cyrilzakka/clinical-trials huggingface dataset:
Frailty Status and Increased Risk for Falls

We hypothesized that the use of anticholinergic medications may precipitate falls differently by frailty status in older adults. Community-dwelling older subjects admitted to the Geriatrics Outpatient Clinic prospectively enter into the study. Frailty status is defined according to the Physical Frailty Phenotype. The drugs are categorized according to the ACB scale

Previous studies have found that the use of drugs with anticholinergic properties relate to increased prevalence of falls in older women and men. Frailty is associated with serious health outcomes including falls, hip fractures, and death. Frailty can be a relevant target to investigate its association with the risk of falls among the users of drugs with anticholinergic properties. A recent evidence suggests that the interaction between being frail and adverse outcomes in older adults receiving polypharmacy or centrally acting drugs is complex and not straightforward across all frailty phenotypes.

We classify the participants frail if they met at least three of five criteria, while those having one or two criteria were pre-frail, and others were non-frail. We determine the anticholinergic burden by using the Anticholinergic Cognitive Burden (ACB) Scale developed by Boustani et al.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling older adults

Exclusion Criteria:

* a history of dementia,
* current delirium or psychotic symptoms,
* taking antipsychotic medications,
* being functionally dependent to others,
* difficulty in communicating with the interviewer,
* terminal illness,
* being bedridden or wheelchair bound (≥2 weeks),
* difficulty in standing or walking,
* incomplete data
Study of Topical Calcitriol in Children With Psoriasis

OBJECTIVES:

I. Determine the therapeutic efficacy and safety of topical calcitriol in children with psoriasis.

PROTOCOL OUTLINE: Patients apply topical calcitriol in petrolatum on a psoriatic lesion daily. Patients also apply petrolatum without calcitriol to another psoriatic lesion daily.

Patients have both lesions photographed prior to therapy, monthly during therapy, and at the completion of therapy. Lesions are assessed weekly for 1 month and then every 2 weeks while on study. Blood samples are collected every 1 to 2 months and urine samples are collected every 2 weeks while on study.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of psoriasis At least 2 lesions with area at least 30-50 cm2

--Prior/Concurrent Therapy--

No other concurrent therapy for psoriasis No concurrent calcium supplements greater than 1,000 mg/day No concurrent prednisone or other drugs affecting serum or urine calcium levels

--Patient Characteristics--

Renal: No high blood or urinary calcium levels

Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception
Ultrasound-guided Selective Supraclavicular Nerve Block for Postoperative Pain Control in Pediatric Patients.

This prospective randomized controlled trial aims to investigate the effect of ultrasound-guided selective supraclavicular nerve block on pain control after Hickman catheter, chemoport, or Perm cath insertion in children.

Pediatric patients undergoing surgical insertion of a Hickman catheter, chemoport, or Permcath are randomly assigned to a test group (Ultrasound-guided selective supraclavicular nerve block with Ropivacaine) and a control group (Nerve block is not performed).

Immediately after induction of general anesthesia, in the test group, the supraclavicular nerve block was selectively performed using ultrasound using 0.1mL/kg of 0.5% Ropivacaine (Maximum dose: 5mL), and the nerve block was not completed in the control group. After that, a Hickman catheter, chemoport, or Permcath is surgically inserted in the usual way and allowed to recover from anesthesia.

The pain score is evaluated between 10 and 30 minutes of entering the recovery room (1 hour after the procedure) and 1 hour, 3 hours, and 24 hours after leaving the recovery room by another research team who is unaware of the group assignment. In addition, the use of additional analgesic drugs and related side effects were collected before discharge.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients receiving Hickman catheter, chemoport, or Perm cath implantation (3 years ≤, \<18 years)
* One or more of the parents (or guardians), after hearing and understanding a sufficient explanation about this clinical trial, decides to participate voluntarily and agrees in writing to abide by the precautions
* In the case of a study subject aged seven years or older, a person who voluntarily decides to participate in this clinical trial and agrees in writing to abide by the precautions after hearing and understanding a sufficient explanation about this clinical trial

Exclusion Criteria:

* Patients who undergo surgery other than the surgery.
* Patients with diseases whose sensitivity to pain is different from that of the general public
* Unstable vital signs (heart rate, blood pressure)
* General contraindications of Ropivacaine
* Patients with a history of allergy to opioids
* Severe renal dysfunction (Creatinine\> 3.0 mg/dl)
* Severe liver dysfunction (aspartate transaminase \> 120 unit/L, alanine aminotransferase \> 120 unit/L)
* Peripheral nervous system abnormalities
* At risk of malignant hyperthermia
* Other cases that the researcher judges to be inappropriate
Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)

This study will assess the safety and efficacy of LFG316 in patients with age related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Best corrected visual acuity (ETDRS scale) of 60 letters or less in the study eye.
* An active choroidal neovascular membrane attributable to neovascular AMD in at least one eye.
* History of treatment (at any time) with at least 3 doses of anti-VEGF therapy in the study eye.

Exclusion Criteria:

* History of recurrent non-response to anti-VEGF therapy in the study eye.
* In the study eye, retinal disease other than AMD (benign conditions of the vitreous and peripheral retina are not exclusionary).
* Choroidal neovascularization due to a cause other than AMD.
* In the study eye, media opacity that, in the investigator's opinion, could interfere with conduct of the study.
* History of infectious uveitis or endophthalmitis in either eye.
* Any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab, bevacizumab, pegaptanib or other VEGF inhibitor.
* Any of the following within 90 days prior to dosing: photodynamic therapy or laser photocoagulation in the study eye; intravitreal steroid in the study eye; or intraocular surgery (including cataract surgery) in the study eye
Cardiac Elastography to Determine Strain and Strain Rates in the Heart

Cardiac elastography is a new technique to analyze strain and strain rates in many organ systems, including the heart. In this study, cardiac elastography derived from the analysis of raw radiofrequency data obtained from a conventional clinical echocardiograph system will be compared to processed information that comes from the same echocardiograph system. The purpose of this study is to determine if cardiac elastography can accurately determine strain and strain rates as compared to more conventional means.


Eligibility Criteria:
Inclusion Criteria:

* Healthy normal volunteers between the ages of 18-70
* Patients scheduled for clinical echocardiogram between the ages of 18-70 who have known heart disease caused by myocardial infarction or cardiomyopathy

Exclusion Criteria:

* Patients less than 18 years old, or greater than 70 years old
* Patients who do not have adequate quality echocardiographic images.
Management of Advanced Non-Small Cell Lung Cancer (NSCLC) and Clinical Outcomes in Patients Who Received Gefitinib in Thailand

The purpose of this study is to determine progression-free survival of lung cancer patients who received gefitinib in clinical practice in Thailand.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as having lung cancer based on histological/cytological findings
* Admitted to the hospital between January 2004 and December 2008
* Treated with gefitinib for at least 3 months

Exclusion Criteria:

* Involvement in the planning and/or conduct of the study
* Participation in another clinical study during the last 3 months
Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma

Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may benefit from sorafenib in combination with TACE.


Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
* BCLC stage B
* Child-Pugh class A
* ECOG performance status of 0
* Etiology: Hepatitis B virus(HBV) infection
* Written informed consent (approved by the Institutional Review Board \[IRB\]obtained prior to any study specific screening procedures
* Patient must be able to comply with the protocol
* Age 18-80 years
* Haematology:Absolute neutrophil count (ANC) \> 1 x 109/L, Platelet count \> 40 x 109/L, Haemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio \< 1.5
* Biochemistry:Total bilirubin \< 2 mg/dL Serum creatinine \< 1.5 x the upper limit of normal
* Life expectancy of \> 3 months

Exclusion Criteria:

* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5 x the upper limit of normal
* Other severe concomitant disease that may reduce life expectancy
* uncontrolled hypertension
* Pregnancy (positive serum pregnancy test) or lactation
* Uncontrolled hypertension
* Serious, non-healing wound, ulcer, or bone fracture
* Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study
* Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
* Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications
High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy

High dose rate (HDR) brachytherapy is a form of radiation treatment using temporary radioactive seeds. This is done by placing very tiny catheters or tubes into the prostate and then inserting temporary radioactive seeds, called Iridium 192, through these catheters. HDR brachytherapy gives precise radiation to the prostate with less radiation given to the normal tissues near the prostate. For patients who have been treated with external beam radiation to the prostate before, HDR brachytherapy can give radiation again to the prostate without exposing the normal tissues around the prostate to significantly more radiation. This may be safer than giving external beam radiation again. The purpose of this study is to test the safety of high dose rate temporary brachytherapy (HDR) for prostate cancer that has come back after external beam radiation. We want to find out what effects, good and/or bad, the treatment has on you and your recurrent prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* KPS \> than or equal to 80
* Able to give informed consent
* Able to complete toxicity scales and questionnaires
* Histologically MSKCC confirmed diagnosis of recurrent prostate cancer.
* Documented history of definitive radiotherapy to the prostate gland
* IPSS of \< than or equal to 15 at the time of evaluation
* PSA \< than or equal to 15 ng/ml
* Organ confined disease

Exclusion Criteria:

* Unable to tolerate general anesthesia
* Abnormal complete blood count. Any of the following:
* Platelet count less than 75,000/ml
* Hb level less than 10 gm/dl
* WBC less than 3.5/ml
* Abnormal coagulation profile:
* INR \> 2.5
* Abnormal Liver function tests (\>1.5 x normal value)
* Abnormal renal function tests (creatinine \> 1.5)
* Evidence of metastatic disease (bone scan, radiographs, MRI findings)
* Prostate volume \> 50 cc
* Unable to meet treatment planning criteria
* History of rectal surgery
* External beam radiation dose to the prostate \> 86.4 Gy if standard treatment planning dose constraints were met
* History of inflammatory bowel disease
* Expected survival \< 1 year
* Unable to undergo bone scan, CT or MRI evaluation
* Unavailable for regular follow up
BNP Pharmacodynamics and Effects on Metabolism in Lean and Obese Subjects

The purpose of this study is to collect data to help researchers better understand the various causes of obesity, which may lead to the development of new obesity treatment options.

Obesity is major metabolic health concern and the potential beneficial effects of natriuretic peptides, specifically B-type natriuretic peptide (BNP) on adipocyte biology, energy expenditure and body weight could be of great significance. This study will provide insight into the mechanisms of dysregulation of the natriuretic peptides system in obesity and will contribute to delineate the roles and the clinical importance of BNP in the treatment of obesity.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years, inclusive
* Men and women
* Able to provide written, informed consent
* Weight stable (± 3 kg) during the 3 months prior to enrollment
* BMI ≤ 25 kg/m2 for lean subjects or ≥ 30 kg/m2 for obese subjects

Exclusion Criteria:

* 1) Diagnosed with any of the following co-morbidities: a) coronary artery disease, angina or heart failure, b) diabetes, c) bleeding disorders, d) infections, e) hepatitis and/or cirrhosis, f) severe asthma or Chronic obstructive pulmonary disease (COPD), g) renal insufficiency, h) bariatric surgery, i) inflammatory bowel disease or malabsorption, j) cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ), k) psychiatric or eating disorders, l) untreated or inadequately controlled thyroid or other endocrine disorders, m) active rheumatoid arthritis or other inflammatory rheumatic disorder
* Pregnant or nursing women
* Presence of clinically significant abnormalities on electrocardiogram;
* Smoking
* Known hypersensitivity to nesiritide or any of its excipients
* Poor intravenous access
* Use of medications: a) nitrates, b) beta-blockers, c) digoxin, d) anti-diabetic agents, e) oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable), f) chronic use of aspirin or other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors, g) other drugs known to affect immune or metabolic function and h) orlistat, phentermine or other weight loss or anorectic agents.
* Your blood pressure at your screening visit is less than or equal to 100/60 or greater than or equal to 160/100.
Machine Learning to Reduce Hypertension Treatment Clinical Inertia

Among individuals with an uncontrolled BP at the current visit, the objective of this study is to compare clinical management of hypertension with and without information from a machine learning algorithm on whether a patient will have uncontrolled blood pressure at their next follow up visit through a case-vignette study.

Among adults with uncontrolled blood pressure (BP) at a clinic visit, clinical inertia is common. Clinical inertia is defined as a failure of providers to initiate or intensify treatment (i.e., adding medication or increasing dosage) when guidelines indicate doing so. Prior studies report that clinicians intensify antihypertensive medication treatment in less than 20% of visits where intensification would have been clinically recommended. Thus, patients who have uncontrolled BP may not receive timely therapy to control their BP. To address this issue, the investigators will use a randomized design to test the hypothesis that clinicians will be more likely to intensify the hypertensive regimen and/or assess nonadherence for patients with uncontrolled BP at the current visit when presented with information that a patient is predicted to have uncontrolled BP at the next visit by a machine learning algorithm.

Eligibility Criteria:
Inclusion Criteria: practicing primary care clinicians who see patients (i.e., internal medicine, family medicine, attending physicians, nurse practitioners) will be eligible to participate -

Exclusion Criteria:

-
Isometric Muscle Training in Patients With Spinal Bony Metastases Under Radiation Therapy

Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures.

Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support radiation therapy and improve above named factors. DISPO was designed to investigate the impact of tailored physical exercise in patients with vertebral metastases as compared to manual therapy (massage etc.). The trial includes patients with painful bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design.

Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures.

Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support radiation therapy and improve above named factors. DISPO was designed to investigate the impact of tailored physical exercise in patients with vertebral metastases as compared to manual therapy (massage etc.). The trial includes patients with painful bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design.

Patients are randomized to one of the following groups: patients in arm A carry out daily physical training consisting of three different isometric exercises under the guidance and supervision of a physiotherapist. Training starts day one (first radiotherapy session), 10 daily units of 30 min each are scheduled during radiotherapy. Patients are expected to continue training until 12 weeks post completion of radiotherapy at home.

Patients in arm B (control group) receive 10 daily sessions of 15 min manual therapy (i.e. massage, etc) starting from day one of radiotherapy.

Follow-up of the patients is scheduled at 12 weeks post completion of radiotherapy incl. CT of the spine and physical examination.

Eligibility Criteria:
Inclusion Criteria:

* solitary or multiple vertebral metastases
* thoracic spine
* lumbar spine
* sacrum
* indication for palliative radiation therapy
* age: 18 - 80 years
* Karnofsky index \> 70%
* bisphosphonate therapy inititated

Exclusion Criteria:

* bony metastases of cervical spine or pelvis
* impending fracture
* other serious illnesses or medical conditions: therapy-refractory unstable heart disease, congestive heart failure NYHA °III and °IV; coagulopathies
* Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators
* Legal incapacity or limited legal capacity
* Positive serum/ urine beta-HCG/ pregnancy
Effect of a Childcare Resource on Cervical Cancer Prevention

Aim 1: Determine the prevalence of unmet childcare needs among women with abnormal cervical cancer screening and establish the relevance of childcare as a social determinant of health in the context of cervical dysplasia.

Aim 2: Conduct a pilot pragmatic patient-randomized control trial (RCT) to evaluate the effectiveness of an intervention linking eligible patients to our childcare facility compared to standard of care on retention in care, defined as show-rate for the initial visit in the gynecology dysplasia clinic. The intervention will consist of 1) patient navigation to our childcare facility prior to the initial visit in the gynecology dysplasia clinic and 2) placement of an electronic medical record (EMR) referral to our childcare facility.

Hypothesis: The study team hypothesizes that women receiving the intervention will have increased retention in care compared to women randomized to standard of care among women with abnormal cervical cancer screening referred to gynecology for diagnostic work-up.

These two aims will demonstrate the significance of childcare as a social determinant of health in the cervical cancer screening and diagnostic continuum by assessing the burden of unmet childcare needs among women with cervical dysplasia and measuring the effect of health system-integrated childcare as an intervention for unmet childcare needs on retention in care and subsequent completion of diagnostic work-up among women with cervical dysplasia. This study will rigorously provide the first evidence illustrating the effect of health systems' investment in addressing unmet childcare needs on preventive care like cervical cancer screening. The findings of this proposed pilot study will be utilized to develop future large-scale studies with extramural funding, building a longitudinal program of research on addressing childcare as a social determinant of health in this and other similar clinical contexts (e.g., breast cancer screening and treatment).


Eligibility Criteria:
Inclusion Criteria:

* All women with abnormal cervical cancer screening referred to Parkland gynecology dysplasia clinic as a new patient

Exclusion Criteria:

* Pregnant women
* Patients \<18 years of age