cyrilzakka/clinical-trials huggingface dataset:
Metabolic Therapy in Patients With Osteoporosis After Hip Fracture by an Orthopedic-rehabilitation-metabolic Team

Metabolic therapy in patients with osteoporosis after hip fracture by cooperation orthopedic-rehabilitation-metabolic: Determination of drug treatment regardless of reaching the follow-up clinic

Osteoporotic hip fractures are a significant cause of morbidity and mortality in older age. Patients with this fracture are at high risk of further fracture, it can be reduced by appropriate metabolic therapy. However, only 30% of patients after a hip fracture receive basic treatment appropriate calcium and vitamin D, only 10-15% receive complementary metabolic therapy more drugs prevent bone resorption, or bone-building drugs as recommended in the literature, the prevention of further fractures. studies conducted in the past have proven, multi-disciplinary team of dedicated financial institution may increase appropriate treatment and improve the quality of care in these patients.

Previous data in our institution has shown that 84% of patients with hip fractures received calcium and vitamin D during hospitalization, but only 47% of the patients came to the metabolic clinic. Moreover, of the patients who came to the metabolic clinic, only 46% were put on complementary metabolic therapy, mostly due to a lack of sufficient vitamin D level. In the present study investigators attempt to treat patients without physical attendance at the metabolic clinic.

Eligibility Criteria:
Inclusion Criteria:

* All patients were analyzed could Department of Orthopedics with a hip fracture

Exclusion Criteria:

-
Chronic Care Management/Patient Relationship Management Proof of Concept

This proof of concept study proposes to evaluate the feasibility of a communications-technology-based chronic care and patient relationship management program to improve diabetes self management among adult diabetic patients in an urban safety net population by providing between-visit reminders and chronic disease support through cell phone text messaging.

The investigators hypothesize that diabetic patients enrolled in the program will be less likely to miss scheduled appointments and will have greater perceived self-efficacy and improved patient satisfaction concerning chronic disease management. No-show rates among patients enrolled in the program are expected to be lower than among patients receiving standard care.


Eligibility Criteria:
Inclusion Criteria:

* patients with diabetes
* receive care at a primary care clinic in the DH system
* between 18 and 76 years of age
* primary language of English or Spanish
* ownership of a qualifying cell phone (SMS text capable)
* ownership of a glucometer.

Exclusion Criteria:

* life expectancy less than six months,
* do not have or cannot use a phone or glucometer
* do not want to participate
SCOPE-Study: Salzburg Chronic Obstructive Pulmonary Disease- Exercise and Oxygen Study

Chronic obstructive pulmonary disease (COPD) is number four of the leading causes of death in the USA and Europe. Moreover, among the top five causes of death, this disease is the only one with increasing mortality rates. Physical training has become an evidence based therapeutic intervention in these patients.

In this study the investigators aim to establish if supplemental oxygen during strength and endurance training improves exercise tolerance. Furthermore, the investigators want to research, if supplemental oxygen has the ability to increase training intensity, which would lead to a greater training effect with respect to respiratory, vascular, inflammatory and anthropometric parameters, as well as quality of life.

SCOPE is a prospective, randomized, double-blinded, controlled, cross-over trial. The investigators aim to enroll 40 patients suffering from COPD aged \>30 years. Inclusion criteria are FEV1 30-60%, and PO2 at rest \>55 mmHg. At baseline, patients will undergo pre-tests including pulmonary, exercise physiological and medical investigations. Prior to the exercise training, an intervention-free control period with usual care is planned. This will be followed by 2 x 6 weeks with physical training (ergometer based endurance training and strength training, using weight lifting machines) with either supplemental oxygen or usual room air (e.g.: first 6 weeks of exercise with oxygen supplementation followed by 6 weeks of room air). After the initial control period and between these two exercise periods, patients will be tested as described in pre-tests, and at the end of the second exercise training period. In addition, the investigators will assess changes in lung function and symptomatic dyspnoea, as well as in quality of life (St. George's Respiratory Questionnaire).

Within this study, the investigators hope to improve rehabilitation programs for COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* COPD with FEV1 pred. 30 to 60%, PO2 at rest \> 55 mmHg and PCO2 \< 45 mm Hg
* age: \> 30 years

Exclusion Criteria:

* Musculoskeletal disease, which prohibits training
* Relevant neoplastic disease with cachexia
* Expected non compliance with the study protocol due to drug and alcohol abuse
* Coronary heart disease defined by angina pectoris or relevant ST-changes during exercise or myocardial infarction in the last 6 months
* Left ventricular ejection fraction \< 40 %
* Renal insufficiency with creatinine \> 2 mmol/liter
* Symptomatic intermittent claudication or peripheral neuropathy
* Anaemia \< 10 mg/dl or red blood count \< 3 Mio/mm3
Ability of Caregivers to Provide Ventilation With the SAVe Resuscitator in a Model

This study will compare three methods of delivering mechanical ventilation using a test lung. Ventilation will be delivered using (1) a mask held in place by a caregiver, (2) a mask strapped to the model using a securing device, and (3) a supraglottic airway. Endpoints include respiratory rate and tidal volume.

To evaluate the ability of caregivers to provide adequate ventilation (respiratory rate and tidal volume) in a model of the upper airway and lungs. Ventilation will be delivered while the mask is held in place by the caregiver, with the mask strapped to the model using the securing device provided with the ventilator, and following placement of a supraglottic airway.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation
* Nurse, respiratory therapist, or physician
* involved in the care of patients requiring ventilation and airway management

Exclusion Criteria:

-
Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders

This study for the conservative management of placenta accreta spectrum disorders (PAS), which are a major cause of maternal morbidity and mortality. The most common management strategy for PAS in the United States is a preterm cesarean-hysterectomy. However, accumulating data show that conservative management is safer and is preferred by some patients. In selected participants (n=15) who desire uterine preservation, the investigators provide the option of conservative management, which will be defined as leaving the placenta in the uterus after delivery of the infant. This is a single-arm single-site pilot study where all participants will be carefully monitored during a standard postpartum inpatient stay and with outpatient follow-up until the uterus is empty.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. A person with a uterus, age 18 or older
4. Currently 16-36 weeks pregnant with an intrauterine gestation
5. History of cesarean delivery AND placenta previa OR anterior low-lying placenta AND suspected of having PAS on prenatal imaging (ultrasound/MRI)
6. Patients for whom the usual management would be cesarean-hysterectomy.
7. Patient desires uterine preservation
8. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.

Exclusion Criteria:

• Have a low antenatal suspicion for PAS based on imaging.
A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects

This is an open-label, single-dose study of up to 4 dose levels of ITI-333 in healthy male and female subjects. Each cohort will enroll 6 subjects. Subjects will have a baseline PET/CT scan and a postdose PET/CT scan using \[14C\]-MDL100907 to characterize 5-HT2A receptor occupancy


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between 18 and 45 years old (inclusive);
* BMI inclusive of 18.0-32.0 kg/m2 at screening and a minimum weight of 50 kg;
* Willing to be confined to the clinical research unit for the duration of the inpatient period of the study;

Exclusion Criteria:

* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal (including history of gastric bypass), pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
* Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SpO2) \< 96% and respiratory rate \< 12 breaths per min;
* History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;
* Any condition which would preclude MRI or PET/CT examination (eg, implanted metal, claustrophobia, unable to fit in PET/CT or MRI scanners).
Clinical Application of Intrapartum Ultrasound

Intrapartum ultrasound monitoring is to be compared with conventional labor monitoring to clarify the accuracy of this technology, and then provide a basis for later related research.

Intrapartum ultrasound monitoring is to be compared with conventional labor monitoring to clarify the accuracy of this technology, and then provide a basis for later related research. All pregnant women intending to have a vaginal delivery were enrolled in the study. After admission, women were randomly assigned to either intrapartum ultrasound (IPUS) or vaginal examination (VE). In IPUS group, the patient was evaluated by ultrasound, including fetal orientation, pelvic and cervical conditions. IPUS and VE were performed every 2 to 4 hours during the first stage of labor and at least hourly during the second stage. The progress of labor, the occurrence of complications and the prediction of the success rate of vaginal delivery were observed. Finally, the investigators compared whether there were any differences in labor and vaginal delivery complications between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women in the delivery room for vaginal trial labor

Exclusion Criteria:

* Those who reject ultrasound
UARK 2005-01 Study of Velcade, Thalidomide, and Dexamethasone (VTD) With or Without Adriamycin® in Relapsed/Refractory Patients

The main goal of this study is to evaluate the effectiveness of the combination of these drugs, and whether they can be given safely together.

In this study, there will be two arms (or groups). One arm will receive Velcade, thalidomide, and dexamethasone (VTD), and the other arm will receive VTD with Adriamycin.

This study has the following specific goal:

To evaluate the efficacy and toxicity of two treatments in multiple myeloma patients, relapsing after at least one course of high-dose treatment and an autologous stem cell transplant, or after at least two lines of conventional chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsing multiple myeloma (MM)
* Patients must have adequate platelet count of \> 20,000 x 10\^9/L, independent of transfusions, unless it is due to massive myeloma infiltration.
* Anticipated life expectancy of at least 3 months
* Ejection fraction by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan performed within 60 days prior to registration; left ventricular ejection fraction (LVEF) \> 40% by ECHO or MUGA.
* Female patients of child bearing age are required to have a negative pregnancy test as indicated in thalidomide safety guidelines
* Patients must have a performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
* All patients must be informed of the investigational nature of this study and must have signed an institutional review board (IRB)-approved informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

* Evidence of central nervous system (CNS) involvement
* Grade \> 2 peripheral neuropathy
* Hypersensitivity to Velcade, boron, or mannitol
* Recent (\< 6 months) myocardial infarction, cerebrovascular accident (CVA)/stroke, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
* Evidence of chronic obstructive or chronic restrictive pulmonary disease.
* Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years.
* Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
* Pregnant or nursing women. Women of child-bearing potential must have a negative pregnancy test documented within one week of registration. Women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study treatment.
Dexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients

The purpose of this study is to assess the efficacy of dexmedetomidine versus propofol for prolonged sedation in trauma and surgical patients.

Design: Open-label, single-center prospective study. Setting: Trauma/Surgical Intensive Care Unit (TSICU) at a Level I academic trauma center.

Patients: Patients 18 years of age or older requiring mechanical ventilation and admitted to the TSICU Interventions: Patients were randomly assigned based on unit bed location to receive dexmedetomidine or propofol for sedation.

Eligibility Criteria:
Inclusion Criteria:

* Patients were included in the study if they were 18 years of age or older,
* mechanically ventilated,
* placed on the institutional sedation protocol,
* expected to require sedation lasting 24 hours after randomization, and
* admitted to the TSICU and followed by the Trauma/Surgical Service.

Exclusion Criteria:

Patients were excluded for any of the following:

* 72 hours or greater since sedation protocol initiation,
* treatment per the institutional traumatic brain injury (TBI) protocol,
* concomitant continuous infusion of a neuromuscular blocking agent,
* heart rate less than 50 beats per minute,
* mean arterial pressure less than 55 mmHg despite fluid resuscitation and vasopressors, and
* use of other alpha-2 agonists within 24 hours of randomization.
Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP

This is a multicenter, centrally registered observational study without a control group. This observational study is a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during the observation period (52 weeks after the start of treatment with this drug) in pediatric patients with psoriasis vulgaris, psoriatic arthritis, or pustular psoriasis who received this drug.

For patients who discontinued or completed this drug before the end of the observation period, the investigator will record adverse events that occurred within 30 days after the day following the last administration of this drug, or the day of discontinuation of the survey (the day when discontinuation of the survey was judged), whichever is later, in the CRF.

If a patient withdraws consent, information will be collected during the observation period up to the date of consent withdrawal.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have obtained written consent from their legally acceptable representative to cooperate in this survey before the start of treatment with this drug
* Patients aged less than 18 years at the start of treatment with this drug
* Patients newly treated with this drug for any of the following diseases: Psoriasis vulgaris, psoriatic arthritis, pustular psoriasis

Exclusion Criteria:

* Prior treatment with this drug
* Participation in an interventional study (e.g., a clinical trial) at the time of starting this drug.
Streamlined Resin Y90 Radiation Segmentectomy for Small HCC

This single-arm feasibility study evaluating the safety and efficacy of streamlining Yttrium-90 (Y90) radioembolization workflow for patients with small Hepatocellular Carcinoma (\&lt;5cm) that have no aggressive features on baseline imaging. This study aims to recruit N=30 patients prospectively and consolidate the current workflow of 2 days of procedures (1st-day mapping angiography followed by nuclear medicine hepatic lung shunt fraction (LSF) calculation using Tc99-MAA planar and SPECT/CT, and 2nd-day Y90 radioembolization followed by nuclear medicine Y90 SPECT/CT) into 1-day procedure. Several studies have shown that hepatic LSF for HCC tumors smaller than 5cm in the absence of macrovascular invasion and portosystemic shunt placement is invariably \&lt;10%. Therefore, the LSF calculation can be safely omitted from the complex workflow of these patients. This study aims to illustrate that this can be done safely and efficaciously to reduce unnecessary patient travel and healthcare resource utilization. Overall, a total of 30 patients will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Has focal Hepatocellular Carcinoma and is deemed to benefit from Yttrium-90 radioembolization by the institutional multidisciplinary tumor board

Exclusion Criteria:

* All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
* The presence of trans-jugular intrahepatic portosystemic shunt
* Total bilirubin level \&amp;gt; 3.0 mg/dL
* Serum albumin level \&amp;lt; 2.5 g/dL
* Aspartate and alanine aminotransferase levels no greater than five times the normal level
* Life expectancy \&amp;lt; 12 weeks
* Eastern Cooperative Oncology Group performance status \&amp;gt; 2
* Patients with chronic lung disease requiring supplemental oxygen at baseline or baseline SpO2 of \&amp;lt;92%
* Patients that have tumors with central anatomical locations close the hepatic hilum or caudate lobe.
* Patients with macrovascular invasion on baseline imaging
* Known hypersensitivity to iodinated contrast agents or to any component of iodinated contrast agents refractory to standard medications (antihistamines, steroids)
* Impaired kidney function (glomerular filtration rate \&amp;lt; 30 as approximated using serum creatinine levels) unless anuric and on dialysis.
* Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 48 hours prior to the treatment or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)
Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness

Dry eye disease (DED) is a common ocular disease, especially in the elderly population. Despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. However, most of the topical lubricants available are not very well characterised and data about efficacy is sparse.

The aim of the present pilot study is to investigate the effect of topically administered lipid based eye drops on tear film lipid layer thickness in subjects with dry eye disease, Meibomian gland dysfunction, blepharospasm and healthy subjects.

Tear film lipid layer and tear film thickness will be assessed using the Lipiview II interferometer and OCT. Measurements will be performed before instillation of the eye drops and every 10 minutes after instillation for one hour. One eye will receive lipid based eye drops, the other eye will receive no eye drops and will be used as control. The study eye will be chosen randomly. In addition, Dynamic Meibomian gland imaging, Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed


Eligibility Criteria:
Inclusion Criteria:

All groups

* Men and women aged over 18 years
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Ametropy \< 6 dpt
* No application of eye drops or ointments in the 24 hours preceding the screening visit as well as the study day Dry eye disease group
* History of dry eye disease ≥ 3 months
* Schirmer I test ≤ 10 mm and ≥ 2 mm or BUT ≤ 10 sec
* Normal ophthalmic findings with the exception of DED Meibomian gland disease group
* Dry eye disease most likely caused by MGD, no other cause identifiable which is more likely (e.g. intake of concomitant medication that could induce DED, systemic diseases such as systemic arthritis or diabetes), as judged by the investigator
* History of dry eye disease ≥ 3 months
* Normal ophthalmic findings except dry eye disease
* BUT ≤ 10 seconds Blepharospasm group
* Clinical diagnosis of blepharospasm
* Normal ophthalmic findings with the exception of blepharospasm and dry eye
* Schirmer I test \> 10 mm and BUT \> 10 sec

Exclusion Criteria:

All groups

* Clinically relevant illness in the 3 weeks before the screening or study day
* Ametropy ≥ 6 dpt
* Pregnancy or planned pregnancy
* Difference of more than 5 mm in Schirmer I test or difference of \> 3 sec in BUT between the two eyes
* Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medical device used in the study
* Treatment with topical or systemic steroids, immune suppressants, NSAIDs: ongoing or in the last 4 weeks
* Treatment with medication known to have a detrimental effect on tear film (e.g. antidepressants, anxiolytics, neuroleptics, antihistaminic drugs, cholinergic drugs, antimuscarinic drugs, phenothiazine, beta blockers): treatment duration ≤ 4 weeks or changed dose since ≤ 4 weeks or during the study
* Alcohol abuse
* Contact lens wear Meibomian gland dysfunction group
* Sjögren's syndrome