cyrilzakka/clinical-trials huggingface dataset:
Mirror Box Imaging Study

The purpose of this study is to evaluate the effects of mirror box therapy on upper extremity, motor recovery and motor functioning in patients that have suffered a stroke.

Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors, with 30%-60% of patients being unable to fully recover functional use of their upper limbs. As recovery may be due to insufficient or inadequate therapeutic interventions, the progress and evaluation of upper limb treatment is currently being investigated.

Mirror Box therapy is a task orientated, non-invasive, economic and patient directed therapy for hemiparetic upper limb post stroke patients. The study is intended to evaluate cerebral reorganization by using mirror therapy. Movements of the stronger limb trick the brain into thinking that the weaker arm is moving and to stimulate the respective brain areas.

Patients are enrolled into two groups using standard upper limb rehabilitation for three weeks followed by standard rehabilitation plus Mirror Box for another three weeks (Group 1). Group 2 will receive the same therapy in inverted order.

Patients will receive clinical and functional assessment at baseline, three weeks and six weeks including brain MRI using functional resting state MRI.

The primary outcome is functional connectivity (correlation coefficient) at baseline and after treatment. Secondary endpoints include motor and functional recovery using outcome measures like Fugl Meyer assessment, Action Research Arm Test, grip and pincer strength. Further secondary endpoints are increase in sensorimotor cortex activation across the period of therapy and cortical reorganization.

Eligibility Criteria:
Inclusion Criteria:

* 18yrs to 105yrs
* Hemiparetic upper limb post stroke
* Capable of providing informed consent
* Intact vision: if diagnosis of peripheral field defect, patient should be able to compensate for it.

Exclusion Criteria:

* Any contraindication to MRI scanning
* Clinically significant psychiatric disorder (e.g. depression)
* Pre-existing neurological or psychiatric disease that could confound the study results.
Ezetimibe-Rosuvastatin Evaluation Study

Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in achieving the target plasma LCL-C level.

Additional study objectives:

1. Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia with respect to changes in the rest of the lipid profile (HDL-C, TC, TG).
2. Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in altering non-HDL cholesterol (non-HDL - cholesterol) levels.
3. The assessment of the achievement of the LCL-C target of patients receiving the stable ezetimibe-rosuvastatin combination according to their cardiovascular risk category.
4. Assessing patient safety throughout treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who have voluntarily consented to participate in the study.
* Adult patients who are already on treatment with the stable combination of ezetimibe-rosuvastatin (Lipopen), at the discretion of the treating physician.
* Adult patient adequately controlled with rosuvastatin and ezetimibe according to ESC / EAS 2019 guidelines.

Exclusion Criteria:

* Patients who have not fully understood the study procedures and have not signed the consent form.
* Patients who are contraindicated for taking the drug according to the Summary of Product Characteristics (MSF) of the study drug.

Hypersensitivity to the active substances or to any of the excipients of Lipopen.

* Pregnancy and breastfeeding.
* Active liver disease involving unexplained, persistent increases in serum transaminases and any increase in serum transaminases that exceeds 3 times the normal upper limit (ULN) or unexplained persistent increases in serum transaminases.
* Patient with severe renal impairment (creatinine clearance \<30 ml / min).
* Patient with myopathy
* Patient receiving concomitant treatment with cyclosporine
A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants

The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to assess pain following subcutaneous (SC) administration of gantenerumab as a high-concentration liquid formulation (HCLF) at different injection speeds. The total duration of the study for each healthy participant will be up to approximately 21 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants (healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram, hematology, blood chemistry, coagulation, serology, and urinalysis)
* Body mass index between 18.0 and 30.0 kilograms per meter squared (kg/m\^2), inclusive
* Female participants of childbearing potential must commit to use two acceptable forms of contraception during the study and until at least 6 months after the follow-up visit

Exclusion Criteria:

* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis
* History or suspicion of drugs of abuse or alcohol addiction
* Smokers who smoke more than 10 cigarettes per day or equivalent amount of tobacco as determined by history
* Pregnant or lactating women
* Positive result on hepatitis B virus (HBV), hepatitis C virus (HCV), or Human immunodeficiency virus (HIV)-1 and -2
* Any familial history of early onset Alzheimer's disease
* Prior administration of gantenerumab
* Participation in an investigational drug medicinal product or medical device study within 90 days before dosing or within seven times the elimination half-life, whichever is longer
* Any abnormal skin conditions or potentially obscuring tattoos, pigmentation, or lesions in the area intended for SC injection
S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer

To compare the progression free survival(PFS) and safety of TS-S vs. TX-X in Patients With Advanced Breast Cancer first-line treatment

To compare progression free survival (PFS) of the S-1 combined with docetaxel followed by maintenance treatment with S-1 and capecitabine combined with docetaxel followed by maintenance therapy with capecitabine in patients with advanced breast cancer first-line treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 ≤ age ≤ 75;
* ECOG 0-2, The expected survival time more than 3 months;
* Histologically or cytologically proven locally advanced or advanced HER-2 negative breast cancer;
* No chemical treatment after Cancer recurrence;
* At least one measurable disease ( as per RECIST1.1);
* Adequate bone marrow functions (ANC ≥1.5×109 /L, PLT ≥100×109 /L, HB ≥90 g/L);
* Adequate renal functions(serum creatinine ≤ 1.5 ULN; creatinine clearance≥50 ml/min);
* liver functions (serum bilirubin ≤ 1.5ULN, AST/ALT ≤ 2.5 ULN);
* Written informed consent;
* Pregnancy test (serum or urine) within 7 days of entry and willing to use the appropriate method of contraception.

Exclusion Criteria:

* Previously chemotherapy with cytotoxic drugs
* Pregnant, lactating women Did not take effective contraceptive measures
* Adjuvant chemotherapy/ neoadjuvant chemotherapy with 5-FU-based chemotherapy or Paclitaxel -based chemotherapy within 1 year after recurrence;
* Her-2 positive or unknown
* Other trails Before 4weeks
* Affection of the absorption of drugs(Unable to swallow、after gastrectomy、Chronic diarrhea and intestinal obstruction
* Organs with rapid progression of invasion(Liver and lung lesions more than 1/2 organ area or hepatic insufficiency)
* Central nervous system disorders or mental disorders
* For docetaxel or fluorouracil or Twain 80 had serious adverse reactions or Allergy to 5-FU
* Severe upper gastrointestinal ulcer or absorption dysfunction syndrome
* Abnormal blood routine (ANC \<1.5×109 /L, PLT \<100×109 /L, HB \<90 g/L);
* Renal functions(serum creatinine \> 1.5 ULN);
* Liver functions (serum bilirubin \> 1.5ULN
* Brain metastases out of control
* Other unapplicable
Gag-layer in the Urothelium of the Human Upper Urinary Tract

Urothelial carcinomas of the lower and upper urinary tract can be considered "twin diseases". Much of the current clinical decision-making surrounding Upper Tract Urothelial Carcinoma (UTUC) is extrapolated from evidence that is based on urothelial carcinoma of bladder patients.

The inner wall of the bladder is coated with a substance called glycosaminoglycan (GAG). GAG is known to form a gel-like layer on the apical cell membrane and act as a barrier against urine and pathogens in the lower urinary tract.

Currently no published research on the presence of a GAG layer in the upper urinary tract exists. However, literature suggests that the ureteral utothelium can be transduced without enhancers, and the ureteral urothelium may be intrinsically different from bladder, both by the presence or absence of a GAG-layer, by different composition/thickness of the GAG-layer.

Any functional differences between the urothelial layers in the bladder and in the upper urinary tract may affect the adeno-virus transduction, which again will have potential impact on future treatment of UTUC patients with a current unmet medical need.

This study will include patients either undergoing radical nephrectomy or radical cystectomy. After organ removal during surgery a biopsi (1x1 cm) will be collected from the ureter and the renal pelvis or from the ureter and the bladder (depending on type of surgery).

These biopsies will be examined and compared, using molecular biotechniques, for the presence of glykosamino glykan (GAG) layer.

There is no project related follow up for patients included, other than what is standard post-operative regime in the department.

Eligibility Criteria:
Inclusion Criteria:

* Bladder cancer or renal cell carcinoma
* Ability to understand and sign informed consent form

Exclusion Criteria:

* Previous history of cancer
* Immune suppressing medication
* Treatment with local or systemic steroids (\< 3 months prior to enrollment)
* Treatment with antibiotics due to urinary tract infection or pyelonephritis (\< 3 months prior to enrollment)
* Previous radiation therapy of the pelvic floor
* Ureteric stent
* Dilatation of the upper urinary tract detected on imaging
* Dilatation of the upper urinary tract detected on imaging
Research on the Correlation Among Magnetocardiography Patterns and Known Cardiovascular Risk Factors in Diabetic Patients

The purpose of this study is to evaluate the correlation among magnetocardiography (MCG) patterns and various known cardiovascular risk factors.

It is well understood that diabetes mellitus (DM) causes various micro- and macrovascular complications. Among them, coronary heart diseases (CHDs) claim most mortality, and diabetes has been considered as "CHD equivalent". Furthermore, the risk of CHD has been noticed to increase in the pre-diabetic stage, suggesting the development of CHD may start in a rather early stage of the disease. Thus, early detection of CHD in diabetic patients seems to be important. However, currently exam methods for CHD in diabetic patients seemed to have their limitations.

Developed in the 1960s, magnetocardiography (MCG) is designed to detect the weak magnetic field generated by the electrical activity of the heart, and has been used widely in the study of fetal cardiac electrophysiology, arrhythmia and ischemic heart disease. However, the MCG pattern in diabetic patients is not fully understood. The aim of the study is to clarify the correlation among various cardiovascular risk factors and MCG pattern in diabetic patients. And, according to the results of the study, we'll evaluate the potentiality of MCG in early diagnosis of CHD in diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Clear consciousness
* Met the diagnostic criteria of DM published by the American Diabetes Association in 2009

Exclusion Criteria:

* not suitable for MCG exam (ex. with pacemaker implantation or indwelling metallic device)
Postprandial Effect of Chinese Tea Flavor Liquor on Selected CVD Risk Factors

Background: human studies of Chinese liquor are sparse. we hypothesis that Chinese Tea Flavor liquor may be beneficial to CVD risk factors postprandially.

Design: three-way crossover design with one week wash time.16 young men were included to consume 60mL Chinese tea flavor liquor(45% alcohol content), Chinese Meijiao liquor 45% alcohol content) or water control.Blood samples were collected fasted, 0.5,1,2,4 hours postprandially.

Tested serum indices: lipids, glucose, insulin, hs-CRP, uric acid, liver function parameters.


Eligibility Criteria:
Inclusion Criteria:

* no CVD history or liver disease, healthy young men

Exclusion Criteria:

* smokers
Assessment of the Hemodynamic Effects of PEEP According to Alveolar Recruitment During the ARDS

The corner stone of the treatment of ARDS is mechanical ventilation with high levels of positive end-expiratory pressure, also called PEEP. A high level of PEEP is recommended and frequently used. But PEEP can lower cardiac output and contribute to circulatory failure during mechanical ventilation. Nevertheless, in theory, the PEEP-induced pulmonary vascular resistance (PVR) increase could depend on the level of alveolar recruitment, but it has never been proven. Thus, the aim of this study is to determine the relation between the high-PEEP induced PVR and the alveolar recruitment or overdistension.

During acute respiratory distress syndrome (ARDS) the application of positive end-expiratory pressure (PEEP) prevents expiratory alveolar collapse. However, it can induce a predominant recruitment effect or, on the contrary, alveolar overdistension. The recruitment/overdistension ratio can be easily assessed using R/I ratio (or recruitment-to-inflation ratio). However, PEEP is likely to lower cardiac output and contribute to the cardiovascular failure that often occurs in patients with ARDS. Among its hemodynamic effects, PEEP is likely to increase pulmonary vascular resistance and, thus, right ventricular afterload. In theory, this effect should only occur if PEEP over-distends the lung volume, compressing the "extra-alveolar" vessels and increasing their resistance. However, this different effect of PEEP on pulmonary vascular resistance depending on the degree of recruitment or overdistension has never been demonstrated during ARDS in humans.

We retrospectively studied data collected from patients with ARDS, monitored by pulmonary artery catheter (PAC), to eventually find a correlation between the high PEEP-induced PVR increase and recruitement/overdistension profile.

Eligibility Criteria:
Inclusion Criteria:

* ARDS diagnosed
* Invasive mechanical ventilation
* Pulmonary artery catheter already in place
* Esophagal pressure measure

Exclusion Criteria:

* Pregnancy
* Prone position at inclusion
* Legal protection measures
Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma

Obstructive lung disease is usually a differential diagnostic consideration when a patient presents with breathlessness or cough. Spirometry is the key diagnostic test used to confirm airflow obstruction particularly in the primary care setting. Airflow obstruction that completely resolves after administration of a bronchodilator, by definition, excludes a diagnosis of COPD. Evaluation of obstructive lung disease must include pulmonary function testing; bronchoreversibility testing is an adjunct in differentiating between asthma and COPD. Bronchoreversibility cannot serve as an absolute diagnostic criterion for separating asthma from COPD.

Vibration response imaging (VRI) technology provides a simple, radiation-free method to image the lungs, by visualizing vibration energy (lung sounds) emitted during respiration cycle. In this study, regional quantitative and qualitative information on vibration response is compared with spirometry in assessing lungs function of COPD and Asthma patients.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to read, understand, and provide written Informed Consent
* Male or Female in the age range of 18-85 years
* Patients referred for evaluation of known or suspected obstructive airways disease.
* Subject is referred for pulmonary function testing with pre-and post- bronchodilator
* BMI \> 21
* Patients who are treated with Bronchodilators should go through a washout period prior the VRI procedure according to the Pulmonary Function Laboratory protocol.
* Stable clinical condition at study baseline evaluation.

Exclusion Criteria:

* Chest wall deformation
* Spine deformation (including severe scoliosis)
* Hirsutism
* Potentially contagious skin lesion on the back
* Skin lesion that would interfere with sensor placement
* Pregnant or lactating females.
Parent Interventions to Prevent Student Drinking

Examine the efficacy of parent interventions to prevent college student drinking in first year students.

The aims of the study are to:

1. efficacy of parent interventions to prevent college student drinking in first year students;
2. examine mediators of efficacy; and
3. examine moderators of efficacy.

Eligibility Criteria:
Inclusion Criteria:

* first year students

Exclusion Criteria:

* none
Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS

The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). The secondary objectives of this study in this study population are to assess the impact of DMF over a 12-month period on patient-reported outcomes (PROs) and health economic-related outcomes and to evaluate additional clinical outcomes at Month 12.


Eligibility Criteria:
Key Inclusion Criteria:

* Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use Protected Health Information in accordance with national and local patient privacy regulations.
* Have the ability to read and understand written English.
* Have access to the internet and are able to complete online assessments on a computer
* Have a relapsing form of Multiple Sclerosis and satisfy the approved therapeutic indication for dimethyl fumarate (DMF) per the United States Prescribing Information (USPI).
* Are being treated for relapsing forms of multiple sclerosis (MS) with glatiramer acetate (GA) but, per the Prescribing Physician, have a suboptimal response (e.g., suboptimal efficacy, intolerance, or poor adherence) to GA or have stopped treatment with GA for relapsing forms of MS as a result of suboptimal response within 30 days of enrollment.
* Have decided to initiate treatment with dimethyl fumarate (DMF) under routine clinical care. The decision to initiate treatment with DMF must precede enrollment.
* Have a complete blood count (CBC) available within 6 months of initiation of treatment with dimethyl fumarate (DMF).

Key Exclusion Criteria:

* Are unwilling or unable to comply with study requirements, or, are deemed unsuitable for study participation at the discretion of the Prescribing Physician.
* Have major comorbid conditions that would preclude their participation in the study as determined by the Prescribing Physician.
* Have a history of malignancy. (Patients with basal cell carcinoma that has been completely excised prior to study entry remain eligible.)
* Have a history of and/or current serious infections.
* Are pregnant or breastfeeding, or are planning to become pregnant or breastfeed.
* Are receiving concomitant disease modifying therapies other than glatiramer acetate (GA) or have initiated treatment with a new disease-modifying therapy since discontinuation of glatiramer acetate (GA).
* Are currently enrolled in any other clinical studies, with the exception of the dimethyl fumarate (DMF) Pregnancy Registry.
* Have received prior treatment with dimethyl fumarate (DMF).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Auricular Acupuncture for Analgesia During Total Hip Arthroplasty

The aim is to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute pain and in reduction of analgesics in patients during total hip arthroplasty


Eligibility Criteria:
Inclusion Criteria:

1. Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective hip arthroplasty because of degenerative osteoarthritis under general anesthesia.
2. Surgery time does not exceed 100 minutes.
3. Patients without previous opioid medication.
4. Patients ranged 45-85 years old.
5. Patients who have given informed consent.

Exclusion Criteria:

1. Pregnant or nursing females.
2. Recidivist alcoholics.
3. Local or systemic infection.
4. Age \< 45 and \> 85 years.
5. Surgery time more than 100 minutes.
6. Intraoperative complications (bleeding, required blood transfusion more than 4 units of packed cells , cardiovascular instability, required catecholamines).
7. Patients consumed opioid medication before surgery.
8. Patients with prosthetic or damaged cardiac valves.
9. Patients who are unable to understand the consent form.
10. History of psychiatric disease.
Mobile Application-Assisted Pressure Injury Management

Pressure injuries develop due to decreased movement, especially in bedridden individuals receiving home care. In Turkey, the management of pressure injuries is carried out by nurses in acute and long-term care settings, and mostly by caregivers for individuals receiving home care. Studies have shown that individuals providing home care have a significant need for training. Today, digital health technologies are used to facilitate access to healthcare professionals and provide workload and cost efficiency. Telehealth services in these technologies can be provided via telephone or mobile applications. In this context, the aim of the study is to examine the effect of nursing services provided via mobile applications on the management of pressure injuries in individuals receiving home care. The study was designed as a randomized controlled experimental type. In the power analysis conducted to calculate the sample size, the sample size was determined as 56, and considering that there may be data losses, 60 people will be included in the study. The "Structured Information Form, Pressure Injury Information Form for Caregivers, Pressure Injury Skill Checklist for Caregivers, and Pressure Injury Follow-up Form" will be used as data collection tools in the study. In this study, it is thought that the nurse's remote monitoring of individuals receiving home care with a mobile application in the management of pressure injuries will contribute to patient safety and care costs.


Eligibility Criteria:
Inclusion Criteria:

* Individuals receiving home care and caregivers
* Individuals over the age of 18
* Individuals with a caregiver who can use the mobile application (The mobile application will be introduced to the caregivers in the first meeting and consent will be obtained from the individual to use it)
* Individuals with a smartphone
* Individuals who can use a smartphone
* Individuals who fill in the data completely
* Individuals with a pressure injury

Exclusion Criteria:

* Individuals who cannot use mobile applications
* Individuals who cannot use smartphones
* Individuals who want to leave the study
* Individuals who have incomplete data collected in the study for various reasons
* Individuals with chronic diseases (Diabetes and Hypertension)