cyrilzakka/clinical-trials huggingface dataset:
Safe Use of New Oral Anticoagulants in Ablation for Atrial Fibrillation

Use of new oral anticoagulants (NOAC) in patients before and after catheter based pulmonary vein isolation (PVI) is still controversial. Experience is reported from consecutive patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or apixaban from Nov 2011 until Dec 2014. Patients are followed for 3 month after ablation. All complications possible being related to the use of NOAC are registered.

Use of new oral anticoagulants (NOAC) in patients before and after radiofrequency ablation with pulmonary vein isolation (PVI) is still controversial. Experience is reported from consecutive patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or apixaban from Nov 2011 until Dec 2014. Patients paused their NOAC treatment for 24 hours before ablation. Patients were routinely followed up after 3 months with a standard formular focused on possible adverse events (major bleeding complications or thromboembolic events) to NOAC treatment. Adverse events related to the use of NOAC were registered during treatment or during 3 months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic atrial fibrillation despite pharmacological treatment.

Exclusion Criteria:

* None
Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

Major depression (MD) is a psychiatric disorder characterized by a persistent feeling of sadness, anhedonia or a decreased perception of pleasurable experiences, as well as appetite alterations and weight variations, sleep disorders, altered psychomotor skills, fatigue, guilt, decreased self-worth, suicidal thoughts and difficulty concentrating in a task (1).

MD is a frequent complication in patients who are diagnosed with advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 to 65 years of age
2. Sex: Male or female
3. Major depressive disorder (MDD) diagnosis as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
4. Palliative stage cancer diagnosis (advanced-disease stage)
5. Who can read and write in spanish
6. Eastern Cooperative Oncology Group (ECOG) 0-2
7. Karnofsky ≥ 50
8. Palliative prognostic index A
9. Not currently undergoing systemic oncologic treatment
10. Patients who agree to participate in the study by signing an informed consent.

Exclusion Criteria:

1. Comorbidities including other psychiatric diseases (additional to MDD, generalized anxiety or panic disorder).
2. Magnetic resonance or computerized tomography with major structural alterations.
3. Pregnant or breastfeeding women.
4. Patients with hypersensitivity to ketamine
5. Cardiac insufficiency
6. Patients with a history of psychosis
7. Patients with first-degree relatives with a history of psychosis
8. Patients with uncontrolled glaucoma
9. Current neurological illness
Compression Bandage in Local Infiltration Analgesia Afte Total Knee Arthroplasty

purpose: to determine wether a compression bandage prolongs analgesia of local infiltration analgesia after total knee arthroplasty

patients are randomised to receive a compression bandage or a non-compression bandage

Eligibility Criteria:
Inclusion Criteria:

* scheduled for total knee arthroplasty
* speak and understand Danish

Exclusion Criteria:

* severe obesity
* allergies to local anaesthetics
Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region

The objective of this observational study is to collect and evaluate data on Health Related Quality of Life (HRQoL) of Spiriva delivered by HandiHaler, using disease specific SGRQ in the national samples of Central \& Central European patients with varying severities of chronic obstructive pulmonary disease (COPD) in the real life setting over the 6 months.

Study Design:

an open-label, uncontrolled and single arm post-marketing surveillance study

Eligibility Criteria:
Inclusion criteria:

* 40 years and older male and female ambulatory outpatients.
* Clinical diagnosis of Chronic Obstructive Lung Disease (COPD) (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines: Forced expiratory Volume in one second (FEV1)/ Forced Vital Capacity (FVC) \< 0.7 and FEV1 \< 80% predicted).
* Stable patient, without exacerbation for at least one month to the study.

Exclusion criteria:

* Uncooperative patients as judged by the physician.
* Patients that have any condition which, according to the participating physician's opinion, might decrease the chance of obtaining satisfactory data to achieve the objectives of the observation study.
* Patients with any conditions excluded as per Country specific package insert.
* Patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems.
Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects

A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance and routes of excretion of ODM-201 in healthy volunteers.

6 healthy male subjects will be enrolled in part 1 and part 2 of the study, respectively

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy males
* Aged 50 to 65 years (inclusive)
* Normal weight defined as a body mass index (BMI) of \>18.5 and \<32.0 kg/m2
* Weight 55 to 100 kg (inclusive)
* Adequate method of contraception during the study and for a period of 6 months after study drug administration

Key exclusion Criteria:

* Evidence of clinically significant disease
* Intake of any medication that could affect the outcome of the study
* Known hypersensitivity to the active substances or the excipients of the drug or any serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
* History of anaphylactic/anaphylactoid reactions
* Clinically significant abnormal biochemistry, haematology or urinalysis
* Current or history of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
* Current use or use within the last 12 months of nicotine products
* Positive drugs of abuse test result
* Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results
* Presence or history of clinically significant allergy requiring treatment
Investigation of Regional Interdependence of the Hip and Spine in Baseball Players With Low Back Pain

Low back pain (LBP) is a common musculoskeletal symptom in athletes. More than 40% percent of high school baseball players reported incidents of LBP during the previous year. University baseball athletes were 3.23 times more likely to have lumbar intervertebral disk degeneration than the nonathletic university students. According to the regional interdependence model, a patient's chief complaints may be directly or indirectly related to or influenced by physical impairments from various body systems and regardless of proximity to the primary symptom(s). Athletes with a chief complaint of LBP frequently demonstrate with mobility restrictions in the thoracic spine and hips, which may contribute to compensatory hypermobility in the lumbar spine and subsequently lead to LBP. Few studies have examined the relationship between thoracic spine mobility and LBP, while many studies investigating the relationship between hip joint mobility and LBP in athletes showed inconsistent results. The inconsistent results may be due to different types of sports and measurement methods. Therefore, the objectives of this research project are to: (1) examine if baseball players with a history of LBP have mobility restriction in the thoracic spine and hips and movement coordination within the spine and hip regions during baseball batting that are different from those without a history of LBP; (2) identify thoracic spine and hip joint mobility and coordination related predictors for batting velocity and LBP in baseball players. This 2-year research project plans to recruitment a total of 110 male baseball players aged between 18 and 30 years from university and community recreational league baseball teams (55 players with a history of LBP and 55 age-matched players without a history of LBP). Participants will receive physical examination for the thoracic spine and hip joints (joint mobility and muscle stiffness) and 3D motion analysis for baseball batting. The results of this research project will guide the development of more specific and effective treatment and preventative training for baseball players with LBP and enhance their batting performance.


Eligibility Criteria:
Inclusion Criteria:

• Baseball players who had experienced at least 2 episodes of LBP that limits their performance for a period of greater than 3 days in the previous year.

Exclusion Criteria:

* Current LBP symptoms including weakness and numbness in the lower extremities
* Previous surgery to the back, upper or lower extremities
* Marked spinal deformity (e.g., scoliosis, or kyphosis)
* Any other orthopedic or medical problem that would have limited their ability to fully participate in baseball training and competition in the last year.
Outcome of GATT Combined With Goniosynechiolysis in Glaucoma Patients With Secondary Synechial Angle Closure.

To evaluate the intraocular pressure reduction effect of combined gonioscopy-assisted transluminal trabeculotomy (GATT) with goniosynechialysis in eyes with secondary synechial angle closure glaucoma.

Glaucoma is a group of diseases that present with cupping of the optic nerve head and visual-field defects. It is the most common cause of irreversible blindness all over the world.Angle-closure glaucoma is a type of glaucoma characterized by narrowing or closure of the anterior chamber angle.

Two major types of angle closure glaucoma are defined by the mechanism of angle closure: in appositional contact, the iris is pushed by a pressure difference between the posterior and anterior chambers due to relative pupillary block, while in synechial contact, the peripheral iris adheres to the trabecular meshwork by peripheral anterior synechiae (PAS). PAS can develop in various ocular conditions, including: ocular inflammation, a post-traumatic condition, after cataract surgery, or with an iris bombe in a pupillary block glaucoma.

Grover et al. described a technique for ab-Interno circumferential trabeculotomy termed gonioscopy-assisted transluminal trabeculotomy (GATT). The procedure aims to create a 360° trabeculotomy from an ab-Interno approach.

GATT procedure is a MIGS technique in which trabecular meshwork is circumferentially bypassed by incising it using a suture or microcatheter.In this technique, aqueous humor passes through the collector channels and episcleral veins through the cleaved open diseased trabecular meshwork.

Elsayed et al previously demonstrated that combining phacoemulsification with GATT in PACG yielded more favorable outcomes in terms of IOP, glaucoma medications and surgical success compared to phacoemulsification alone.However, to date, no studies have looked at the outcomes of combining goniosynechialysis with GATT in secondary angle closure glaucoma. In fact, most studies looking at the outcomes of GATT in different types of glaucoma excluded eyes with synechial angle closure.

Goniosynechialysis (GSL) is the process of physically separating PAS, which can develop in the trabecular meshwork due to various conditions including primary and secondary cases of angle closure.

So, for those cases of synechial angle closure glaucoma combining GATT and GSL might aid in the IOP lowering effect required.

Eligibility Criteria:
Inclusion Criteria:

* Patients with secondary synechial angle closure glaucoma
* Involving more than 180 degrees of the iridocorneal angle
* Requiring surgery for uncontrolled IOP despite maximum tolerated therapy.

Exclusion Criteria:

* Eyes with PACG.
* Eyes with neovascular glaucoma. (Some apparently stable NVG cases would have remnants of neo-vessels in the angle that are hidden behind the synechiae).
* Eyes with retinal pathology.
* Eyes requiring combined phacoemulsification and GATT.
* Eyes with corneal pathology that can preclude surgery and imaging.
To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HU-045 and Xeomin® in Patients With Moderate to Severe Glabellar Lines


Eligibility Criteria:
Inclusion Criteria:

* 19 Years to 65 Years(Adult, Older Adult)
* 2(Moderate) and/or above of Facial Wrinkle Scale (FWS) score at frown in investigator's live assessment.
* Subject who signed voluntarily in informed consent form and fully understood about this clinical trial.

Exclusion Criteria:

* Subject who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
* History of bleeding disorder
* Infection, dermatological condition or scar at the treatment injection sites
* Subject who has marked facial asymmetry
* History of facial nerve palsy or eyebrow/eyelid ptosis
* History of surgical procedures affecting on the lines of forehead and/or middle of the forehead areas
* History of malignant tumor within 5 years (except for basal cell carcinoma
* Any disease and condition that, in the view of the investigator, would interfere with study participation
* History of alcohol or drug addiction
* Subject who has been treated with any botulinum toxin drug within 6 months
* Persons who have received the following drugs with systemic muscle relaxant action within 4 weeks of screening
* Subjects taking more than 1,000 IU/day of anticoagulants, antiplatelet agents, NSAIDs, or vitamin E within 7 days prior to administration of the investigational drug (excluding low-dose aspirin)
* A person who has received a retinoid series of medications during the following period as of the time of screening
* Subjects who have hypersensitivity reaction to investigational drug or local anesthetics
* History of Anaphylaxis or severe combined allergy disease
* Subject who has physically untreatable glabellar lines like that can't be spread out even if someone forces it to spread out
* Pregnant and lactating women F- ertile women and men who have plans to pregnancy and who do not agree to appropriate contraception.
* Participant who has been treated with any investigational drug within 30 days from screening
* Subject who are not eligible for this study based on investigator's judgement.
Acupuncture for Obesity on Serum Metabolic Parameters

This research is planned to build a basis about the effect of acupuncture on serum metabolic parameters in pre-menopausal obese women with economic evaluation.

It is consisted with two sub research.

First, clinical research to assess the effect of acupuncture for obesity on serum metabolic parameters will be processed with randomized, patient-assessor blinding, and sham-acupuncture controlled study design. 120 subjects would be collected and divided into two groups(experimental and placebo, 60 subjects each). Experimental group will undergo with real acupuncture treatment(manual acupuncture + electroacupuncture) twice a week, for 6 weeks. The effect on serum metabolic parameters will be assessed at 0 and 6 weeks.

Second is qualitative research to make a basis through the evaluation of economic efficacy and patients' satisfaction with acupuncture treatment for obesity.

Eligibility Criteria:
Inclusion Criteria:

* volunteers through announcements and advertisements
* premenopausal adult women (19 years of age or more)
* clinical diagnosis of obesity (Body mass index: 25 kg/m2 or more)

Exclusion Criteria:

* previously or currently having endocrine disease such as hypothyroidism or Cushing's syndrome, heart disease, lung disease, diabetes, malignant tumor, cholelithiasis, severe kidney impairment, severe liver impairment, anorexia nervosa or hyperorexia
* experience of taking medicines which might affect body weight and the concentration of serum metabolic parameters such as anorectic, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, or medicines affecting absorption, metabolism, and excretion in the past 3 months
* experience of taking beta-blocker or diuretic for the treatment of hypertension in the past 3 months
* surgical treatment for the treatment of obesity
* currently or might be pregnant or breast-feeding
* experience of taking other experimental medicines in the past month
* weight loss of 10% or more of previous body weight in the past 6 months
* who stopped smoking in the past 3 months or who have irregular smoking habit
* pacemaker
* currently receiving any treatment for obesity
* other inadequate subjects assessed by the study investigators
Load Quantitative MRI Study of Incipient LBP Patients.

The mian purpose of this study is to analysis the imaging changes in 3.0T MRI of lumbar small joints, intervertebral discs, ligaments and muscle in hospital nurses first suffered with low back pain.

Low back pain is a common clinical disease seriously affects the quality of people's lives. And this disease takes up a large proportion in the crowd. Incipient lumbago is hard to diagnose and often hidden morbidity. If early symptoms are ignored by patients, it will greatly influence the quality of life in the future. This study will use 3.0T MRI to distinguish the difference of lumbar small joints, intervertebral discs, ligaments and muscle between the normal and the pain.

Firstly, we recruit nurses with low back pain in one group, with the normal as control. Then the subject will accept 3.0T MRI scanning at the same time. Before scanning we will determine the MRI sequence to make sure the imageis are clear enough. At last, we will analysis the photos in the image processing workstation, reconstruct the anatomical structure in the scanning area. All of this is to find a possible reason or explanation in the occurrence of incipient lumbago through the comparison of two group's images.

Eligibility Criteria:
Inclusion Criteria:

1. Female between 18 and 27 years of age
2. Subject who has worked as a nurse less than three years and will continue working as a nurse no less than one year
3. Back pain has happened more than 2 times In the past 12 months(every time lasts 2 days or more),or never happened
4. Subjects who do not participate any other study concerning pain prevention currently and in the next year
5. According with magnetic resonance inspection standard
6. NO spectical low back pain and no other serious diseases in the other systems

Exclusion Criteria:

1. Subjects who has a family history of low back pain
2. Subjects who are Suffering from specific low back pain
3. Subjects who are suffering from serious somatic disease and/or psychic disease
4. Subjects who are suffering from chronic pain disease and need long-term use of drug therapy
5. Subjects who are pregnant, planning to have a baby in 1 year or less than 6 months after delivery
6. Subjects who are suffering from chronic cardiac, respiratory, liver and kidney complaint symptomatically
7. Subjects who have had a spinal operation
MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults

Study to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) Zidebactam in healthy adult human subjects.

A double-blind, placebo-controlled study where healthy adult subjects will be randomly assigned to receive either of the investigational products (Zidebactam or placebo) in 2 multiple ascending dose (MAD) cohorts.

Primary Objective: to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) zidebactam in healthy adult human subjects.

Secondary Objective: to evaluate the pharmacokinetics (PK) of multiple escalating doses of IV zidebactam in healthy adult human subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).
2. Medical history without any major pathology/surgery in the last 6 months prior to screening.
3. All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.
4. Resting supine blood pressure of 90 to 139 (systolic)/40 to 89 (diastolic) mmHg and a resting pulse rate of 40 to 100 beats per minute.
5. Calculated creatinine clearance ≥80 mL/min (Cockcroft-Gault method).
6. Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator.

Exclusion Criteria:

1. History of clinically significant food or drug allergy, including known hypersensitivity to β lactam drugs or other related drugs.
2. History of Clostridium difficile induced diarrhea or infection within 1 year before screening
3. Consumed more than 28 units of alcohol per week at any time in the 6 months before investigational product administration
4. History/evidence of clinically relevant pathology related to the cardiovascular system, central nervous system, respiratory tract, gastrointestinal tract, endocrinology, immunology, hematology or any other systemic disorder/major surgeries, that in the opinion of the Principal Investigator would confound the subject's participation and follow-up in the study.
The Effect of Horizant (Gabapentin Enacarbil) on Augmentation

Restless Legs Syndrome (RLS) is a common neurological disorder. Augmentation is the main complication during long-term DA treatment of RLS. This study aims to examine effect of Horizant (Gabapentin Enacarbil) on Augmentation in RLS patients.

This is an Open label single arm study. The purpose of the study is to demonstrate the efficacy of Horizant in patients with RLS who exhibit augmentation while on Dopaminergic therapy. Adult patients (age 18-85 years) with diagnosis of primary RLS (diagnosed by study investigators) with augmentation on dopaminergic therapy will be screened for participation in the study. RLS diagnosis will be made by the study investigators using International RLS study group criteria. Patients with augmentation on dopaminergic therapy as defined by NIH 2007 with ASRS of 5 to 15 will be offered to participate in the study. Inclusion and exclusion criteria are listed below. The study will be performed after approval of the Institutional Review Board of the University of Missouri.

A total of 50 subjects will be entered into the study over a period of 1 year. Written consent will be obtained from all patients. After pre-participation evaluation for eligibility, subjects will be selected and enrolled in the study and followed for a total of 6 follow up visits (Days 0, 30, 90, 120, 180, 360). Subjects Enrollment period will last up to 12 months. The total duration of study will be 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with diagnosis of RLS for more than one year.
2. Patients who are on DA therapy for 6 months or longer.
3. Patients who developed Augmentation (on stable dose of DA) lasting for 3 months or longer.
4. Augmentation severity rating scale of 5 to 15.
5. Both males and females
6. Age range = 18-85 year

Exclusion Criteria:

* Known Hypersensitivity to Horizant or Gabapentin products
* Peripheral neuropathy
* Radiculopathy
* Peripheral vascular disease
* Uremia \[abnormal blood urea nitrogen (BUN) or Creatinine on Comprehensive Metabolic Panel (CMP)\]
* Anemia
* Patients who are currently pregnant
* Patients who currently take opioids, lithium, anti-nausea medications (e.g. metoclopramide), dopaminergic antagonists (e.g. Haloperidol), 1st generation antihistamines (e.g. diphenhydramine, pseudoephedrine), anti-psychotic medications and iron therapy.
* Subjects with impaired decision making capability.