cyrilzakka/clinical-trials huggingface dataset:
Dyslipidemia in Cardiovascular Disease

A multi-center, randomized, double-blinded equivalence clinical trial to evaluate efficacy and safety of LipiLou 20 mg versus Lipitor 20 mg in hypercholesterolemic patients with higher risk cardiovascular disease in Korea.


Eligibility Criteria:
Inclusion Criteria:

1. Dyslipidemic patients with high-risk cardiovascular disease meeting more than 1 requirement below (LDL-C ≥ 100mg/dL) 1) Coronary artery disease

   * diagnosed with atheroma in Coronary CT or Angiography, or SPECT positive or Treadmill test positive 2) Diabetes Mellitus 3) intervened with stent in coronary artery disease more than 1 year before 4) diagnosed with atheroma in carotid artery 5) Peripheral artery disease
2. Aged 20\~85 years
3. Volunteers consented with participating clinical trial and submitted consent paper

Exclusion Criteria:

1. Experimental examination at screening 1) Active liver disease or more than 2 x ULN of AST/ALT 2) Creatine Kinase \> 2 x ULN 3) Creatinine \> 2.5mg/dL 4) Triglycerides \> 500mg/dL
2. intervened with stent in coronary artery disease less than 1 year before
3. Hyper-sensitive or resistant to other HMG-CoA reductase inhibitors, or experienced serious adverse events
4. Patients taking dyslipidemic treatments within 4 weeks (HMG-CoA reductase inhibitors, fibrates, nicotinic acids or bile acid resins, etc.)
5. As uncontrolled DM patients, HbA1c≥11% or fasting plasma glucose ≥200mg/dL
6. DBP \> 100mmHg, SBP \> 160mmHg
7. Diagnosed with myopathy
8. Appear to be a risk of myopathy below

   * renal impairment or prior renal dysfunction
   * hypothyroidism
   * genetic defects or family history of myopathy
   * experienced prior muscle toxicity with taking statins or fibrates
   * prior liver disease or higher intakes of alcohol
   * aged over 70, and a risk of myopathy
9. Women pregnant or breast-feeding
10. Women capable of pregnancy without using contraceptives
11. contra-indicated medically or mentally, or forbidden legally
12. Enrolled to other clinical trial within 4 weeks
13. Impossible to participate clinical trial according to investigator's decision
Exercise for Brain Regeneration in Epilepsy

Nearly 100 million Americans are affected by neurological disorders with an overall cost above $765 billion for the more prevalent conditions. Given this significant burden, effective treatments to prevent dementia and new disease modifying therapies are urgently needed.

Regeneration of lost neurons with new ones (i.e., neurogenesis) is compromised at early stages of dementia and in part correlates with cognitive impairment in Alzheimer's disease. Boosting the neurogenesis delays the cognitive impairment in animal models of dementia and has been proven beneficial in improving the memory in rodent studies.

Aerobic exercise is the most potent known stimulator of neurogenesis in animal models. A crucial next step is to translate endogenous regenerative strategies to people. The purpose of this study is to demonstrate the feasibility and investigate the effects of an exercise program on neurogenesis and cognitive improvement in epilepsy patients.

Neurogenesis studies in healthy and dementia patients have only been performed on postmortem tissue, which prevents investigation of treatment outcomes. Patients with mesial temporal lobe epilepsy (MTLE) typically do not respond to medications and uniquely among related dementia disorders undergo corrective surgical treatment, providing a unique opportunity to study the value of regenerative interventions on hippocampal electrophysiology and neurogenesis. Using this unique approach, this study will investigate the neurogenesis and cognitive improvement in epilepsy patients.

Ten people with MTLE who are recommended for surgical treatment as part of their standard care will be enrolled and randomly assigned to High Impact (n=5) and Low Impact (n=5) exercise groups. The duration of exercise programs will be 12 weeks and study arms will undergo the same protocol except for the target heart rate which will be higher in the High-Impact group. Exercise will be performed at home using a recliner bike under the supervision of caregiver and study personnel. Participants will undergo cognitive, exercise and clinical assessment at baseline and after completing the three-month exercise therapy; then surgically resected tissue will be analyzed for regeneration and epileptiform activity. The investigators will assess whether exercise would yield clinical benefits in terms of seizure frequency/intensity or cognitive ability, and whether the ability of the adult human brain to self-repair can be enhanced. It is hypothesized that the proposed exercise regimen is feasible and will improve the neurogenesis levels and cognition.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* Medically resistant mesial temporal lobe epilepsy
* Candidacy for standard or selective temporal lobectomy

Exclusion Criteria:

* Age of older than 65 years
* Pregnancy
* Physical disabilities or medical conditions preventing from participation in exercise program
* Inability to receive exercise equipment at home
* Cognitive/developmental disabilities restricting the participation in exercise program
Manual Therapy on Balance and Mood States

The aims of this study was to compare the effectiveness of a protocol of manual therapy on the static balance, dynamic balance and mood states in health participants. This study will consist of a randomized controlled trial. Participants will be healthy subjects divided into 2 groups, being an experimental group that will receive a manual therapy session and a control group without treatment. It will be evaluated at the start of the study, after treatment and one week later.

Background

Evidence suggest that the application of manual therapy could be effective in multiple pathologies, but there are few studies which have investigated the effectiveness of manual therapy in to balance and mood states.

Objective To compare the effectiveness of a protocol of manual therapy on the static balance, dynamic balance and mood states in health participants.

Metods

This is a randomized controlled trial which will be carried out with young adults. The sample will be divided into 2 groups: a) experimental group that will receive a manual therapy session; b) a control group without treatment. All subjects signed the informed consent and confidentiality of the data was reserved according to the Helsinki declaration. The treatments were carried out in the laboratories of the University of Valencia and the project was approved by the institution's ethics committee.

The experimental group to receive manual therapy (Bilateral manipulation lumbosacral, hip joint gapping, stretching the hip rotators with hip and knee flexion, femorotibial gapping, decompression of connective tissue of the patellofemoral region, internal and external joint line opening in laterality, mobilization of the base of the fibula, tibiofibular-talus gapping, and muscle strengthening). The control group will not receive treatment and only evaluations will be performed.

Outcomes

The evaluations will consist of the following variables: Star Excursion Balance Test (SEBT), Unipedal Stance Test (UPST), Patient Global Impression of Change (PGIC) and POMS (Profile Of Mood States). Evaluations will be carried out at three times: at the beginning of the study, after treatment and one week later.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 30 years
* That they can take all the tests from the study evaluations.

Exclusion Criteria:

* Those who are doing some balance training program.
* Individuals who have some deterioration in balance, regardless of whether the cause is the vestibular system, the visual, proprioceptive, any surgery.
* Participants suffering from tingling or numbness.
* Those who have pain in the lower limbs greater than 3 on the Visual Analog Scale.
* That the lower limbs or in the lumbosacral region have orthopedic problems or traumatic injuries, they will not be able to participate either, including as such scoliosis, ligament pathologies, osteoarthritis, prostheses.
* Pregnancy.
Ferrous Sulfate Versus Iron Amino Acid Chelate

Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and the leading cause of anemia in the world; this can occur at any age, but preschool children are at particular risk of developing it. This condition may cause serious repercussions for life, being a public health threat of considerable importance worldwide.

Food fortification is considered the most effective solution to counter this situation, because it can help more people than other solutions. It is going to carry out a community trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as a dietary supplement in preschool children of Medellin with depleted levels of iron; in terms of increasing ferritin levels in blood and maintain hemoglobin levels. It is hypothesized that at the end of the study the effect of milk fortified with iron amino acid chelate won't be less than the effect of fortified with ferrous sulfate.

It is hoped that the results may contribute, albeit indirectly, to improve the health status of children with depleted levels of iron whom consume iron-fortified products.


Eligibility Criteria:
Inclusion Criteria:

Children who

* Belong to institute FAN in Medellín
* Attend full time to institute FAN (eight hours)
* Have 2 to 5 years inclusive
* Submit depleted levels of iron (ferritin level equal to or less than 24 mg/L)

Exclusion Criteria:

Children who

* Submit anemia (hemoglobin level equal to or less than 11 g/dL)
* Have not stool analysis before intervention
A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer

The purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) grading.


Eligibility Criteria:
Inclusion criteria:

1. Female subjects with confirmed locally recurrent or metastatic carcinoma of the breast who have received prior taxane therapy and at least one prior cytotoxic chemotherapy regimen for advanced disease.

Exclusion criteria:

1. Subjects who have received prior ixabepilone therapy.
2. Subjects with prior participation in an eribulin clinical study, even if not assigned to eribulin treatment.
3. Subjects with pre-existing neuropathy Grade greater than or equal to 2.
4. Subjects with a history of diabetes mellitus Type 1 or 2.
5. Subjects with bilateral mastectomy which included bilateral axillary lymph node dissection.
6. Subjects with missing digits required for vibration assessment.
7. Subjects with any other concurrent diseases or conditions that would be expected to interfere with neuropathy assessments, which may include vitamin deficiency, sequelae of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy, or alcoholic or inflammatory neuropathy.
Effect of Ketoconazole on the Pharmacokinetics of Refametinib

The purpose of this study is to see if there is a difference between the way your body absorbs and distributes BAY86-9766 when given alone or in combination with ketoconazole, a drug which may affect how much BAY86-9766 is absorbed, distributed or eliminated from the body


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject
* Age: 18 to 45 years (inclusive) at the first screening examination / visit
* Body mass index (BMI): 18.5 to 32 kg/m² (inclusive)
* Ability to understand and follow study-related instructions. Subject, who is a sexually active man and has not been surgically sterilized, must consent that he uses a condom during intercourse and ensures that his female partner practices adequate contraception, or he must be willing to refrain from sexual intercourse from the beginning of the trial (signing of the informed consent) until 30 days after last study drug administration

Exclusion Criteria:

* Clinically significant disease or condition
* Retinal pathology or vien occlusion
* Left Ventricular ejection Fraction(LVEF) \<60% (as measured at screening) by Multiple Gated Acquisition Scan(MUGA) or echocardiogram
Assessment of a Vaginal Ring With Meloxicam on Ovarian Cycle in Fertile Women

In this study, the investigators propose to assess if a non-hormonal agent is absorbed by a local route (vaginal) and to observe the effect on follicular development.

Each volunteer will participate for 3 menstrual cycles, beginning with one menstrual control cycle without treatment, following by one menstrual cycle with meloxicam ring administration, and finishing with another control menstrual cycle.

Meloxicam will be administered in the second menstrual cycle via a vaginal ring in two doses of 2.4 g or 3.0 g/ring. The safety of the vaginal ring and the absorption of meloxicam will be assessed. Also the effect on follicular development and if it maintains ovarian cyclicity, as shown in a recent study with oral administration, will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Previous (or history of) proven fertility
* Regular menstrual cycle
* Surgically sterile
* Without breastfeeding
* Haemoglobin at least 11g/dL
* Willing to participate in the study

Exclusion Criteria:

* Allergy to meloxicam or other NSAID
* Allergy to silicone polymer
* Vaginal discharge non diagnosticated
* History of shock toxic syndrome
* History of : gastrointestinal, bleeding, renal, liver, heart, brain,clot, endocrine or pulmonary disorders
Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP)

This is a multi-center, hospital based, cross-sectional study based on data from patient medical records, including laboratory results. The study will include adult patients with chronic (\> 1 year duration) primary Immune Thrombocytopenia (ITP) only. Patients will be identified based on a laboratory confirmed diagnosis of ITP in the medical records, where there is also a physician-confirmed diagnosis of primary ITP. If patients consent to take part in the study, a routine clinical visit will also serve as the study visit.

All study participants will have a routine blood test as part of their standard clinical care at the study visit, and this same procedure will be used to collect supplementary blood samples to assess a variety of biomarkers.

Data will be collected using a combination of chart review, clinical outcome assessment administration, and laboratory results through blood tests.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with chronic (ITP with \> 1 year duration) primary ITP living in the USA or the UK:
* On ITP pharmacologic treatment, regardless of last platelet count (below or above 100 x 10\^9 counts/L);
* Patients in remission as per their most recent blood test (platelet count \>100 x 10\^9 counts/L) and without ITP-specific treatment for less than 1 year
* Adult patient who are 18 years or older at index date
* Patient who has received at least one initial first line therapy (corticosteroids \[CS\]/ intravenous immunoglobulin \[IVIg\]/ANTI d) with initial response (platelet count ≥ 50 x 10\^9 counts/L) as of index date

Exclusion Criteria:

* Secondary ITP
* Patients in remission as per their most recent blood test (platelet count \>100 x 10\^9 counts/L) and without ITP-specific treatment for 1 year or more
* Patients with recent or active infection recorded 14 days or less before index date; patients with uncontrolled chronic infections or who were recently diagnosed with a chronic infection (≤14 days of index date).
* Patients with vaccination in 28 days before index date
* Patients treated with rilzabrutinib on or before index date
Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study

External radiation given in 25 fractions or so together with weekly chemotherapy and followed by 3 or 4 fractions of brachytherapy is the standard of care for patients with locally advanced cervical cancer.

This study investigates the role of shortened external radiotherapy regimen (hypofractionated radiotherapy) by randomizing patients to this experimental regimen versus the standard of care.The purpose of this study is to access the feasibility of patient accrual to this trial in the Canadian setting and to provide an initial evaluation of cancer response and treatment tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* International Federation of Gynecology and Obstetrics (FIGO) IA or IB1 cervical cancers if not surgical candidates, but amenable to definitive chemoradiotherapy as proposed in this trial.
* FIGO Stage IB2, IB3, IIA or IIB cervical cancers
* FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria:

  1. largest node is less than 3 cm
  2. less than 3 pathological nodes
  3. No nodes located in the common iliac chain.
  4. Cervical confined or with parametrial invasion
* Histologically-confirmed invasive uterine cervical carcinoma of subtypes squamous cell, adenocarcinoma or adenosquamous cell
* Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin
* Brachytherapy candidate

Exclusion Criteria:

* FIGO stage IIIA, IIIB, IIIC2, IVA or IVB
* FIGO stage IIIC1 with node greater than 3 cm, common iliac node or greater than 2 pathological nodes
* Previous pelvic or abdominal radiotherapy
* Patients requiring paraaortic nodal irradiation
* Inflammatory bowel disease
* Connective tissue disorder (eg. scleroderma, systemic lupus erythematous)
* Neuroendocrine, glassy cell, small cell, adenoid cystic carcinoma, adenoid basal carcinoma, clear cell, serous, endometrioid, verrucous carcinoma, melanoma, and sarcoma histologies
* Patient unable to undergo MR scan
* Eastern Cooperative Oncology Group (ECOG) performance status greater than 3
* Not a cisplatin candidate
Relation of Skin Closure Method to Groin Wound Infections After Proximal Femoral Artery Exposure.

This study aims to asses whether the rate of surgical wound infections in vascular surgery procedures involving exposure of the proximal femoral artery can be reduced using a different skin closure technique.

Summary of the research plan

Background - According to published articles the frequency of groin wound infections after peripheral revascularization varies substantially depending on the source from 5% up to 27%.

Aims of the study - The aim of this randomized clinical trial is to evaluate whether the number of groin wound infections can be reduced with an intradermal skin suture compared to the commonly used metal staples skin closure method.

Methods and study design - This is a randomized clinical trial of patients undergoing a vascular procedure which includes an incision in the groin. The patients will be randomized (1:1) to two different wound closure techniques: subcuticular suture or metal staples. After the procedure the patients will be controlled for four to six weeks and the infection rate in each group is recorded. A clinical diagnosis of infection according to Centre for Disease Control (CDC) guidelines will be recorded, no microbiological samples will be routinely collected.

Statistical analysis - A power analysis has been conducted based on Finnish RCT studies and a retrospective study from our own hospital (submitted to Annals of Vascular Surgery 1/2018) which included all isolated groin wounds from Turku University Hospital Vascular Surgery clinic 2015-2016. According to this analysis between 130-150 patients are needed for each group.

Time and schedule- This is a multicenter trial. Ethical committee approval was acquired in 2015. The randomization will start in the spring of 2018 in the University Hospital of Turku. Later in the year in the other hospitals that are participating in the study once the regional authorities have given their consent.

Ethical aspects - Ethical committee approval was obtained in 2015. The wound closure techniques are all in everyday use already, nothing new and experimental will be used.

Budget - This study is a critical part of quality control and improvement in vascular surgery. The funding will be applied from the Finnish Academy and EVO funding from the ERVA.

Eligibility Criteria:
Inclusion Criteria:

* Primary procedure to the groin, isolated groin wound

Exclusion Criteria:

* Emergency procedure, secondary procedure, wound is a part of a larger wound in the same limb
SC2i Tissue and Data Repository Protocol

The purpose of this study is to collect samples of blood, urine, cerebrospinal fluid (CSF, the fluid that surrounds the brain and spinal cord), wound tissue and/or wound fluids, and other body fluids and tissues from people who have been seriously injured or ill. The samples will be used to develop and assess tests and/or tools that doctors can use to decide the best treatment plan for seriously injured or ill military personnel and for civilians. Additonal protocols to use the samples will be submitted as separate protocols.


Eligibility Criteria:
Inclusion Criteria:

* Patients with injury or illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at SC2I sites (Grady Memorial Hospital, Emory Univeristy Hospital, and Duke University Health Systems)
* Healthy volunteer control subjects to include individuals without any known injury or end-stage organ disease and patients who have recovered from prior injury.
* Ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of incapacitated patients, a willing surrogate able to give written informed consent.

Exclusion Criteria:

* Any condition that, in the opinion of the attending physician, would place the patient or volunteer subject at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, coagulopathy, or technical considerations that would prevent acquisition of sufficient tissue or fluid for clinical use. Acquisition of samples from patients requiring active transfusion or with transfusion-associated coagulopathy will be considered as appropriate study candidates at the discretion of the attending physician.
Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial

The purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling.

Determine the efficacy of dynamic splinting in treating patients with hallux limitus, in a randomized, controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Reduced flexibility in AROM of extension in the great toe
* Pain that is worsened by walking and/or squatting
* Impaired gait pattern

Exclusion Criteria:

* Metatarsal stress fracture
* Interdigital neuroma
* Sesamoid pathology
* Gout
* Metatarsalgia