cyrilzakka/clinical-trials huggingface dataset:
Community Pharmacists and Opioid Misuse

Opioid medication misuse and overdose have reached epidemic proportions in the US. Community pharmacy is a potentially valuable resource for addressing opioid medication misuse. This study will manualize and establish the feasibility, acceptability, and clinical effect of a community pharmacist-led intervention aimed at: improving opioid mediation regimen adherence, eliminating misuse, connecting patients to additional care, and safeguarding against overdose.

The current small scale single-blinded randomized controlled study will build on our preliminary studies by manualizing and examining the feasibility, acceptability, and clinical effect for the Brief Intervention Medication Therapy Management (BI-MTM) model. BI-MTM is a multicomponent community pharmacy-based intervention. BI-MTM is designed to: (1) promote opioid medication regimen adherence, (2) reduce opioid medication misuse, (3) connect participants with patient navigation (a chronic condition care model) to increase self-management of health conditions that increase risk for misuse, and (4) provide naloxone rescue training referrals. Patients will be screened across 14 months for opioid medication misuse in an urban community pharmacy affiliated with a major medical system. Patients positive for misuse will be randomly assigned to BI-MTM (n=23) or Standard Medication Counseling (n=23). Standard Medication Counseling is the Centers for Medicaid and Medicare Services requirement for pharmacists in the US wherein pharmacy patients filling prescriptions receive information and opt-in counseling. This study will demonstrate feasibility and acceptability of BI-MTM for community pharmacy patients who misuse their opioid medications for future intervention implementation in a fully powered randomized trial. This study will also generate preliminary data regarding opioid medication misuse elimination and increases in participant self-management activation for comorbid health conditions that increase risk for misuse.

Eligibility Criteria:
Inclusion Criteria:

* Opioid Misuse

  -≥18 years
* English speaking

Exclusion Criteria:

* Are pregnant (given potential pre/post-natal opioid use complications among pregnant women/offspring)
* Cannot provide collateral contact information for ≥2 contact persons (to ensure consistent contact/follow up)
* Do not have a reliable landline or mobile phone to be contacted by study staff
* Are only filling buprenorphine (given some formulations are not indicated for pain)
* Plan to leave the area for an extended period of time in the next 3 months
* Have had a psychotic and/or manic episode in the last 30 days
Multinational Monitoring of Trends and Determinants in Cardiovascular Disease (MONICA)

To foster collaboration between the World Health Organization MONICA Project and the NHLBI Study of Atherosclerosis Risk in Communities (ARIC). To ensure that valid comparisons could made between findings in MONICA and ARIC by supporting activities to standardize coding, classification, and analysis of coronary and stroke events, risk factors, and medical care according to MONICA protocol.

BACKGROUND:

The MONICA Project was undertaken by the World Health Organization (WHO) as a ten year international effort to measure the trends in cardiovascular mortality and coronary heart disease and cerebrovascular disease morbidity and to assess the extent to which these trends were related to changes in known risk factors, daily living habits, or major socioeconomic features. Pilot studies were completed in 1981 in four countries and by 1985 there were 41 MONICA's in defined communities in 27 countries. Each study site covered a population of around 300,000 persons and was expected to be studied for a decade. The centers measured the incidence of cardiovascular disease--particularly coronary heart disease and cerebrovascular diseases--and assessed the extent to which these trends were related to changes in known risk factors (smoking, blood lipids, blood pressure, diet), daily living habits, health care, and major socioeconomic factors in the study populations. MONICA was also expected to introduce, in the countries concerned, new health statistical methods that would lead to more effective use of national health information systems.

As an Associate Member of MONICA, NHLBI received copies of unclassified project documentation and was represented at meetings of MONICA Principal Investigators. However, central data analysis and quality control evaluations were not available to associate members.

Under this contract, NHLBI received summary tabulations of: population demographics and vital statistics including the numbers of total deaths and of cardiovascular, coronary heart disease and stroke deaths among residents of each Reporting Unit; fatal and non-fatal coronary and stroke events; ECG abnormalities, chest pain symptoms, and cardiac enzyme measurements; population survey prevalence rates and distributions of risk factors including but not limited to blood pressure, total cholesterol, other lipids and lipoproteins, height, weight, and cigarette consumption; hospitalizations and medical care for cardiovascular conditions; case fatality rates within 28 days of onset of a heart attack, stroke, or other cardiovascular event. The NHLBI also received reports on the quality of the data and performance at each site based on the circulation and evaluation of test case histories.

Eligibility Criteria:
No eligibility criteria
A Study to Access of Daratumumab Combined With VRD in the Treatment of Patients With Standard-risk Newly Diagnosed MM

This is an open-label, single arm study to access the effect of treatment with D-VRD in patients with newly diagnosed standard risk multiple myeloma.

Research object:Newly diagnosed standard-risk multiple myeloma (NDMM) diagnosed according to the International Myeloma Working Group (IMWG) standards and who have been assessed to receive Autologous Stem Cell Transplantation (ASCT) but actively refused.Objective: To explore the therapeutic options of daratumamab (D) combined with bortezomib (V), lenalidomide (R) and dexamethasone ( d) for objective assessment of patients who can receive ASCT but not to receive transplantation.Main indicators:negative rate of minimal residual disease (MRD) upon completion of cycle 8 (24 weeks).

Eligibility Criteria:
Inclusion Criteria

1. Age ≥ 18 years and ≤ 70 years, male or female；
2. Newly diagnosed multiple myeloma (NDMM) ；
3. Transplant-eligible；
4. Non-17p-, t(4;14) , t(14;16)；
5. Expected survival ≥12 weeks;
6. Eastern Cooperative Oncology Group (ECOG) scores 0 - 2.
7. Subjects should have adequate hemostatic and liver and kidney meet the following examination criteria: (without ongoing supportive treatments):

   1. Complete blood count (CBC) results: absolute neutrophil count（ANC） ≥ 1.0 × 109/L, platelet count ≥ 75 × 109/L (if the proportion of plasma cells in the bone marrow is \> 50%, subjects with platelets ≥ 50 × 109/L will be eligible), Hb ≥ 70 g/L.
   2. Blood biochemistry: creatinine clearance ≥ 30 mL/min, alanine aminotransferase (ALT) ≤ 2.5 × upper limit normal (ULN)，aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN. Serum calcium ≤14.0 mg/dL (≤3.5 mmol/L);
8. Normal cardiopulmonary function;
9. The patient agrees to join the clinical trial and signs an informed consent form.

Exclusion Criteria

1. Poor hypertension control;
2. Have received ASCT or anti-tumor systemic therapy;
3. Peripheral neuropathy or neuralgia of grade 2 or higher;
4. During pregnancy or lactation or planning to become pregnant;
5. History of other malignant tumors within 5 years;
6. Subjects positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema pallidum (syphilis) antibody, hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) and HBV DNA.
7. Participating in other clinical trials;
8. Allergic to the drugs in the treatment plan;
9. Receiving any other experimental drugs or experimental medical devices;
10. The investigator believes that the patient has other conditions that are not suitable for participating in this study.
11. Patients with R-ISS Phase III

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Prevalence of Insufficient Analgesia in Caesarean Section Under Neuroaxial Anesthesia (PAICAN)

Pain during caesarean section under neuraxial anesthesia is often underestimated and could be related to perinatal psycholocal disorders.

The implementation of an evidence-based anesthestic management protocol for caesarean sections aims at reducing intraoperative and postoperative pain.

This prospective observational single-center study aims at determining whether this protocol helped to reduce the prevalence of insufficient analgesia in during caesarean sections.

Caesarean surgery is one of the most frequent surgeries around the world and neuroaxial anesthesia is the preferred anesthesia technique in most settings. Still, many women experience pain during caesarean section, and it has implications in their birth experience. The PAICAN study (Prevalence of Insufficient Analgesia in Caesarean Section under Neuroaxial Anesthesia) aims to study how the implementation of a specific protocol of anesthetic management during caesarean section reduces the intraoperative pain and the need of postoperative painkillers.

Other objectives are:

* To study the adherence to the new protocol in our centre
* To understand the mechanisms of the failure of neuraxial anesthesia
* To study the related factors to insufficient analgesia during surgery (demographic, obstetric, anesthetic, etc.).

Hypothesis: the implementation of an anesthestic management protocol for caesarean sections under neuroaxial anesthesia decreases the prevalence of insufficient analgesia during surgery and in the recovery room.

Design: Prospective observational single-center study.

Eligibility Criteria:
Inclusion Criteria:

- Pregnant women aged 18 or more undergoing a caesarean section under neuraxial anesthesia

Exclusion Criteria:

* Non pregnant women
* Women under 18 years old
* General anesthesia as first option for anesthesia
* Refusal to participate in the study
* Women with cognitive impairment or held in an institution by legal or official order
Intestinal Remodeling And Reprogramming of Glucose Metabolism Following Laparoscopic Roux-en-Y Gastric Bypass

The purpose of this study is to investigate small intestinal remodeling and reprogramming of glucose metabolism in patients with Type 2 Diabetes Mellitus (T2DM) who undergo laparoscopic Roux-en-Y Gastric Bypass (RYGB). Our specific goal is to determine if the gene and protein expression levels of GLUT-1 are up regulated in the Roux limb and whether this is a major mechanism for the remission of T2DM following RYGB.

The two aims of the study are: 1) to demonstrate that the basement membrane glucose transporter 1 (GLUT-1) is upregulated in the Roux limb following RYGB, and 2) to demonstrate that the upregulation of GLUT-1 is a major mechanism for the improvement in glycemic control observed in T2DM patients undergoing RYGB.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Type 2 Diabetes Mellitus
2. Age between 18 and 65 years of age
3. BMI \> 35kg/m²
4. Diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.

Exclusion Criteria:

1. Patients undergoing revision from another bariatric procedure to RYGB
2. Presence of a seizure disorder (GLUT-1 deficiency syndrome)
3. Use of Tricyclic antidepressants
4. Use of tobacco products
the Quality of Life Assessment of Lung Cancer Patients in China

The goal of this study is assess the quality of life of advanced non-small cell lung cancer (NSCLC) patients who are undergoing first-line chemotherapy, analyze the current status and tendency of quality of life (QOL). The method is to use the Functional Assessment of Cancer Therapy-Lung (FACT-L) scales, assess the quality of life before the chemotherapy, after 1st cycle of chemotherapy and after 2nd cycle. After 3 time-points, investigators analyze all the subscales and constructs of FACT-L. The assumption is the quality of life will be better after 2 cycle of chemotherapy.

1. Lung cancer is the most deadly cancer in the world, 85% lung cancer are non-small cell lung cancer (NSCLC). The quality of life of NSCLC patients become more and more important, because of most NSCLC is incurable.
2. The recruitment will take place in 20 center all over the country and 500 patients will enrolled.

Eligibility Criteria:
Inclusion Criteria:

* age: \>18 and \<75 years old
* pathological or cytological diagnosis confirmed advanced non-small cell lung cancer
* Eastern Cooperative Oncology Group Performance Status: 0-2
* have never receive any kind of anti-cancer chemotherapy
* agree to regularly assessment of quality of life
* sign the informed consent form

Exclusion Criteria:

* Currently attending any antitumor drug clinical trials
* Pregnancy or breast-feeding women
* Currently receiving anti-tumor chemotherapy, or received any antitumor chemotherapy previously.
* not suitable to participate in this test
LCI and Bronchial Inflammation in Patients With BO

The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the results of the Lung Clearance index (LCI) . Further this study evaluates bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years compared with an age- and sex-matched control group. The investigators will perform a pulmonary function test (body plethysmography with DLCO) and compare the results with the LCI. Further we will measure the fraction of exhaled nitric oxide (FeNO) and draw a blood sample to determine the level of systemic inflammation. Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers. This study will set baseline markers for future interventional studies.

The purpose of this study is to compare lung function values with the Lung clearance index of 20 Patients with Bronchiolitis obliterans aged between 6 up to 28 years. Further we aim to compare the bronchial Inflammation between the patients and a reference group with similar age conditions to determine possible outcome-parameters for following interventional studies.

The sputum samples will be processed and quantitatively analyzed to get a profile of the cytological composition.

(Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) and by cytometric bead assay (CBA).)

Methods and Work Programme:

* Measurement of nitric oxide in expired air (FeNO)
* Lung function testing with spirometry and body plethysmography
* Lung clearance index (LCI)
* Bronchodilation
* Blood test: blood count, CRP, RAST, serum inflammatory mediators, (genetic markers of the non-specific pulmonary defense system)
* Induced sputum for inflammatory mediators and microbiological investigations

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* between 6 and 28 years of age
* Known Bronchiolitis obliterans

  * no Bronchiolitis obliterans(depending on the study group)
* Ability to perform lung function tests and inhalation

Exclusion Criteria:

* Acute illness with systemic or bronchial inflammation
* every chronic condition or infection (eg HIV, tuberculosis, malignancy)
* pregnancy
* known alcohol and/ or drug abuse
* Inability to understand the extent and scope of the study
* Participation in another study
Cardiac Metabolic Remodeling After Pulmonary Vasodilator Therapy in Pulmonary Arterial Hypertension: A Pilot Study

Pulmonary arterial hypertension(PAH) is associated with the development of right heart failure. In the setting of heart failure, the heart shifts to increasing dependence on glucose metabolism. In this study, the investigators will perform cardiac positron emission tomography/magnetic resonance imaging (PET/MRI) scans to measure glucose metabolism in the heart before and after initiation of pulmonary vasodilator therapy for pulmonary arterial hypertension.

Pulmonary arterial hypertension is associated with the development of right heart failure. In the setting of heart failure, the heart shifts to increasing dependence on glucose metabolism. In this study, the investigators will perform cardiac positron emission tomography/magnetic resonance imaging (PET/MRI) scans to measure glucose metabolism in the heart before and after initiation of pulmonary vasodilator therapy for pulmonary arterial hypertension. By utilizing a rest-exercise protocol and continuous PET imaging acquisition, we can capture real-time changes in glucose uptake in the heart in response to acute exercise. By coupling these measures of dynamic glucose utilization with MRI-based cardiac function, we will determine cardiac metabolic efficiency.

Eligibility Criteria:
Inclusion Criteria:

* World Health Organization(WHO) group PAH secondary into idiopathic pulmonary arterial hypertension(IPAH) or connective tissue disease associated pulmonary arterial hypertension (CTDPAH)
* New York Heart Association (NYHA) classification I - III heart failure
* Vasodilator therapy naive
* Able to provide informed consent

Exclusion Criteria:

* Metabolic disorders such as uncontrolled diabetes (A1c \> 8%) that may interfere with FDG uptake
* Baseline 6-minute walk distance (6MWD) \< 400 feet or NYHA class IV heart failure
* Musculoskeletal abnormalities that would prevent exercise
* Contraindications to MRI
Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties

The study aims to examine the intra-rater, inter-rater, and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes.

Therefore, changes occur in standing weight-bearing points, loading zones, and gait biomechanics. The thickened plantar fascia increases the risk of developing diabetic foot with increased peak-plantar pressure, and therefore, plantar fasciitis is more common in individuals with diabetes than in healthy individuals. The myotonometer studies showed that chronic diabetes history increases dynamic stiffness, which is one of the mechanical properties of the plantar fascia, and that as the severity of the disease increases, fascial stiffness also increases. The aim of the study is to examine the intra-rater, inter-rater, and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Body mass index \< 30 kilogram/meter square
* Willing to participate in the study
* Diagnosed with Type 2 Diabetes
* HbA1c level ≥ 6.5% mmol/mol
* Fasting plasma glucose ≥126 mg/dl
* Random plasma glucose ≥ 200 mg/d

Exclusion Criteria:

* History of lower extremity injuries
* Ulceration localized on plantar fascia
* Age ≥ 65 years
* Any use of medication that will affect muscle tone
Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma

The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of progression free survival (PFS).

The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of progression free survival (PFS).

Eligibility Criteria:
Inclusion Criteria:

* Female aged ≥18 years
* Patients with newly diagnosed, histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous) who have undergone initial surgery up to 3 weeks before randomization and are selected to receive first line Standard of Care chemotherapy (optional prolongation to 6 weeks after surgery)
* Optimally debulked (zero residuum) or maximal residuum \<1cm
* Eastern Cooperative Oncology Group (ECOG) Performance status 0,1,2

Exclusion Criteria:

* FIGO I,II,IV epithelial ovarian cancer
* FIGO III clear cells epithelial ovarian cancer
* Non-epithelial ovarian cancer (OvCa), borderline tumors (tumors of low malignant potential)
* Post-surgery residual disease with lesion(s) \>1cm
* Prior or current systemic anti-cancer therapy for ovarian cancer \[for example chemotherapy, monoclonal antibody therapy (bevacizumab), tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy\]
* Previous or concurrent radiotherapy to the abdomen and pelvis
* Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas
* Patient co-morbidities:Human immunodeficiency virus (HIV) positive, human T-lymphotropic virus (HTLV) positive, Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis
* Evidence of active bacterial, viral or fungal infection requiring systemic treatment
* Clinically significant cardiovascular disease including:

Symptomatic congestive heart failure Unstable angina pectoris Serious cardiac arrhythmia requiring medication Uncontrolled hypertension Myocardial infarction or ventricular arrhythmia or stroke within a 6 month period before inclusion, ejection fraction (EF) \< 40 percent or serious cardiac conduction system disorders, if a pacemaker is not present
Bone Marrow Collection in Healthy Volunteers (iCell)

This is a observational study in which healthy found volunteers are recruited to donate 50 ml of bone marrow aspirate to enable preclinical studies to obtain proof of concept and safety of a bone marrow derived stem cell preparation named AMARCELL. The prepared AMARCELL is only for animal studies and after completion of the preclinical program, the intention of AMARCELL is to treat humans with a traumatic Spinal cord injury.

Coded anonymized patient data

Eligibility Criteria:
Inclusion Criteria:

* Men in the age range of 21-30 years and/or women in the age range of 21-30 years and taking birth control medication to prevent pregnancy
* Written informed consent
* Healthy as concluded by the answers given to questions in a short health questionnaire

Exclusion Criteria:

* Pregnancy or lactation period
* Volunteers who are unable to comply with the rules of this project. Important is if the volunteer can not follow the schedule of the appointments.
* Abuse of alcohol, medicines or illicit drugs.
* Legally protected people