cyrilzakka/clinical-trials huggingface dataset:
Back to the Future: Bridging the Hospital to Home Continuum After Hip Fracture

The purpose of this study is to determine whether is is feasible and acceptable to deliver a telephone based coaching intervention compared with education alone in community dwelling older adults (age 60 and older) after a fall related hip fracture.

The investigators propose a randomized controlled trial design to inform the development of a larger scale study to test effectiveness of a clinician supported telephonic self management intervention for older adults after hip fracture. The primary aim is to determine feasibility and acceptability of the intervention, and the secondary aim is to measure statistical trends on quality of life at 4 months after fracture in community dwelling older adults. In parallel, we will conduct a process evaluation to ascertain key features of the intervention via qualitative interviews of participants and health care professionals involved in delivery of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults (men and women) over 60 years of age
* Fall related hip fracture
* Community dwelling
* English speaking

Exclusion Criteria:

* Dementia
* Medical co-morbidities precluding physical activity (significant heart failure, palliative conditions etc.)
* Profound hearing loss
PCR Based CEUS in BI RADS 4A Nodules

The aim of this study was to investigate the added value of Principal Component Regression (PCR) based contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS).

The aim of this study was to investigate the added value of Principal Component Regression (PCR) based contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS). The study included patients with 4A nodules confirmed by core biopsy and/or surgery. The CEUS parameters were assessed and PCR scores were calculated to evaluated the added value in BI-RADS 4A nodules.

Eligibility Criteria:
Inclusion Criteria:

patients with BI-RADS 4A breast lesion

Exclusion Criteria:

(i) absence of a pathologic diagnosis; (ii) presence of breast nodules that were too large to compare with normal parenchyma; (iii) patients with radiotherapy and chemotherapy of breast cancer; and (iv) skin disorders.
The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed ITP

A single-arm, open-label study to evaluate the efficacy and safety of Acetylcysteine plus high-dose Dexamethasone in adults newly diagnosed with primary immune thrombocytopenia (ITP).

This is a prospective, open-label, Phase II, single-arm interventional trial performed in a single center in China. The investigators explore the efficacy and safety of Acetylcysteine plus high-dose Dexamethasone in adults newly diagnosed with primary immune thrombocytopenia.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed
2. Platelet count less than 30×10\^9/L on two occasions or Platelets above 30×10\^9/L combined with bleeding manifestation (WHO bleeding scale 2 or above)
3. Subject is ≥ 18 years and ≤80years
4. Subject has signed and dated written informed consent.
5. Fertile patients must use effective contraception during treatment and observational period
6. Negative pregnancy test

Exclusion Criteria:

1. Have an impaired renal function as indicated by a serum creatinine level \> 2.0 mg/dL
2. Have an inadequate liver function as indicated by a total bilirubin level \> 2.0 mg/dL and/or an aspartate aminotransaminase or alanine aminotransferase level \> 3×upper limit of normal
3. Have a New York Heart Classification III or IV heart disease
4. Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
5. Have active hepatitis B or hepatitis C infection
6. Have a HIV infection
7. Have active infection requiring antibiotic therapy within 7 days prior to study entry
8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
9. Previous treatment with rituximab
10. Previous splenectomy
11. Had previous or concomitant malignant disease
12. Not willing to participate in the study.
13. Expected survival of \< 2 years
14. Intolerant to murine antibodies
15. Immunosuppressive treatment within the last month
16. Connective tissue disease
17. Autoimmune hemolytic anemia
18. Patients currently involved in another clinical trial with evaluation of drug treatment
Trial to Investigate the in Silico Optimization of Insulin Treatments

The primary objective of this study is to assess the performance of an in silico designed alternative protocol for control of stress hyperglycemia of inpatients treated for Coronary Artery Bypass Graft (CABG) or valve replacement surgery in the University of Virginia cardiothoracic ICU.

The hypothesis of the study is that settings for the Glucommander protocol can be optimized in silico to achieve statistically improved low blood glucose index (LBGI) within the subpopulation of CABG and valve replacement patients who both receive Glucommander-based insulin therapy and meet Manufacturer's guidelines for starting with an initial multiplier value of .052, without risking clinically significant increase in exposure to hyperglycemia.

Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted for CABG and/or open heart valve surgery
2. Must have a 0.05 initial multiplier setting for the Glucommander based on the manufacturers recommendations
3. Age of 40-75, inclusive

Exclusion Criteria:

1. History of severe hypoglycemia within six months of hospital admission
2. Currently undergoing dialysis or renal replacement therapy
3. Women of childbearing potential
4. Patients with endocarditis needing valve replacement
5. Participation in another clinical trial at the time of screening.
A Trial of SHR-1210 in Combination With SHR6390 in Patients With Advanced CRC, NSCLC and HCC

This is a Phase Ib/II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With SHR6390 (a CDK4/6 Inhibitor) in Patients With Advanced Colorectal Cancer, Non-small Cell Lung Cancer and Hepatocellular Carcinoma.

The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage.

The first part of the study is the Dose-finding Phase designed to establish the safety of SHR-1210 Combination With SHR6390 at different dose Levels(150mg QD or 100mg QD ). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses .

This study aims to evaluate the safety and efficacy of SHR-1210 combination with SHR6390 in the treatment of advanced CRC,NSCLC and HCC.


Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily participate in this study and sign informed consent .
* Men or women aged 18-75 years
* Has confirmed by histology and cytology advanced and/or metastatic colorectal cancer patients, the advanced (Ⅲ B/Ⅳ period) in non-small cell lung cancer，Or patients with advanced hepatocellular carcinoma confirmed histologically or cytologically or clinically，At least one measurable lesion that meets the RECIST v1.1 criteria without local treatment.
* The patients can swallow pills normally.
* ECOG score was 0 or 1.
* Have a life expectancy of at least 12 weeks.
* The functions of vital organs meet the following requirements (excluding the use of any blood components and cytokines during screening) : Neutrophils≥1.5 x 109/L, Hb≥9g/dL; Plt≥90 x 109/L, ALB≥3g/dL, TSH≤ULN(Upper Limit Of Norma), TBIL ≤ 1.25 x ULN, ALT and AST ≤ 1.5 x ULN, AKP≤ 2.5 x ULN, CR≤ 1.5 x ULN
* Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.

Exclusion Criteria:

* Subjects had any active autoimmune disease or history of autoimmune disease.
* Subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone therapy to achieve immunosuppression. It is still in use within 2 weeks before enrollment.
* Subjects with severe allergic reactions to other monoclonal antibodies.
* The subjects had a central nervous system metastases of clinical symptoms.
* Central lung squamous cell carcinoma, or NSCLC with large vascular invasion confirmed by imaging.
* A heart condition or disease that is not well controlled.
* Subjects had active infections.
* Other clinical trials of drugs were used within 4 weeks prior to the first administration.
* The subjects have received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1 or CDK4/6 inhibitor treatment in the past.
* There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.
A Study of Obinutuzumab Evaluating Efficacy, Safety and Cost of Disease Management in Participants With Chronic Lymphocytic Leukemia and Comorbidities

This multicenter, single arm, non-interventional, observational study will evaluate the efficacy and safety of obinutuzumab in daily clinical practice in participants with chronic lymphocytic leukemia (CLL). The study will also assess cost of disease management. The total length of the study is 42 months.


Eligibility Criteria:
Inclusion Criteria:

* Participants with untreated CLL and comorbidities, for which the physician has already decided to use obinutuzumab in association with chlorambucil

Exclusion Criteria:

* Participation in another clinical trial during the study
Educational Intervention Targeting Statin Therapy and Compliance in Diabetic Patients

The objective of the study is to measure changes in compliance to statin therapy in patients with type 2 diabetes after an educational intervention. This intervention is part of the therapeutic education of the diabetic patient, carried out throughout the follow-up of his/her diabetes.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* Type 2 diabetes
* Following treatment with statins
* Hospitalization in the diabetes day hospitals of the Saint Philibert or Saint Vincent Hospitals (Lille, France).
* Ability to answer the Girerd test in both interviews (in the individual interview and by phone)
* Patient informed to participate in the study
* Signed patient's consent.

Exclusion Criteria:

* Patients under guardianship
AONDA Therapeutic Indication Study I

This study will be used to support assessment of AIR OPTIX® NIGHT \& DAY® AQUA (AONDA) Soft Contact Lenses' safety and performance in accordance with updated European Union Medical Device Regulation (EU MDR) requirements.

In this retrospective observational study, the subject wore AONDA as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of a corneal condition with pain for which AONDA Soft Contact Lens as a therapeutic contact lens was placed on one or both eye(s) at Baseline.
* Baseline and Follow-up (up to 1 year from Baseline) charts available.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic contact lens wear or confounds study results during the data collection period, as determined or known by the Investigator.
* Used systemic or ocular medication that would confound study results during the data collection period, as determined or known by the Investigator.
* Other protocol-defined exclusion criteria may apply.
Study to Evaluate the Need of Needle Change for Application of Intramuscular, Subcutaneous and Intradermal Injection.

Comparing the pain intensity on a numeric scale (0-10) with intramuscular and subcutaneous injection between a retractable fixed syringe needle and the technique involving needle exchange; Comparing bruise formation following administration of insulin subcutaneous injections between RFS and the conventional technique.

Method Study site A clinical trial was conducted in two medical-surgical units in a hospital in the period from June 15th to November 30th, 2009, after approval by the Ethics and Research Committee.

Intervention In a group of patients the investigators used syringes with retractable fixed needle to administer subcutaneous and intramuscular injections. In the group of control, the investigators used the standard technique to administer medications.

Population of study Patients were sequentially enrolled through a lottery system of exposure using random numbers kept in sealed, opaque envelopes.

Sampling design and sample size Subcutaneous injection The sample size was based on the expected proportion of bruising following the injection. It was expected that 40% of patients would show bruising with the conventional technique and 20% with the technique under study for subcutaneous applications. With an alpha error of 5% (p = 0.05) and power of study of 80% (beta error of 20% or 0.2) 240 patients were included, 120 in each group.

Intramuscular injection The sample size was based on the proportion of patients with moderate to severe pain. It was considered normal the incidence of moderate to severe pain in 30% with a needle exchange, whereas it was considered an increase of up to 40% with the retractable fixed needle. The investigators included 500 patients in each group.


Eligibility Criteria:
Inclusion Criteria:

* The investigators included all patients over 18 who agreed to participate in the study for subcutaneous and intramuscular injections. The monitoring was done after the reading, comprehension check, and signing of the Term of Free Consent and Clarification.

Exclusion Criteria:

* The investigators excluded patients taking anticoagulants or those who had coagulation disorders, injuries, or skin changes.
The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques

This study aims to explore whether the increased supply of dietary plant sterols and plant stanols have any influence on serum levels of phytosterols and on consistency of carotid atheromatous plaques.

This is a double-blind randomized study. The study population will consist of 30 consecutive patients who will undergo an elective carotid endarterectomy due to a tight asymptomatic stenosis. The patients will be randomized into two groups consuming either plant sterol (2g/day) or plant stanol (2g/day) spreads for two to six weeks, until the operation. Serum lipids, lipoproteins and sterols will be analyzed at the randomization, before the operation and one month after the operation. The carotid arteries will be examined for their composition of sterols.

This study gives new information concerning the relationship between dietary consumption of plant sterols and stanols and the sterol composition of the carotid plaques.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic tight carotid plaques
* Age 40-80

Exclusion Criteria:

* No
Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe

This is a descriptive, observational, multi-country European cross-sectional study of new users of dabigatran etexilate that aims to characterise on- and off-label status and other medical characteristics at the time of the first captured prescription of dabigatran etexilate in each database. The study will be conducted using Cegedim Strategic Database (CSD, France), Danish National Databases (Denmark) and Clinical Practice Research Datalink (CPRD, UK).

Study Design:

Eligibility Criteria:
Inclusion criteria:

1. Have at least 1 year of enrolment in the electronic database.
2. Have not been prescribed dabigatran etexilate during the 1-year period prior to the index date.
Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty

A Randomized controlled trial aiming to investigate whether ascorbic acid has a role in preventing vancomycin induced nephrotoxicity or not in critically ill patients.

Critically ill patients who have gram positive infection (MRSA) and need vancomycin will be assigned randomly into two groups. The first group will be given vancomycin intravenous only (15-20 mg/kg) every 8-12 hours , while the second group will take vancomycin intravenous (15-20 mg/kg) every 8-12 hours plus ascorbic acid 1 gram twice daily orally just before the vancomycin administration by half an hour. Patients will be monitored for one week where serum creatinine, BUN, urine output, trough level will be measured. Acute kidney injury will be determined according to RIFLE criteria.

Eligibility Criteria:
Inclusion Criteria:

* Adults who are critically ill and with MRSA infection suspection.

Exclusion Criteria:

1. Pregnancy or breast feeding.
2. Known allergy to either vancomycin or ascorbic acid.
3. Base line serum creatinine ≥2mg/dl.
4. Patients receiving other nephrotoxic drug (e.g., aminoglycosides, amphotericin B, cisplatin or calcinurine inhibitors).
5. Anticepated administration of contrast medium within 7 days.
6. Patients suffering from some underlying diseases (e.g., cancer, HIV infection, systemic lupus erythematoses,or urinary tract stones).
7. Unlikelyhood of receiving the study medications for at least 72 hours
Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)

The objective of this non-interventional study is to confirm that with standard OsvaRen® treatment it is possible to achieve in at least 60% of the patients the levels of phosphorus, total calcium, and iPTH seen in the CALMAG study also in the normal clinical practice.

Only a small fraction of haemodialysis patients meet the published NKF-KDOQI standards for calcium, phosphorus, calcium x phosphorus product and intact parathyroid hormone. One of the reasons is the still difficult and insufficient therapy with phosphate binders. Even though calcium containing phosphate binders have been proven to be effective, they are reported to lead in certain patients to hypercalcaemia. This observational study therefore not only evaluates the efficacy of the phosphate binder OsvaRen® (containing calcium acetate and magnesium carbonate) but also the frequency of untoward events in daily practice as well as to the state of hyper-/ hypoparathyroidism as represented by serum iPTH values and the practice patterns used to adjust to and to fully exploit the qualities of the different available phosphate binders. In addition, the compensatory actions of the physicians, such as adaptation of the dialysate calcium or the combination with non-calcium containing phosphate binders, are going to be monitored. In order to receive additional safety data in the context of daily practice, the frequency of untoward events related to the treatment will be documented and analysed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Signed Informed Consent
* Patient on maintenance haemodialysis, online haemodiafiltration, or peritoneal dialysis at the time of OsvaRen® prescription
* Patients being treated with OsvaRen® for up to 6 months at the day of inclusion

Exclusion Criteria:

* Prior participation in this observational study
* Use of OsvaRen® for purposes other than those indicated in the Summary of Product Characteristics (SmPC) / package leaflet
Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Non-Small Cell Lung Cancer And Bronchial Disease

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against non-small cell lung cancer.

PURPOSE: This clinical trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with non-small cell lung cancer and bronchial disease.

OBJECTIVES:

Primary

* To test the hypothesis that the immune response in non-small cell lung cancer patients treated with photodynamic therapy (PDT) is T cell mediated.

Secondary

* To test the hypothesis that PDT potentially affects survival rates in these patients.
* To test the hypothesis that T lymphocytes mediate an immune response that affects survival in PDT treated patients.

OUTLINE: Patients deemed suitable for photodynamic therapy (PDT) are offered PDT. Patients are divided into 2 groups according to whether or not they receive PDT. All patients are referred to radiation and medical oncology for standard of care adjuvant therapy (beginning after completion of this study).

* Group 1 (PDT): Patients receive porfimer sodium IV over 3-5 minutes and undergo irradiation with red light 48 hours later. Patients receive 2 more treatments at 2-day intervals.
* Group 2 (non-PDT): Patients undergo a baseline bronchoscopy and a repeat bronchoscopy at 4 weeks.

Blood sample, bronchoalveolar lavage fluid, and tumor tissue are collected after each treatment (group 1) or at time of each bronchoscopy (group 2) and assayed for the presence of lymphocyte phenotypes Th1, Th2, Treg, and Th17. After completion of study therapy, patients are followed at 1 month after PDT and then every 3 months for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have a diagnosis of non-small cell lung cancer, of any stage, with obstructive or hemorrhagic endobronchial disease receiving PDT treatment.

Exclusion Criteria:

* Patients that have undergone PDT, chemotherapy or radiation therapy within the past 3 months will not be considered for enrollment.
* Patients taking antioxidant therapy will be excluded from enrollment due to potential interaction with the potential oxidative mechanism of action of Photofrin®. These antioxidants would include beta-carotene, lutein, Lycopene, Selenium, Vitamin A, Vitamin C, Vitamin E.
Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)

Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).

JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new Tuberculin PPD drug substance to the standard PPD-S2.

Eligibility Criteria:
Inclusion Criteria:

1. Males or nonpregnant females age 18 to 60 years
2. Documented PPD reactivity of 5 to 21 mm in the past, documented in a medical record. Self-reported PPD reactivity will be accepted if medical records cannot be obtained.
3. Give written informed consent to participate
4. Generally healthy, as determined by medical history and targeted physical examination, if indicated
5. Possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study preparation or the readings of the injections
6. Comprehension of the study requirements; expressed availability for the required study period, including readings at the nominal time points of 48 and 72 hours

Exclusion Criteria:

1. Prior PPD test within the past 30 days
2. Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
3. History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in the past
4. Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is uncertain of his/her BCG vaccination status
5. Presence of conditions that may suppress TST reactivity