cyrilzakka/clinical-trials huggingface dataset:
Preventing Opioid Overdose Mortality in the United States

This study aims to conduct a randomized controlled trial of 105 syringe services programs (SSPs) throughout the United States to understand the effectiveness of a multifaceted, facilitation-based strategy at advancing naloxone implementation effectiveness within SSPs. Together, these efforts can improve access to naloxone for people at high risk of overdose, thereby improving our nation's response to the opioid overdose epidemic.

We conducted a randomized controlled trial of SSPs throughout the United States (US) and US Territories. Prior to the trial, 342 SSPs were known to be operating throughout the US and US Territories. Our team launched a national survey of syringe services programs (NSSSP) in February 2019 of all known SSPs operating throughout the United States and its Territories, receiving a response from 263 (77%) SSPs. Among the responding SSPs, 94% were implementing overdose education and naloxone distribution (OEND), and a total of 105 of SSPs implementing OEND were recruited into the trial. SSPs were randomized in a 1-to-1 fashion to either receive the OEND best practice recommendations (comparison SSPs) or the OEND best practice recommendations along with facilitation-based implementation strategies as detailed below (intervention SSPs).

We tested the effectiveness of a multifaceted, facilitation-based strategy at advancing OEND implementation effectiveness within SSPs. Implementation effectiveness is 'an organization-level construct that refers to the aggregated consistency, quality, and appropriateness of innovation use (OEND) within an organization (SSP).'

Eligibility Criteria:
To be eligible, an organization must have: 1) met the definition of an SSP - an organization whose primary function is to distribute drug use supplies to participants to reduce harms associated with drug use, 2) implemented OEND for a minimum of 6 months, and 3) completed the national survey of syringe services programs fielded February-July 2019. We excluded organizations such as fire departments or emergency departments of hospitals that offered supply distribution since it would be an ancillary function of these organizations and OEND programs that were not part of a syringe services program.
Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia

This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized for this study (2000-2008).


Eligibility Criteria:
Inclusion Criteria:

* Male
* aged 50 years or older
* diagnostic claim for BPH
* prescription claim for an AB and a 5ARI in the observation period (5ARI must occur within a 6-month window after the AB).
* continuously eligible for 6 months prior to and 12 months after index prescription date

Exclusion Criteria:

* prostate or bladder cancer during the study period
* any prostate-related surgical procedure within 5 months of the index prescription date
* prescription claim for finasteride 1 mg for male pattern baldness during the study period
* 5ARI therapy prior to initiation of AB therapy
Small Airways Involvement in Smoker Asthmatic Patients: a Pilot Study

Asthma is an inflammatory disease affecting the whole respiratory system, from central to peripheral airways. Anti-inflammatory treatment with inhaled corticosteroids (ICS), with or without long-acting β2-adrenoceptor agonists (LABA), is the cornerstone of asthma management \[GINA Guideline - available at www.ginasthma.com\]. Nevertheless, a considerable subset of asthmatic patients neither benefits from ICS nor gain optimal asthma control even with ICS/LABA combinations.

The involvement of the distal lung, i.e. the peripheral membranous bronchioles \< 2 mm in diameter (so-called small airways), in the pathogenesis of asthma has been extensively investigated and its significance debated. However, whether specifically targeting distal lung abnormalities can lead to further clinical benefit is still an open question. In this context, interest has been raised by hydrofluoroalkane (HFA) pressurised metered-dose inhalers, which can deliver compounds with a mass median aerodynamic diameter that is significantly smaller than other available devices, leading to increase peripheral airways drug deposition.

Up to 30% of asthmatic patients smoke, mirroring the rate found in the general population. Several data document that smoking habit negatively affect corticosteroid efficacy in asthma. In particular, asthmatic patients who smoke experience faster lung function decline, increased frequency of exacerbations and reduced asthma control despite being regularly treated. Several molecular mechanisms have been proposed to address the issue of reduced corticosteroids responsiveness in smoker patients. However it has been never investigated whether reduced corticosteroid responsiveness in asthmatic patients who smoke can be related to more severe small airways involvement leading to impaired distribution or impaired peripheral deposition of inhaled corticosteroids. If this is the case, asthmatic patients who smoke might benefit from a pharmacological approach able to target and to reach small airways.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-50 years old, at stage 2-3 according to GINA international guidelines
* patients must be free from an exacerbation from at least 2 months
* patients must be on inhaled treatment (ICS alone or combination ICS/LABA) other than extrafine formulations from at least 3 months.
* according to smoking habit, patients will be divided in two groups:

  1. nonsmokers: patients who never smoked
  2. smokers: patients with a smoking habit ranging from 10 to 20 pack/years.

Exclusion Criteria:

* to avoid possible overlapping with chronic obstructive pulmonary disease, patients will not be included in the study if any of the following exclusion criteria are present:

  * aged \> 50 years
  * heavy-smoker patients (pack/years \> 20)
  * patients with a not fully reversible airflow obstruction (i.e. post-bronchodilator FEV1/FVC \< 70%)
  * patients with an impaired diffusion capacity (DLCO \< 80%v predicted).
Predictors for Recurrence of Atrial Fibrillation After Electrical Cardioversion

In patients with persistent atrial fibrillation (AF), electrical cardioversion is very effective in restoring sinus rhythm if modern, biphasic cardioverters are used. However, approximately 50 per cent of the successfully cardioverted patients experience a recurrence of AF within a few weeks. Therefore, valid predictors for AF recurrence would be of great clinical relevance, to avoid unnecessary procedures.

In the PRE-ELECTRIC study, we will investigate the predictive value of potential new biomarkers with respect to AF recurrence within 30 days after electrical cardioversion. We will investigate serum and plasma biomarkers, electrocardiological markers and echocardiographic variables in this respect. The study will be undertaken as a prospective cohort study at Bærum Hospital, Vestre Viken Hospital Trust, with national and international collaborators.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years referred for electrical cardioversion for persistent atrial fibrillation
* Signed, informed consent

Exclusion Criteria:

* Patients \< 18 years
* Patients with paroxysmal atrial fibrillation
* Patients unwilling to participate or without consent competence
A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)

This is an open label Phase 2, 2-stage, 2-cohort study to evaluate rucaparib in combination with nivolumab in patients with high-grade serous or endometroid ovarian cancer.

Patients entering the following cohorts must have BRCA mutational status confirmed by a central lab:

* Cohort A1: No BRCA mutation in tumor; high level of LOH (loss of heterozygosity)
* Cohort A2: BRCA mutation in tumor


Eligibility Criteria:
General Inclusion Criteria:

* ≥ 18 years of age
* Adequate organ function
* Life expectancy ≥ 16 weeks
* Women of childbearing potential must have a negative serum pregnancy test
* High-grade serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
* Received 1 or 2 prior regimens, including ≥ 1 prior platinum-based therapy and have platinum-sensitive disease
* Relapsed/progressive disease (confirmed by radiologic assessment)
* Willing and able to have a biopsy of tumor at screening and after 4 weeks of treatment.
* Measurable disease (RECIST v1.1)- Cohort A1 only
* ECOG performance status of 0 to 1

General Exclusion Criteria

* Active second malignancy
* Central nervous system brain metastases
* Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis.
* Active, known or suspected autoimmune disease (eg, autoimmune hepatitis).
* Condition requiring systemic treatment with either corticosteroids
* Prior treatment with a PARP inhibitor or immune checkpoint inhibitor.
* Non-epithelial tumors (pure sarcomas) or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors. Mixed Mullerian tumors/carcinosarcomas are allowed.
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery

Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in various types of major surgery (orthopedic surgery, spine surgery, cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is being conducted to compare the efficacy of tranexamic acid plus standard of care versus standard of care in reduction of blood loss in patients undergoing major abdominal surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing major abdominal surgery (Biliary strictures, Pancreatico-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy, Gastrectomy, Other major abdominal surgeries with similar expected blood loss)

Exclusion Criteria:

* Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia.
* Patients with known coagulopathy.
* Patients with anemia (hemoglobin levels less than 8 mg/dl)
* Patients with documented DVT or PE at screening or in past three months.
* Patients with any associated major illness (e.g., severe cardiac or respiratory disease).
* Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
Financial Incentives to Exercise for Adolescents

Among youth populations, American Indians have the highest prevalence of diabetes in the United States. This study will use exercise as the principal lifestyle modification approach to reduce the risk of diabetes in this population. The Choctaw Nation of Oklahoma has several excellent, but underutilized wellness facilities in their Health Services Area in rural Southeast Oklahoma, a low socioeconomic region. It has been established that exercise lowers diabetes risk, and many overweight/obese, insulin resistant American Indian youth who live in this region would benefit from an increase in regular exercise. The challenge is to modify behavior so that routine exercise is established and maintained. The proposed study will test whether monetary incentives can elicit greater frequency and duration of exercise in American Indian youth when transportation and access barriers are reduced.

Study participants in the intervention arm of the study will be asked to exercise on 3 days per week for 48 weeks. Clinical and physical assessments will be performed at baseline and after 16, 32 and 48 weeks. Participants will be randomized into one of two groups. Each group will receive payment for exercise sessions completed but one group will be on a fixed schedule of compensation and the other will have a schedule that incentivizes frequency or duration of exercise. In addition, two reference groups of age-matched participants who are normal weight and subclassified as having either low or high levels of physical activity and fitness will be tested. The reference groups will complete baseline tests and will not enter the exercise intervention program.

Eligibility Criteria:
Inclusion Criteria for exercise intervention cohort:

* 11.0-20.9 years old
* overweight or obese
* family history of diabetes (primary or secondary relative)
* not in sports or exercise program (3 or fewer days per week of moderate-to-vigorous intensity physical activity, MVPA) for prior 3 months
* Tanner stage 2 or above

Inclusion Criteria for reference group cohort:

* 11.0-20.9 years old
* normal weight
* For low physical activity subgroup: not in sports or exercise program (3 or fewer days per week of MVPA) for prior 3 months
* For high physical activity subgroup: \>30 minutes of structured MVPA on \>3 days/week over the preceding 3 months
* Tanner stage 2 or above

Exclusion Criteria for all participants:

* metabolic, endocrine, cardiovascular, kidney disease
* orthopedic problems that limit physical activity
* medications or treatments that would interfere with the outcomes and interpretations
* smoking or tobacco use
* alcohol or illicit drug use
* pregnancy
First-in-human Trial of Home Brain Pressure Measured Using Kitea ICP Sensor, Placed During Hydrocephalus Shunt Surgery.

Patients with hydrocephalus have an abnormal build-up of fluid around the brain and need a tube surgically implanted to drain that fluid. Patients and their caregivers live with the constant fear that the tube will block. Warning symptoms include irritability, headaches and vomiting. Unfortunately, there is no way of telling when fluid build-up is causing a rise in brain pressure and potentially impeding blood flow to the brain (life threatening) except for a brain scan in hospital and possibly hospitalisation.

The investigators want to improve the lives of patients with hydrocephalus. They have developed a tool for parents and caregivers to monitor the pressure in the brain remotely via a sensor placed alongside the drainage tube. The device has been shown to be safe and to give reliable brain pressure readings using a large animal model (sheep). This study is a first-in-human safety study to show it is safe for patient use.

Participants with hydrocephalus who are at risk of repeated bouts of hospitalisation associated with shunt failures and therefore likely to benefit from being able to monitor intracranial pressure will be recruited. 10 adult (\>16 years) and 10 children (1-15 years) participants will be recruited in a staggered fashion to allow appropriate evaluation of outcomes. Participants will be recruited when they present to hospital requiring a shunt placement (or revision). At the same time as this surgery, the Kitea Sensor will be placed in the brain near the shunt. Participants will be asked to make measurements of their brain pressure at home using the Kitea ICP System for the next 3 months. Aside from the placement of the Kitea Sensor and home measurements of ICP using the Kitea ICP system, all clinical interventions will be standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a condition requiring cerebral spinal fluid shunting who are undergoing initial shunt placement or shunt revision surgery.
* Adults: Age \> 16 years; Children: Age \>1 and \<15

Exclusion Criteria:

* Adults: Unable to give informed consent
* Paediatric: Failure to obtain assent in a cognitively competent child along with parental consent or parent unable to consent.
* Cortical mantle \< 20 mm
* Neurologic or other condition that would prevent compliance with protocol
* Terminal illness with expected survival \< 1 year
* Unable to participate in follow-up for 3 months (e.g., travelling overseas for an extended period)
* Underlying medical condition that would make the participant more prone to surgical infections
* Other active implanted medical devices e.g. pacemaker, cochlear implant, implantable cardioverter defibrillator, deep brain stimulation devices
* Participants with conditions likely to require radiation therapy
A Study of GPC3 Redirected Autologous T Cells for Advanced HCC

Intravenous infusion of CART cells in the treatment of solid tumors may be not a suitable choice. Because by intravenous infusion, T cells first entered into the blood circulation, but the number of T cells accumulated at the tumor site is limited, while the probability is high that CART cells contact with normal tissue where target protein is expressed, leading to a more potential off-target side effect. In this study, CART cells infused to the body is mediated by the method of transcatheter arterial infusion(TAI), which is one kind of tumor intervention therapy pathway. We hope by this means could improve the local CAR-T cell numbers，meanwhile reduce the potential side effects.

Patients treated with leukapheresis from which peripheral blood mononuclear cells are purified. T cells are activated and then re-engineered to express chimeric antigen receptors (CARs) specific for GPC3. Cells are expanded in culture and returned to the participant by transcatheter arterial infusion at the dose of .(1-10)×106 CAR positive T cells/kg. The cells perfusion process would last for 15min to 2 h via an ambulatory infusion pump. A single dose of 1.5 grams/m2 of cyclophosphamide will be given two days before CART cell infusion.

Eligibility Criteria:
Inclusion Criteria:

* GPC3 expression positive and histologically confirmed as hepatocellular carcinoma;
* Aged between 18 and 69;
* Persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients;
* Life expectancy greater than 6 months;
* Satisfactory organ and bone marrow function as defined by the following: (1) creatinine \<1.5mg/dl; (2) albumin \>2; (3) cardiac ejection fraction of \>55%; (4) hemoglobin\>9g/dl, bilirubin 2.0×the institution normal upper limit;
* Without bleeding disorder or coagulation disorders;
* Dont allergy to Radiocontrast agent;
* Birth control;
* Adequate venous access for apheresis, and no other contraindications for leukapheresis;
* Voluntary informed consent is given.

Exclusion Criteria:

* Pregnant or lactating women;
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary;
* Patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before;
* Four weeks before recruit accepted radiation therapy;
* Previously treatment with any gene therapy products;
* Feasibility assessment during screening demonstrates\<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation;
* Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases);
* Patient with severe acute hypersensitive reaction;
* Taking part in other clinical trials;
* Study leader considers not suitable for this tiral.
A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease

The purpose of this study is to determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Moderate-to-Severe Alzheimer's disease
* Mini-Mental State Examination (MMSE) Score between 5 to 14, inclusive
* Stable on donepezil for at least 6 months

Exclusion Criteria:

* Other causes of dementia
* Major structural brain disease
* Unstable medical condition or significant hepatic or renal disease
Efficacy and Safety of DEB-BACE With Sequential Arotinib and Tirelizumab in the Treatment of Advanced NSCLC

This is a prospective, open-labelled study to evaluate the efficacy and safety of arterial infusion chemotherapy combined with drug loaded microspheres embolization with sequential arotinib and tirelizumab in the treatment of advanced NSCLC. The progression-free-survival (PFS) will be evaluated as the primary endpoints.


Eligibility Criteria:
Inclusion Criteria:

1. Has fully understood and voluntarily signed an written Informed Consent and agreed to follow the research plan treatment and visiting plan;
2. Aged \>=18 years, \<= 85 years;
3. Patients with NSCLC diagnosed by imaging and histopathology; TNM stage was III-IV;
4. Initial diagnosis, failure of first-line treatment, refusal or inability to perform routine treatment (surgery, radiotherapy and chemotherapy);
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
6. Expected survival period ≥ 3 months.

Exclusion Criteria:

1. Known hypersensitivity to any of the study drugs or excipients;
2. Hypertension that is not controlled by the drug;
3. International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 × ULN;
4. WBC count \< 3000 /mm3;
5. Platlet count \< 50000 /mm3;
6. Poorly controlled diabetes before enrollment;
7. Clinically significant electrolyte abnormalities judged by researchers;
8. Patients with obvious evidence of bleeding tendency or medical history of hematochezia within 3 months before enrollment;
9. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade \> 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) \< 50%;
10. Active infection or serious infection that is not controlled by drug;
11. History of clinically significant hepatic disease (ALT and/or AST \>5 times the upper normal limit);
12. Women who are pregnant or lactating;
13. Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g;
14. Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions, which according to the judgment of the investigator, it is reasonable to suspect that the patient is not suitable for the use of the study drug.