cyrilzakka/clinical-trials huggingface dataset:
Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™

This is a multi-center, open label, single group, observational study designed to evaluate the effects of a Cardioplexol™ preparation and administration training program proposed to cardiac surgeons and cardiotechnicians inexperienced in the use of Cardioplexol™.

The training program aims at increasing the efficacy of Cardioplexol administration while reducing the risk of false manipulations. During the training possible risks and consequences of incorrect applications as well as the measures to take in case of administration error, are discussed. The training program includes one standardized theoretical part and one practical part consisting of a direct intra-operative coaching of surgeons practicing their first 2 operations.

The effect of the training will then be assessed by evaluating each trained surgeon's 4 next consecutive patients operated with Cardioplexol and without the coach.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between 18 and 80 years of age;
* The patient's pre-operative evaluation indicates the need for a primary elective cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve repair/replacement;
* The operation can be carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine;
* Patients who provide signed written informed consent.

Exclusion Criteria:

* Pre-operative EF of less than 30%;
* Pre-operative IABP;
* Pre-operative catecholamine support;
* History of myocardial infarction within less than 7 days;
* Previous history of cardiac surgery, including the implantation of a pace maker or an ICD;
* Active myocarditis and/or endocarditis;
* Aortic valve insufficiency severity grade more than 1;
* Under dialysis;
* Pre-operative serum creatinine value of more than 2.0 mg/dl;
* Known hematologic disorder;
* Treatment with anti-vitamin K;
* History of HIT;
* Participating in a concomitant research study of an investigational product;
* Pregnant or lactating;
* Intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
Deep Brain Stimulation (DBS) of the Nucleus Basalis Meynert (NBM) to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease

In the study at hand, six patients with light to moderate Alzheimer's disease will be enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert.

In the study at hand, six patients with light to moderate Alzheimer's disease will be enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert. The stereotactic implantation of the electrodes will be guided by computerized tomography (CT) and magnetic resonance tomography (MRT).

Basically, even though deep brain stimulation is an invasive method, there are only few side effects. Surgical risks correspond with the risk of DBS in morbus Parkinson or other movement disorders (0,4-6%).

After the baseline examination, the patients will be implanted with the electrodes; accordingly all follow-ups are accomplished postoperative. From the second week after the operation, the conventional stimulation takes place as a doubleblind, randomized change between ON and OFF periods. Modifications of the stimulation parameter to obtain the best possible result are possible.

Throughout the one-year observation-period, the patients will be followed closely to monitor the effects of DBS on their cognitive abilities, psychopathological well being, the quality of life, praxie and nutritional condition using standardized neurological and psychiatric rating scales.

Eligibility Criteria:
Inclusion Criteria:

* German speaking male/female subjects
* age:60-80
* AD assessed by DSM-IV, ICD-10 and NINCDS-ADRDA-Scale
* no Lewy-Body-dementia or other form of dementia
* MMST \>18 and \<26
* stable psychopharmacological medication
* no psychotic symptoms, no suicidal tendency
* education for at least 8 years
* written informed consent of the patient
* consent of at least two family members
* no contraindication regarding PET-examination
* no contraindication regarding anesthesia or stereotactic operation

Exclusion Criteria:

* legal accommodation
* clinical co-morbidity
* contraindication of MRT examination
* psychotic symptoms last six months
* aggressive behavior or suicidal tendency
* verbal IQ \<85
* stereotactic operation in previous history
* neoplastic neurological diseases
* serious organic disease
Functional and Metabolic Effects of Ketone Bodies on Human Atrial Tissue in Patients With and Without Heart Failure

This proof of concept study aims to evaluate the effects of applying ketone bodies to human atrial tissue biopsies using an atrial strips model and high resolution respirometry.

Ketone bodies are high energy molecules which are naturally occurring in the body during fasting or stress.

Recently, ketone bodies have been shown to improve cardiac function in patients with heart failure(1) through a mechanism, which has yet to be elaborated.

We wish to evaluate the effects of ketone body administration on cardiac tissue subjected to ischemia reperfusion injury. We will evaluate contractile force of the and the mitochondrial performance. Cardiac atrial tissue will be obtained from patients undergoing coronary artery bypass grafting (CABG) or valve replacement surgery. Patients will be recruited after signing an informed consent and allocated in heart failure / non-heart failure groups based on a clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* EF \< / \> 45%, hospitalized for elective CABG or heart valve surgery

Exclusion Criteria:

* Myocardial infarction within 4 weeks, atrial fibrillation, medically treated thyroid disease, oral treatment with opioids.
Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females

A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen.

A pharmacokinetic (PK) drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen. All participants will receive an oral contraceptive containing progestin and estrogen throughout the duration of the study. Participants will also receive a single dose of erenumab, administered by a healthcare provider in cycle 3. Serial PK samples will be collected at specified time points to characterize the PK of the oral contraceptive progestin and estrogen components with and without the presence of erenumab.

The study consists of three 28-day cycles and a follow-up period. The first 28 day cycle is an acclimation period when participants initiate oral contraception (Cycle 1). During Cycle 2 and 3 the PK of ethinyl estradiol (EE) and active metabolites of norgestimate (ie, norelgestromin \[NGMN\] and norgestrel \[NG\]) will be characterized following the last active dose of oral contraceptive in each cycle (cycle day 21). Erenumab will be given in cycle 3 (cycle day 10); 24-hour PK characterization of norgestimate and EE metabolites will occur 11 days after administration of erenumab, which will maximize the potential for detecting a drug-drug interaction.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female ≥18 to ≤45 years old at the time of enrollment
* Regular monthly menstrual cycle during the last 12 months
* Good general health based on a medical history evaluation and physical examination
* No clinically significant abnormalities in laboratory tests at screening
* Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures

Exclusion Criteria:

* Intolerance to any recent oral contraceptive in the last three (3) years,
* Female subjects with a positive serum pregnancy test at screening
* Female subjects not willing to inform her sexual partner of her participation in the clinical study
* Use of any over the counter or prescription medications within the 14 days or 5 half lives (whichever is longer)
* Nicotine use eg cigarettes or equivalent during 12 months prior to day 1 and through the duration of the study
Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung

Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung

PRIMARY OBJECTIVES:

I. Determine the 1-year survival rate in patients with unresectable malignant pleural mesothelioma treated with erlotinib.

II. Determine the response rate in patients with measurable disease treated with this drug.

III. Determine the frequency and severity of toxic effects of this drug in these patients.

IV. Measure epidermal growth factor receptor (EGFR) expression, EGFR gene amplification, and other activation products in the EGFR signaling pathway in tumor samples and correlate with clinical outcomes in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually for 1 year.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14-18 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignant pleural mesothelioma

  * Epithelial
  * Sarcomatous
  * Biphasic
* Measurable or nonmeasurable disease
* Not amenable to extrapleural pneumonectomy
* No known CNS metastases
* Performance status - Zubrod 0-1
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver involvement of tumor)
* Creatinine no greater than 2 times ULN
* No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
* No active peptic ulcer disease
* No intractable nausea or vomiting
* Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube
* No known history of the following:

  * Dry eye syndrome
  * Sjogren's syndrome
  * Keratoconjunctivitis sicca
  * Exposure keratopathy
  * Fuch's dystrophy
  * Other active disorders of the cornea
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No HIV-positive patients receiving combination antiretroviral therapy
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer that is in complete remission
* No prior biologic therapy for this tumor
* No prior chemotherapy for this tumor
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* See Disease Characteristics
* At least 4 weeks since prior major surgery (e.g., thoracotomy or laparotomy), excluding minor surgeries (e.g., mediastinoscopy, thoracoscopy, or minor biopsies)
* Recovered from prior surgery
* No prior surgical procedures affecting absorption
* No prior investigational anticancer agents for this tumor
The Foot and Ankle Ability Measure (FAAM) is Translated From English to Turkish and Assess the Validity and Reliability in Athletic Population Who Have Foot and Ankle Disorders.

Sport activity induces a relevant risk for lower extremities especially ankle and foot structures. Athletes who participate in basketball, volleyball and soccer are predisposed. Self-reported outcome instruments have been used by clinicians to assess the treatment interventions effectiveness directed at patients with pathologies and identify impairments, disabilities and quality of life. The assessment of musculoskeletal injuries can be problem without clinical, radiological examination and on scores from patient-based questionnaires. The information from these questionnaires provides us good evidence if there is not interpretation of obtained scores. The Foot and Ankle Ability Measure (FAAM) is a self-reported outcome instrument for patients with foot and ankle disorders available in English, German, and French. The FAAM has a sports subscale and activity of daily living (ADL) subscale that can assess the activities that requires higher level. The aim of this study is to translate the FAAM into Turkish language, perform a cross-cultural adaptation, and investigate the reliability, validity of the translated version in athletic population


Eligibility Criteria:
Inclusion Criteria:

1. Participants should be professional athletes
2. Age ranges must be 18-40 years old
3. Clinical diagnosis of ankle and foot injury

   1. Acute condition
   2. Chronic condition
4. Injuries must to happened in sport activities.

Exclusion Criteria:

1. If athletes had injuries to hip, knee, lower leg within the previous 6 months before the study.
2. The history of surgery to the above-mentioned areas.
3. Coexisting musculoskeletal injuries in other body parts, or chronic conditions.

   1. Systematic diseases
   2. Neurological or vascular conditions.
   3. Alcohol abuse
   4. Psychiatric disorders
CVI Alterations in FD: a Prospective, Multicenter, Observational Cohort Study

Fabry disease (FD) is a rare X-linked lysosomal storage disorder caused by α-galactosidase A (GLA) gene mutations leading to reduced or undetectable α galactosidase A (α-Gal A) enzyme activity, resulting in progressive accumulation of globotriaosylceramide (GL3) and its deacylated form globotriaosylsphingosine (Lyso-GL-3) in multiple organs, causing neural, renal, cardiac, dermatological, gastrointestinal and ophthalmic manifestations, even leading to life-threatening complications. Cardiovascular and cerebrovascular complications (i.e. heart failure, stroke, etc.) or end-stage renal disease even premature death can be seen in severe cases. The life expectancy of male patients is reduced by 15\~20 years, while that of female patients is reduced by 6\~10 years.

The exact prevalence of FD is currently unknown. Based on an estimated prevalence of 1:60,000, there are approximately 23,000 affected FD patients in China. The clinical manifestations of FD are diverse and non-specific, which may lead to misdiagnosis in patients with non-typical clinical manifestations in the absence of a family history of FD. Cardiac involvement can be recognized in up to 68% patients with FD, significantly higher than in other organs, and the positive screening rate for FD in adults with unexplained left ventricular hypertrophy (LVH)/hypertrophic cardiomyopathy was 0.9%.

Cardiovascular disease is the leading cause of death in patients with FD cardiomyopathy (40.2%). The 2020 Expert Consensus Document on the Management of Cardiovascular Manifestations of Fabry Disease recommends early screening in patients with suspected LVH for early diagnosis. Therefore, strengthened screening strategy in high-risk patients with LVH will improve the diagnosis and treatment of FD in China.


Eligibility Criteria:
Inclusion Criteria:

Patients to be enrolled in this study should fulfill all 3 criteria (a, b, and c) at screening:

1. Patients with a maximum myocardial wall thickness (left ventricular posterior wall or septum) of ≥13 mm at the end diastole on echocardiography;
2. At least two or more "warning signs" associated with FD ("warning signs" include cardiac "warning signs", extracardiac "warning signs", or family history)
3. Aged 18 years old or older;

cardiac "warning signs" of FD:

Concentric LVH or papillary hypertrophy or right ventricular hypertrophy on echocardiography

ECG abnormalities (eg, shortened PR interval, wide QRS complex, right bundle branch block, ST-segment depression, etc.)

Extra-cardiac "warning signs" of FD

Angiokeratomas

Acroparesthesia

Hypohidrosis

Premature stroke (\<50 years of age)

Corneal verticillate

Renal impairment accompanied by proteinuria

Hearing loss

Family history

Family history of X-linked inherited disorder (renal disease or cardiac disease)

Exclusion Criteria:

1. LVH patients with a clear etiology;
2. Combining any other clinical condition with a life expectancy less than 1 year;
3. Refuse to give informed consent or refuse to be followed-up.
Establishment of a Model for Predicting the Prognosis of HBV-related Decompensated Liver Cirrhosis Based on RFH-NPT

For all countries, chronic liver disease and liver cirrhosis is one of the important disease burdens. Malnutrition is an important complication of liver cirrhosis, which always runs through the course of liver cirrhosis. According to a lot of scientific research evidence, as the consensus of experts all over the world, malnutrition in patients with liver cirrhosis is closely related to poor outcome. Therefore, early and accurate identification of the risk of malnutrition is very important to improve the prognosis of patients with liver cirrhosis.

The purpose of this study was to study the relationship between malnutrition-related indexes and prognosis in patients with liver cirrhosis. 2000 patients with liver cirrhosis were prospectively included, laboratory indexes related to malnutrition and other evaluation indexes were recorded, and long-term follow-up was made to observe the short-term and long-term prognosis of patients with liver cirrhosis. At the same time, a prognostic prediction model was established based on multivariate Cox regression, and a series of in-depth studies and verification were carried out on this basis.

Malnutrition is one of the most common complications associated with liver cirrhosis, which is more likely to occur in patients with decompensated liver cirrhosis. Malnutrition will further lead to muscle loss, that is, the occurrence of myomyositis, which is an important cause of adverse outcome in patients with liver cirrhosis. it is associated with increased risk of death, portal hypertension-related complications, increased infection rates and longer hospital stays. At the same time, liver cirrhosis with portal hypertension leads to esophageal and gastric varices and intestinal mucosal edema, which affects the function of the digestive system and poses a greater challenge to the nutritional maintenance of patients with liver cirrhosis. Therefore, timely nutritional assessment and early intervention decision-making on admission is an important aspect of clinical management of patients with liver cirrhosis.

For the screening of malnutrition in patients with liver cirrhosis, the commonly used screening tools are MST, MUST, NRS-2002, RFH-NPT and so on. For the screened high-risk population, further specific nutritional assessment is needed, there are four main types. The first is a diet-related assessment conducted by a professional dietitian. The second is the body composition analysis represented by muscle mass, such as bioelectrical impedance analysis (BIA), CT, ultrasound and so on. The third is the functional evaluation, of which the more common are five-meter walking speed and grip strength test. The fourth is part of the comprehensive evaluation tools, represented by SGA and RFH-SGA.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with liver cirrhosis

Exclusion Criteria:

* Patients who refuse the follow-up of outpatient department
Effectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis

Transcranial Direct Current Stimulation (tDCS) is a promising non-invasive brain stimulation technique in chronic pain. There is no study investigating the effectiveness of tDCS in radiating chronic lower extremity pain related to lumbar spinal stenosis (LSS). The aim of this study is to investigate the effects of tDCS on pain, walking capacity, functional status and quality of life in patients with chronic pain related to LSS.

32 patients diagnosed with chronic pain related to LSS will be enrolled in this prospective, randomized, double blind, placebo-controlled study according to inclusion/exclusion criteria. Patients in active group will receive 10 sessions of anodal tDCS delivered over primary motor cortex (M1) with a constant current of 2 miliAmpers for 20 minutes. Patients will be evaluated at baseline, on day 1, 5 and 10 (after the session) and 5 days, 1 month and 3 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Magnetic resonance imaging evidence of narrowing of the central canal, lateral recess, and/or foramen.
* Persistent leg pain for at least 3 months
* An average pain intensity score (during walking) of at least 4 out of 10 on the Visual Analog Scale at screening and randomisation
* Persistent neurogenic claudication for at least 3 months
* stable pharmacological treatment for pain and sleep disorders for at least 1 month before the study and throughout the trial
* If present, coexisting low back pain intensity should be less than leg pain intensity.

Exclusion Criteria:

* Patients with other neurological or psychiatric disorders including ongoing major depression (Beck Depression Score\>14)
* Uncontrolled/unstable endocrinologic, cardiovascular, pulmonary, hematologic, hepatic, renal disease
* Inflammatory diseases, cancer
* Severe hip and/or knee osteoarthritis that affects Treadmill Walking Test
* Absolute/relative contraindications of tDCS (past head trauma resulting with loss of consciousness, epilepsy, past neurosurgical intervention, intracranial hypertension, implanted devices, migraine, chronic-severe headache episodes, a history of side effects with non-invasive brain stimulation techniques, skin diseases, pregnancy)
The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate Injections

Participants with multiple sclerosis that are currently treated with glatiramer acetate (GA, Copaxone®) injections and have redness, pain, swelling, itching or a lump at the injection site will be recruited to examine histamine response of three topical treatments to reduce these symptoms.

Participants are asked to be in this study because they have multiple sclerosis, are currently treated with glatiramer acetate (GA, Copaxone®) injections and have redness, pain, swelling, itching or a lump at the injection site.

The purpose of this study is to determine if the use of ethyl-a-guanida-methyl ethanoate (AGEE) will decrease histamine response measured by redness, swelling, and itch response following subcutaneous injection of glatiramer acetate (GA) for the treatment of Multiple Sclerosis (MS).

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Between ages 19-65
* Laboratory supported diagnosis of multiple sclerosis
* Currently treated with injectable GA, experiencing wheal and flare after injection

Exclusion Criteria:

* Unable to give informed consent
* Treated with any other therapy for Multiple Sclerosis