cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 75 years with a clinical diagnosis of first onset,
* Persistent (i.e. tinnitus should never be absent for \> 24 hours in a row), subjective, uni- or bilateral tinnitus present for at least 3 months but not more than 12 months

Exclusion Criteria:

* Clinical diagnosis of intermittent or pulsatile tinnitus
* Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Menière's disease, otosclerosis, etc)
Risk Factors of Rebleeding After Peptic Ulcer Bleeding: a Nationwide Cohort Study

The purpose of the investigators study is to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding.

The investigators are performing a nationwide population based cohort study to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding. The results of the investigators study should give us information about patients who are at high risk of rebleeindg and enable us to manage these patients appropriately.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with peptic ulcer bleeding by endoscopy
* Patients who consent to be enrolled in the study

Exclusion Criteria:

* Patients who refuse to be enrolled in the study
From Active to Palliative Care: Emotional Burden and Self Efficacy in Patients and Caregivers

This study aims to evaluate psychological dimensions in patients and caregivers in the transition phase from active to palliative care.

After being informed about the study, all patient giving written informed consent will enrolled and evaluated at T0 through the General Self-Efficacy Scale (GSE), Resilience Scale (RS-14), Toronto Alexithymia Scale (TAS-20), Integrated Palliative Care Outcome Scale (IPOS) and Caregiver Inventory (CGI).

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Patients who are not undergoing active treatments (OLT)
* Suitability of the patient for palliative care
* Ability to express informed consent

Exclusion Criteria:

* Age \< 18 years
* Patient not eligible for palliative care (active treatments)
* Comorbidity factors that make enrollment impossible
* Inability to give informed consent
* Psychiatric disorders prior to the current pathology
* Severe speech impairment
Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome

This is an open-label phase 2 study recruiting low, moderate, and high likelihood ACS patients from approximately 60 centers. Patients will be imaged with iodofiltic acid I 123 for the detection of myocardial ischemia. Readers independent of the clinical study centers will review results of imaging studies in a blinded fashion at an imaging core lab. The resulting independent reading of the images will be compared against the truth standard for ACS.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent and are willing to comply with protocol requirements
* Are 40 years of age or older.
* Are being evaluated for possible ACS.
* If female, then not of childbearing potential as documented by history or has a negative serum or urine pregnancy test within 4 hours prior to receiving the test drug and agrees to use an acceptable form of birth control.

Exclusion Criteria:

* \<40 years of age.
* Females who are pregnant or lactating.
* History of left ventricular ejection fraction (LVEF)=40%.
* History of MI.
* Acute ST segment elevation on ECG.
* Left bundle branch block on ECG.
* Known history of significant allergy to x-ray contrast media or iodine/iodides.
* Currently or formerly on medication that targets fatty acid uptake or metabolism, eg ranolazine, (Ranexa).
* Administered radiopharmaceutical other than rubidium-82 or thallium-201 within 2 days prior to study enrollment.
* Underwent cardiac stress testing of any kind within 2 days prior to study enrollment.
* Serum creatinine level \>2.0 mg per dL.
* Received investigational compound and/or medical device within 30 days of admission into this study.
* Q-wave abnormalities consistent with previous MI
Analysis of Health Status of Сomorbid Adult Patients With COVID-19 Hospitalised in Fourth Wave of SARS-CoV-2 Infection

Depersonalized multi-centered registry initiated to analyze dynamics of non-infectious diseases after SARS-CoV-2 infection in population of Eurasian adult patients.

Assessment of hospital course and health status during 3, 6, 12 months after discharge in COVID-19 patients in cohorts with comorbidities and without comorbidities. Evaluation of comorbidity impact to severity of novel coronavirus disease and comorbidity impact to demand for medical care.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed COVID-19

Exclusion Criteria:

* Age under 18 years.
* Refusal to be involved in study;
Analgesic Efficacy of Serratus Anterior Plane Block in The Rib Fractures Pain

Serratus Anterior Plane Block (SAPB) is a facial plane block that was first described by Blanco in 2013 and that blocks the lateral cutaneous branches of the T2-T9 intercostal nerves, the intercostobrachial nerve, n. thoracic longus, n. thoracodorsalis nerves. Case and case series have been reported in the literature on the use of SAPB in rib fractures, and it has been reported as an effective analgesia method. We apply SAPB to patients with rib fractures with pain in our clinic.

Our aim is to evaluate SAPB for patients with rib fractures pain and to compare them with the control group in terms of total analgesic consumption and pain scores.

After Ethics Committee approval patients with rib fracture pain and have a Numerical Rating Scale (NRS) score of ≥ 4, included the study. The patients were randomized by the closed envelope method. The patients were divided into two groups as the SAPB-performed group (Group S) and the Control group (Group K). Intravenous patient-controlled analgesia (PCA) device prepared with tramadol was applied to all patients.

Eligibility Criteria:
Inclusion Criteria:

Rib fracture pain and had a Numerical Rating Scale (NRS) score of ≥ 4 ASA I-II-III

Exclusion Criteria:

Patients with infection at the injection site Coagulopathy Allergy to amide-type local anesthetics History of peripheral neuropathy Hepatic and/or renal failure Refusing the procedure
Dopamine Modulation of Motivation and Motor Function in Major Depression & Inflammation

A large body of evidence on depression heterogeneity point to an "immunometabolic" subtype characterized by the clustering of immunometabolic dysregulations with atypical behavioral symptoms related to energy homeostasis. Motivational and motor impairments reflected by symptoms of anhedonia and psychomotor retardation in major depression are closely related to alterations in energy homeostasis, are associated with increased inflammation, and may be a direct consequence of the impact of inflammatory cytokines on the dopamine system in the brain. In the proposed project, the investigators will examine the effect of dopamine stimulation on motivation and motor function in patients with major depression and healthy controls and the role of inflammation using a double-blind, randomized, placebo-controlled, cross-over design. If successful, this study would provide crucial evidence that pharmacologic strategies that increase dopamine may effectively treat inflammation-related symptoms of anhedonia and psychomotor retardation in major depression.


Eligibility Criteria:
Inclusion Criteria:

For patients with major depressive disorder:

* diagnosis of major depressive disorder according to DSM-5
* free of antidepressant medication

For healthy participants:

* C-reactive protein (CRP): ≤ 1 mg/l
* free of antidepressant medication
* free of any current psychiatric disorder

Exclusion Criteria:

* diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, dementia, and current/past alcohol or drug dependence
* central nervous system diseases
* neurological diseases
* suspicious undiagnosed skin lesions or a history of melanoma
* narrow-angle or wide-angle glaucoma
* bronchial asthma
* history of peptic ulcer disease
* history of seizures
* any severe somatic disease
* current infections or chronic inflammatory diseases (e.g., rheumatic diseases, inflammatory bowel disease)
* pregnancy / breast-feeding
* class 3 obesity (body mass index of 40 or higher)
* Use of medication containing reserpine (certain antihypertensive agents), tricyclic antidepressants, bon-selective monoamine oxidase (MAO) inhibitors, antiparkinsonian drugs, sympathomimetic drugs, tetrabenazine.
1068GCC Evaluate Efficacy & Explore Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma

Patients are asked to be in this study if they have multiple myeloma and are having tingling, numbness and pain from taking bortezomib (velcade®). Patients who have been diagnosed with multiple myeloma often take bortezomib (velcade®).

This research is being done to find out if acupuncture can reduce the nerve pain, tingling, and/or numbness patients experience due to bortezomib (velcade®).

Acupuncture is a medical technique of inserting very thin needles into the "energy points" on the body with the aim to restore health and well-being. It has been used widely to treat pain, such as lower back pain and nerve pain. In this study we will see if acupuncture can be used to ease nerve pain and tingling, numbness that is caused by bortezomib.

Information gained from this clinical trial will provide insight into the efficacy and mechanism of acupuncture in reducing Bortezomib-induced Peripheral Neuropathy (BIPN) in multiple myeloma patients. It will examine the effect of acupuncture on serum proinflammatory cytokine and β-endorphin levels to further understand the mechanism of acupuncture on a molecular level. This study is the first clinical trial studying the effect of acupuncture on treating BIPN. It is also the first study to explore the mechanism of acupuncture through frequent small amount of blood draws at six time points to detect changes in proinflammatory cytokines and β-endorphins. It has the potential to identify a minimal risk non-pharmacological intervention to alleviate BIPN symptoms, and to significantly improve our understanding of the mechanism of acupuncture.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of multiple myeloma.
* Greater than or equal to grade 2 BIPN as defined by the National Cancer Institute - -Common Toxicity Criteria (NCI-CTC) 4.0.
* BIPN symptoms persist after bortezomib has been discontinued.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
* Men and women who are ≥ 18 years old
* The patient is aware of the nature of his or her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.

Exclusion Criteria:

* Prior acupuncture within the past month.
* Life expectancy is \< 3 months.
* Plan to go on experimental drug for multiple myeloma that is known to cause peripheral neuropathy in the next 14 weeks.
* Concomitant treatment with chemotherapy, unless approval is given by the Principal Investigator.
The Impact of Anemia of Chronic Disease on Chronic Obstructive Pulmonary Disease Patients

Hypothesis:

The first part of the study is a survey on the prevalence of anemia of chronic disease (ACD) among COPD patients. The 2nd and 3rd part will test 2 null hypotheses (Ho): 1.serum inflammatory markers and plasma erythropoietin do not differ between COPD patients with and without ACD and 2. exercise capacity does not differ between COPD patients with and without ACD.

Rationale-Aim:

ACD is an immune driven disorder, developing in subjects suffering from chronic inflammatory diseases. COPD is a disorder very likely to be associated to ACD due to its systemic inflammatory dimension. Currently, data on the prevalence of ACD and on the level of inflammatory markers which are implicated in the pathogenesis of ACD in COPD subjects are limited and controversial. Furthermore, there is no data on the effect of ACD on exercise capacity of COPD subjects.

Based to the aforementioned, this study has three goals:

1. to determine the prevalence and the epidemiologic characteristics of ACD in a population of clinical stable COPD patients
2. to investigate whether the levels of serum inflammatory markers and of plasma erythropoietin differ between COPD patients with ACD and without ACD
3. to determine potential differences regarding the aerobic exercise capacity between these two groups, using the cardiopulmonary exercise testing (CPET).


Eligibility Criteria:
Inclusion Criteria:

* 1st part of the study:

  * COPD clinically stable (patients with post-bronchodilation FEV1/FVC \<0.7 and no acute exacerbations, hospital admissions or treatment changes in the last 3 months).
  * 2nd and 3rd part:
  * As above.

Exclusion Criteria:

* 1st part of the study:

  * history of asthma,
  * history of respiratory infection in the last 3 months
* 2nd and 3rd part: As above and additionally:

  * history of malignancy or haematologic disorder
  * acute or chronic inflammatory disease
  * systematic or autoimmune disorder
  * thyroid disease
  * liver cirrhosis
  * heart failure (ejection fraction \<55%)
  * history of gastrointestinal or other hemorrhage
  * renal failure (GFR\<60 ml/min/1.73m2)
  * blood transfusion in the last 4 months
  * administration of cortisone in the last month
  * pregnancy
  * mental impairment
  * medical conditions which are contraindications to exercise testing, such as:
* acute myocardial infarction (in the last 6 months)
* unstable angina
* left main coronary stenosis or its equivalent
* syncope
* symptomatic severe aortic stenosis or other moderate stenotic valvular disease
* uncontrolled arrhythmias causing symptoms
* acute pulmonary embolus or pulmonary infarction
* thrombosis of lower extremities
* suspected dissecting aneurysm
* pulmonary oedema
* room air desaturation at rest \<85%
* severe untreated arterial hypertension at rest (\>200 mmHg systolic, \>120 mmHg diastolic)
* high degree atrioventricular block
* hypertrophic cardiomyopathy and
* orthopedic impairment that compromises exercise performance
Silver Doped Ceramic Coated Orthopedic Implants

In this study, CE (European Conformity) marked, domestic manufactured standard orthopedic implants will be used after silver HA coating with electrospray method in 30 patients requiring hip joint prostheses, intramedullary nails or external fixator in 30 patients to antimicrobial effectiveness. These patients will be tasted for liver and kidney functions and blood and urine silver levels in addition to routine tests such as full blood, complete biochemistry, C-reactive protein, erythrocyte sedimentation rate required in the normal diagnosis and treatment processes,

In this study, considering the differences in bone contact surface area and interactions; hip joint prostheses, intramedullary nails and external fixator implants to be used in 30 patients . CE (European Conformity) marked, domestic manufactured standard orthopedic implants will be used in patients after silver HA coating with electrospray method. These patients will be tasted for the evaluation of liver and kidney functions and blood and urine silver levels in addition to routine tests such as full blood, complete biochemistry, C-reactive protein, erythrocyte sedimentation rate required in the normal diagnosis and treatment processes, and will be monitored for at least 12 months. The performance of coating to be applied and any unwanted side effects in normal conditions of use will be evaluated..

Eligibility Criteria:
Inclusion Criteria:

1. Men and women between the ages of 18-65
2. Patients without heart, lung, renal or hepatic insufficiency
3. Patients without epilepsy, cerebrovascular attack or ischaemia
4. Patients without antibiotic allergy
5. Patients who have low immune defense mechanisms such as malignancy, diabetes mellitus, polytrauma, and open fracture
6. Patients using oral or parenteral corticosteroids, methotrexate, cyclosporine or other immunosuppressive drugs - -

Exclusion Criteria:

1. Pregnant women
2. Patients with another silver implant in their body, such as a silver-coated stent
3. Patients with known allergy or hypersensitivity to silver
4. Patients with too many antibiotics due to recurrent infections
Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm

The rational of this study is to provide evidence on the safety and efficacy of a new chewable tablet of mebendazole compared to the standard tablet in preschool- and school-aged children infected with hookworm.


Eligibility Criteria:
Inclusion Criteria:

* Male or female children aged between 3 and 12 years;
* Written informed consent signed by caregiver;
* Was examined by a study physician before treatment;
* Provided two stool samples at baseline;
* Hookworm EPG \> 100 and at least two Kato-Katz thick smears slides with more than one hookworm egg;

Exclusion Criteria:

* Pregnant;
* Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, such as can upon initial clinical assessment;
* Suffers from severe anemia (Hb \< 80 g/l);
* Received anthelminthic treatment or metronidazole within past four weeks.
* Attending other clinical trials during the study.
Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study

Cumulative radiation dose, cost, contrast induced nephrotoxicity and increased demand for computed tomography aortography (CTA) suggest that duplex ultrasonoraphy (DU) may be an alternative to CTA-based surveillance. The investigators compared CTA with DU during endovascular aneurysm repair (EVAR) follow-up.

Patients undergoing EVAR have radiological follow-up data entered in a prospectively multicenter database. The gold standard test for endoleak detection was CTA. DU interpretation was performed independently of CTA and vice versa.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were followed after EVAR, whatever the trademark and the model of the stentgraft (bi-iliac or mono-iliac)
* Age \> 18 years old
* Patient with social insurance
* Signature of informed consent

Exclusion Criteria:

* patients who underwent EVAR with a fenestrated or branched stentgraft
* Obese patients (BMI \> 30)
* Patients with severe renal insufficiency (Creatinine Clearance \< 30 ml/mn)
* Patients who can't practice both an CT scan with iode injection and duplex ultrasound test over a period of one month
Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention

The primary aims of this randomized controlled trial are to evaluate efficacy potential of SPEEDI at enhancing reaching and play based problem solving compared to infants receiving usual care.

The primary aims of this randomized controlled trial are to evaluate efficacy potential of SPEEDI at enhancing reaching and play based problem solving compared to infants receiving usual care. The secondary aim is to assess the efficacy potential of SPEEDI to impact motor and cognitive development as assessed using commonly used clinical outcome measures. The exploratory aims are to assess the impact of SPEEDI on parent child interactions and feeding skills. The findings will provide crucial initial efficacy estimates to be used in a larger definitive clinical trial of SPEEDI.

Eligibility Criteria:
Inclusion Criteria:

* born extremely preterm (˂29 weeks of gestation) OR 10 born preterm and diagnosed with a neonatal brain injury including intraventricular hemorrhage grade 3 or 4, periventricular white matter injury, or hydrocephalus requiring a shunt.
* Medically stable by 40 weeks of gestation, including being off ventilator support
* Live within 50 minutes of the hospital.
* English Speaking mother
* Mother willing and able to participate in the study with the infant subject

Exclusion Criteria:

* Genetic syndromes or musculoskeletal deformities
Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral Nerve Excitability

The purpose of this study is to compare the effect of intravenous ropivacaine and lidocaine on the receptive field of primary sensory afferents and their influence on the vascular bed.

\*Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

1. Male
2. Age: 18 - 65 years
3. Weight: 50-100kg
4. Height: 155-195cm
5. Signed and dated informed consent
6. Sufficient command of German language

Exclusion criteria:

1. Contraindications to the class of drugs under study
2. Vulnerable subjects (intellectually or mental impaired)
3. Known hypersensitivity to class of drugs or the investigational product
4. Drug abuse
5. Known peripheral neuropathies
6. Diabetes mellitus
7. Chronic alcohol consumption
8. Congestive heart disease
9. Participants of other studies during study period
10. Smoker
FES to Improve Crouch Gait in CP

The overall goal of the proposed work is to develop and to assess the feasibility of using functional electrical stimulation (FES) system to improve crouch gait in individuals with cerebral palsy that may prevent the typical downward spiral of walking function decline in individuals with CP that occurs from adolescence into adulthood.

Aim 1: To assess the feasibility of using a multiple channel FES system to produce an immediate neuroprosthetic effect to reduce crouch gait in children and adolescents with spastic diplegic CP.

Aim 2: To assess the feasibility of using a multiple channel FES system as a therapeutic training tool to produce lasting neurotherapeutic effects of diminished crouch gait in children and adolescents with CP.

Eligibility Criteria:
Inclusion Criteria:

* Age 10-18
* Spastic CP (di-, tetra-, or triplegia)
* Levels I-II GMFCS classification
* Sufficient covering of the femoral head in the acetabulum (migration % \< 40)
* Mild crouch gait (minimum knee flexion 21-40o during stance)
* Potential to gain \> 20 degrees knee extension improvement in stance phase
* Minimum of 0o ankle dorsiflexion passive range of motion (PROM)
* Visual, perceptual, cognitive, and communication skills to follow multiple step commands for attending to exercise and data collection
* Seizure-free or well controlled seizures

Exclusion Criteria:

* Athetoid, ataxic, or hemiplegic CP
* Significant scoliosis (primary curve \> 40°)
* Spinal fusions extending into the pelvis
* Severe tactile hypersensitivity
* Joint instability or dislocation in lower extremity
* Lower extremity surgery or fractures in the past year
* Botox injections to Lower extremity in the past 6 months
* Implanted medical device contraindicated with application of FES
* Severe spasticity in Lower extremity (Mod Ashworth 4)
* Lower extremity joint pain during walking
* Hx of pulmonary disease limiting exercise tolerance or Hx of cardiac disease
* Severely limited range of motion / contractures (\>15o knee flex or \>15o hip flex contractures)
* Pregnancy