cyrilzakka/clinical-trials huggingface dataset:
Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients.

The purpose of this 24-week study is to evaluate the impact of recovery coach intervention on rates of treatment retention, illicit opioid use, and readmission among hospitalized patients newly initiated on buprenorphine or methadone compared to the control intervention.

Patients with opioid use disorder (OUD) frequently utilize hospitals due to soft tissue infections and other conditions that require inpatient level of care. Prior studies have indicated that OUD patients are often amenable to initiating buprenorphine treatment and can be successfully linked to outpatient treatment. However, hospitalized OUD patients initiated on buprenorphine have much lower treatment retention rates at 6-months compared to OUD patients initiating treatment in the outpatient setting. As such, there is a great need to identify strategies to improve treatment retention in this patient population. There is a growing body of evidence for the benefits of recovery coaches, who provide peer-delivered support services in the community. Tracing their origin to mutual support groups to supplement traditional clinical services, recovery coaches are individuals with lived experience of recovery. Studies of recovery coaches have demonstrated greater treatment retention, reduced substance use, and reduced inpatient utilization. However, no prior studies have examined the impact of recovery coaches in improving medication-assisted treatment retention. As such, the aim of this 24-week study is to evaluate the impact of recovery coach intervention on rates of treatment retention, illicit opioid use, and readmission among hospitalized patients newly initiated on buprenorphine or methadone compared to the control intervention. Patients who are successfully initiated on buprenorphine or methadone, and are willing to engage in treatment after discharge, will be eligible to enroll. Assessments will be conducted at baseline, 4 weeks, 12 weeks, and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* English speaking, adults aged 18-75
* Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of opioid use disorder, severe, actively using illicit opioids until the time of hospitalization
* Have a working telephone
* Can identify at least 2 individuals who can act as points of contact following discharge from the hospital
* Willing to engage in treatment (either a psychosocial treatment program AND/OR medication treatment with methadone or buprenorphine)

Exclusion Criteria:

* Liver function test \>3x upper normal limit
* Pregnant
* Psychotic disorder, active suicidality or homicidality
* Condition likely to be terminal in 24 weeks such as cancer
* Unable to perform consent due to mental status
* Engaged in substance abuse treatment in the last month prior to admission
Lithotripsy and Analgesia With 3D Hypnosis Mask

The study is a randomised trial of hypnosis with 3D virtual reality headset (intervention group) versus control group with no hypnosis and no virtual reality headset to compare remifentanil consumption during shock wave lithotripsy.

The study is for patients undergoing shock wave lithotripsy in outpatient surgery unit.

It is proposed that using hypnosis with 3D virtual reality headset will reduce the requirements for intravenous remifentanil in a randomised controlled trial of one hundred and six patients.

Remifentanil is an opioid commonly used for lithotripsy. Shock wave lithotripsy is a commonly performed procedure associated with moderate pain and anxiety, in outpatient surgery unit. Opioids can cause unfavourable side-effects, most notably respiratory depression, sedation, nausea and vomiting

It is expected that by using 3D virtual reality to reduce pain and anxiety, there will be a reduced requirement for intravenous remifentanil.

The study will measure the dose of remifentanil required by patients randomised to receive either hypnosis with 3D virtual reality headset (intervention) or no hypnosis and no 3D virtual reality headset (control group).

Patients will be followed up prior to hospital discharge to assess their remifentanil use and pain, anxiety, comfort and their satisfaction with 3D virtual reality headset.

This new device is a non-pharmacological adjunct and can reduce pain intensity during procedure, reduce opioid use and length of stay in hospital and improve the patient experience whilst potentially reducing complications of intravenous opioid.

This study findings will be of interest for patients involved in surgery or investigative procedures normally carried out with intravenous opioids or sedation.

Eligibility Criteria:
Inclusion Criteria:

- Shock wave lithotripsy and outpatient surgery

Exclusion Criteria:

* Epilepsy
* Deafness, Blindness
* Schizophrenia, Hallucinations
* No french-speaking
* Autistic
* Motion sickness
BLIS - Breastfeeding Levonorgestrel IUD Study

We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery between those who get the IUD placed early or later.

Increasing use of the levonorgestrel intrauterine device (LNG IUD) has become a cornerstone of U.S. efforts to decrease our nation's high rate of unplanned pregnancy. Many women initiate use of this method in the post partum period. The major advantage of immediate postplacental LNG IUD insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with the intense demands of newborn care, but any contraceptive method initiated in the postpartum period must not interfere with breastfeeding.

Our long-term goal is to understand the impact of hormonal contraceptives, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that quality of breastfeeding is not negatively affected by progestin-only hormonal contraceptives.

We will pursue three specific aims comparing women randomized to immediate post-placental vs. delayed (4-6 week) postpartum LNG IUD insertion:

Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups Aim #2: To determine timing of lactogenesis in both groups Aim #3: To assess breastfeeding continuation, exclusivity, and satisfaction as well as continuation and satisfaction with the LNG IUD at 26 weeks postpartum in both groups

This proposal will support a non-inferiority RCT where participants will be randomly assigned to immediate postplacental insertion (within 10 minutes of placental delivery) or delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on breastfeeding impact of early postpartum initiation of the LNG IUD.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, 18-40 year old pregnant women
* Intend to breastfeed
* Desire the LNG IUD as their method of contraception
* Agree to be randomized to early versus standard postpartum insertion
* Have delivered a healthy term infant (37 weeks gestation)
* Willing to complete all study related procedures, visits and questionnaires

Exclusion Criteria:

* Chorioamnionitis
* Obstetric complications including transfusion
* Severe pregnancy induced hypertension
* Prolonged hospitalization
* Coagulopathy
* Liver disease
* Undiagnosed genital bleeding, or other relative contraindication to LNG IUD insertion (known or suspected pregnancy, uterine cavity abnormality, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in the LNG IUD).
NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia

The purpose of this study is to determine the recommended dose of NC-6004 according to the dose-limiting toxicity (DLT) in combination with Gemcitabine, and to assess the efficacy, safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chemo-naive, advanced pancreatic cancer
* Nonresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer

Exclusion Criteria:

* Pulmonary fibrosis or interstitial pneumonia
* Marked pleural effusion or ascites above Grade 2
* Severe drug hypersensitivity
* Metastasis to the central nervous system and brain
Effects of Mill's Manipulation Along With Muscle Energy Technique in Lateral Epicondylitis

The effects of Muscle Energy Technique intervention have been investigated in recent studies in Lateral Epicondylitis. Some studies have been conducted about mills manipulation and Muscle Energy Technique but according to the literature review there is no study exist to determine the effects of Mill's Manipulation along with Muscle Energy Technique in Lateral epicondylitis. Because of this reason, further research required to find out the effects of Mill's Manipulation along with Muscle Energy Technique in pain, Range of motion and disability in lateral epicondylitis. So the aim of the study is to determine whether these techniques are effective and should be incorporated frequently in a clinical setting in relation to the conventional therapy. This study will help the clinician for the identification of the better and quick treatment regime which will have no adverse effects and risks and making them more effective, efficient for the patient with lateral epicondylitis.


Eligibility Criteria:
Inclusion Criteria:

* Patient that have been diagnosed with lateral epicondylitis (pain and point tenderness over lateral epicondyle and / or 1-2cm distal to epicondyle).
* Both male and female patients between the age group of 18 to 45 years old.
* Any of the following tests positive: Cozen Test, Mills, Maudsley.

Exclusion Criteria:

* History of rheumatic arthritis
* History of elbow instability
* History of former fracture of the elbow
* History of cervical radiculopathy.
* History of radial tunnel syndrome (Patient with RTS will report pain over lateral forearm approximately 3 to 5 cm distal to the elbow worsens with rotational movements of the forearm).
* History of any neoplasia
* Any congenital or acquired deformity of upper limb.
* History of trauma.
* History of Corticosteroid injection within 6 months.
* Individual having symptoms of vertigo
Drug Interaction Study of Digoxin and BI 10773

The objective of the study is to investigate the relative bioavailability of digoxin after concomitant multiple oral administration of BI 10773 and a single dose of digoxin in comparison to digoxin given alone to healthy male and female subjects.


Eligibility Criteria:
Inclusion criteria:

-Healthy male and female subjects

Exclusion criteria:

-Any relevant deviation from healthy conditions
Interest of Indocyanine Green in Neoplastic Prostatic Tissue

Prostate cancer, with more than 70,000 new cases and 8900 deaths a year in France, is a major public health problem. Until 28% of patients treated with surgery will present a positive surgical margin resulting in an incomplete clearance of the tumoral process and exposing so the patient at a local, systemic recurrence and increased morbidity. An increasing number of international publications have shown (ICG) was interesting for the detection of the sentinel lymph node, in the surgery of tumors of type hepatocarcinoma and liver metastases from colorectal diseases, but also in the surgery of the kidney, bladder or breast. ICG has affinity for tumor and tissues around the tumor related to micro-vascular histology for a localized and specific deposit (EPR effect).

The detection of ICG 's deposits is now possible with to the use of a device which allow to visualize the infra-red fluorescence (NIR; Near Infra-Red) for objects larger than 0.15 mm. Thanks to this feature, the location of residual tumor tissue when performing a radical prostatectomy could be made much easier.

The ability of ICG to detect a surgical margin positive intraoperatively has never be evaluated. We want to perform a monocentric prospective ex-vivo pilot in order to evaluate the diagnostic performance of fluorescence in the detection of surgical margins compared to pathologic analysis. This study will be conducted in 37 patients operated on for a radical prostatectomy after systemic injection of 0, 25 mg/Kg of ICG 24 h before the surgery. The fluorescence analysis will be performed in the operation room and then specimen will be sent to the laboratory for an analysis as usual. Two pieces of prostate will be prelevated according to a protocol. The histopathological procedure will be performed without knowledge of fluorescence analysis. Except the ICG injection the medical procedure won't be changed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with prostatic cancer proved by biopsy and needing total prostatectomy with or without curettage.
* Patient affiliated to a social security scheme
* Patient has given its informed consent

Exclusion Criteria:

* contra-indication to surgery
* non confirmed adenocarcinoma diagnostic
* antecedent of prostatic cancer treatment
* antecedent of pelvic surgery
Closing the Gap in Care in Seronegative Inflammatory Arthritis

Rheumatologists treating patients with seronegative arthritis will be randomized to treat their patients to a target or to treat their patients under their usual standard of care. All physicians will perform an initial chart audit. Following the initial chart audit, all physicians in the treat-to-target group will receive accredited educational training. Six months after the initial chart audit, all physicians will perform a repeat audit to see if patients are assessed more systematically and treated to a target of low disease state.


Eligibility Criteria:
Inclusion Criteria:

* Canadian Rheumatologist

Exclusion Criteria:
A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

The aim of this study is to evaluate the effectiveness and safety of Reduning Injection for mild type of hand-foot-mouth disease.

By adopting a multi-center, prospective, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Reduning Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and to provide medical evidence of Reduning Injection for HFMD, especially to offer suggestions in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of severe hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; More than 1/3 patients should be diagnosed by etiological examination.
* Less than 48 hours of occurrence of mild symptoms, with an armpit temperature of more than 37.5 degrees Celsius.
* Less than 48 hours of occurrence of tetter or herpes.
* Age of 1-13 years.
* Patients or their guardians agree to participate in this study and signed the informed consent form.

Exclusion Criteria:

* Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc.
* With history of allergies on the experimental medicine, or severe allergies to other medicines.
* Using other western medicine or Chinese medicine for treating HFMD when consulted.
* Attending other clinical studies on HFMD after diagnosed.
Automatic Real-time Diagnosis of Gastric Mucosal Disease Using pCLE With Artificial Intelligence

Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables real-time histological evaluation of gastric mucosal disease during ongoing endoscopy examination. However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 80;
* agree to give written informed consent.

Exclusion Criteria:

* Patients under conditions unsuitable for performing CLE including coagulopathy , impaired renal or hepatic function, pregnancy or breastfeeding, and known allergy to fluorescein sodium;
* Inability to provide informed consent
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with bilateral cataracts
* candidate for presbyopic lens

Exclusion Criteria:

* \>1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
* pre-existing conditions that could skew the results
Evaluation of Long-Term Sequelae After Thrombophlebitis, i.e. Deep Venous Thrombosis of the Lower Extremities

The purpose of the study was to evaluate efficacy and safety of the new acute treatment of deep venous thrombosis by use of low-molecular-weight heparin compared with standard treatment using unfractionated heparin, especially concerning long-term morbidity.

Deep-venous thrombosis (DVT) remains a common clinical problem (annual incidence 0.10-0.16%) and long-term morbidity as chronic venous insufficience (CVI) in 10-30%.

As to recurrent DVT, initial treatment with Low-Molecular-Weight Heparin ( to-day's terminology Fractionated Heparin (FH)) and Unfractionated Heparin (UFH) has shown equal efficiency, whereas the efficacy concerning long-term morbidity has only more recently been published.

This study was initiated to compare the efficacy of UFH and FH concerning the incidence of CVI after symptomatic DVT at short-term and long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* First DVT with or without known risk factors except overt cancer
* Second DVT more than two years after the first if the patient was without clinical signs of CVI.

Exclusion Criteria:

* Contraindication to anticoagulation therapy
* Candidate to thrombectomy with arterious-venous fistula or thrombolytic therapy
* Known cancer at the time of the DVT diagnosis
* Patients unable to cooperate for anticoagulation therapy or manage the tests.
Sorafenib Plus TACE Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced HCC

This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of Sorafenib combined with transarterial chemoembolization as adjuvant treatment for resectable advanced hepatocellular carcinoma, compared with Sorafenib alone. The primary endpoint is recurrence-free survival. This trial planned to recruit 158 patients who received curative hepatic resection with resectable advanced hepatocellular carcinoma. The patients will be randomized into Sorafenib group and Sorafenib+TACE group as 1:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

1. Primary hepatocellular carcinoma without any treatments.
2. Received curative hepatic resection
3. ECOG score 0-1
4. Child-Pugh grade A
5. Sufficient liver and kidney function

Exclusion Criteria:

1. Diffused lesions; tumor thrombosis in SMV or IVC.
2. Extra-hepatic metastasis.
3. Contraindication of TACE, like portal-systemic shunt, obvious atherosclerosis, etc.
4. Allergic to the contrast agent of TACE
5. Dysfunction of liver, kidney or bone marrow.
6. Concomitant other malignant tumor or HIV infection
Asthma Partnership for Minority Children

To evaluate the efficacy of a community-based intervention to improve asthma management for parents, children and health care providers.

DESIGN NARRATIVE:

Forty-two (42) elementary schools in urban Baltimore and Washington, DC, served as recruitment sites and approximately 300 students with moderate to severe asthma were enrolled. All participants enrolled in the A+ Asthma Program. Primary care practitioners of these students were randomized to a minimal contact program or to the A+ asthma physician partnership. They were offered a menu of educational offerings to improve their knowledge and skills. The primary outcome measure was emergency care use. Secondary measures included physician practices, hospitalization, health care utilization, restricted activities, medication use, school absences and coping skills.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Lactobacillus Kefiri LKF01 (DSM32079) in Newborns Born by Caesarian Section

The mode of delivery affects the diversity and colonization pattern of the gut microbiota during the first year of infants' life.

Probiotics have been observed to positively influence the host's health, but to date few data about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns born by elective caesarian sectional be randomized to a Lactobacillus kefiri LKF01 DSM32079 (LKEF) supplementation or placebo for 21 days. Changes in the gut microbiota composition were detected by using a Next Generation Sequencing technology.


Eligibility Criteria:
Inclusion Criteria:

* Term newborn
* Adeguate for gestational age
* Born by elective cesarean section
* Otherwise healthy newborn

Exclusion Criteria:

* major acute or chronic disease
* use of probiotics/antibiotics
* gastrointestinal malformation, cystic fibrosis, other genetic diseases
* concurrent participation in other clinical trials