cyrilzakka/clinical-trials huggingface dataset:
Biomarkers in Acute Cardiac Care

The primary aim of the study is to investigate new cardiac biomarkers and algorithms to diagnose acute coronary syndrome in patients with suspected acute myocardial infarction.

The primary aim of the study is to detect and evaluate new cardiac biomarkers, evaluate and improve acute coronary syndrome (ACS) risk scores, which takes into account clinical, gender specific, psycho-social and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint of acute myocardial infarction.

Secondary study aims are :

* To provide estimates for the incidence of ACS in patients presenting with recent onset chest pain;
* To provide accurate, quantifiable measures of precursors of ACS;
* DNA, RNA, cells, and serum/plasma for comprehensive genetic, gene expression and proteomic studies
* To explore the impact of ACS candidate genes on cardiovascular risk stratification by using genome-wide analyses and a biological systems approach;
* To explore proteins relevant for ACS;
* To allow the identification of new therapeutic targets;
* To evaluate the impact of socio-economic factors on ACS and CAD risk.

Patients will be followed up during the hospital stay. Afterwards a telephone follow-up will take place after 30 days, 6, 24 and 48 months.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms suggestive of acute myocardial infarction
* Ability to provide written informed consent in accordance with Good epidemiological Practice and local legislation
* Individuals at least 18 years old

Exclusion Criteria:

- Insufficient knowledge of the German language (able to understand and write the German language)
Comparison of Sit-to-stand Test With Six-minute Walk Test in Bronchiectasis and Healthy Children

Children with bronchiectasis and age-matched healthy controls will be evaluated with sit-to-stand test and six-minute walk test and utilization of STST in determining functional capacity will be investigated.

Bronchiectasis (BE) is a chronic condition which is characterized by the permanent abnormal widening of the bronchi as a result of repetitive airway infections and inflammation. Disabling cough and shortness of breath, excess mucus production, progressive airway obstruction and loss of skeletal muscle mass are the primary factors that impairs exercise tolerance in BE patients. Imaging modalities and pulmonary function test are insufficient to determine disease burden or the prognosis thus it is stated that exercise tolerance and quality of life should also be evaluated in these patients.

Exercise tolerance can be evaluated using cardiopulmonary exercise test by directly measuring oxygen consumption but the field tests such as six-minute walk test (6MWT), shuttle walk test or stair climbing tests also provides reliable data on exercise tolerance by measuring functional capacity. Among field tests, 6MWT is the most commonly used test for evaluating functional capacity in cardiopulmonary patients. Although 6MWT is easy to apply and does not require any special equipment, it still requires a 30-m long corridor and a total testing time of approx. 20 minutes considering the pre- and post-test resting periods which may impair its feasibility in some clinical settings.

Sit-to-stand test (STST) is firstly developed for older population to measure mobility related function and physical performance. Today, it is widely used in various populations including cardiopulmonary diseases such as cystic fibrosis, chronic obstructive pulmonary disease and heart failure. The investigator's aim in this study is to investigate whether STST is utilizable for evaluating functional capacity in children with BE.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-cystic fibrosis bronchiectasis

Exclusion Criteria:

* Hospitalization history in past month
* Diagnosis of other chronic pediatric diseases which may impair exercise tolerance such as cerebral palsy or neuromuscular disease
* Candidates for lung transplantation or history of lung transplantation
Manipulation of Arterial Pressure in Acute Ischemic Stroke

This is a controlled clinical trial among non thrombolysed acute ischemic stroke patients to determine the effects of three levels of arterial pressure on death and neurological disability. After the admission in the vascular unit of the Emergency Department the patients are randomized to maintain during the first 24h the Systolic Arterial Pressure in tree levels of pressure: 140 to 160 mmHg; 161 to 180 mmHg and 181 to 200 mmHg. The end point of the study is the Modified Rankin score and mortality in three month after the discharge.

To maintain the tree levels of systolic arterial pressure during de first 24h we will use one of the two strategies:1) infusion of 500 to 1000ml of saline solution and/or norepinephrine solution to increase de systolic pressure or 2) infusion of esmolol or nitroprussiate solution to decrease de pressure. Every patient will have a transcranial doppler study in the first 24h to measure the mean velocity of cerebral arteries.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older, with the first Acute Ischemic Stroke within the first 6 hours of the symptoms and not candidate to thrombolysis
* We will also include patients with previous Ischemic Stroke with Ranking score 0 or 1

Exclusion Criteria:

* Improuvment of the symptoms rapidly (in the first 15 min after admission)
* Seizures not related do the acute ischemic stroke
* Previous ischemic stroke in the last 6 weeks and with Ranking score \> 1
* Haemorrhagic stroke
* Anticoagulation
* Hypoglycemia
* Shock
* Acute heart failure
Playware Technology for Balance Training

This study evaluates the use of Playware technology for balance training. Falling among elder is a costly problem. Research shows that training can help prevent falls. Pilot studies of the use of Interactive Modular Tiles (IMT) show that the participants can highly increase their physical abilities.

The interventions group will train using interactive modular tiles. The tiles include preprogrammed games that create playful training for the participants.

The control group will receive "usual care", which here refers to normal day activities.

The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time.

This study will investigate the use of one form of exergames called IMT how this compared to usual care of elderly people 70+. The trial will consist of two groups, one for training with the IMT and usual care that will receive the care provided to non-patients elderly, which at this moment is no additional treatment other than recommendations.

The study will be single blinded, randomized controlled trial. It will be funded by the patient@home project and Entertainment robotics. Concealed allocation and intention-to-treat analysis will be used. Measurements will be taken at baseline and after intervention. Upon acceptance the protocol will be registered in clinicaltrials.gov.

The trial's results will be reported using domains and categories described in the taxonomy developed by the Prevention of Falls Network Europe, to allow future synthesis of evidence, or study replication.

The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.

The control group will not train.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling
* 70+ years

Exclusion Criteria:

* A previous diagnosis of strong dementia or a cognitive decline that prevents the understanding of simple instructions or guidelines;
* A previous stroke with a severe neurological impairment, such as loss of strength, and perceptual or language limitations;
* A severe visual deficiency;
* Inability to maintain a standing position, even with the use of a walking aid or other device;
* Participating in rehabilitative training.
A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection

The purpose of this study is to compare the performance of cotton and flocked swabs for vaginal self-sampling.

Vaginal self-sampling for Human Papillomavirus (HPV) testing has been proposed as an efficient method cover hard-to reach populations in developing countries. While the recent cheap cotton swabs have traditionally been used for deoxyribonucleic acid (DNA) detection, recent studies have questioned their efficacy by reporting the superiority of the more expensive flocked swabs.

The objective of this study is to compare the performance of cotton vs flocked swabs for cellular retrieval and HPV DNA quantification after vaginal self-sampling.

A total of 120 women will be recruited. Inclusion criteria will be as follows: 21 years of age or older, attending the colposcopy clinic, understanding the study procedures and able to comply with the study protocol. Pregnant women, those having previously had a total hysterectomy, and women with ongoing menstruation will be excluded. Each woman will collect two different vaginal self samples: one with the cotton swab and one with the flocked swab. Subsequently, a flow cytometric analysis, as well as a real time PCR analysis and a cytologic evaluation for specimen adequacy will be run on each sample. Agreement between the two methods will be calculated using the kappa statistic (κ).

Eligibility Criteria:
Inclusion Criteria:

* attending the colposcopy clinic
* accepts voluntarily to take part to the study and signs the informed consent form

Exclusion Criteria:

* pregnancy
* previous hysterectomy
* ongoing menstruations
Effects of Obex in Overweight and Obese Patients

* Obesity is an important and growing public health worldwide
* Obesity is highly related to the development of metabolic syndrome, diabetes, cardiovascular diseases and cancer
* An extensive body of evidence from efficacy trials has shown that weight loss is achievable, however, a modest weight loss is achieved in a small proportion of patients
* Important adverse events have been reported with the use of antiobesity drugs.
* The use of natural products with potential effects inducing weight loss is an alternative strategy for treating patients with overweight and obesity. However, efficacy and safety should be evaluated in RCT.
* Obex combines different molecules with potential effects inducing weight loss and control on metabolic parameters such as fasting glucose, cholesterol and triglycerides.
* Therefore, the administration of Obex in overweight and obese patients with impaired fasting glucose could be an excellent strategy to induce weight loss and ameliorate the metabolic disturbances related to obesity and overweight.


Eligibility Criteria:
Inclusion Criteria:

* Overweight and Obese subjects with and without IFG
* Ability to provide informed consent

Exclusion Criteria:

* Presence of diabetes mellitus, hepatic, renal or cardiovascular disease
* Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc)
* Sepsis or any other condition that could potentially interfere with treatment
* History of bariatric surgery
* Pregnancy or lactation
* Concomitant disease with reduced life expectancy
* Severe psychiatric conditions
* Anyone with chronic medical conditions requiring regular intake of any prescription medications.
* Used drugs for weight loss (e.g., Xenical \[orlistat\], Meridia \[sibutramine\], Acutrim \[phenylpropanolamine\], Accomplia \[rimonabant\], Alli \[low-dose orlistat\], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
* Are actively participating in, or have participated in a formal weight loss program within the last 3 months
Impact of Therapeutic Footwear and Plantar Orthoses on Diabetic Neuropathic Foot in Quality of Life and Functionality

This study determines the effectiveness of plantar orthoses and custom-made orthopedic footwear in functional level and quality of life of persons with diabetes type 2 and diabetic peripheral neuropathy. This study is important due the loss of protective sensation, feet are vulnerable to minor trauma caused by plantar pressure as well as mechanical and thermal injuries. Thus, Plantar Orthoses become necessary to reduce PP and align the foot. Additionally, it is known that footwear is the most frequent cause of diabetic foot injury, since ulceration is frequently a consequence of the continuous trauma provoked by inadequate footwear. For a higher efficacy in the treatment of the foot, it is also necessary to use custom-made orthopedic footwear, indicated in the treatment of foot pathologies.

The lack of studies that evaluate the impact of this treatment on clinical measures such as quality of life and functional level, led to the development of this study, comparing a standard treatment (standard footwear and plantar orthoses) with an optimal treatment suggested in diabetic foot guidelines (therapeutic footwear and plantar orthoses).

This clinical trial includes 2 parallel intervention groups with a pre- and post-test analysis. In the standard footwear (SF) group, plantar orthoses, standard footwear and education on foot self-care were applied and in the orthopedic footwear (OF) group the same intervention was applied, but with orthopedic footwear.

Both intervention groups were evaluated at two different time points, with the pre-test taking place at the beginning of the study (T0 - Baseline) and the post-test taking place 4 months after the application of the treatment (T4). In the middle of the study, at two months (T2) a questionnaire was applied in order to understand the adherence and the perception of individuals about the intervention applied.

The screening of diabetic peripheral neuropathy was made with the Michigan Neuropathy Screening Instrument (MNSI) and the description of the sample with an evaluation questionnaire.

The FL was evaluated through the Lower Extremity Functional Scale (LEFS), physical tests and the postural, static and dynamic barometric assessment. QoL was assessed with SF-36 and the adherence and satisfaction with a questionnaire created ad hoc.

Eligibility Criteria:
Inclusion Criteria:

* Presence of type 2 DM;
* Have at least 6 months from diagnosis of DM;
* Presence of Diabetic Polyneuropathy;
* No history of plantar orthoses and orthopedic footwear use.

Exclusion Criteria:

* Active ulceration;
* Severe osteoarticular deformities;
* Presence of cognitive impairment;
* Gait with technical devices;
* Diagnosis of neurological pathology that can affect the gait pattern;
* Diagnosis of another pathology that can negatively influence the study: depression, the presence of uncontrolled cardiovascular diseases and active cancer.
* Surgical interventions on the spine and lower limbs, with less than 1 year of recovery.
Three Small Doses of HCG Versus Booster Dose of HCG on Ovum Pickup Day

To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles triggered with GnRH agonist. Two strategies are compared supplementing the luteal phase with three small doses (500 IU) of HCG and giving a booster dose of HCG (1500 IU) on the day of ovum pickup.


Eligibility Criteria:
Inclusion Criteria:

* High responder females undergoing antagonist protocol IVF/ICSI cycle
* More than 14 MII oocytes
* Estradiol more than 3500 pg/ml on day of trigger

Exclusion Criteria:

* Any other protocol
* Normal or poor responders
Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure

The purpose of this study is to determine the acute efficacy of intrathecal clonidine to reduce blood pressure in hypertensive subjects with poor blood pressure control and describe its effects on cardiovascular function.

Hypertension occurs commonly, is associated with major morbidity and mortality, and responds poorly to current therapies in a small minority of compliant patients. The goal of this investigator-initiated study is to determine whether intrathecal administration of clonidine reduces blood pressure in hypertensive patients, focusing on a group who often achieve inadequate blood pressure control with multiple drug therapy.

After consent, pts will be screened and if qualified brought into center and intrathecal injection of clonidine given. Patients will be closely monitored for 4 hours, while data is collected.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hypertension
* Stable systolic blood pressure \>140 mmHg and \< 190 mmHg
* On 3 or more antihypertensive medications
* On a diuretic
* Patients must be able to understand the risks

Exclusion Criteria:

* Allergy to clonidine
* Presently on clonidine orally or transdermally
* Known or suspected correctable causes of secondary hypertension
* Breast Feeding or Pregnant women
* Unstable Ischemic Heart Disease
* Unstable Angina
* Intracoronary Stent Placement
* Coronary bypass within last 6 months
* Myocardial Infarction within last 6 months
* Congestive Failure
* Cardiac Arrhythmias
* Known Cerebral Vascular Disease
* Renal Disease
* Evidence of Injection Site Infection
* Known Bleeding Disorders
* Hepatic Insufficiency
* Renal Insufficiency
* Participation in an investigational drug study within 30 day of enrollment
* Prohibited Medications:

  * Clonidine
  * Yohimbine
  * Tricyclic Antidepressants
  * Mirtazapine
  * Digitalis
  * Reserpine
  * Guanethidine
  * Non-Steroidal Anti-inflammatory Medication
  * Alcohol or Barbiturates within 48 hours of study procedure
A Study of Recormon (Epoetin Beta) in Anemic Patients With Non-Myeloid Malignancy

This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly epoetin beta subcutaneous injections (30,000 International Units \[IU\]) in anemic patients with solid tumors. The anticipated study duration is 4 months, and the target sample size is 40 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a non-myeloid malignancy
* Anemia

Exclusion Criteria:

* Transfusion of red blood cells within 2 months of study drug
* Treatment-resistant hypertension
* Acute or chronic bleeding (requiring therapy) within 3 months of study drug
Nailfold Capillaroscopic Assessment in Pediatric Uveitis Patients

Pediatric uveitis accounts for 5-10% of uveitis cases. it may be infectious or noninfectious in etiology. The etiology of noninfectious uveitis may be autoimmune. The most common causes of pediatric uveitis are idiopathic and juvenile idiopathic arthritis-associated uveitis. Uveitis morbidities in pediatric patients include cataract, glaucoma, and amblyopia. Pediatric uveitis may be accopanied by involvement of the ocular vasculature, such as retinal vasculitis. We hypothesize that there are differences in systemic microcirculation between pediatric uveitis patients and healthy pediatric controls.

The systemic microcirculation will be investigated through nailfold capillaroscopic (NFC) assessment with noninfectious uveitis and healthy pediatric controls.

The NFC parameters are:

capillary density (number of capillaries per mm), dilated capillaries (apex of \>20µm), avascular areas, the presence of microhemorrhages, and capillary morphology (normal, multiple crossings, tortuous, bushy, ramified, non-convex, or bizarre capillaries).

Eligibility Criteria:
Inclusion Criteria:

* patients with uveitis \< 18 years old

Exclusion Criteria:

* infectious uveitis
* age \> 18 years old
Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)

The objective of the study is to determine if treatment with Ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. The primary study objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study objective is to determine if subject compliance with CPAP treatment of their sleep apnea is improved in subjects taking Ramelteon (their compliance may be improved because they would have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo arm.

Randomized, double-blind, placebo-controlled, parallel arm clinical trial with two study arms.

Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnea
* Insomnia
* Age\>60

Exclusion Criteria:

* Cognitive impairment
* Active alcohol or substance abuse
* Active use of other sedative-hypnotic agents
* Active use of fluvoxamine (drug interaction with Ramelteon
* Evidence of hepatic dysfunction (Ramelteon contraindicated) on liver function panel
* Presence of Periodic Limb Movement Disorder or Restless Legs Syndrome
* Severe Chronic Obstructive Pulmonary Disease
Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa

Parkinson's Disease is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the major DA metabolising enzyme in man.

Safinamide is an inhibitor of MAO-B. This is a phase III trial to evaluate the efficacy and safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a stable dose to levodopa in subjects with advance idiopathic Parkinson's Disease.

The principal efficacy measure is the increase in mean daily "on" time during the 18-hr diary recording period.


Eligibility Criteria:
Inclusion Criteria:

Male and female between the ages of 30 to 80 years with diagnosis of idiopathic Parkinson's Disease of more than 5 years duration, with a Hoehn and Yahr stage of I-IV during an "off" phase.

Be levodopa-responsive and have been receiving treatment with a stable dose of levodopa for at least 4 weeks.

Have motor fluctuations, with \>1.5 hours "off" time during the day. Be able to maintain an accurate and complete diary (18-hour)

Exclusion Criteria:

Patients with medical conditions and/or taking concomitant medications that would have put them at risk, interfered with the study evaluations, or made them unable to complete the requirements of the study;.

Be in a late stage of Parkinson's Disease, and experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms.

Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months.

Have received treatment with safinamide previously. History of, or current depression psychosis (e.g. schizophrenia or psychotic depression) Evidence of dementia or cognitive dysfunction. History of allergic response to anticonvulsants, levodopa, or other anti-Parkinsonian agents.

Hypersensitivity or contraindications to MAO-B inhibitors. Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy.