cyrilzakka/clinical-trials huggingface dataset:
Happy Hands - an E-self-management Intervention for People With Hand Osteoarthritis

The main aim of this project is to assess the effect, cost-effectiveness and user experiences with using an e-self-management intervention in addition to treatment as usual compared to treatment as usual alone in patients with hand osteoarthritis. The study is an RCT comprising approx 400 participants with hand osteoarthritis recruited from primary and secondary healthcare in all four health regions in Norway.

Hand osteoarthritis (OA) is a highly prevalent rheumatic joint disease, and the number of people living with debilitating hand OA will continue to rise in the coming decades due to increased life expectancy. Research shows that patients with hand OA have poor access to recommended treatment, and in Norway, they are increasingly referred to surgical consultation before having received recommended first-line treatment. Thus, there is a need to develop easily viable models of care for patients with hand OA that make recommended treatment available across different healthcare levels.

Our hypotheses are that an e-self-management intervention for people with hand OA will improve pain and function and be more cost-effective compared to treatment as usual, and that this app can easily be implemented in both specialist and primary healthcare. The hypotheses will be tested and explored in a randomized controlled trial, with a qualitative study nested within this trial.

The main research questions are:

1. To evaluate whether a 12-week e-self-management intervention is more effective in improving pain and function (according to the OMERACT-OARSI responder criteria26) compared to usual care in patients with hand OA (randomized controlled trial).
2. To determine the cost-effectiveness of the e-self-management intervention compared to usual care after 6 months (randomized controlled trial).
3. To explore patients' experience of barriers and facilitators for adopted and continued use of a e-self-management intervention for treatment of hand OA (qualitative interviews).

Secondary research questions will also be assessed.

Approx 400 patients will be recruited in this multicenter randomized controlled trial where patients with hand OA are allocated to either usual care or a 12-week e-self-management intervention delivered through a smartphone app (the HAPPY Hands app). Outcome measures are collected at baseline, 3 months (=end of intervention) and 6 months

Eligibility Criteria:
Inclusion Criteria:

* People diagnosed with hand osteoarthritis
* Possessing a smartphone

Exclusion Criteria:

* cognitive deficits
* are scheduled for hand surgery within the next 3 months
* do not talk or understand Norwegian,
* have uncontrolled serious comorbidities
Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography

This was a multi-center, prospective clinical trial in which the subject was her own control. Approximately 950-1400 female subjects were enrolled at five (5) sites in the United States. Subjects were from either a Screening population or a biopsy population and were imaged first on a conventional 2D full filed digital mammography system then on a 3D tomosynthesis system.

The resulting images from the this portion of the study were then randomized into a reader study.

The purpose of this clinical study was to compare the 3-D tomosynthesis system used in conjunction with a conventional 2-D digital imaging system (2-D plus 3-D images) to the conventional 2-D digital imaging system (2-D images), and to determine whether the 2-D plus 3-D images compared to the 2-D images alone would:

1. Reduce the recall rate And/or
2. Improve ROC area due to improved breast cancer detection and/or improved lesion classification.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Any ethnic origin
* No contraindication for screening mammography

Exclusion Criteria:

* Significant breast trauma
* Pregnancy
* Lactating
* Breast implants
* Previous breast cancer
* Previous surgical biopsy
* Placement of an internal breast marker
* Unable to understand and or execute written informed consent
Study Design of 'Influence of Sarpogrelate in Patients With Renal Impairment or Diabetes Mellitus' Study

The purpose of the SERENADE trial is to evaluate the safety and efficacy of sarpogrelate in patients with CKD or DM after DES implantation.

The rates of stent failure after percutaneous intervention (PCI) have declined after introduction of the drug eluting stent (DES). However, chronic kidney disease (CKD) or diabetes mellitus (DM) still remains a strong clinical predictor of poor prognosis with DES. Sarpogrelate, a selective 5-HT2a receptor antagonist, has antiproliferative effects as shown by its reduction of neointimal hyperplasia and smooth muscle cell proliferation as well as a potent antiplatelet agent inhibiting of 5-HT-induced platelet aggregation. However, the efficacy and safety data for sarpogrelate in patients with CKD or DM are limited. We aimed to test whether sarpogrelate has beneficial effects in patients with CDK or DM treated with DES.

The SERENADE trial is a multicenter, off-label, prospective, placebo-controlled randomized study to test the superiority of triple anti-platelet therapy (TAT; aspirin, clopidogrel and sarpogrelate) to the conventional dual antiplatelet therapy (DAT; aspirin and clopidogrel) in preventing late lumen loss 9 months after the index procedure in patients with CKD or DM. A total of 220 patients exhibiting coronary artery disease (CAD) with DM or CKD will be randomized to TAT or DAT (1:1 ratio) after DES implantation. Primary endpoint is late lumen loss at 9 months assessed by quantitative coronary angiography (QCA). Secondary efficacy endpoints are composites of major adverse cardiovascular events (MACE) including cardiac death, nonfatal myocardial infarction (MI), and target lesion revascularization. Secondary safety endpoints are major bleeding event and hepatic or renal impairments.

The SERENADE trial will give insight whether adjunctive therapy with sarpogrelate is helpful for patients with high risk profiles such as CKD or DM after DES implantation.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic CAD (including acute coronary syndrome) or positive stress test and a native coronary lesion (\>50% diameter stenosis by visual estimation on coronary angiogram and reference diameter \> 2.5 mm)
* AND CKD or DM patients

Exclusion Criteria:

* if they had contraindication to aspirin, clopidogrel or sarpogrelate.
Influence of an Anterior Latarjet-type Abutment Operation on Scapular Dyskinesia and the Muscular Stabilization Mechanisms of the Scapula (DyScapLat)

The aim of this study is to assess the influence of anterior abutment surgery using the Latarjet method on the kinematics of the scapula. The sub-objectives will be to show that Latarjet-type surgery does not lead to scapular dyskinesia and modification of muscle activity compared to a control group that has not undergone an operation.


Eligibility Criteria:
Inclusion Criteria:

* Patient Group:

  * Male between 18 and 40 years-old
  * Practice a regular sports activity before the injury (s) requiring surgery
  * Present the clinical criteria leading to anterior abutment surgery using the Latarjet method
  * Surgery performed by surgeons from the Jean-Mermoz Private Hospital (69008 Lyon)
  * Have followed a post-surgery self-rehabilitation program

Control group:

* Male between 18 and 40 years-old
* Practice a regular sports activity

Both group:

oPatient having signed an informed consent o Subject affiliated or beneficiary of a social security scheme

Exclusion Criteria:

Patient group:

* Have another shoulder pathology on the side of the operated limb or on the contralateral side
* Present a constitutional hyper laxity
* Have stiffness or recurrence of dislocation of the shoulder post-surgery
* Have a body mass index greater than 30 kg / m² (to ensure sufficient accuracy to measure the movements of the scapula)
* Wear a pacemaker or any other metal device (e.g. patch with metal material)
* Present a contraindication to the use of measuring devices (intolerance to a weak electromagnetic field)

Control group:

* Present during the study or have presented in the past any musculoskeletal pathology in the right or left shoulder (WOSI or WORC score greater than 250).
* Have a body mass index greater than 30 kg / m² (to ensure sufficient accuracy to measure the movements of the scapula)
* Wear a pacemaker or any other metal device (e.g. patch with metal material)
* Present a contraindication to the use of measuring devices (intolerance to a weak electromagnetic field)

Both group :

o Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
A Novel Method to Assess the Cornea Biomechanical Properties With Schiotz Tonometer

This study aims to use Schiotz tonometer to evaluate the corneal biomechanical properties. The administration of Schiotz tonometer is according to the routine protocol which is use to measure intra-ocular pressure. The results obtained from Schiotz tonometer will be compared with results obtained from ORA and/or Corvis.

Schiotz tonometer, since it firstly be developed more than 100 years ago by Hjalmar Schiotz, has been regarded as a classical method to evaluate intraocular pressure (IOP). In present study, we aims to measure the corneal biomechanical properties with schiotz tonometer and elucidate the clinical significance of this novel measurement. The corneal biomechanical property was calculated with subtracting the value displayed under loaded weight 5.5g from that under loaded weight 7.5g. We named the corneal biomechanical properties obtained with schiotz tonometer as Mulee factor, and the formulation is Mulee factor=value under loaded weight 7.5g (Value 7.5G)-value under loaded weight 5.5g (Value 5.5G).

Eligibility Criteria:
Inclusion Criteria:

* People without the disease mentioned in exclusion criteria part.

Exclusion Criteria:

* Patients with ocular diseases including keratitis, conjunctivitis, history of chronic eye/systemic diseases except myopia and keratoconus, history of ocular surgery except LASIK, pregnant or lactating females.
Sex-specific Association With Kidney Disease

Oxidative stress is involved in the pathophysiology of diabetic nephropathy. The superoxide-generating nicotinamide adenine dinucleotide phosphate-oxidase 2 (NOX2, encoded by the CYBB gene) and the antioxidant enzyme glutathione peroxidase 4 (GPX4) play opposing roles in the balance of cellular redox status. In the present study, we investigated associations of single nucleotide polymorphisms (SNPs) in the regulatory regions of CYBB and GPX4 with kidney disease in patients with type 1 diabetes.

In the present study, three cohorts of type 1 diabetic patients (one Brazilian and two French/Belgium cohorts) were studied for the association with diabetic nephropathy (DN) with a total of 1396 patients. The patients were classified according to the urinary albumin-to-creatinine ratio (ACR) or urinary albumin excretion rate (UAER) in absence of nephropathy, defined as ACR \<30 mg/g or UAER \< 20 µg/min or \< 20 mg/L and plasma creatinine \<1.7 mg/dL; incipient nephropathy, defined as persistent microalbuminuria (ACR 30 - 300 mg/g of creatinine or UAER 20 - 200 µg/min or 20 - 200 mg/L) and plasma creatinine \<1.7 mg/dL; established diabetic nephropathy, defined as past or present macroalbuminuria (ACR \>300 mg/g of creatinine or UAER \>200 µg/min or \> 200 mg/L) and plasma creatinine \<1.7 mg/dL; advanced diabetic nephropathy, defined as past or present macroalbuminuria, plasma creatinine \>1.7 mg/dL and any renal replacement therapy. Genotyping of polymorphisms was performed by Real Time PCR using fluorescent-labelled probes.

Eligibility Criteria:
Inclusion Criteria:

* Overt 10 years of Diabetes Mellitus (Brazilian cohort)
* Diagnostic of diabetes before the age of 35 years, with initial ketosis and requirement for permanent insulin treatment within 1 year of diagnosis and past or present diagnosis of diabetic retinopathy. (Genesis cohort).
* Diagnostic of diabetes before the age of 35 years and past or present diagnosis of severe diabetic retinopathy. (GENEDIAB cohort).

Exclusion Criteria:

* Patients presenting autoimmune diseases, HIV or HCV infections (Brazilian cohort)
* Patients with glomerular filtration rate \< 60 mL min-1 1.73 m2 without diabetic retinopathy (Brazilian cohort)
* Terminal cancer and personal disability (GENEDIAB cohort).
Evaluating the Role of Intra-articular Injections of Platelet Rich Plasma (PRP) in Patients With Rheumatoid Arthritis.

To evaluate the therapeutic effect of 3 local doses of PRP intra-articular injection in patients with RA regarding the improvement of disease activity and quality of life versus placebo.

100 patients with RA fulfilling the 2010 ACR-EULAR classification criteria for RA were recruited from the outpatient clinic of the Rheumatology and Rehabilitation department. All patients were subjected to clinical and laboratory assessment, visual analog score (VAS) scale and Health Assessment Questionnaire (HAQ). Fifty patients were injected intra-articularly with 3 doses of PRP and 50 patients who serve as a control injected with 3 doses of placebo at 4 weeks intervals for the tender joints and revaluated at 1, 3 months post the last injection regarding the same evaluating tools.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as RA regarding 2010 new criteria of RA, both sex,aged20-60 years old.

Exclusion Criteria:

* Patients with Local abscess,
* systemic illness as (diabetes mellitus, malignancy),
* patients on opioids analgesics.
* pregnancy, blood disorders(coagulopathy, thrombocytopenia),
Very-Low Nicotine Cigarettes and Non-Daily Smokers

The purpose of this research study is to investigate the impact of different nicotine levels in cigarettes among non-daily smokers. This research may help inform the Food and Drug Administration (FDA) on how best to regulate tobacco products in the future, with the goal of improving public health.

The overall goal of the study is to assess the effects of switching to Very-Low-Nicotine-Content cigarettes (VLNCCs) among non-daily, or intermittent smokers (ITS). This is a two-arm randomized study with an own-cigarette baseline control. After a 2-week baseline period smoking their own cigarettes, 455 ITS will be randomized (double-blind) for 10 weeks to smoke experimental cigarettes, either: (a) normal nicotine content cigarettes (NNCCs; 0.8 mg) or (b) VLNCCs (0.07 mg), each matched to menthol status of subjects' preferred brand. ITS are more likely to be African-American (AA) smokers; thus AA smokers will be oversampled (to one third of the total sample). Change in cigarette consumption is the primary end-point, and biomarkers of smoke exposure and measures of smoking intensity are also assessed.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older, and smoking cigarettes for at least 3 years
* smoking, on average, 4-27 days per month
* smoking at current rate for at least the previous 3 months
* willingness to try novel cigarettes

Exclusion Criteria:

* active plans to quit or actively seeking smoking cessation treatment in the next 3 months
* severe psychiatric disorders that may interfere with study procedures
* current, regular (i.e., monthly or more) use of nicotine replacement or other tobacco products, by self-report
* exclusive use of roll-your-own cigarettes (since the study uses manufactured cigarettes)
* \[for female participants\] being pregnant or breastfeeding, or planning to become pregnant, by self-report
* current use of medications such as Chantix (varenicline), Zyban, Wellbutrin, or bupropion for any purpose, including stopping smoking
* occurrence of heart attack, stroke, or angina in the past 3 months
Serratus Plane Block and Pectointercostal Block

ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. Patients will divide into 2 groups. Deep serratus plane block will perform with 0,25 %bupivacaine 20 ml at the midaxillary 5. rib, bilaterally for Group I. At Group II, deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally . General anesthesia with sevoflurane and remifentanil will perform to the all patients. Postoperative pain scores, morphine consumption and complications will record till the 24.th hours.

ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. General anesthesia with sevoflurane and remifentanil will perform to the all patients. Patients will divide into 2 groups. Serratus plane block for group I and serratus plane block+pectointercostal block for Group II will perform bilaterally. Ultrasound guided deep serratus plane block will perform with 0,25% bupivacaine 20 ml at the midaxillary 5. rib, for Group I. At Group II, ultrasound guided deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally. Patient controlled analgesia will perform with Morphine ( 1 mg bolus+ 10 min lockout+4 hours limit 10 mg) at postoperative period. Patients will evaluate with visual analogue scale (VAS) for postoperative pain scores till the first 24.th hours. Postoperative pain scores (VAS), morphine consumption and complications will record till the 24.th hours.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients
* Female
* who will undergoing Breast reduction surgery

Exclusion Criteria:

* ASA III and over patients
* who reject to join the study
* male gender
Descriptive Analysis of G-CSF Use in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated

Purpose:

With the existing recombinant human granulocyte colony-stimulating factors (G-CSFs) patents expiring and the FDA approval of new biosimilar and innovator biologics, patients being treated with Grade III and IV myelosuppressive chemotherapy regimens will have additional therapeutic options. This observational study will describe the patient characteristics of new users of G-CSFs. It will describe in the treatment cohorts a primary outcome of hospitalizations for febrile neutropenia. The BBCIC will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator G-CSFs.

Additional information:

To most effectively interpret results from this descriptive analysis it is important to consider that this protocol was not designed to support a hypothesis. This information is being provided to the public in the interest of transparency and for demonstrating the BBCIC's Distributed Research Network's (DRN) ability to define exposures, outcomes, covariates and confounders. When published, the report will caution that the protocol does not support any ability to compare safety or effectiveness but instead is to be used only to explore the feasibility of future, more detailed comparative analyses and to better understand the capabilities of the BBCIC project. Further, the report will caution that information from this protocol should not affect use of the medical products described in any way and the fact that the BBCIC is performing this descriptive analysis in no way suggests there is a safety or effectiveness issue with any of the products described.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with baseline period of 183 days with continuous medical and pharmacy coverage preceding the first prescription fill for G-CSF
* Breast or lung cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF.

Exclusion Criteria:

During baseline 365 days, any patient with a claim for (or with)

* Chemotherapy drug.
* Skilled nursing facility (SNF) or hospice care
* Diagnosis for a secondary breast cancer diagnosis
* A second cancer diagnosis (i.e., not breast, lung, lymphoma)
* Bone marrow or stem cell transplant
* Radiotherapy
* Chemo cycle \>First: (exclude any chemotherapy cycles post the index G-CSF date)
* HIV/AIDS
* Hepatic disease
* Other non-oncology related neutropenia
Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension

The objective of this study is to evaluate efficacy, safety and tolerability of the valsartan+amlodipine association in patients with mild to moderate essential hypertension, in comparison to amlodipine alone.

Patients should have mild to moderate essential hypertension \[grades 1 and 2 of WHO classification (8)\]. The diastolic blood pressure threshold for inclusion in this study is 95 mmHg, as these patients are more likely to benefit from association therapy than patients with lower diastolic blood pressure.

For safety reasons, patients with severe hypertension (grade 3 of WHO classification) will not be included in this study. Moreover, patients developing severe hypertension (MSDBP \> 110 mmHg and/or MSSBP \> 180 mmHg) during the open-label treatment phase will be discontinued from the study.


Eligibility Criteria:
Incl- Patients with mild to moderate essential hypertension (grade 1 and 2 of WHO classification).

- Patients with essential diastolic hypertension measured by a standard aneroid or mercury column sphygmomanometer showing MSDBP \> 95 mmHg and \< 110 mmHg and MSSBP \<180 mmHg.

Exclusion Criteria:

* Severe hypertension (grade 3 of WHO classification: DBP \>= 110 mmHg and/or SBP ≥ 180 mmHg) or malignant hypertension.
* Inability to completely discontinue all antihypertensive medications safely for a period of at least 2 weeks as required by the protocol.
* Evidence of a secondary form of hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
Pancreatico Enteric Anastomosis Post Pancreaticoduodenectomy

The aim of this study is to make a step for evaluation and presentation of a safe technique for pancreatico-jejunostomy that help in minimizing post-operative morbidity and mortality in pancreatic cancer patient by comparing Blumgart anastomosis with Cattell warren technique of anastomosis.

Study Design This study is a randomized prospective clinical trial. Methods of randomization: Randomized block design

The objective of the study was to evaluate the effect of Blumgart anastomosis versus Cattell Warren techniques for pancreatico-jejunostomy regarding

* Surgical technique
* Peri-operative outcome including

  1. Length of hospital stay
  2. Post-operative pancreatic fistula
  3. ICU admission and stay
  4. Operative time
  5. Other morbidity and mortality

Data collection:

All data will be collected for each group and will be divided into Patients' factors, intraoperative and postoperative factors. Patients' factors include patients' demographics, co-morbidities, neoadjuvant treatment, Pathology and Biliary drainage. Intra-operative factors include type of Pancreaticoduodenectomy (PD) (Whether classic or PPPD), Operative time in hours and estimated blood loss in ml, pancreatic duct and texture of pancreas. Post-operative factors include the short term post-operative course which will be divided into specific complications (pancreatic leakage, biliary leakage, delayed gastric emptying, 2ry hemorrhage, intra-abdominal collection, deep wound infection, Portal Vein (PV) - Superior Mesenteric Vein (SMV) thrombosis and general surgical complications.

Eligibility Criteria:
Inclusion Criteria:

* Known Pancreatic head cancer diagnosed radiologically.
* Operable and borderline pancreatic cancer.
* Patients who will undergo upfront surgery and those who received neoadjuvant chemotherapy are included.

Exclusion Criteria:

* Metastatic patients.
* Locally advanced cases.
* Patients with comorbidities who are unfit for major surgical procedures.
* Patients with very small pancreatic duct where the pancreatic duct can't be identified.