cyrilzakka/clinical-trials huggingface dataset:
Arrow Chloragard Peripherally-Inserted Central Catheters (PICC) Study

A prospective study evaluating the timing, incidence and relationship of commonly occurring complications related to the use of peripherally-inserted central catheters. All subjects will receive PICC access using the Arrow PICC with Chloragard Technology.


Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥ 18 years requiring a PICC for a period of fourteen days or greater (note: maximum study period is 90 days)
* Ability to comply with study requirements inclusive of the follow-up duplex ultrasound procedures and, as applicable, recording of PICC management, interventions and related treatments in the inpatient and outpatient setting in the daily subject diary
* Patients cognitively and physically able to give written consent to participate in the study or patient has a legally authorized representative (LAR) who may give written consent to participate in the study

Exclusion Criteria:

* Previous history of (within 3 months) or current diagnosis of venous thrombosis within the venous tract of the proposed catheter
* History or diagnosis of peripheral or central vein stenosis (on proposed insertion side)
* History or diagnosis of veno-occlusive disease
* History or diagnosis of superior vena cava syndrome
* Known, pre-existing diagnosis of hypercoagulation disorder unrelated to underlying disease
* Previous enrollment in this study
* Currently pregnant or breast feeding
* Previous axillary lymph node dissection on the same side as intended catheter insertion site unless cleared by physician and patient consent
* Skin condition at or within 15 cm of the proposed catheter insertion site, including signs and symptoms of inflammation, rash, crusts, wounds with drainage, sites of intravenous infusion infiltration or extravasation, hematoma, phlebitis and or thrombophlebitis
* Medical, social, and/or psychological problems precluding subject from study participation
* Stage 2, 3 or 4 chronic kidney disease or serum creatinine \> 3 mg/dl or Glomerular Filtration Rate (GFR) less than 60 mL per minute per 1.73 m2 unless cleared by a nephrologist for participation
* Known allergy or sensitivity to chlorhexidine
Barriers to Cervical Cancer Screening

This study evaluates barriers to cervical cancer screening among non-compliant women.

PRIMARY OBJECTIVE:

I. To further identify barriers to cervical cancer screening in women, we will identify non-compliant patients and survey them to better understand barriers that have led to inadequate screening.

OUTLINE: This is an observational study.

Participants complete a survey on study.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 21-65
* Non-compliant for cervical cancer screening within Mayo Clinic Primary Care

Exclusion Criteria:

* Women less than 21 or older than 65
* Complaint for cervical cancer screening within Mayo Clinic Primary Care
* Women who decline participation
Low Back Pain and Comorbid Posttraumatic Stress Disorder

The aim is to test whether the psychotherapeutic intervention Somatic Experiencing targeting Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the outcomes of guided physiotherapy against chronic back pain development.

Introduction: Patients with low back pain after injuries often demonstrate symptoms of PTSD measured via the Harvard Trauma Questionnaire Scale (HTQ). It has been found that PTSD and pain may maintain each other.

Methods: Thousand consecutive patients with Low Back Pain (LBP) referred to the Spine Center are screened for PTSD. It is expected that 140 patients will meet the inclusion criteria and be randomized to Guided Physiotherapy or to Guided Physiotherapy plus 12 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'.

Effect parameters are: Pain, daily function, EuroQOL and (HTQ), anxiety and depression, fear avoidance (Tampa Scale for Kinesiophobia) and pain catastrophizing (PCS) on entry, and at 6/12 months.

Eligibility Criteria:
Inclusion Criteria:

* Back pain: from 1/2 Y duration or longer
* Trauma according to HTQ

Exclusion Criteria:

* Planned surgery, comorbid psychiatry (except PTSD and mild to moderate depression), personality disorders, drug or medical abuse
Assessment of the Different Etiological and Susceptibility Markers in Patients With Pancreatitis: Investigating IG4, Cytomegalovirus, Coxsackie- Virus, Genetic Polymorphism of Vitamin D Receptor Gene

Acute pancreatitis (AP) is a multifactorial disease. AP represents a significant number of hospital admissions. Most of the patients are admitted in an acute setting. Early identification of its etiology is an essential step toward the rational approach, both for its implications in the immediate therapy and the prevention of recurrence. Although often obvious, the etiological workup of acute pancreatitis can be challenging.

Acute pancreatitis is the most common pancreatic disorder. Although acute pancreatitis is a benign disease, it often progresses to a serious state, and mortality is still high. Autoimmune pancreatitis (AIP) was first used to describe cases of pancreatitis with narrowing of the pancreatic duct, enlargement of the pancreas, hyper-γ-globulinaemia, and antinuclear antibody (ANA) positivity serologically by indirect immunofluorescence (IIF). The main differential diagnosis is pancreatic cancer, which can be ruled out through radiological, serological, and histological investigations.

Cytomegalovirus (CMV) is a common viral pathogen in humans. It is a lytic virus that causes a cytopathic effect in vitro and in vivo. Seroprevalence for CMV worldwide ranges from 60%-100% but the severity of illness varies. Primary CMV may be asymptomatic or may cause a mild and self-limiting mononucleosis-like syndrome. The self-limiting course of CMV infection typically includes fever, malaise, splenomegaly, mild hepatomegaly, small increases in serum transaminase activity, and variable elevation of serum alkaline phosphatase. CMV infection can cause severe hepatitis, meningitis, encephalitis, myelitis, colitis, pancreatitis and pneumonitis. Coxsackie-B virus can also cause acute pancreatitis.

VDR are also expressed on pancreatic Ɓ cells, and may play an essential role in maintaining normal insulin levels in accordance to glucose concentrations and to maintain glucose tolerance. Because vitamin D acts through VDR, their impairment or reduced functionality, e.g., as a result of polymorphisms occurring in the VDR gene, may have a crucial impact on the balance in the vitamin D concentration in the circulation, and the final metabolite activity throughout the body.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of acute pancreatitis.
* Patients of age 20 years or more who are willing to participate in the study and give their consent for same.

Exclusion Criteria:

* with a history of severe liver disease,
* sepsis
* Chest disease.
The Dementia Symptom Management at Home Program Hospice Edition

Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our public health. While many persons with dementia are cared for by friends and family in the community with the assistance of home healthcare and hospice, most clinicians and agencies are ill prepared to care for this population and therefore have difficulty assisting patients and caregivers in maintaining quality of life leading to adverse patient outcomes, increased caregiver stress and burnout, and healthcare utilization. This study will utilize a cluster randomized controlled design with 6 care teams at a single study site to examine the ability of a multi-component evidence-based practice hospice care quality improvement program for registered nurses, social workers and chaplains to improve the quality of life and reduce healthcare utilization for persons with dementia and their informal caregiver.


Eligibility Criteria:
Inclusion Criteria:

* PWD over the age of 65
* Admitted to MJHS hospice agency
* The patient and family caregiver speak English and/or Spanish.
* The informal caregiver is ≥18 years of age and spends at least 8 hours per week with the patient.
* Patients who score ≥6 on the Quick Dementia Rating Scale (at least mild impairment).

Exclusion Criteria:

* Patients with a separate Axis 1 diagnosis other than forms of dementia, depression or anxiety.
* PWD residing in assisted living facilities, nursing homes or board and care homes
* PWD solely receiving infusion or home health aide services.
The Use of Sennosides With Pico Salax in Bowel Preparation for Colonoscopy: a Study of Optimal Dose and Timing

The objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different doses and administration times. The primary outcome is number of bowel motions produced. Secondary outcomes include the quality of bowel cleansing and patient tolerability.

We will compare different doses and administration times in patients booked for morning colonoscopy. The primary outcome is number of bowel motions produced in total by the sennosides. Secondary outcomes include the quality of bowel cleansing and patient tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female patients 18 to 75 years of age inclusive
* Patients who require an outpatient colonoscopy with a split dose Pico-Salax prep

Exclusion Criteria:

* Colonoscopy requiring the use of a large volume prep (eg Colyte, PEG)
* Ileus or bowel obstruction
* Previous colorectal surgery
* Ascites
* Recognized renal impairment (defined as GFR less than normal in 3 months prior to enrolment)
* Pregnancy
* Recent (\<6 months) myocardial infarction or unstable angina.
A Trial of Pyridoxamine to Lower Urine Oxalate in Subjects With Stone Disease or Hyperoxaluria

To determine whether pyridoxamine can decrease oxalate excretion in subjects who have normal oxalate excretion (but who have had kidney stones), and in subjects who have primary hyperoxaluria.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years
* History of stone formation
* Good Renal function
* Normal urinary excretion of stone-promoting chemicals(Ca, uric acid, oxalate, citrate), except for subjects with hyperoxaluria for Study

Exclusion Criteria:

* Pregnancy
* Hyperparathyroidism
* Enteric hyperoxaluria.
* Obstructive uropathy
* Infection (struvite) stones
* Severe dietary Ca++ restriction or deficiency
* Recent significant cardio-vascular events
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis

The purpose of the trial is to study the safety and efficacy of long term use of once daily applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to calcipotriol alone in the same gel.

The primary response criteria will be the incidence of adverse drug reactions of any type, and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.


Eligibility Criteria:
Inclusion Criteria:

* Scalp psoriasis amenable to topical treatment with a maximum of 100 g of study medication per week
* Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
* Extent of scalp psoriasis involving more than 10% of the total scalp area
* Disease severity on the scalp graded as Moderate, Severe or Very Severe according to the Investigator's Global Assessment of disease severity

Exclusion Criteria:

* PUVA or Grenz ray therapy anywhere on the patient within 28 days prior to randomisation
* UVB therapy anywhere on the patient within 14 days prior to randomisation
* Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on, scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 6 months prior to randomisaiton
* Systemic treatments with a potential effect on scalp psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 28 days prior to randomisation
* Any topical treatment for scalp psoriasis or any other skin disease on the scalp (excluding medicated shampoos, emollients and hair conditioners) within 14 days prior to randomisaiton
* Topical treatment for other skin disorders with very potent WHO group IV corticosteroids within 14 days prior to randomisation
* Planned initiation of, or changes in dose of concomitant medication that could affect scalp psoriasis (e.g., beta blockers, antimalarial drugs, lithium) during the study
* Current diagnosis of guttate, pustular, exfoliative or erythrodermic psoriasis
* Patients with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin
* Known or suspected severe renal insufficiency or severe hepatic disorders
* Patiens with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
* Trial subjects should be using an adequate method of contraception
Quality of Life of Pancreatic Cancer Patients:Psychometric Validation of Chinese Version in Taiwan

This study will investigate the reliability and validity of Chinese version of the quality of life scale in EORTC QLQ-PAN26 and EORTC QLQ-C30 on pancreatic cancer patients in Taiwan

1. Verify the reliability and validity of Chinese version of the EORTC QLQ-C30 Quality of Life Scale and the chinese version of the EORTC QLQ-PAN26 Quality of Life Scale.
2. Verify the construct validity of the Chinese version of the EORTC QLQ-PAN26 Quality of Life Scale, perform factor analysis, test-retest reliability, and known group validity
3. Verify the criterion related validity of Chinese version of the EORTC QLQ-C30 Quality of Life Scale and the SF-36 Quality of Life Scale

Eligibility Criteria:
Inclusion Criteria:

1. Paitent who aged over 20, with clear consciousness, is capable of communicating with Chinese.
2. Pancreatic Cancer patients(stage I.II.III.IV)
3. The subject who agrees and is willing to participate in the research after explaining the purpose of the research.

Exclusion Criteria:

1. Patient who is younger than 20 years old, illiterate, or is unable to cooperate with intervention measures.
Circadian Sleep-wake Cycles and Light Therapy in Borderline Personality Disorder

Individuals with borderline personality disorder (BPD) frequently suffer from emotional instability, daytime fatigue and sleep disturbances. The investigators examined circadian rhythms, sleep and well-being in women with BPD under their habitual life conditions with and without light treatment.

Treated women diagnosed with BPD were investigated during 3 weeks without and 3 weeks with morning LT. Rest-activity cycles were continuously measured using wrist actigraphy, together with proximal skin temperature. Saliva samples were collected weekly to determine the diurnal melatonin rhythm. A range of self-ratings and questionnaires were used to assess depression and clinical state throughout the 6-week protocol. Ten matched healthy women followed the same 6-week protocol without light treatment.


Eligibility Criteria:
Inclusion Criteria:

* Borderline Personality Disorder (DSM IV-criteria)
* German-speaking
* normal ocular function

Exclusion Criteria:

* lack of compliance
Using Telehealth to Address Alcohol Misuse in HIV Care

This project will test the effects of a telehealth counseling program on reducing alcohol use and improving HIV viral control among people with HIV who drink heavily. In total, 600 heavy drinkers with HIV will be assigned to either (a) a single session of brief counseling on alcohol use or (b) brief counseling plus referral to a telehealth counseling program that includes multiple sessions of counseling by videoconferencing and text messaging support. To understand the effects of the program, participants' alcohol use, HIV outcomes, and health will be assessed over a 2-year period.

The purpose of the proposed study is to test the real-world effectiveness of the ReACH (Reducing Alcohol use and related Comorbidities in HIV care) telehealth counseling protocol in a pragmatic Hybrid Type 1 effectiveness-implementation randomized trial. The study will recruit 600 heavy-drinking PLWH from four federally-qualified health centers in geographically distinct regions across the U.S, which provide services to over 14,000 PLWH. Upon completing enrollment, participants will be randomized to receive either single-session brief intervention (BI) by phone with referral to local treatment when appropriate or BI plus referral to ReACH telehealth counseling (TC). Participants will complete follow-ups through 24 months after baseline to assess longer-term changes in drinking and health outcomes. The study will test the hypothesis that TC compared to BI will result in (a) reduced number of drinks consumed per week and frequency of heavy drinking and (b) increased odds of having an undetectable viral load at 12- and 24-month follow-ups. Secondary outcomes include self-reported ART adherence, engagement in condomless sex with non-exclusive partners, frequency of other substance use, phosphatidylethanol levels (a biomarker of recent alcohol use), and Veterans Aging Cohort Study index scores. The study also will examine potential moderators of TC effectiveness. As a secondary aim, implementation measures corresponding to aspects of the Dynamic Sustainability Framework will be assessed including implementation outcomes of acceptability, appropriateness, and feasibility guided by Proctor's Implementation Outcomes Framework. Thus, this pragmatic Hybrid Type 1 trial will help establish the real-world effectiveness of the ReACH TC intervention while also providing key implementation-related measures and outcomes that will inform future ReACH TC scale up and sustainability.

Eligibility Criteria:
Inclusion Criteria:

* In care for HIV at one of 4 participating federally qualified health centers, report at least one heavy drinking day (4+ drinks) or average more than 7 drinks per week in the past 30 days

Exclusion Criteria:

* need for supervised alcohol detoxification, as indicated by having a history of severe withdrawal symptoms such as seizures and delirium tremens.
T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam

The aim of the study was to compare the activity (efficacy and safety) of Ertapenem administered according to a short treatment for three days versus a short treatment for three days with AS in patients with an community acquired IAI of mild to moderate severity.

The study project is a prospective, randomized controlled investigation. The study will be performed in the Department of Transplant, General and Emergency Surgery of St Orsola-Malpighi University Hospital (Bologna, Italy), a large teaching institution, with the participation of all surgeons who accept to be involved in.

The study is designed and conducted in compliance with the principles of Good Clinical Practice regulations.

The tolerability and efficacy of a 3 days treatment with Ampicillin- Sulbactam (AS 3g x 3/ day i.v.) is compared a 3 days regimen with Ertapenem (1 g/day i.v.). in patients with localized peritonitis with a blinded evaluation of efficacy end points. Evaluation of cure or failure is blinded by use of designated third party individuals who are unaware of the treatment assigned to the patients.

Eligibility Criteria:
Inclusion Criteria:

Adult patients ( \> 18 years) requiring surgical intervention within 24 hours of diagnosis, for localized IAI infections (i.e extending beyond the organ wall but confined near the hollow viscus, mild to moderate in severity):

* Acute appendicitis: Ruptured or perforated with abscess
* Acute diverticulitis with perforation and/or abscess
* Acute cholecystitis (including gangrenous) with either rupture or perforation
* Acute gastric and duodenal ( \> 24 hours) perforation
* Traumatic (\> 12 hours) perforation of the intestines
* Secondary peritonitis due to perforated viscus
* Intra-abdominal abscess (including of liver and spleen)

Exclusion Criteria:

* Traumatic bowel perforation requiring surgery within 12 hours
* Perforation of gastroduodenal ulcers requiring surgery within 24 hours
* other intra-abdominal processes in which the primary etiology was unlikely to be infectious.
* Patients lactating or pregnant
* Patients with a history of allergy, hypersensitivity, or any severe reaction to the study antibiotics
* Patients with rapidly progressive or terminal illness;
* Patients with a history or presence of severe hepatic or renal disease (e.g. creatinine clearance \< 0.5 ml/min/1.73 m2);
* Patients with a concomitant infection that would interfere with evaluation of response to the study antibiotics.
Rehabilitation on Equal Terms - The ReMig Study

The ReMig-study aims to increase knowledge about rehabilitation needs, the rehabilitation process of arabic-speaking migrated women with BC, to increase the prerequisites for optimized and equal cancer care. The study aims to map migrated Arabic-speaking women's breast cancer rehabilitation with a focus on mental and physical recovery, lifestyle habits as well as satisfaction and goals with the rehabilitation and compare these outcomes with the outcomes of Swedish-speaking women. Further aim is to explore migrated Arabic-speaking women´s experiences and attitudes towards breast cancer rehabilitation.

Annually, over 2 million women are diagnosed with breast cancer (BC) globally, of which about 8300 in Sweden. Today, 20% of the Swedish population is foreign born and previous research has shown that women who have migrated are particularly vulnerable when diagnosed with BC. Research focusing on migrated women is sparse as they are often excluded from research, but available research shows that experience and management of BC differs depending on ethnicity, that the women to a lesser extent participate in BC screening and rehabilitation and that they have a higher mortality than Swedish born women. In recent years, measures to promote early BC diagnosis have been initiated, but knowledge of how optimized rehabilitation should be ensured to promote recovery and reduce the socioeconomic burden is lacking.

This study aims to map the rehabilitation of migrant Arabic-speaking women with a focus on mental and physical recovery, lifestyle habits and satisfaction and goals with the rehabilitation in the first year after BC diagnosis and compare these outcomes with Swedish-speaking women. Further to elucidate migrated Arabic-speaking women´s experiences and attitudes towards breast cancer rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Undergone treatment for primary breast cancer
* ≤18 years old
* Ability to communicate in the Arabic language
* Written informed consent

Exclusion Criteria:

* Recurrent disease
* Palliative diagnosis
* Pregnancy
* Prior history of breast cancer
* Inability to participate in the study due to cognitive impairment