cyrilzakka/clinical-trials huggingface dataset:
Technology-Assisted Prescription Opioid Safety Education

This study will develop a technology-based brief educational intervention for hospitalized patients that will be discharged with an opioid prescription. The Investigators will conduct a small randomized clinical trial of T-POSE to determine whether it improves patients: knowledge and reduces the incidence of Non-Medical Prescription Opioid Use (NMPOU).

Non-medical use of prescription opioids (NMPOU) can be generally defined as not taking opioids as prescribed, which could occur unintentionally or intentionally. In 2014, 4.3 million adults in the United States (U.S.) were estimated to engage in NMPOU (Center for Behavioral Health Statistics and Quality 2014). Some patients may take a dose more frequently than prescribed because they were not receiving adequate pain relief from the prescribed dosage. While others may continue to take opioids longer than prescribed because their pain is persistent and/or they like the euphoric effects of opioids. According to a recently released Truven Health Analytics-NPR Health Poll, the majority (57%) of Americans have taken a prescription opioid and 35% of those had concerns (e.g., addiction, effectiveness, side effects) about prescription opioids. These findings suggest that while Americans are aware, some even concerned, of the potential dangers associated with prescription opioids that their utilization patterns continue to increase (Boddy 2017). Because opioids are prescribed by a physician, patients may believe that these medications are safe and they may be unaware of the risks associated with misuse and abuse of opioids. NMPOU may lead to increased risk of drug overdose, addiction, diversion and use of heroin. Many individuals with opioid use disorders initiated NMPOU before transitioning to heroin (Banerjee et al. 2016; Cerda et al. 2015) and report that their first exposure to an opioid was prescribed by a physician. This underscores the need for empirically-tested educational interventions that can potentially reduce NMPOU and diversion. Prescription opioids have an important role to play in health care and blanket policies to restrict access to prescription opioids are not appropriate, rather the hypothesis is that harm can be reduced by fundamentally changing our approach to opioid medication safety.

Eligibility Criteria:
Phase I Inclusion Criteria:

* Subject is being discharged from the hospital with a prescription opioid
* English Speaking
* Willing and able to use a tablet

Phase II Inclusion Criteria:

* Willing and able to provide informed written consent
* Subject is being discharged from the hospital with a prescription opioid
* English Speaking
* Willing and able to use a tablet

Exclusion Criteria:

* Visual or hearing impediment that would inhibit communication with the Study Pharmacist and use of the laptop
* Cognitive or mental state prohibiting informed consent
* Patient reported opioid use disorder
Cerclage vs Cervical Pessary in Women With Cervical Incompetence

Cervical insufficiency (CI), responsible for 8% of preterm births (PB), is used to describe painless cervical dilation leading to recurrent second-trimester pregnancy losses/births of otherwise normal pregnancies. Structural weakness of cervical tissue was thought to cause or contribute to these adverse outcomes. The term has also been applied to women with one or two such losses/births or at risk for second-trimester pregnancy loss/birth. Cervical pessary and cervical cerclage are both considered as preventive treatments in women at risk for PB. This study aims to demonstrate that the cervical pessary could reduce the preterm birth rate before 37 weeks of gestation in women with prior PB due to cervical insufficiency or in women with prior PB and a short cervix in the current pregnancy.

Methods/Design: This is an open-label, pilot, multicentre, prospective, randomised controlled trial (RCT). Enrolees are women with singleton pregnancies and previous PB based on CI (primary intervention, \<16 weeks) or in case of previous PB and a short cervical length in current pregnancy ≤ 25 mm (secondary intervention, \<24 weeks). Women are randomised (1:1) either to cervical cerclage or pessary treatment. The primary outcome is the spontaneous preterm birth rate before 34 weeks of gestation. The sample size was calculated, as a pilot study, based on the estimated population that we will be able to recruit during the duration of the trial: 60 women, 30 for each group (cervical cerclage and cervical pessary group) to observe, at least a reduction in the PB rate \< 34 weeks from 34% to 27% in the pessary group, as does cerclage.

Discussion: The outcome of this study will show the effectiveness of a cervical cerclage and of a cervical pessary in this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Minimum age: 18 years
* Previous PB based on CI (primary intervention, \<16 weeks) or in case of previous PB and a short cervical length in current pregnancy ≤ 25 mm (secondary intervention, \<24 weeks). Women are randomised (1:1) either to cervical cerclage or pessary treatment.

Exclusion Criteria:

* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
* Threatened preterm labour at time of randomization
* Spontaneous rupture of membranes at time of randomization
* Chorioamnionitis at time of randomization
* Active vaginal bleeding
* Placenta previa
Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel

This clinical trial is intended to evaluate the impact, efficacy, and safety of Chitosan formulated adhesion inhibitor, SurgiShield when used in the process of wound healing after endoscopic sinus surgery.


Eligibility Criteria:
Inclusion Criteria:

* older than 21 years of age
* both side sinusitis
* will undergo endoscopic sinus surgery
* volunteers with informed consent and signature

Exclusion Criteria:

* suppressed immunity patient
* systemic grave condition
* pregnant
* cancer
* severe disease patients
* asthma patients
* AIDS
* cystic fibrosis
* ciliary immobility syndrome
* neutropenia neutrophil
* immunoglobulin deficiency
* wound healing immune disease
* severe liver disease
* severe kidney disease
* lymph or blood clotting disorder or patients treated with coagulants
* patients taking oral or parenteral glucose for diabetes thrombocytopenia
* infectious disease
* currently lactating
* severe septal deviation
* case where there is a severe difference in sinusitis state between sides of nose: there is a 3 or more score difference on the Lund-Mackey CT scan scoring system PNS(ParaNasalSinus)
* shellfish allergy
* food allergy
* had endoscopic sinus surgery in the past
* patient with large sinus polyps
* patients who have received treatment for extrasinus complication
0.9% Saline Versus Balanced Solutions in Severe Diabetic Ketoacidosis

Severe diabetic ketoacidosis (DKA) is a potentially serious complication of diabetes mellitus. The treatment regimen is based on insulin and rehydration. The choice of rehydration solution is a question that remains open. We sought to compare the effect of sodium chloride 0.9% (SC) versus ringer lactate (RL) in the resolution of severe DKA as well as on the variation of electrolytes.

We design an open randomized trial in adult patients admitted to our ICU for severe DKA. The insulin therapy protocol was identical and the randomization concerned the rehydration solution either by SC or RL. The primary endpoint was resolution of DKA at H48 defined by a composite endpoint (glycemia \<11 mmol/l, bicarbonates \> 15 mmol/l or pH\>7.30 and anion gap \<16). The secondary endpoints were resolution of DKA at H24, change in base excess to ≥ -3 meq/L at 48 h and H24 and change in electrolytes, insulin requirements, length of stay and mortality. Blood gases, ionogram with chloride and lactate were performed at baseline, H6, H12, H24 and H48.

Eligibility Criteria:
Inclusion Criteria:

- All patients aged 16 and over hospitalized in intensive care for severe ketoacidosis defined as arterial pH ≤ 7.25 (or serum bicarbonate ≤ 15 mmol/L) and blood glucose ≥ 14 mmol/L and need for ICU.

Exclusion Criteria:

* \< 16 Y
Deep Learning Signature for Predicting Complete Pathological Response to Neoadjuvant Chemoimmunotherapy in Non-small Cell Lung Cancer

The purpose of this study is to evaluate the performance of a CT/PET/ WSI-based deep learning signature for predicting complete pathological response to neoadjuvant chemoimmunotherapy in non-small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

1. Age ranging from 20-75 years;
2. Patients who underwent curative surgery after neoadjuvant chemoimmunotherapy for NSCLC;
3. Obtained written informed consent.

Exclusion Criteria:

1. Missing image data;
2. Pathological N3 disease.
Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers

The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if \<5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Women with metastatic ductal adenocarcinoma breast cancer
* 18 years old or more
* Hormone receptors positive breast cancer (ER+ and/or PR+) on the last pathological analysis available.
* Acceptable patient's clinical situation compatible with chemotherapy or hormonotherapy administration
* PS \<4
* Life expectancy \> 3 months
* Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection
* Information of the patient and signature of the informed consent form

Exclusion Criteria:

* Patient treated by chemotherapy or hormonotherapy for their metastatic disease (treatment failure under adjuvant hormonotherapy are accepted)
* Her2 positive breast cancer
* History of other stage II or III cancer in the 5 years. History of other metastatic cancer (whatever the time between the two cancers).
* Persons deprived of their freedom or under guardianship.
* Women unable to comply with the medical follow-up of the study for geographical, social or mental reasons.
Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

The investigators of the study want to investigate the complex interactions between glucose metabolism, food intake/weight loss, and different appetite regulating hormones after ESG in comparison with conventional laparoscopic sleeve gastrectomy (LSG).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Scheduled for endoscopic or laparoscopic sleeve at Hvidovre Hospital
* HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
* HbA1c \< 48 mmol/mol and fasting plasma glucose \< 6.1 mmol/l at inclusion
* BMI\<45

Exclusion Criteria:

* Hemoglobin \< 6.5 mmol/l at inclusion
* Pregnancy or breast feeding
* Medication affecting the planned examinations
Effects of Functional Motor Control on Pain, Flexibility, Lower Extremity Function With ITBS

The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by non-probability convenient random sampling technique. Subjects in group A will receive functional motor control exercises. Group B will receive conventional exercises.

The objective of this study is to determine the effects of functional motor control exercises on pain, flexibility and lower limb functional. It will be randomized controlled trial (RCT) research design at Pakistan sports board through non probability convenience sampling technique on 72 runners' athletes which will be allocated using random sampling through computerized generated number into Group A and Group B, 36 athletes will be in each group. Group A (interventional) will be given conventional training with functional motor exercise and Group B (control) will be given conventional training. There will be 3 sessions in a week for 6 weeks. The baseline scoring will be on 1st day, follow up will be taken at 6th week. Assessment will be made by Numeric pain rating scale, Lower extremity functional scale (LEFS), Single leg mini squat, Y balance. Data will be analyzed during SPSS software version 26. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two group

Eligibility Criteria:
Inclusion Criteria:

* male and female athlete within 19-40 years,
* running a minimum average of 15 running kilometers,
* Runners with one sided iliotibial band syndrome for at least 3 months were included,
* Pain along IT band at either Gerdy's tubercle or the lateral femoral epicondyle during running,
* positive stiffness with Ober's test, and
* reporting pain during Noble's compression test.

Exclusion Criteria:

* Individuals with a history of previous knee trauma of past 6 months,
* Individuals with a history of previous knee surgery of past 6 months,
* Other knee abnormalities including patellofemoral joint pain,
* popliteus tendinitis,
* lateral meniscal injury,
* Degenerative joint disease, and
* lateral collateral ligament sprain to the affected side.
Efficacy of Transcatheter Radiofrequency Ablation of Atrial Flutter With Standard Irrigated Catheter With Flexible Tip

The purpose of this study is to evaluate the efficacy of transcatheter ablation of atrial flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual success of the procedure.

No more available data

Eligibility Criteria:
Inclusion Criteria:

* Both sexes; age\>18 yrs
* ECG documentation of at least 2 episodes of common atrial flutter or evidence of ongoing atrial flutter.
* No contraindications to transcatheter radiofrequency ablation by a standard 4mm irrigated flexible tip catheter
* Patients willing to accept the tests and to follow standard procedures
* Patients who understand the nature of the procedure and who are willing to participate and to sign the informed consent before enrollment

Exclusion Criteria:

* Atrial fibrillation
* Any arrhythmia requiring antiarrhythmics in the 6 months post procedure
* Intra atrial thrombosis
* NYHA class IV
* Unstable Angina or Acute Myocardial Infarction (AMI) in the last 3 month
* Untreated Wolf Parkinson White syndrome
* Contraindications to oral anticoagulation
* Life expectancy \< 12 month
* Major surgery or interventional procedure already planned in the 6 month following ablation
* Pregnancy or breast-feeding
* Participation in another study
Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development

Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in infants. We have earlier investigated cobalamin status in healthy children and we observed metabolic evidence of impaired cobalamin status during the first 6 months, but not later in life.

The purpose of this study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.

During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. A metabolic profile consistent with impaired cobalamin status is prevalent in breast-fed infants. Whether this profile reflects immature organ systems or cobalamin deficiency has not been clarified.

Low levels of cobalamin, elevated levels of total homocysteine (tHcy), cystathionine and/or methylmalonic acid (MMA) in the blood are measures of impaired cobalamin status.

The purpose of this randomized, controlled study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.

Six weeks old infants will be randomly assigned to receive either an intramuscular injection with 400 µg cobalamin or no intervention. Concentrations of cobalamin and folate in serum, and total homocysteine (tHcy), methylmalonic acid (MMA) and cystathionine in plasma will be determined at inclusion and at the age of 4 months. A questionnaire on infant and maternal nutrition, vitamin supplementation, growth parameters, parity and maternal use of tobacco will be completed.

Eligibility Criteria:
Inclusion Criteria:

* 6 weeks old infants
* The infant should be healthy and not have any serious malformations
* The mother should be healthy and not have any serious disorders or use any daily medications
* The mother should have an ordinary omnivorous diet

Exclusion Criteria:

* If there are evidence of serious infant disease during the study period, the infant should be excluded from the study
Problem Solving and Cardiovascular Disease Risk Management in Diabetic Blacks

The purpose of this study is to test a measurement tool and a new training intervention for problem solving in self-management of high cardiovascular disease (CVD) risk in African Americans with type 2 diabetes.

BACKGROUND:

African Americans with type 2 diabetes carry a high burden of CVD risk and adverse vascular events such as stroke and peripheral vascular disease. CVD risk factors of suboptimal blood pressure, lipids, and glycemic control are controllable through medical management and lifestyle behavior modification. The traditional primary care medical management model for these chronic CVD risks is inadequate, and models are shifting toward increased disease-related decision-making and self-management on the part of the patient. Yet, precise methods for: 1) identifying patients with ineffective disease-related problem-solving skills, and 2) providing patients with disease-related education that incorporates problem-solving and decision-making skills, have yet to be determined

DESIGN NARRATIVE:

The study will test a measurement tool and a novel training intervention for problem solving as applied to self-management of high CVD risk in African Americans with type 2 diabetes. The specific aims are to: 1) assess the validity and reliability of an empirically derived assessment tool of effective versus ineffective CVD risk-related problem-solving ability (the Health Problem Solving Scale, HPSS), 2) develop a novel intervention to teach CVD risk-related problem-solving skills to ineffective problem solvers, and 3) conduct a pilot study with a sample of African Americans with type 2 diabetes who have a high CVD risk profile (suboptimal blood pressure, lipids, and/or HbA1c) AND ineffective CVD risk-related problem-solving skills, as measured by the HPSS. The principal investigator is the recipient of a Research Scientist Development Award. Her career goal is to become an independent researcher in self-management of CVD risk in high-risk African American populations, and to be a leader in the development and translation into practice of novel, theory-driven and empirically based interventions to improve patient self-management of CVD risks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes
* African American by self report
* High CVD risk profile, defined as having one or more of the following:1) suboptimal A1C (greater than 7 percent); 2) suboptimal blood pressure (SBP greater than 130 mmHg and/or DBP greater than 80 mmHg); 3) suboptimal lipid control (LDL greater than 100 mg and/or HDL less than 40 mg)
* Willing and able to give informed consent

Exclusion Criteria:

* Plan to leave area prior to study completion
* Severe diabetes complications that would interfere with the study
* End-stage disease
Focusing Implementation to Bring Effective Reminders (FIBER)

FIBER is 4-year study that will evaluate the implementation of a large-scale population-based colorectal cancer screening patient reminder and coordinated follow-up program. The CRC screening program began in 2007 with Kaiser Permanente Northwest (KPNW),a not-for- profit, integrated health system in Oregon and Washington. FIBER consists of 1)a practical randomized controlled trial at the start of the program, followed by 2) a longer-term cohort study as all remaining eligible patients receive the program, and 3)a qualitative evaluation. FIBER will evaluate the factors that are associated with implementation success across multiple levels: patient, primary care provider (PCP) team, specialists (gastroenterologists, general surgeons, pathologists), and other health plan staff and systems.


Eligibility Criteria:
Inclusion Criteria:

* KPNW members since 2005
* Men and women, aged 50-80 who were due for CRC screening during a 24-month period of time.

Exclusion Criteria:

* KPNW members who were part of a previous quantitative study.
LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis

Lateral lumbar interbody fusion (LLIF), as a minimally invasive technique, is an indirect decompression technique, and its decompression effect is not as thorough as traditional posterior decompression surgery. For certain patients with severe lumbar stenosis, additional posterior decompression is required. However, whether additional posterior decompression is necessary for these patients is unknown. Radiographic predictors of failed indirect decompression via LLIF is unknown. In current randomized, controlled trial , the investigators compare the clinical outcomes of patients with severe lumbar stenosis who received LLIF plus posterior decompression and those without posterior decompression.

The current randomized controlled trial consists of two groups. Patients included in the study are with Schizas's stenosis grades C. Patients in one group received transpsoas lateral lumbar interbody fusion. Patients in the other group received transpsoas lateral lumbar interbody fusion plus posterior decompression. Patients will be followed for one year. Clinical outcomes of the two groups will be compared. And radiographic predictors of failed indirect decompression via LLIF will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients who are 50 - 80 years of age.
* Patients who present with symptomatic Grade I or II degenerative spondylolisthesis at one or two contiguous lumbar levels between L1 and L5 and who are surgical candidates for interbody lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic claudication with or without back pain.
* Patients who have been unresponsive to at least 6 months of conservative treatments or who exhibit progressive neurological symptoms in the face of conservative treatment.
* Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.

Exclusion Criteria:

* Patients with lumbar pathologies requiring treatment at more than two levels.
* Patients who have had previous lumbar fusion surgery.
* Patients with congenital lumbar stenosis.
* Patients with radiographic confirmation of Grade IV facet joint disease or degeneration.
* Patients with noncontained or extruded herniated nucleus pulposus.
* Patients with active local or systemic infection.
* Patients with rheumatoid arthritis or other autoimmune disease.
* Patients who cannot undergo magnetic resonance imaging (MRI).
* Patients who are mentally incompetent.
* Patients with BMI over 30kg/m2 or less than 18 kg/m2.