cyrilzakka/clinical-trials huggingface dataset:
Prisons Evaluation of a One-stop-shop InterVentiOn

A prospective historically controlled study to assess the effect of an intervention integrating point-of-care hepatitis C (HCV) RNA testing, non-invasive liver fibrosis assessment, fast-tracked direct-acting antiviral (DAA) prescription, and linkage to hepatitis care (a 'one-stop-shop' intervention), on the proportion of participants initiating DAA therapy among people who are recently incarcerated within reception correctional centre(s) in Australia.


Eligibility Criteria:
Inclusion criteria

1. has provided written, informed consent to participate;
2. is male and ≥18 years of age on enrolment;
3. has been incarcerated within the last six weeks;
4. is HCV DAA treatment naïve;
5. is able and willing to provide informed consent and abide by the requirements of the study.

   For HCV RNA positive participants commencing treatment:
6. if HIV-1 infected must also meet the following criteria:

   1. HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry (Baseline) and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load; and
   2. be on HIV antiretroviral therapy (ART) for at least 4 weeks prior to study entry using an ART regimen that is allowable with the selected DAA regimen as determined by the current PI and the Liverpool drug interaction website (http://www.hiv-druginteractions.org/ )

Exclusion criteria

For HCV RNA positive participants commencing treatment, the subject will be excluded if they have:

1. untreated HIV co-infection;
2. chronic HBV co-infection;
3. any clinically significant condition, history or concomitant medication known to contraindicate DAA therapy or would not be suitable for management within a prison-based treatment setting;
4. is unable to gain an accurate reading on the fibroscan or the result is invalid;
5. known clinical or laboratory evidence of cirrhosis, or cirrhosis documented on fibro-elastography (\> 12.5 Kpa).
Tidal Model's Effect on Coping and Self-Esteem

The aim of the study was to determine the effect of the psychiatric nursing approach based on the Tidal Model on coping and self-esteem in people with alcohol dependency.


Eligibility Criteria:
Inclusion Criteria:

* People with alcohol dependency were included in the study who were between 30 and 50 years of age who were admitted for treatment to the Alcohol and Substance Addiction Treatment clinic.

Exclusion Criteria:

* People with alcohol dependency who were severely depressed with a Beck Depression score of 41 or more and those with severe anxiety(a Beck Anxiety score of 26 or more) were not included in the study.
Psychosis: Early Detection, Intervention and Prevention

The primary aim of this application is to conduct a randomized, controlled clinical trial of a specialized mental health service delivery system specifically developed for prodromal psychotic disorders. The intervention is Family-aided Assertive Community Treatment (FACT). The goal of the treatment is prevention of psychosis and disability. This study will assess experimentally the clinical effectiveness of this new type of mental health service. Other domains of outcome include cognitive dysfunction and functional disability.

The proposed study will be part of a larger program, Portland Identification and Early Referral (PIER), under foundation, NIH and Center for Mental Health Services sponsorship, that has established a population-based system of early detection for Greater Portland, Maine. Previous and present effort has educated and trained the community-at-large and all health, education and other professionals, with the result that referrals are occurring at the expected frequency. The principal strategy is to intervene early, prior to onset, in the course of the onset of psychotic disorders to arrest the development of psychotic symptoms and functional disability. The test treatment is a specialized combination of psychoeducational multifamily group and assertive community treatment.

The project will support a team of clinical staff with the ability to: a. foster detection of prodromal disorders in the Greater Portland community by general practitioners, guidance counselors, mental health professionals and the general public; b. accurately assess individuals at high risk for psychosis; c. reliably deliver an evidence-based psychosocial and, if indicated, pharmacological treatment package using standardized methodology. The research study will test, in a randomized controlled trial, the symptomatic and functional outcome of treatment in 100 subjects ages 12 to 35 identified by that system. It will allow the analysis of key social factors contributing to psychosis and their interaction with the treatment conditions and each other.

Eligibility Criteria:
Inclusion Criteria:

* Prodromal psychotic symptoms
* Age 12-35
* In catchment area (greater Portland, Maine)

Exclusion Criteria:

* Previous or current psychotic episode
* IQ less than 70
* Outside catchment area
* Toxic psychosis
The Effect of the Education Given to Nursing Students With Web 2.0 Tools on the Level of Participation, Attitude, Interest and Motivation

In this study, it is aimed to examine the effects of the education given to nursing students with web 2.0 tools on students' participation, attitude, interest and motivation levels.

The research was conducted as a randomized controlled experimental study. The study population consisted of 150 students between October 2022 and January 2023, and the sample of the research consisted of 110 individuals selected from the population using the improbable random sampling method. "Descriptive Feature Form," "Teaching Material Motivation Scale," "Course Interest Scale", Attitude Scale Towards Learning and ''absence charts'' were used to collect data.

In the analysis of data; percentile distribution, chi-square, Fisher- Exact test, t-test in independent groups, paired samples t Test were used.


Eligibility Criteria:
Inclusion Criteria:

* To be a student,
* 18 years and older
* Volunteer

Exclusion Criteria:

* Students who are not required to attend the course are not included.
Evaluating a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium

We investigate the potential pharmacokinetic drug-drug interaction between metformin extended release and rosuvastatin in healthy male volunteers who receive metformin extended release alone, rosuvastatin alone, and both together in a 3 period repeatedly.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteers, age 20 to 55 years.
2. The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
3. Liver enzyme (AST, ALT) level exceeds one and a half times more than maximum normal range.
4. Systolic blood pressure \<90mmHg or Diastolic blood pressure \< 60 mmHg, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg(Sitting blood pressure) during the screening procedure.
Effects of a Spine Navigation System on Op-time and Radiation Exposure

The goal of this study is to prospectively collect information about the operative time and intraoperative radiation experienced by patients undergoing posterior spinal fusion procedures guided by the MvIGS spine navigation system.

This is a single-center, prospective case series to assess the use of the Machine-vision Image Guided Surgery (MvIGS) spine navigation system for treatment of spinal stenosis, scoliosis, and spondylolisthesis that requires fusion. This is a single-arm, open-label study. All participants will undergo their single and multi-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under MvIGS intraoperative navigation guidance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of spinal stenosis of the lumbar spine with degenerative spondylolisthesis, all grades, and planning to undergo surgical fusion;
* Skeletally mature adults between the ages of 18-85 years at the time of surgery;
* Has completed at least 6 months of conservative therapy for degenerative diagnosis, if appropriate; and,
* Personally signed and dated an informed consent document prior to any study-related procedures, indicating that the patient has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* History of malignancy, craniocervical junction pathology, cervical and thoracic locations, and/or previous lumbar operation;
* Significant peripheral neuropathy or acute denervation secondary to radiculopathy, caused by conditions other than spinal stenosis;
* Significant peripheral vascular disease (defined as diminished dorsalis pedis or tibial pulses);
* Morbid obesity, defined as BMI \> 40 kg/m2;
* Active systemic or local infection;
* Active hepatitis (defined as receiving medical treatment within two years);
* Immunocompromised, such as but not limited to being diagnosed with Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, or Thymic Hypoplasia;
* Insulin-dependent diabetes mellitus or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing;
* Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for \> 1 month within last 12 months;
* History of Paget's disease, osteomalacia, or any other metabolic bone disease;
* Involved in study of another investigational product that may affect outcome;
* Women who are pregnant, lactating or anticipate becoming pregnant within 24 months post-surgery;
* Non-English speaking;
* Patients who are incarcerated;
* Worker's compensation cases; or,
* Patients involved in active litigation relating to his/her spinal condition.
The Antiseptic Outcome of Traditional Hand Scrubbing Versus Hand Rubbing in Surgical Room

Hand hygiene is the cornerstone of aseptic techniques to reduce surgical site infection. The traditional surgical antisepsis involves scrubbing the skin with povidone-iodine or chlorhexidine gluconate. Recently, a waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers was developed to provide a comparable antiseptic effect. The investigators perform a randomized controlled trial to compare the antiseptic effectiveness of the waterless hand rubbing, the classic surgical handwashing with povidone-iodine and chlorhexidine solutions.

This single centre, randomized trial recruited surgical team members in Taipei Medical University-Shuang Ho Hospital at November 2014. 255 episodes of hand washing are enrolled. The participants are assigned equally to use either a waterless hand rub (Group R), or traditional scrub formation with 10 % povidone-iodine (Group I) and 4% chlorhexidine (Group C). Hand washing time, microorganisms on hands before and after scrubbing is recorded. The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates after hand washing. The secondary outcomes is hand microbial flora after surgery and duration of hand washing.

Eligibility Criteria:
Inclusion Criteria:

* Surgical staff members, both surgeons and scrub nurses

Exclusion Criteria:

* Participants were excluded if they were medical or nursing students
* Allergy to the experimental materials
Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with irinotecan works in treating patients with advanced non-small cell lung cancer.

OBJECTIVES:

* Determine the antitumor activity and toxicities of irinotecan and paclitaxel in patients with advanced non-small cell lung cancer.

OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes. Treatment continues weekly for 2 weeks followed by one week of rest. Courses are repeated every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 11-22 patients will be accrued for this study over 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic non-small cell lung cancer for which no curative therapy exists
* Stage IIIB with pleural effusion allowed
* Measurable or evaluable disease
* CNS metastases allowed if disease stable at least 4 weeks following completion of surgery and/or radiotherapy and no anticonvulsant required

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* ECOG 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin less than 2.0 mg/dL
* SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if tumor involves liver)

Renal:

* Creatinine clearance at least 70 mL/min

Other:

* No other malignancies within past 3 years except nonmelanomatous skin cancer and carcinoma in situ of the cervix
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective birth control
* No active infection
* No concurrent medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior systemic chemotherapy for lung cancer
* No prior irinotecan or paclitaxel

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* At least 4 weeks since prior wide field radiotherapy
* No prior radiotherapy to greater than 20% of bone marrow allowed

Surgery:

* See Disease Characteristics
* Recovered from prior surgery
Effects of Combined Rectus Sheath and Ilioinguinal Nerve Block on Opioid Consumption in HALDN

The goal of this double-blind randomized control clinical trial is to investigate the effectiveness of regional anaesthesia blocks (rectus sheath block and ilioinguinal nerve block) on pain management in patients undergoing hand assisted laparoscopic donor nephrectomy surgery. The main question it aims to answer is:

Does combined rectus sheath block and ilioinguinal nerve block lower the amount of postoperative opioid consumption? Does reduced postoperative opioid consumption reduce the incidence of potential opioid related side effects? Does the application of nerve block affect length of hospital stay?

Researchers will compare patients who had nerve blocks with regional anaesthesia to a placebo group to see if total postoperative opioid consumption.

Participants will be randomly divided in two. Regional anaesthesia with local anaesthesia or a placebo will be performed. Patients will be followed 24 hours postoperatively to measure total opioid consumption.

Possible side effects, complications and length of hospital stay will be noted.

In this study, it was planned to provide pain management after HALDN by applying a combined rectus sheath block and ilioinguinal nerve block. It is aimed to demonstrate the postoperative analgesic effectiveness of combined rectus sheath and ilioinguinal nerve block applied in addition to general anaesthesia in HALDN surgery. It was aimed to examine the amount of narcotic analgesic consumption in patients who received local anaesthetic for the first 24 hours after surgery. Regional anaesthesia applications with physiological saline, defined as 'Sham Block' in the literature, were preferred as the comparison group.

This method is a widely used comparison method and is used to obtain a double-blind study design.

Eligibility Criteria:
Inclusion Criteria:

* The donors reviewed by the transplant committee and deemed suitable for nephrectomy.
* Laparoscopic hand assisted donor nephrectomy operation is planned.

Exclusion Criteria:

* Allergy to any of the drugs to be used in treatment
* Patients using chronic narcotics or narcotic receptor agonists
* Patients with psychiatric disorders
* Patients with chronic organ failure
* Patients without end organ damage
* The patients who did not give consent
* Foreign national patients
* Patients with American Society of Anaesthesiologists (ASA) physical status classification score III and above
Technology-assisted Language Intervention (TALI)

This study is testing the effectiveness of augmentative and alternative communication technology among deaf or hard of hearing children for improving language development. Children will be randomized to receive either the technology intervention or treatment as usual


Eligibility Criteria:
Inclusion Criteria:

* Age 3-10 years
* Documented permanent bilateral hearing loss with severity levels clinically defined moderate to profound).
* Identified with a language deficit, defined by either the ratio of language standard scores to nonverbal intelligence quotient \<.85 or a differences in nonverbal IQ and language standard scores of 10 points. Language scores may either be receptive or expressive.
* Currently receiving speech-language therapy.

Exclusion Criteria:

Mild hearing loss and unilateral hearing loss

* primary language other than English
* significant motor impairments
* nonverbal IQ \<80
* children with severe communication disorders (i.e. autism spectrum disorders).
Get With the Guidelines Atrial Fibrillation Registry

Get With The Guidelines-Atrial Fibrillation is designed to assist hospital care teams in consistently providing the latest evidence-based treatment for their AFib patients. At the same time, it offers a means of monitoring the quality of AFib care in U.S. hospitals and building a database for continued research and further quality improvement.

Get With The Guidelines-Atrial Fibrillation was initiated in 2013 with over 88 U.S. hospitals participating is designed to assist hospital care teams in consistently providing the latest evidence-based treatment for their AFib patients. At the same time, it offers a means of monitoring the quality of AFib care in U.S. hospitals and building a database for continued research and further quality improvement.

Achievement measures tracked through Get With The Guidelines-Atrial Fibrillation:

1. ACEI/ARB at discharge for LVSD
2. Assessment of thromboembolic risk factors
3. Beta Blocker at discharge
4. Discharged on FDA-approved anticoagulation therapy
5. PT/INR planned follow-up
6. Statin at discharge in AF patients with CAD, CVA/TIA or PVD.

Quality measures tracked through Get With The Guidelines-Atrial Fibrillation:

1. Aldosterone antagonist at discharge
2. Atrial fibrillation patient education
3. Anticoagulation therapy education
4. CHA2DS2-VASC reported
5. Discharge heart rate \<110bpm
6. Smoking cessation
7. Warfarin at discharge for valvular atrial fibrillation

Additional measures collected by Get With The Guidelines-Atrial Fibrillation can be viewed at: http://www.heart.org/idc/groups/heart-public/@private/@wcm/@hcm/@gwtg/documents/downloadable/ucm_451183.pdf

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized with nonvalvular Atrial Fibrillation or Atrial Flutter

Exclusion Criteria:

* Patients who do not have nonvalvular Atrial Fibrillation or Atrial Flutter
* Patients under 18 years of age
* Patients not admitted as inpatients.
* Patients on comfort care only
* Patients discharged to hospice.
Screening To Obviate Preterm Birth

Our objective is to investigate the predictive value of a panel of biomarkers associated with two biologically plausible pathways of preterm birth: membrane breakdown and cervical remodeling. The investigators will obtain cervical length, cervicovaginal fetal fibronectin, and a panel of novel cervicovaginal biomarkers associated with cervical remodeling in a prospective cohort of symptomatic women with a singleton pregnancy at high risk for preterm birth in an effort to better risk stratify this cohort.

Preterm Birth is a complex syndrome for which several different biologically plausible pathways have been proposed, including mechanical uterine distension, abruption, inflammation, and/or activation of the fetal hypothalamic-pituitary-axis. However, despite our knowing the complexity of this syndrome and the different pathways involved, there is a paucity of clinical studies investigating whether detection of more than one of these pathways in a single patient might enhance the identification of those at greatest risk for preterm birth. We propose investigating the predictive value of a panel of biomarkers associated with two biological plausible pathways - membrane breakdown and cervical remodeling - that must be involved in the pathogenesis of preterm birth. Specifically, we propose measuring cervical length and collecting cervicovaginal fetal fibronectin as well as a panel of novel cervicovaginal biomarkers that reflect molecular pathways involved in cervical remodeling in a prospectively collected cohort of symptomatic women with singleton fetuses at high risk for preterm birth. Through this study we hope improve risk stratification of this high risk cohort.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy between 22- 33 6/7 weeks of gestational age.
* Must be experiencing one ore more of the following symptoms including but not limited to preterm contractions, abdominal cramping, back pain, vaginal pressure, or light vaginal bleeding.

Exclusion Criteria:

* Women with a multi-fetal pregnancy
* Intra uterine fetal demise
* Preterm premature rupture of membranes
* Overt chorioamnionitis