cyrilzakka/clinical-trials huggingface dataset:
EMMA: Empowerment, Motivation and Medical Adherence

EMMA: Empowerment, Motivation and Medical Adherence. A consultation program based on dialogue tools for adults with poorly regulated Type 2 diabetes.

Traditionally, the success of patients to manage their diabetes has been judged by their ability to adhere to a prescribed therapeutic regimen, and efforts have been spent developing strategies to promote adherence. It is estimated that 20% to 50% of patients with chronic conditions are not adherent to their prescribed medication regimen, with non-adherence being defined as \<80% adherence to prescribed, relevant medication. The treatment regimen often comprises several elements such as poly-pharmacy including insulin administration, self-monitoring of blood glucose, diet and physical exercise. It is thus not just a matter of 'taking a pill or not' but implies lifestyle changes, knowledge and competence, and internal motivation for self-management. The investigators developed a consultation program based on dialogue tools. The EMMA program aims to support medication adherence and blood glucose control by facilitating rapport, exploring patient concerns and challenges, enabling knowledge exchange and supporting goal-setting and action-planning. A pilot test of the program appeared feasible and acceptable to patients and health care professionals and showed significant decrease on HbA1c. EMMA is now ready to be tested in a randomized controlled study (RCT) study.

Eligibility Criteria:
Inclusion Criteria:

* Adults Type 2 diabetes ≥ 18 år
* Type 2 diabetes ≥ 1 år
* HbA1c ≥ 64 mmol/mol (≥ 8%) at the last three measures before randomisation
* Taking medication for Type 2 diabetes • - Speak, read and understands Danish

Exclusion Criteria:

* Participating in other intervention research projects during the trial period
* Being treated by a psychiatrist or psychologist during the period
* Reduced sight or blindness
Study Comparing the Tolerability and Viral Reduction of the Combination of IFN a-2b XL + Ribavirin Versus Peg IFN a-2b + Ribavirin in Patients With Chronic Hepatitis C, Genotype 1 or 4

Three-parallel-arm, open-label, international (France and Romania) study, comparing three treatments

The purpose of this study is to confirm if IFN alfa-2b XL has a better antiviral activity and tolerability as compared with current marketed reference, while combined with ribavirin, in a 3-month therapy setting.

Interferon alfa-2b XL (IFN alfa-2b XL) is a novel sustained release interferon α-2b drug product that is being developed by FLAMEL TECHNOLOGIES using its Medusa® technology, aiming at reducing the toxicity and enhancing the biological response. In the present study, patients will be randomly assigned to either IFN alfa-2b XL 27 MUI, IFN alfa-2b XL 36 MUI, or IFN peg alfa-2b 1.5 µg/kg, all administered once a week for 12 weeks by subcutaneous injections, in combination with weight dosed ribavirin daily administered orally in two divided doses. Doses will be adapted according to the dose modification guidelines for combination therapy labelled in the ribavirin prescribing information.

Eligibility Criteria:
Inclusion Criteria:

* Patient having voluntarily signed the Informed Consent Form prior to any study specific procedure being performed
* Male or female HCV genotype 1 or 4 infected patients (positive serum HCV RNA), aged between 18 and 65 years inclusive, with a body mass within the range over or equal of 45Kg and below or equal to 100 Kg
* Patient being either naïve to therapy, either non-responder to previous standard Peg-interferon α + ribavirin therapy,
* With no absolute contra-indication to interferon α or ribavirin
* Female patients must be non-lactating and of non-childbearing potential, or have a negative pregnancy test results to enter the study
* No evidence of acute or advanced liver disease, uncontrolled diabetes, cardiovascular, immunological, or thyroid disease, and no recently diagnosed malignancy
* Vital signs within normal ranges, or if outside the normal ranges, not deemed clinically significant in the opinion of the Investigator. An ECG with no clinically significant abnormalities

Exclusion Criteria:

* History of solid organ transplantation
* Severe systemic infection, uncontrolled diabetes, cancers, associated liver disease
* General anesthesia or recent blood transfusion
Magnetic Resonance Imaging (MRI) in Amyotrophic Lateral Sclerosis (ALS)

This is a pilot study to identify the degree of grey and white matter involvement in patients with Amyotrophic Lateral Sclerosis (ALS) utilizing non-invasive techniques. The imaging to be utilized will be the 7 Tesla (7T) magnetic resonance imaging (MRI) of the brain. These results will be correlated to the ALS Functional Rating Scale - Revised (ALSFRS-R) score to assess if any changes in MRI can be predictive in the disability of the ALS patients at baseline and at 6 month intervals. The participants will be asked to return every 6 months for a neurological examination, ALSFRS-R assessment, measurement of the vital capacity and MRI as outlined above to monitor progression of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females who are 18 - 80 years old.
* The participants will meet the standard diagnostic criteria for possible or probable ALS (based on El Escorial criteria). They will have been diagnosed by a Johns Hopkins Neurologist.
* Healthy controls will be recruited by their interest in assisting the ALS population.

Exclusion Criteria:

* Forced vital capacity less than 60 % of predicted value.
* Documented orthopnea on ALSFRS-R or otherwise unable to lie flat in an MRI scanner for the duration of the study.
* Presence of pacemakers, aneurysm clips, shrapnel or otherwise disallowed implanted metallic devices for obtaining an MRI scan.
* Pregnant or lactating females
* Glomerular filtration rate (GFR) less than 60
* History of: encephalitis, extensive white matter disease, intracranial hemorrhage, cerebral palsy, allergy to dye and/or IV drug abuse.
Evaluation of Telerehabilitation Following Inpatient or Outpatient Rehabilitation Phase II

Telerehabilitation is implemented in the Pensionsversicherungsanstalt (PVA) as an independent rehabilitation offer following a rehabilitation phase II. This offer primarily includes physiotherapeutic training units in group settings and in individual counselling, as well as health-related educational sessions and doctor's consultations via video conferencing, initially for rehabilitation patients with diseases of the musculoskeletal system or oncological diseases. The first stage of the implementation process was evaluated with a focus on acceptance, usability and feasibility from the perspective of patients and treatment team.

The evaluation was based on a convergent mixed methods design (Creswell \& Plano Clark, 2017) to draw on the strengths of qualitative and quantitative research approaches (Creswell \& Creswell, 2018). Qualitative and quantitative data were generated in parallel and treated equally. The perspective of the patients (N = 86) was collected through online questionnaires and in-depth telephone interviews (N = 22) and that of the treatment team through a questionnaire survey (N = 32) and focus group interviews (N = 24). The administrative team (N = 8) was asked for their assessment in a focus group interview. Technical difficulties in the implementation of telerehabilitation were documented by the treatment team. The consolidation of these multi-perspective results took place at the level of interpretation.


Eligibility Criteria:
Inclusion Criteria:

Patients who have completed rehabilitation (phase II) with the indications:

* musculoskeletal diseases
* oncology.

Exclusion Criteria:

* Failure to obtain the declaration of consent
* Lack of the required technical aids (mobile phone, tablet or PC)
* Lack of the technical skills to operate the app and thus to participate in telerehabilitation.
Cerebral Regional Oxygenation with Manual Versus AutoFlow Ventilation

Anesthesia induction is associated with hemodynamic imbalances that can affect the blood flow to major organs. Moreover it can result in deoxygenation as well. During standard anesthesia induction the patient is manually ventilated with a circle-valve-mask system until the effect of muscle relaxant shows of. Near-infrared spectroscopy (NIRS) is a modification of a well-known peripheral pulse oxymetry that is used in the detection of the regional oxygen saturation (rSO2) in organs, including brain, liver, muscle, and intestines. In this study we will compare the regional oxygenation status of the patients during anesthesia induction in which either standard manual ventilation or mechanical ventilator-assisted ventilation was performed. AutoFlow(R) mode of Draeger-Perseus mechanical ventilator will be used for the ventilator-assisted ventilation.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) physical status I-II

Exclusion Criteria:

* ASA III or above
* Congenital or traumatic brain injury
* Allergy to NIRS probe material
* Cardiac or vascular disease, including heart failure or hypertension
* Difficult mask ventilation and difficult intubation
* Thoracic surgery
* Head and neck surgery
* Emergency surgery
* Obesity
Comparing Modified Meek and Mesh Techniques

This is a clinical trial study that compare two plastic surgery techniques in patients with third degree of burning and both techniques are used in all patients but in different areas of burning sites of the patients.

PATIENT REGISTRATION:

The patients are registered after careful examination for third degree of burning and based on the need for skin grafting and of course a written consent were acquired. Excluded patients were those with an infected lesion or those who did not allow us to enter them into the study.

Progression of the treatment results of both techniques were visited by the surgeon regularly.

At the end of the study the data were checked with other similar studies. The acquired data were compared to other external data sources via medical records.

There were two standard operating techniques: modified meek skin grafting technique and mesh skin grafting technique.

The data was analyzed by chi-square and t-test.

Eligibility Criteria:
Inclusion Criteria:

* third degree of burning

Exclusion Criteria:

* infected lesions
Evaluation of Renal Function in Patients With Hyperthyroidism

To evaluate the effect of subclinical and overt Hyperthyroidism in renal function

* Thyroid disorders are very common with a high prevalence among the general population. Thyroid diseases are associated with many detrimental effects that have a serious impact on various body systems.(1)

  * Hyperthyroidism can be overt or subclinical. Overt hyperthyroidism is defined as low serum thyroid stimulating hormone (TSH) and elevated serum thyroxin (T4), tri-iodothyronine (T3), or both. Whereas subclinical hyperthyroidism (SCH) is defined as low serum TSH level with normal serum levels of T3 and T4.(2)
  * The relationship between thyroid hormones and kidney function is well-known for many years. Thyroid diseases adversely affect renal physiology; meanwhile, kidney diseases could result in thyroid dysfunction.
* Thyroid hormones contribute to the maintenance of water and electrolyte balance, and participate in the renal transport system. Hyperthyroidism results in an increased glomerular filtration rate (GFR) by about 18-25%. due to increased renal blood flow and activation of renin angiotensin-aldosterone system (RAAS). Also, these changes have been reported in patients with hyperthyroidism.(3-5)
* Several mechanisms were found playing roles on increasing both the size and functional capacity of kidney:

  1. Thyroid hormone directly influences the expression and activity of most of renal transporters by direct binding of thyroid hormone to the promoter region of a transporter gene (6)
  2. In hyperthyroid state beta-adrenergic receptors in kidney cortex, and synthesis and secretion of renin by juxtaglomerular cells are increased, which in turn enhance angiotensin-converting enzyme activity.(7)
  3. Increased RAAS activity results in afferent arteriolar vasodilatation and efferent arteriolar vasoconstriction with a consequent increase in the filtration pressure...(8) D) Hyperthyroidism increases systolic blood pressure by increasing heart rate, decreasing systemic vascular resistance, raising cardiac output, and increases nitric oxide production which all contributes to the hyper dynamic circulation. Hyperthyroidism results in increased renal blood flow.(7)
* Observed that both BUN and creatinine levels increased significantly after euthyroidism was achieved in hyperthyroid patients, these findings point out to true decline in renal function rather than a mere adaptation to hemodynamic changes.

Although the mechanistic link between thyroid and kidney disease remains unclear, hyperthyroidism may have significant effect on renal function

Eligibility Criteria:
Inclusion Criteria:

* Patients aged (18_80 years) diagnosed subclinical and overt Hyperthyroidism with overt Hyperthyroidism

Exclusion Criteria:

1. Patients with D.M
2. Patients with Hypertension
3. Patients with CKD or ESRD
4. IHD
5. Pateints receiving medication known to affect renal function as contrast agent, non-steroidal anti-inflammatory drugs and ACEIs
Comparison of the Effect of Capsular Bend on the Rotational Stability Between Two Toric Intraocular Lenses

(1) To compare the difference of rotational stability and CBI between AcrySof IQ(SN6AT) and TECNIS(ZCU) after cataract surgery. (2) To evaluate the influence of capsular bending on the rotational stability of these two kinds of intraocular lenses.

To compare the difference of rotational stability and CBI between AcrySof IQ(SN6AT) and TECNIS (ZCU) torus intraocular lenses implanted after cataract surgery, and analyze the influence of capsular bag bending on the rotational stability of two kinds of astigmatism correction intraocular lenses after cataract surgery.

Eligibility Criteria:
Inclusion Criteria:1.The patient's age is over 18 years old. 2.Diagnosed as age-related cataract Corneal astigmatism measured before operation is \> 0.75 D or predicted after operation after taking into account surgical astigmatism (SIA).

3.Pupil diameter \> 7 mm after mydriasis. 4.The astigmatism meridian between IOLMaster and Pentacam is the same (the meridian difference between the two instruments is within 15).

5.After operation, the anterior capsule completely covered the edge of intraocular lens optical surface.

6.Able to understand, cooperate and complete all follow-up.

-

Exclusion Criteria:

1. Moderate and severe dry eye
2. There is irregular corneal astigmatism.
3. Combined with other ophthalmic diseases Previous history of ophthalmic surgery.
4. The capsulorhexis is too large or eccentric, which can not cover the optical zone of intraocular lens all around, and there are intraoperative or postoperative complications.

   -
A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Surgery

This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk major surgery.


Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing high risk major surgery in subjects with cardiovascular disease who are at risk of AKI.

Exclusion Criteria:

* Ongoing or recent history of sepsis
* Has recent documented acute kidney injury.
* Subject is scheduled to have a total or partial nephrectomy.
Phase II Study of Afatinib Plus Bevacizumab in the Treatment Epidermal Growth Factor Receptor (EGFR) Exon G719X, S768I, and L861Q Mutation Metastatic Non-Small Cell Lung Cancer

There is no report afatinib plus bevacizumab in the treatment of EGFR G719X, S768I, and L861Q single or compond mutation of metastatic non-small-cell lung cancer (NSCLC). The purpose of this study is to study afatinib combined with bevacizumab in the management of it.

Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent \[%\] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. The hypothesis is that afatinib plus bevacizumab in patients with metastatic NSCLC characterized by EGFRuncommon mutations with G719X, S768I, and L861Q. Efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis).

Eligibility Criteria:
Inclusion Criteria:

* Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon G719X, S768I, L861Q mutation Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or 2 Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study

Exclusion Criteria:

Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis Participant has a contraindication to the use afatinib or Bevacizumab
Measuring Skin Electrical Potential With the Kelvin Probe: Minimizing Noise

The Scanning Kelvin Probe measures surface electrical potential without actually touching the skin. This is a pilot study to evaluate methods of minimizing noise during Scanning Kelvin Probe measurements. This project will focus specifically on noise arising from physical movement and environmental electrical field.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years

Exclusion Criteria:

* chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc)
* movement disorders/tremors
* extensive scars on the hand
* latex-allergies
* cardiac implantation, metallic joint/bone replacements (defibrillator or pacemaker)
Evaluation of the Efficacy and Tolerability of ABO/MEG-B-09 in Children With Acute Cough

The present clinical trial will examine the use of ABO/MEG-B-09 syrup in children with acute cough as compared to a placebo syrup.

Subjects will be asked to take 4 doses of 5 ml containing a mixture of honey and other natural ingredients or a placebo syrup everyday, during 8 days. The following outcomes will be noted down in a diary: occurence and severity of diurnal and nocturnal cough events (cough score) and symptoms, impediment of normal life activities (school, sleeping), the number of medical visits and type of medication needed if any.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 3 and 6
* Acute cough - lasting 1-3 weeks
* Written informed consent by the parents/legal tutors
* Parents/legal tutors must be willing not to give to the child other medications or products for the treatment of cough during the study period, unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study
* Parents/legal tutors must be willing to comply with the study protocol

Exclusion Criteria:

* Children treated with immunostimulators and immune regulating drugs during the last month before starting the study
* Children with immunodeficiencies or immune suppression
* Children with chronic diseases - Pulmonary Diseases, Renal insufficiency, Heart diseases
* Children treated with antibiotics, including prophylactic treatment
* Children being treated with systemic corticosteroids - including oral aerosol inhaler
* Children with potential immunosuppressive viral diseases - Measles, Chickenpox, Rubella, Infectious mononucleosis - within the last month
* Children who have participated in previous studies with experimental products within the last month
* Children with asthma or suspected diagnosis of asthma
* Children with bacterial diseases - Pneumonia, Sepsis
* Children with diabetes because of the high content of sugar of the study products - ABO/MEG-B-09 and placebo
* Children allergic to any study product ingredients
* Children/Parents/legal tutors with psychological condition that may, in the investigator's opinion, adversely affect their co-operation with the study protocol - syrup administration or compilation of the diary
Vitamin D and Exercise in Falls Prevention

The aim of the study is to investigate the effects of exercise and vitamin D supplementation on reducing falls and injuries in community-dwelling, independent-living women aged 70-79 years of age. The investigators will test the following hypothesis:

1. Exercise including strength, balance and mobility training will improve muscle functioning and body balance, and thus reduce falls by 30% compared with non-exercisers.
2. Vitamin D intake will improve muscle functioning and thus prevent falls by 30% compared with placebo.
3. Together vitamin D and exercise have a stronger influence on fall prevention than either used alone.
4. Training improves mobility functions and bone health.
5. Supervised training twice a week with daily home training will improve physical functioning thus resulting in reduced fear of falling.
6. Reduced fear of falling and improved physical functioning help older people to stay physically active, which further improve their quality of life.

Falls account for over 80% of all injury-related admissions to hospital among older people. Although there is evidence that both exercise and vitamin D improve neuromuscular and cognitive function, and may thus reduce the risk of falls and fractures, these two factors have never been evaluated together in a clinical trial. This study is a randomized 24-month intervention in elderly women. The investigators hypothesize that exercise and vitamin D supplementation reduce falls and injuries including fractures in community-dwelling, independent-living women 70-79 years of age. The eligible participants will be randomly assigned into one of four groups:

1. exercise with vitamin D
2. exercise with placebo
3. no exercise with vitamin D
4. no exercise with placebo. The rational of this study is to provide important information on how to maintain and improve physical functioning and thus prevent falls and fractures of elderly people. In addition, if fear of falling can be declined with this program, it will further help elderly people to keep physically active and maintain their functional capacity and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* female
* age 70-80 years old
* lives at home independently
* has fallen at least once during the previous year
* no contraindication to exercise
* understands the procedures of the study
* has been informed of X-ray radiation doses of the DXA and pQCT investigations

Exclusion Criteria:

* moderate-to-vigorous exercise more than 2 hours per week
* regular use of vitamin D, or calcium + vitamin D supplements
* a recent fracture (during preceding 12 months)
* contraindication or inability to participate in the exercise program
* marked decline in the basic activities of daily living (ADL-test)
* cognitive impairments (Mini Mental State Examination, MMSE-test \< 18)
* persons with chronic disease conditions, such as Parkinson's disease