cell infusion and post-infusion safety monitoring,
* Follow-up (Week 2, 3,4,5, Months 1, 2,3,4,5,6,9 and 12)

Eligibility Criteria:
Inclusion Criteria:

* Age 12 years and above
* Mild or moderate bone marrow failure defined by satisfying specific conditions.
* Diagnosis of telomere biology disorders

Exclusion Criteria:

* Women of child bearing potential or breastfeeding.
* Patients with cancer who are on active chemotherapeutic treatment.
* Patients with severe bone marrow failure.
* Clonal cytogenetic abnormalities associated with MDS or AML on bone marrow examination.
* Uncontrolled bacterial, viral or fungal infections.
* Prior allogeneic marrow or stem cell transplantation.
* Patients who are not eligible for G-CSF and plerixafor dosing.
* Patients who are not eligible for the apheresis.
* Patients currently taking or have taken danazol and androgens within 60 days prior to Day 1.
* Patients with any other clinically relevant acute or chronic diseases which could interfere with the patients' safety during the trial, expose them to undue risk, or which could interfere with study objectives.
* Patients who have participated in another clinical trial with an investigational drug within the previous 30 days.
Persistent Pulmonary Hypertension of the Newborn

The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent by the parent(s) or the legal representative(s).
2. Term and near term newborns (gestational age \> 34 weeks).
3. Post natal age ≥ 12 hours and \< 7 days.
4. Weight at birth ≥ 2,000 g.
5. Idiopathic PPHN or PPHN due to parenchymal lung disease
6. Documented diagnosis of pulmonary hypertension (PH) confirmed by echocardiography.
7. Need for continued inhaled nitric oxide (iNO) at a dose \> 10ppm after at least 4 hours of continuous iNO treatment.
8. Two oxygenation index (OI) values ≥ 12 taken at least 30 minutes apart, in the 12 hours prior to randomization and while the patient is receiving iNO treatment.
9. Mechanical ventilation with fraction of inspired oxygen (FiO2) ≥ 50% at randomization.

Exclusion Criteria:

1. PH associated with conditions other than PPHN.
2. Immediate need for cardiac resuscitation or extracorporeal membrane oxygenation (ECMO).
3. Lethal congenital anomalies.
4. Congenital Diaphragmatic Hernia.
5. Significant structural cardiac anomalies.
6. Medically significant pneumothorax.
7. Active seizures.
8. Expected duration of mechanical ventilation of less than 48 hours.
9. Mean systemic blood pressure \< 35 mmHg despite therapy with volume infusions and cardiotonic support.
10. Hepatic failure or all conditions with alanine aminotransferase (ALT) values \> 2 x upper limit of normal (ULN).
11. Renal function impairment such as serum creatinine \> 3 x ULN or anuria.
12. Known intracranial hemorrhage grade III or IV.
13. Either hemoglobin or hematocrit level \< 75% of the lower limit of normal (LLN).
14. Thrombocytopenia (platelet count \< 50,000 cells /µL).
15. Leukopenia (WBC \< 2,500 cells/ µL).
16. Any condition precluding the use of a nasogastric/orogastric tube.
17. Administration of prohibited medication prior to randomization.
Developing a PrEP Adherence Intervention Targeting At-Risk and Substance Using Women

The purpose of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy on adherence of a community-informed intervention for tenofovir/emtricitabine (TDF/FTC) pre-exposure prophylaxis (PrEP) engagement among street-based female sex workers (FSW) in Baltimore, Maryland.

This study is a prospective two-group trial comparing the efficacy of a comprehensive PrEP adherence program compared to PrEP standard of care among FSW. Outcomes will be assessed through self-reported PrEP adherence as well as biological adherence indicators.

The intervention includes three main components: 1) group PrEP engagement sessions, which include four educational sessions that situate PrEP in a broader framework of access and barriers to care, provider/patient communication, sexual health, HIV/sexually transmitted infection (STI) education, harm reduction around drug use, stigma, risk compensation and safe sex, and health/science literacy; 2) peer navigation, which aims to help women navigate healthcare engagement with the SPARC nurse practitioner and other providers; and 3) an mHealth component, consisting of a two-way text messaging system through which women will receive automated daily messages and weekly messages requesting adherence reports.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Assigned female at birth and identify as a woman
* Traded sex for money or drugs at least three times in the past three months
* HIV negative
* Willing to initiate PrEP
* Not knowingly pregnant or planning to become pregnant during the following 6 months.

Exclusion Criteria:

* Currently taking PrEP for HIV prevention
* Inability to provide informed consent in English
* Women who are determined as too high or drunk
* Women who are cognitively impaired
* Does not agree to data sharing with the Baltimore City Health Department