cyrilzakka/clinical-trials huggingface dataset:
Telemonitoring Among Patients With Multiple Myeloma

A two-arm open-label parallel-group randomized controlled trial will be conducted to compare the telemonitoring (MM e-coach) with standard MM care. This study aimed to recruit 150 patients with recently diagnosed multiple myeloma (RDMM), starting first or second line of treatment. Blinded primary outcome is adherence by pill count after start of treatment at 1-3 months. Secondary outcomes are patient reported outcomes: Groninger frailty index (GFI), quality of life (EQ-5D-5L, EORTC-QLQ-C30), shared decision making (SDM-Q-9), self-reported adherence (MARS-5), single item questions, patient experiences (PREMs), adverse events, overall survival (OS) and progression free survival (PFS). Patient reported outcomes were developed and integrated in the e-coach MM to regularly measure digitized outcomes of MM patients from time of RDMM until 12 months post-diagnosis. Online measurements will be performed at baseline (0), 3, 6, 9 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a participant (patient) must meet all of the -following criteria:

* signed informed consent
* \>18 years
* recently diagnosed MM patients with first-line or second-line treatment
* able to complete patient-reported outcome measures and experiences
* have minimal digital skills to check if they are able to interact with an e-coach
* can read and understand Dutch.

Participants who meet any of the following criteria will be excluded from participation in this study

* psychiatric illness requiring secondary-care intervention
* too ill to engage with the intervention in the opinion of the clinical care team
* no perspective of \>12 months survival.
Tablet-based Application for Cognitive Therapy

Cognitive impairments such as deficits in attention, executive functions, perception, language, speech, arithmetics, and memory are very common symptoms after acquired brain injury, which can be caused by neurological diseases such as stroke, cerebral haemorrhage or traumatic brain injury. Around 83% of patients with brain injury suffer from a sequelae of cognitive impairments.

Since the effects caused by neurological diseases can vary greatly from person to person, intensive and individual neuro-rehabilitation is necessary to help patients return to an independent life in the best possible way. In the DACH area (i.e., in Germany, Austria, and Switzerland), patients with cognitive impairments following brain injuries generally receive this intensive and interdisciplinary treatment while being hospitalised in an inpatient clinic following acute medical care.

However, once they leave inpatient care facilities, there are insufficient treatment options readily available to them due to limitations/shortages in the healthcare system's resources, although studies indicate that an increase in therapy time (both in outpatient settings at home or in care facilities) enables greater, long-term rehabilitation progress and faster reintegration and participation in everyday life. Thanks to recent technical advancements, digital treatment options now promise the availability of sufficiently frequent and intensive treatment outside of clinic settings. In that context, the myReha therapy software (available as an app on iOS ad Android tablets), a certified medical device, was developed to enable patients to receive individualised and intensive therapy regardless of the healthcare system's constraints. To test the effectiveness of the myReha therapy software, in this two-arm, randomised, controlled study, patients in the intervention group receive treatment through the myReha therapy software in addition to their usual standard care (i.e., care-as-usual - CAU), while the control group only receives CAU. Treatment outcomes (i.e., rehabilitation progress) are measured based on the CERAD-plus.


Eligibility Criteria:
Inclusion Criteria:

* Cognitive impairment (deficits in attention, arithmetics, executive functions, memory, language, perception) according to CERAD-plus after a diagnosed brain injury ≥ 4 weeks ago
* No prior experience with a therapy app for neurological deficits
* Motivation to use the therapy software regularly
* Sufficiently good German language skills prior to the brain injury

Exclusion Criteria:

* Being unable to use a tablet without assistance
* Severe visual or hearing impairment that interferes with the performance on psychometric testing procedures
* Any pre-existing speech or language disorder or dementia prior to the onset of brain injury
* An ongoing outpatient or inpatient rehabilitation at the time of study inclusion or planned rehabilitation of the primary disease during the study period
* Serious disabling disease(s) which, in the opinion of the investigator, would preclude participation in the study until the follow-up phase
* Pregnancy
Fluid Responsiveness Predicted by a Stepwise PEEP Elevation Recruitment Maneuver in Mechanically Ventilated Patients

Hemodynamic and fluid optimization during perioperative period can reduce postoperative morbidity. The assessment of preload and determination of whether the patient is fluid responsive is still challenging. Static preload indices such as central venous pressure are not accurate to assess fluid responsiveness contrary to dynamic preload indices such as pulse pressure variation (PPV) and stroke volume (SV) variation. However, such indices suffer from several limitations and should be used under strict conditions. Alternative dynamic methods such as lung recruitment maneuvers (LRM) have been developed LRM can be used to reopen or prevent collapsed lung under mechanical ventilation so as to decrease respiratory complications. LRM induces a transient increase in intra-thoracic pressure and decreases in venous return, leading to a decrease in left ventricular end-diastolic area and stroke volume. Several studies have shown that the PEEP-induced decrease in stroke volume is related to pre-existing preload responsiveness. Few studies have also shown that LRM can represent a functional test to predict fluid responsiveness. However, monitoring stroke volume during LRM to assess fluid responsiveness is costly, and cardiac output devices may not be reliable. In this context, central venous pressure (CVP) or systemic arterial parameters monitoring are easily accessible and inexpensive during major surgery.

The aims of the current study were

1. to assess the ability of a LRM with a stepwise increase of PEEP to predict fluid responsiveness in mechanically ventilated patients,
2. to identify the best criteria for fluid responsiveness prediction between variations of systolic aortic pressure (SAP), mean arterial pressure (MAP), diastolic aortic pressure (DAP), pulse pressure (PP) and central venous pressure (CVP),
3. to compare the ability of these criteria with pulse pressure variation (PPV) to predict fluid responsiveness

Eligibility Criteria:
Inclusion Criteria:

* needing invasive arterial blood pressure and pulse contour analysis (PICCO system) for cardiac output measurement,
* central venous pressure monitoring,
* using of protective mechanical ventilation
* Indication for fluid expansion
* Admitted in the intensive care unit of CHU of St ETienne

Exclusion Criteria:

* right ventricular dysfunction
* significant valvulopathy,
* ejection fraction less than 50%,
* arrhythmia
* contraindication to LRMs
Clinical Practice of AECOPD Management in China

The purpose of this study is observe clinical practice including glucocorticoids treatment in AECOPD in China.

It is widely recognized that the global social and economic burden of Chronic obstructive pulmonary disease (COPD) is high; affecting an estimated 64 million people worldwide. It was reported the prevalence of COPD in China population over 40 years old is about 8.2% (Zhong Nanshan et al, 2007). According to the report on China Chronic Disease, COPD is the second disease of Disability Adjusted Life Years. The economic burden of COPD is tremendous in China. Cost analysis in 2006 showed that every COPD patient in urban would pay 1732.24 $ on medical cost every year, indirect cost on nurse and traffic is 231.6 $, total cost would account for 40% of average family income in 2006(Chiang CH.,2008).AECOPD is one of most important cause leading to COPD death. Corticosteroid is essential for AECOPD management and recommended by domestic and international guidelines. But it shows that corticosteroid use for treating AECOPD in China is around 70% from market research in big hospitals, and less report about how steroid is used for AECOPD management was published, including distribution, dosage, treatment duration, etc. The healthcare resources utilization for treating AECOPD in China is also unclear.

Eligibility Criteria:
Inclusion Criteria:

1. ≥40 years old
2. Hospitalization treatment due to AECOPD since Sep, 2013
3. Diagnosed by GOLD 2013 as COPD at least 3 months before AECOPD based on treating physician's judgment
4. Provided informed consent or informed consent waiver

Exclusion Criteria:

1. Participation in any interventional clinical study within 3 months before being recruited in the study.
2. Ongoing AECOPD during recruitment timeline
3. The patients whose symptoms haven't recovered and then discharge by themselves
4. The primary diagnosis of hospitalization is not AECOPD
Investigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on Betaferon

The study aims to investigate the relationship between sleep quality, quality of life,other disorders and therapies in Multiple Sclerosis (MS) patients treated with Betaferon.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age with relapsing remitting multiple sclerosis or a clinically isolated syndrome and an expanded disability status scale score ≤5.
* Patients must be on treatment with Betaferon and tolerate Betaferon according to the investigator's evaluation, but should not have received Betaferon longer than six months.
* Written informed consent must be obtained

Exclusion Criteria:

* Patients who do not tolerate Betaferon according to the investigator's evaluation or have been treated with Betaferon for more than six months.
* Patients receiving any other disease modifying drug or MS specific treatments
* Contraindications of Betaferon described in the Summary of Product Characteristics.
The Compliance Project Concerning People With Schizophrenia

The purpose of this study is to determine whether individual and/ or system orientated interventions can help the problem of people with schizophrenia dropping out of their drug treatment

50% of people with schizophrenia do not take the prescribed medication leading to repeating relapses with loss of social and cognitive skills.

The individual intervention is based on "Motivational Interviewing" by Miller and "Concordance Strategies" by R. Gray.It is a cognitive behavioral therapy.

The system orientated intervention is building on principles from quality assurance and clinical risk managing. It seeks to improve the quality in the medical treatment by use of standards, monitoring, audit and root cause analysis,and thereby trying to find weak points in the system and subsequently improve the common practice.

Eligibility Criteria:
Inclusion Criteria:

* Diagnoses of schizophrenia or schizoaffective psychosis
* 23 years or more
* Ethnic dane
* Living in the city of Odense.

Exclusion Criteria:

* not subject to legal action
Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

Primary Objective:

- To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients.

Secondary Objectives:

* To assess the effects of lixisenatide over 24 weeks on :

  * percentage of patients reaching HbA1c\<7% or ≤6.5%,
  * 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test,
  * fasting plasma glucose (FPG),
  * change in 7-point self-monitored plasma glucose (SMPG) profile),
  * body weight,
  * change in daily basal insulin dose.
* To assess lixisenatide safety and tolerability.
* To assess anti-lixisenatide antibody development.

Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up)

Eligibility Criteria:
Inclusion criteria :

- Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year at the time of the screening visit insufficiently controlled with basal insulin± metformin.

Exclusion criteria:

At screening:

* Age \< legal age of adulthood.
* HbA1c\<7% or \>10.5%.
* Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit.
* If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit.
* History of hypoglycemia unawareness.
* Body Mass Index (BMI) ≤20 kg/m².
* Use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty

Sensitive renal markers have been studied abundantly in connection with open heart, liver and transplantation surgery; however in major orthopaedic surgery their use is anecdotal. The aim of the present study is to evaluate use of sensitive renal markers, NGAL (Neutrophil gelatinase associated lipocalin ), KIM-1 (Kidney injury molecule- 1), LFABP (liver-type fatty acid-binding protein), and IL-18 (interleukin -18), in patients coming for elective TKA (total knee arthroplasty) as a pilot study before large study concerning acute kidney injury in orthopaedic surgery.

Acute renal deterioration is a serious adverse event in elective surgery. Serum creatinine based diagnostics of acute kidney injury may delay diagnosis and produce false negative results since serum creatinine is affected by diet, muscle mass, used hydration therapy. In recent times new markers have been developed and tested in order to find sensitive, fast and reliable marker of renal deterioration.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* allergy to NSAIDs

Exclusion Criteria:

* no informed consent
The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With Monotherapy.

The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination treatment in patients with essential hypertension uncontrolled with losartan 100mg monotherapy.

* Quality assurance plan was implemented by site monitoring, including data validation and registry procedures and Source data verification to assess the accuracy, completeness by comparing the data to external data sources (medical records and paper case report forms).
* Data dictionary contains the registry, including the source of the variable, coding information (MedDRA ver12.0), and normal ranges.
* Statistical analysis were performed using SAS® Version 9.2, SAS institute, Cary, NC, USA

Eligibility Criteria:
Inclusion Criteria:

* 20 aged or over
* Patients with blood pressure measured at Visit 1; 90mmHg≤MSDBP mmHg if on anti-hypertensive drugs, 95mmHg≤MSDBP mmHg if not on anti-hypertensive drugs
* Patients with blood pressure measured at Visit 2 were 90mmHg≤MSDBP mmHg (non-responder to Losartan 100mg for 4-week treatment)

Exclusion Criteria:

* Patients with too high Blood pressure

  •≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
* History of hypersensitivity to CCB ,Angiotensin II receptor blockers or Sulfonamide.
* Secondary hypertension or suspected to be
Observational Study of Azilsartan/Chlorthalidone and Irbesartan/Hydrochlorothiazide in Hypertension and Obesity.

This is an observational prospective study of azilsartan medoxomil / chlorthalidone compared with irbesartan / hydrochlorothiazide in routine therapy of patients with arterial hypertension and obesity.

Observational Prospective stUdy of aZilsartan medoxomil/ chlorthalidone compared with irbesartan/hydrochlorothiaZide combination therapy in patients with arteriaL hypertension and obEsity in routine clinical practice (PUZZLE).

The study population is 94 patients with untreated or poorly controlled arterial hypertension and obesity.

The main inclusion criteria are:

1. Male and female 35-55 year old.
2. Diagnosis of essential arterial hypertension I-II grade.
3. Patients with obesity (BMI ≥ 30 kg/m²)
4. Patients with untreated arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg and no previous antihypertensive treatment.
5. Patients with poorly controlled arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive treatment.
6. Written informed consent.

The main exclusion criteria are:

1. Patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease ≥ 4 grade, diabetes).
2. Patients with secondary arterial hypertension.
3. Patients with intolerance of angiotensin II receptor blockers, thiazide diuretic.
4. Patients with contraindication to study drugs in accordance with Russian instruction.
5. Patients currently enrolled in other clinical trials. The treatment period is 6 months. The study plan includes 4 basic and 1 additional visits are planned: initial visit, 3 follow-ups (including additional) and study-end visit.

Eligibility Criteria:
Inclusion Criteria:

1. male and female 35-55 year old,
2. diagnosis of I-II grade essential AH,
3. patients with obesity (BMI ≥ 30 kg/m²),
4. patients with untreated AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg, no previous antihypertensive therapy),
5. patients with poorly controlled AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive therapy),
6. written informed consent form (ICF).

Exclusion Criteria:

1. patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease stage ≥ 4, diabetes),
2. patients with intolerance of ARB, thiazide diuretics,
3. secondary AH,
4. patients with contraindication to study drugs in accordance with Russian instruction,
5. patients currently enrolled in other clinical trials.
Effect of Sleep Apnea on Blood Pressure Control and Outcome Early After Subarachnoid Hemorrhage

In this observational study patients with subarachnoid hemorrhage (SAH) will be screened for sleep apnea (SA) to investigate if SA is associated with impaired blood pressure control and worse clinical outcome early after SAH.

Patients admitted with non-traumatic SAH will be consented and screened for sleep apnea within 48 hours after hospital admission. Blood pressure and clinical outcome will be monitored throughout ICU treatment and hospital stay, respectively. Diagnosis of sleep apnea will be confirmed on follow-up 3-6 month after SAH by sleep apnea screening (portable cardiorespiratory monitoring and out-of-center polysomnography, respectively).

Eligibility Criteria:
Inclusion Criteria:

* Subarachnoid Hemorrhage (Hunt \& Hess 1 to 4)
* \> 18 years of age
* Ability to consent for study of healthcare proxy able to confirm patient will to participate

Exclusion Criteria:

* Stoke within 3 month prior to admission
* Intubation prior or within 24 hours after admission
* no healthcare proxy
Blood Flow Change After Free Flap Surgery in Diabetic Patients

We aim to evaluate the flow change of arterial anastomosis site during free flap surgery in diabetic patients.

Objective: flow change of arterial anastomosis site during free flap surgery in diabetic patients.

Background: No research was published about flow change of arterial anastomosis site of the free flap during surgery.

Plan: Using Duplex sonography, various parameters related flap perfusion will be evaluated before and after the administration of alprostadil.

Eligibility Criteria:
Inclusion Criteria:

1. Plan to receive free flap transfer under general anesthesia
2. Age: \>=18 and \<80 years old
3. History of diabetes mellitus
4. Administration of alprostadil during surgery
5. Volunteer, who are provided written informed consent prior to study participation

Exclusion Criteria:

1. Refuse the participation of study
2. \>= American society of anesthesiologist physical status IV
3. Use of any vasopressor or inotropic for hemodynamic instability before participation of study
4. Inappropriate subjects who are identified by researchers
Transition to College/Miami University

The current project will test whether a computerized training program, Cognitive Bias Modification (CBM), can be used as a prevention inoculation tool to reduce vulnerability to anxiety among incoming college students. Those not in the CBM condition will complete a symptom tracking condition (ST). We will also test whether ST influences vulnerability to anxiety among incoming college students.


Eligibility Criteria:
Inclusion Criteria:

* First and Second year students
* Entered college in fall of 2017
* Fluent in English
* LSAS-SR score greater than or equal to 14 and less than or equal to 74.
Preoperative Two Hours Carbohydrate Load On Pediatric Patient Undergoing Elective Surgery

This work evaluated the systemic effect of different preoperative carbohydrate (CHO) loads in pediatrics undergoing elective surgery.

Children undergoing surgery experience stress due to disruptions in their daily routine and exposure to various perioperative circumstances that induce anxiety and pain.

The management of perioperative nutrition in pediatric patients is a crucial aspect of patient care.

The concept of preoperative carbohydrate (CHO) loading has gained attention as a potential strategy to mitigate these drawbacks. The administration of a CHO-rich drink two hours preoperative has been proposed to maintain euglycemia, decline IR, and enhance postoperative recovery

Eligibility Criteria:
Inclusion Criteria:

* Age from 5 to 10 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I and II.
* Scheduled for elective surgery.

Exclusion Criteria:

* Diabetes mellitus.
* Insulin resistance (IR).
* Renal or hepatic insufficiency.
* Esophageal or gastric surgery or gastrointestinal disorders history (including gastroesophageal reflux, hiatal hernia, or gastritis).
Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema (TSUBASA)

This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Provided signed, written informed consent
* 20 years of age or older with diabetic macular edema

Exclusion Criteria:

* Active proliferative diabetic retinopathies (PDR) in the study eye
* Uncontrolled diabetes mellitus and hypertension
* Known steroid-responder