cyrilzakka/clinical-trials huggingface dataset:
Medication Reconciliation Technology to Improve Quality of Transitional Care

This study addresses the problem of inadequate medication reconciliation as patients cross boundaries between inpatient and outpatient care (ambulatory care). The purpose of this study is to determine whether a new, computer-based application, integrated with electronic prescribing, improves erroneous discrepancies between pre-hospital medications and medications upon patients' return to ambulatory care.

This project will test a systems-based intervention of the electronic medical records system. The specific aims of this study are to integrate a new electronic medication reconciliation (MR) system with an electronic prescribing system, conduct a randomized controlled trial of MR, and determine whether electronic facilitation of MR alters MR and the incidence of medication errors in ambulatory care. On a patient's hospital admission, a new Web-based MR module will receive an automatically compiled outpatient medication list. Following discussion with the patient, medical personnel will update the list, which will then be delivered to the computer-based provider order entry system and become actionable for prescribing. Main outcomes include adverse drug events and erroneous discrepancies between the pre-admission medication list and the medication list upon the patient's return to ambulatory care. We hypothesize that electronic facilitation of inpatient MR will improve completion of MR and will decrease the incidence of drug-related medical errors.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Medicine Service during a 12-month period
* Physicians who provide inpatient or ambulatory care for participating patients.
* Pharmacists who provide care for participating patients.

Exclusion Criteria:

* Patients admitted but not seen in a primary-care clinic within the preceding 12 months
* If an enrolled subject is determined to be a prisoner or pregnant woman, then the study will discontinue the subject for research purposes or will submit an amendment at that time.
Sympathetic Mechanisms in Obesity-Crossover Design

We will study obese hypertensive subjects in a randomized, crossover study to determine if two weeks sympathetic blockade improves endogenous glucose production. Subjects will be studied on 3 different occasions after two weeks of receiving either placebo, amlodipine (vasodilator arm) or moxonidine (study arm). The order of the studies will be determined using computer-generated randomization. Patients will be blinded as to which treatment they are receiving on each day. An investigator blinded to the treatment assignment will perform the analysis of the data.


Eligibility Criteria:
Inclusion Criteria:

* Males and females of all races between 18 and 65 years of age
* Hypertension defined by two or more properly measured seated blood pressure readings \>130/85 mmHg or currently on antihypertensive medication.
* Obesity will be defined as having a body mass index (BMI) ≥ 30 kg/m2.
* Able and willing to provide informed consent.

Exclusion Criteria:

* Pregnancy or breast feeding
* Current smokers or history of heavy smoking (\>2 packs/day)
* History of alcohol or drug abuse
* Previous allergic reaction to study medications
* Type I diabetes.
* Cardiovascular disease other than hypertension such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy
* History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack
* History or presence of immunological or hematological disorders
* Impaired renal function
* Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
* Treatment with any investigational drug in the 1 month preceding the study
* Inability to give, or withdraw, informed consent
* Other factors which in the investigator's opinion would prevent the subject from completing the protocol (i.e., clinically significant abnormalities on clinical, mental examination or laboratory testing or inability to comply with protocol, inability to find IV access)
Personalized Dual-target RTMS for Patients with Refractory Schizophrenia

The goal of this clinical trial is to evaluate the efficacy of personalized dual-target rTMS for treating patients with refractory schizophrenia and to investigate its underlying neural mechanisms using functional MRI.

The main questions it seeks to address are:

Does the dual-target rTMS protocol improve clinical symptoms in patients with refractory schizophrenia? What neural circuit changes, as assessed by functional MRI, occur following rTMS treatment?

Participants will:

Undergo personalized, dual-target rTMS treatment daily for 3 weeks. Complete baseline and post-treatment assessments, including clinical symptom scales (PANSS, HAMA, HAMD) and neuropsychological tests (MoCA, DST, VFT, Stroop Test, and AVLT).

Have structural and resting-state functional MRI scans before and after treatment.

Be monitored for any treatment-related adverse events.

This open-label clinical trial aimed to evaluate the efficacy and underlying neural mechanisms of a personalized dual-target rTMS protocol for treating patients with refractory schizophrenia. Patients with refractory schizophrenia were prospectively recruited and underwent 3 weeks of rTMS treatment.

Before treatment, structural and resting-state functional MRI data were collected from each patient. Clinical symptom severity was assessed using the Positive and Negative Syndrome Scale (PANSS), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD). For patients experiencing auditory verbal hallucinations, the Auditory Hallucination Rating Scale (AHRS) was also administered. Additionally, a battery of neuropsychological tests was conducted, including the Montreal Cognitive Assessment (MoCA), Digit Span Test (DST), Verbal Fluency Test (VFT), Stroop Test, and Chinese Auditory Verbal Learning Test (AVLT).

After completing the 3-week rTMS treatment, clinical symptom severity, treatment-related adverse events, and structural and resting-state functional MRI data were reassessed.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed by independent psychiatrists using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition;
2. disease duration longer than six years;
3. hospitalization two or more times;
4. aged 18-60 years;
5. a stable dosage of antipsychotic medication for at least four weeks before inclusion, and retention of this stable dose for the duration of the study.

Exclusion Criteria:

1. accompanied by other mental illnesses or histories;
2. pregnant;
3. a history of severe head trauma or neurological disease;
4. focal brain lesions on T1- or T2-weighted fluid-attenuated inversion-recovery MRI;
5. a history of rTMS or electroconvulsive therapy in the six months prior to the study; and
6. metal objects in the head or any other contraindication to MRI.
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.


Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent.
* Age ≥ 18 years and of either sex.
* Willing to comply with protocol instructions, including allowing all study assessments.
* Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2
* Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
* Arterial supply adequacy confirmed
* Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
* Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
* Acceptable state of health and nutrition

Exclusion Criteria:

* History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B.
* Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication.
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
* A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
* Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
* Refusal of or inability to tolerate compression therapy.
* Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
* History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
* Any prior exposure to HP802-247 or its vehicle.
Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason

The investigators plan to compare contrast-enhanced ultrasound to CT and MRI for the detection and quantification of intestinal inflammation in the the setting of pediatric small bowel Crohns disease

The proposed study will investigate the use of an FDA-approved ultrasound microbubble contrast agent (Lumason; Bracco Diagnostics) in pediatric and adult Crohn's disease patients undergoing either MR enterography (MRE, or MRI of the bowel) or CT enterography (CTE, or CT of the bowel). In April 2016, Lumason was FDA approved for intravenous administration and imaging of the liver in children. Imaging of the bowel will employ an identical administration method to that described for liver imaging, but the ultrasound transducer will be placed over the affected intestines as opposed to liver.

Eligibility Criteria:
Inclusion Criteria:

* histologic evidence of small bowel Crohn's disease, or clinical evidence of disease (including radiologic confirmation \[either CT or MRI\] and receiving medical therapy for Crohn's disease).
* Between ages 10 and 18 years.
* Undergoing clinically-indicated CTE or MRE with evidence of active disease based on pediatric gastroenterologist clinical assessment

Exclusion Criteria:

* Patients under the age of 10 or over the age of 18.
* Pregnancy or breast feeding. Urine pregnancy testing will be performed on all female study participants of reproductive potential.
* Obesity/body habitus preventing visualization of small bowel affected by Crohn's disease by ultrasound (Body mass index ≥30 kg/m2
* Subject inability/unwillingness to consent or child assent, including severe developmental delay/mental retardation.
* Prior allergic-like reaction or other severe adverse event to Lumason or any of the active ingredients in Lumason (SPECIFIC CONTRAINDICATION from Package Insert).
* Known unstable cardiopulmonary conditions (including any history of acute myocardial infarction/acute coronary artery syndrome, arrhythmia, and congestive heart failure), ongoing acute or chronic kidney disease (eGFR \<30 ml/min), moderate/severe chronic lung disease, and end-stage liver disease.
A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma

Over the past 15 years, intravenous chemotherapy has become the most popular conservative (eye-saving) method for retinoblastoma treatment because it is often effective and usually safe. In recent years, there has been much interest in providing highly focused (focal) chemotherapy to a diseased organ including the liver, brain, and eye. With focused chemotherapy, the chemotherapy drugs are injected directly into the ophthalmic artery (the artery that supplies blood to the eye). A benefit of focal chemotherapy delivery is that it decreases the chance of toxicity to other organs such as bone marrow suppression (causing low blood counts) and the development of other cancers in the future.

The management of retinoblastoma includes systemic chemotherapy (carboplatin, etoposide, and vincristine), thermotherapy, cryotherapy (freezing treatment), laser photocoagulation, plaque radiotherapy, external beam radiotherapy, and enucleation. The treatment is tailored to each individual case. Over the past 15 years, intravenous chemotherapy has risen as the most popular conservative (eye-saving) method for retinoblastoma management because it is effective and safe. In recent years, there has been keen interest in providing chemotherapy more focally to a diseased organ including the liver, brain, and eye. The benefit of focal chemotherapy delivery is to avoid toxicity to other organs and this toxicity includes the risk of future cancers.

Eligibility Criteria:
Inclusion Criteria:

* Advanced retinoblastoma in one or both eyes
* Recurrent retinoblastoma after failure of previous treatment
* No age limit (usually kids presenting with retinoblastoma present in the 1st two decades of life)
* Judged by principal investigator to be medically and physically able to undergo the procedure

Exclusion Criteria:

* Recurrent retinoblastoma which is treatable with other conservative measures
* Invasive retinoblastoma (retinoblastoma that has grown locally outside of the eye, for example, into the bone around the eye)
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up

The goal of this clinical investigation is to learn if training with Emagina device can improve flexibility of the perineum during childbirth with the help of a balloon that inflates in the genital area according to a time-limited exercise program specifically developed to optimize results, in adult, pregnant women with their first child (single fetus) less than 24 weeks of amenorrhea at the time of inclusion (i.e. during the 5th month of pregnancy).

The main questions it aims to answer are:

* Does the Emagina training program improve perineal flexibility during pregnancy ?
* Does the Emagina training program reduce the proportion and importance of perineal tears, as well as the proportion of sutures and episiotomies during childbirth ?

Researchers will compare Emagina group to a Control group (no intervention) to see if Emagina device works to improve perineum flexibility.

Participants will :

* measure the flexibility of their perineum on 2 occasions 90 days apart, with or without perineal training
* perform perineal training with the Emagina medical device or follow current practice
* fill out e-questionnaires regarding quality of life, lifestyle, pelvic static disorders, sexual activity and urinary incontinence


Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years of age
* Singleton (fetus)
* Primiparous subject
* Subject less than 5 months pregnant (between 20 and 24 week of amenorrhea)
* Subject affiliated to a social security plan
* Subject who has given written consent prior to any specific procedure related to the clinical investigation
* Subject able to understand and complete the clinical investigation questionnaires
* Subject having a smartphone and being able to download the Emagina app

Exclusion Criteria:

* High-risk pregnancy (subjects presenting pregnancy-related risks will be excluded from participating in this clinical investigation, including risks of premature delivery, cases of symptomatically low-lying placenta and any contraindications to sexual relations)
* Scheduled cesarean section prior to inclusion
* History of vaginal or perineal surgery prior to pregnancy
* Pelvic anomalies
* Threatened preterm delivery prior to inclusion
* Vaginismus
* Use of Epi-no prior to inclusion
* Collagenosis or other chronic disorders affecting collagen
* Planned home birth
* Nerve damage and other illnesses that reduce sensitivity to pain in the genital area (i.e. paraplegia, multiple sclerosis, diabetic neuropathy, medication that alters sensitivity in the genital area, vulvar varicose veins).
* Persons deprived of liberty, under guardianship or trusteeship
* Drug or alcohol abuse
* Dementia, mental impairment, or psychiatric pathology that may compromise subject informed consent and/or compliance with the protocol and trial monitoring
* Subject unable to comply with protocol monitoring for psychological, social, family or geographic reasons
Baldachin: Ceiling HEPA-filtration to Prevent Nosocomial Transmission of COVID-19

In this study, a patient space occupied by a patient with confirmed COVID-19 in an open-space multiple bed area in the Intermediate Care Unit will be equipped with a mobile, optimally placed high efficiency particulate air ("HEPA")-equivalent air filtration unit ("Baldachin") in addition to existing hospital policy infection prevention and control measures. The investigators are going to evaluate this intervention regarding its capacity to prevent the nosocomial onwards transmission of Sars-COV2 to patients located in the same multiple-bed open space patient area.

SARS-CoV-2 transmission includes a considerable amount of long-distance aerosol transmission. Ideal isolation is in single rooms. Isolation in special care multiple bed open-space patient areas (e.g. in the Intensive and Intermediate Care Unit) is set back to onsite isolation with distancing and ventilation as partial mitigation measures against nosocomial transmission.

The investigators want to assess the effect of supplementation of existing room ventilation by means of an optimally placed mobile high efficiency particulate air ("HEPA") filtration unit ("Baldachin") in the ceiling area over confirmed COVID-19 infected patients on nosocomial onwards transmission to patients located in the same open-space multiple bed area. In order to quantify the effect, the investigators will determine the proportion of nosocomially infected individuals as assessed by nasopharyngeal swab on day 4 after the last exposure amongst all in the same room exposed patients in cardiovascular open-space Intermediate Care Unit rooms with "Baldachin" vs. open-space Intermediate Care Unit rooms without "Baldachin".

Eligibility Criteria:
Inclusion Criteria:

* Adult inpatients of included open-space IMC units with lab-confirmed SARS-CoV-2 infection, symptom onset or date of test ≤10 days prior inclusion.

Exclusion Criteria:

* Pregnancy, unability to give consent (e.g. informed consent form not available in patient language or non-judicious)
Validation of Urdu Version of Leicester Cough Questionnaire (LCQ)

Leicester Cough Questionnaire (LCQ) is a patient reported, 19-item tool, and it comprised physical, psychological, and social elements. The objective of the study is to cross culturally adapt LCQ in Urdu language and to find the reliability and validity in patients of COPD.

It is a three-stage study. Leicester Cough Questionnaire (LCQ) will be adapted in Urdu and will be first tested for its content validity by using content validity index (CVI).

In the second stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be pilot run; tested for its validity and reliability. In the third stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be tested for its validity and reliability in patients with COPD.

114 Patients with COPD will be selected according to inclusion criteria. Intra class correlation coefficient (ICC), Cronbach's alpha and factor analysis will be used to analyze the data.

Cough is a common symptom of asthma, COPD, and bronchiectasis, little is known about how it affects health status; therefore any negative effects may go unnoticed in these situations. Leicester Cough Questionnaire (LCQ) is a patient reported, 19-item tool, and it comprised physical, psychological, and social elements. To the extent of author's knowledge, this widely used Leicester Cough Questionnaire (LCQ) has not been translated and validated for Urdu-speaking patients with COPD.

The objective of the study is to cross culturally adapt LCQ in Urdu language using international guidelines used for translation of instrument from its source language to target language and to find the reliability, validity, sensitivity, and specificity of the Urdu version of Leicester Cough Questionnaire (LCQ) in patients of COPD. It is a three-stage study.

Leicester Cough Questionnaire (LCQ) will be adapted in Urdu and will be first tested for its content validity by using content validity index (CVI). In the second stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be pilot run; tested for its validity and reliability. In the third stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be tested for its validity and reliability in patients with COPD. 114 Patients with COPD will be selected according to inclusion criteria. Intra class correlation coefficient (ICC), Cronbach's alpha and factor analysis will be used to analyze the data.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with GOLD II, III and IV Chronic Obstructive Pulmonary Diseases
* Having age18 years or more
* subjects having chronic cough (\> 8 weeks)
* Subjects understanding Urdu

Exclusion Criteria:

* A previous history of other lung disorders
* Pregnant females, subjects having Infections
* Any systemic disorder which is unstable
* Subjects who are not willing to participate
* subject with Cognitive \& speech disorders