cyrilzakka/clinical-trials huggingface dataset:
Combined Therapy of Posterior Subtenon Triamcinolone Acetonide and Intravitreal Bevacizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion

This study compares the efficacy of intravitreal bevacizumab monotherapy only or combined therapy of posterior subtenon's triamcinolone acetonide and intravitreal bevacizumab for the treatment of macular edema associated with branch retinal vein occlusion.


Eligibility Criteria:
Inclusion Criteria:

1. The participant must have macular edema associated branch retinal vein occlusion.
2. The participant has retinal photographs, optical coherence tomography (OCT) and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice.
3. The participant must be willing and able to comply with the protocol.

Exclusion Criteria:

1. The participant has BRVO with other ocular vascular diseases such as central retinal vein occlusion, hypertensive retinopathy, etc.
2. The participant has any additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
3. The participant has a history of treatment for BRVO in the study eye with focal laser photocoagulation, intravitreal triamcinolone acetonide injection or intravitreal Bevacizumab injection
4. The participant has a history of intraocular surgery (including lens replacement surgery).
5. The participant has a history of ocular trauma, or current ocular or periocular infection (including any history of ocular herpes zoster or simplex).
The Role of Anchoring and Distraction in the Effectiveness of Mindfulness on Reducing Emotional Reactivity

The current study aims to investigate the effectiveness of the 8-week Mindfulness-Based Cognitive Therapy for Life (MBCT-L) on the use of anchoring and distraction as emotion care/regulation strategies. It is hypothesized that anchoring and distraction are related but different processes, which could be evidenced by fMRI. The investigators further hypothesized that mindfulness training could lead to functional changes in the brain, which could also be evidenced by fMRI.

To test the hypotheses, the participants will be randomly allocated to either the experimental group or the waitlist control group. Both groups will complete behavioral measures and an fMRI experiment before the experimental group's intervention (T0). The experimental group will receive Mindfulness-Based Cognitive Therapy for Life (MBCT-L) between T0 and T1, while the waitlist control will receive no treatment during this period. Both groups will complete the behavioral measures and the fMRI experiment again after the experimental group finishes the MBCT-L course (T1).

Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* Currently registered in post-graduated program with professional counselling training

Exclusion Criteria:

* History of neurological or other disorders affecting the brain (such as encephalitis, epilepsy, birth defects, or polio)
* Have experienced a concussion, head or brain trauma, seizures, loss of consciousness
* Have been injured in the eye by a metallic foreign body.
* Have been injured by metallic foreign body (e.g. bullet, shrapnel)
* History of sickle cell anemia/kidney disease/diabetes, asthma, or allergies
* Long-term use of medication is required
* Currently pregnant or breast feeding.
* Had the following conditions or implants in their body:

  * Surgical clips
  * Cardiac pacemaker
  * Neurostimulator/internal electrodes
  * Insulin pump
  * Internal shunt
  * Metal screen / suture
  * Cochlear implants
  * Hearing aid
  * Eye implants/eyelid springs
  * Orthopaedic devices (e.g. pins, nails, screws)
  * Prosthetic heart valve
  * Breast tissue expander
  * Tattoo or permanent eye-lining
  * Body ring
  * Patch/Blood Glucose Monitor
  * Dentures
  * Intrauterine contraceptive device
  * Metal blockage in the blood vessel/metal foreign body in the body
Expanded Access to Provide SUVN-502 for the Treatment of Subjects With Alzheimer's Disease

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to SUVN-502 for the treatment of Alzheimer's Disease. Investigator as well as the subject/caregiver must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the patient's medical history and program eligibility criteria.

Subjects will not be evaluated for efficacy and safety during the expanded access.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed the 30 week treatment period of study CTP2S1502HT6 as planned and wish to continue treatment with SUVN-502.
* Subject (or subject's legally acceptable representative) and caregiver must sign the Informed Consent Form (ICF) to participate in the study.

Exclusion Criteria:

* Has participated or is participating in any other clinical (investigational) study after completion of CTP2S1502HT6 study.
* Is treated or likely to require treatment during the study with any medication prohibited by this expanded access program.
Nasal Packing Duration and Development of Pharyngitis After Septorhinoplasty Surgery

Septoplasty or septal reconstruction is a corrective surgical procedure performed to straighten the nasal septum. It may be associated with numerous complications. To minimize these complications, both nasal cavities are frequently packed with different types of nasal packing. In our study we will try to find relationship between duration of nasal packing and postrhinoplasty sore throat and pharyngitis.

Nasal packing affects swallowing by different mechanisms. It may affect swallowing as a result of nasal congestion, constant mouth breathing, throat dryness and pharyngitis.

Postoperative sore throat causes patient dissatisfaction and poor pain control. Several interventions could be performed to reduce sore throat and pharyngitis and increase patient satisfaction , which may not be convenient for all patients, such as gargling or sprays

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II patients
* aged from 20 to 40 years old
* undergo septorhinoplasty

Exclusion Criteria:

* Bleeding disorders
* Uncontrolled hypertension
* Cardiovascular diseases
* Uncontrolled diabetes mellitus
* Collagen disorders
* Pregnancy
Prospective Interventional Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant

Lesions in the cartilage are common disorders. Arthroscopy lavage and debridement micro fracturing, mosaic plasticity as well as osteochondral autograft transplantation (OATS) are methods used for treatment of the lesions. Some have shown to help the patients but there is an ongoing treatment gap especially for patients with knee lesions and early osteoarthritis.

Episurf Medical has developed a Focal Knee Resurfacing (FKR) implant, the Episealer® implant. The implant is used for treatment of focal cartilage lesions of the lateral or medial femoral condyle in order to alleviate pain and improve range of motion.

In this study, the investigators aims to establish if this implant is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing)

Lesions in the cartilage are common disorders. In the knee, cartilage lesions are found in over 50 % of all arthroscopies, where 25 % of these are of focal character and the majority are found in the medial femoral condyle. The quality of life of patients with focal cartilage defects is significantly affected and it has been shown that the quality of life is affected to the same extend as in patients scheduled for knee replacement. Arthroscopy lavage and debridement micro fracturing, mosaic plasticity as well as osteochondral autograft transplantation (OATS) are methods used for treatment of the lesions. Some have shown to help the patients but there is an ongoing treatment gap especially for patients with knee lesions and early osteoarthritis.

Episurf Medical has developed a Focal Knee Resurfacing (FKR) implant, the Episealer® implant. The implant is used for treatment of focal cartilage lesions of the lateral or medial femoral condyle in order to alleviate pain and improve range of motion. The implant and surgical instruments are customized to each patient's joint anatomy, position, and size of injury, based on patient-specific images (MRI).

In this study, the investigators aims to establish if this implant is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible
* Minimal age of 18 years old (Preferred age group \>40 years)
* Suitable for implant, to be determined by analysis of MRI imaging. Suitability is set by the size and location of the lesion. The maximum size of the lesion is set at 6cm².
* Informed consent obtained

Exclusion Criteria:

* Active or recent (\<1 yr) septic arthritis of the involved knee
* Associated symptomatic untreated ligamentary or meniscal pathology in the involved knee
* (Severe) osteoarthritis in the involved or other compartments of the involved knee
* Severe osteoporosis
* MRI not possible (eg. due to pacemaker)
* Marked valgus- or varus alignment (\>6 degrees)
Study of Relative Bioavailability of Mobic Manufactured in China in Comparison With Mobic Manufactured in Germany in Chinese Healthy Volunteers

The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany


Eligibility Criteria:
Inclusion Criteria:

* Chinese healthy male volunteers as determined by result of screening
* Written informed consent in accordance with Good Clinical Practice (GCP)
* Age \>= 18 and \<= 40 years
* Broca \> - 20% and \< + 20%

Exclusion Criteria:

* Any finding of the medical examination (blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* Hypersensitivity to Mobic and/or non-steroidal anti-inflammatory drugs
* Intake any drugs within 1 month before randomization
* Participation in another trial with an investigational drug within the last 2 month or during the trial
* Smokers ( \>= 10 cigarettes or \>= 3 cigars or \>= 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol or drug abuse
* Blood donation within the last 1 month
* Excessive physical activities within the last 5 days
* History of hemorrhagic diatheses
* History of gastro-intestinal ulcer, perforation or bleeding
* History of bronchial asthma
Breathing Protocol in Breath-hold Divers

The aim of this randomized controlled trial study was to assess the effects of an 4-week exercise program on the recovery capacity after a voluntary maximal apnea. Participants will be randomly allocated to perform an experimental breathing protocol (NR-HB), or an usual training using their usual breathing (UB) protocol.

It is a multi-center study. 2 different Spanish Freedivers Centres are included in the study (Madrid and Zaragoza).

Divers were randomly assigned to receive an experimental training (NR-HB) or to be included in the Control Group (UB).

The trial included two study visits. Each exercise training program will be applied sessions per week during 4 weeks. Participants received baseline assessments at the beginning of any intervention, and post-intervention assessments at the end of the fourth week.

Eligibility Criteria:
Inclusion Criteria:

* Absence of pain or illness
* No changes in cognitive ability
* Over 18 years old.
* Member of the Spanish Federation of Underwater Activities.
* Positive medical examination that allows the diver to practice voluntary apnea.

Exclusion Criteria:

* People with systemic diseases, tumors, infections, pacemakers, history of epilepsy, hydrophobia, pregnancy women, pharmacological treatment.
* To be participating in other physical activities during the experimental research
A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease

This multicenter, double-blind, randomized, placebo-controlled study will evaluate the effect of dalcetrapib 600 mg on artherosclerotic disease progression, lipid profile and biomarker profile and long-term safety profile of dalcetrapib in patients with coronary artery disease. Atherosclerotic disease progression will be measured 1. Coronary Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography 2. Carotid B-Mode Ultrasound Intima Medial Thickness (IMT) and total plaque volume in subjects undergoing coronary angiography who have coronary artery disease (CAD). Patients will be randomized to receive dalcetrapib 600 mg orally once a day or placebo. The anticipated time on study treatment will be 24 months. The target sample size is 800-1000 patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over the age of 18 years
* Angiographic evidence of coronary artery disease
* Ultrasound evidence of carotid artery disease
* Treated appropriately for dyslipidemia

Exclusion Criteria:

* Previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or CETP-vaccine within the last 3 months before study start
* Previous coronary artery bypass graft surgery (CABG) or probable need for CABG in the next 24 months
* Myocardial infarction in the target coronary artery for IVUS between the initial IVUS examination and randomization
* Patients who have symptomatic congestive heart failure at baseline (New York Heart Association class III or IV)
* Severe anemia
* Uncontrolled hypertension
* Poorly controlled diabetes
Gut-derived Neuropeptides in Cerebrospinal Fluid of Patients With Parkinson's Disease and Healthy Controls

In previous work, the investigators analyzed the concentration of gut-derived peptides (ghrelin, pancreatic polypeptide \[PP\]) in serum of patients with Parkinson's disease (PD). The investigators have shown that the secretion pattern differs between PD patients and controls. Beside ghrelin and pancreatic polypeptide other gut-derived peptides (e.g. Glucagon-like-Peptide 1\[GLP-1\], Amylin, etc.) might be relevant for PD as well. The rational to investigate gut-derived peptides in the neurological disorder Parkinson's disease (PD) is based on the following considerations:

* Receptors for gut-derived peptides are expressed in Central Nervous System (CNS) structures that are affected by the neurodegenerative process underlying Parkinson's disease
* Gut-derived peptides are involved in the modulation of higher brain functions (mood, cognition, reward-related behaviour) that are frequently altered in Parkinson's disease.
* The secretion of gut peptides is (co-)regulated by the vagal nerve that is dysfunctional in Parkinson's disease.
* Certain gut-derived peptides (ghrelin, GLP-1) stimulate neurogenesis and might be able to prevent cell death in neurodegenerative disorders, including Parkinson's disease.

Objective:

Collection of CSF and serum samples in a standardized way in order to quantitatively measure the concentration of gut-derived peptides (ghrelin, leptin, glucose-dependent insulinotropic peptide \[GIP\], GLP-1, amylin, PP, peptide YY \[PYY\], and insulin). Scientific questions:

1. Do CSF (and serum) concentrations of these gut peptides differ between PD patients and controls?
2. Do CSF (and serum) concentrations of the investigated peptides correlate with clinical and / or epidemiological characteristics of the investigated subjects (age, gender, BMI, disease duration, severity of motor impairments, presence of non-motor symptoms, co-morbidities, medication, etc.)?


Eligibility Criteria:
Main Inclusion Criteria:

* Informed consent to participate
* Capability to understand risks of study-related procedures
* For PD cohort: diagnosis of (idiopathic) Parkinson's disease

Main Exclusion Criteria:

* Pregnancy
* Subjects incompetent to provide informed consent
* Subjects that cannot undergo a lumbar puncture for medical reasons (thrombocytopenia, anticoagulation, increased cranial pressure)
* For control cohort: presence of a neurodegenerative disorder
This Clinical Study Evaluates the Performance and Safety of Biorithm Research Kit Versus CTG in Prenatal Monitoring of Pregnant Participants.

This clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants.

The Biorithm Research Kit system used in this study consists of femom fetal monitor (known as fetal monitor), a digital gateway and a cloud storage. It's intended for monitoring of maternal and fetal physiological parameters. It includes non-invasive fetal monitor or device, that monitors fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) in the antepartum period.

Eligibility Criteria:
Inclusion Criteria:

* Have a singleton pregnancy
* Should be at and above 28 weeks of pregnancy
* Should have a valid indication for antenatal FHR monitoring as part of their pregnancy management, as per local hospital policy
* Able to speak English or have access to an interpreter and provide Informed Consent

Exclusion Criteria:

* Participants with an intellectual or mental impairment
* Participants with a known allergy or hypersensitivity to ECG gel electrodes
* Participants in pain, with contractions or in labour
* Known fetal cardiac or genetic abnormality
* Participant with a pacemaker
Exposure of Salvaged Blood to Inflammation and Oxidative Stress: the Effect of Different Anticoagulant Regimes (HECICS)

The primary aim of this randomized controlled study is to determine whether the use Anticoagulant Citrate Dextrose Solution--Formula A (ACD-A) in cell salvage reduces inflammation and oxidative stress in cell saver blood compared to heparin. The secondary aim is to determine whether any differences in activation can be correlated to any differences in postoperative clinical outcome.

The first primary outcome of this study is the difference in concentration of pro- and anti-inflammatory markers and markers of oxidative stress in the cell-free fraction of the centrifugate of the unwashed autologous blood/anticoagulant mixture in the cell saver reservoir, after correction for cardiopulmonary bypass (CPB) time up to the start of the first washing cycle and contact time of the anticoagulant (either ACD A or heparin) with the saved blood:

* total antioxidant status (TAS)
* Total thiols in proteins (TTP)
* oxidized LDL (oxLDL)
* Pro-inflammatory markers: interleukins (IL), IL-6, IL-8, myeloperoxidase (MPO)
* Anti-inflammatory marker: IL-10

The second primary outcome of this study is the difference in direct quality of the washed, salvaged red blood cells (RBC):

* Blood smear: evaluation by light microscopy
* Osmotic fragility
* Haemoglobin and hematocrit
* Free haemoglobin
* Free iron
* Lactate
* pH Confounding factors (CPB duration, contact time of anticoagulant with saved blood, time since first washing cycle in case of multiple washing cycles) will be controlled for.

Secondary outcome:

The difference in concentration of the same pro/anti-inflammatory and oxidative stress markers in patient plasma preoperatively vs immediately before and after transfusion of cell saver blood (2 to 3 hours after transfusion and before extubation or transfusion of allogenous blood).

* C-reactive protein (CRP)
* TAS, TTP
* oxLDL
* IL-6, IL-8, IL-10
* MPO Markers for hemolysis in patient plasma preoperatively vs immediately pre- and post-transfusion of the salvaged RBC (indirect quality of the washed salvaged RBC).
* Free Hb
* Free iron, ferritin, transferrin
* Haptoglobin
* Hepcidin

Eligibility Criteria:
Inclusion Criteria:

Elective cardiac revascularization surgery patients: subgroup analysis for

* on pump coronary artery bypass grafting (CABG)
* off pump CABG (OPCABG)

Exclusion Criteria:

* Urgent procedures
* Severe shock
* Active infection
* Inflammatory diseases
* Active neoplasia
* Immune suppressive drugs
* Active or recent renal replacement therapy (RRT)
* Anticoagulation or anti-aggregation therapy that hasn't been timely interrupted according to guidelines (12,13)
* Need for allogenous blood transfusion before completion of data collection
* Massive peroperative bleeding that cannot be safely managed while collecting study data
Prospective Evaluation of Near and Intermediate Visual Outcomes With Monofocal Intraocular Lenses: The Mast Study

The purpose of this study is to evaluate the near and intermediate visual outcomes of patients who have undergone routine cataract surgery (removal of cloudy crystalline lens) with phacoemulsification (the break-up and removal of cloudy lens) and monofocal IOL ( a plastic lens implanted to replace eye's natural lens) placement in the capsular bag in at least one eye.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients at least 18 years of age
* Patients who underwent routine cataract surgery with phacoemulsification and monofocal iol placement in the capsular bag in at least one eye within the last 36 months
* At least 1 month postop before follow-up evaluation
* All Patients must have a DCVA of 20/25 or better
Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis

The purpose of this study is to correlate Endoscopic Ultrasound (EUS) criteria for chronic pancreatitis with surgical pathology.


Eligibility Criteria:
Patients who are eligible are individuals who have:

* normal pancreas
* suspected chronic pancreatitis
* established chronic pancreatitis (by ERCP, MRI, previous EUS, CT)
* pancreatic cancer

Patients who are not eligible are individuals who have:

• an uncorrectable coagulopathy (platelet \<50,000, INR\>1.5), or bleeding disorder, or are unable to discontinue anticoagulation 5-7 days prior to EUS (aspirin and bridging therapy with lovenox are allowed, clopidogrel is not allowed)
Rheumatoid Arthritis DMARD Intervention and UtilizationStudy

To systematically collect and document use patterns, effectiveness and safety of DMARD treatments currently used in the management of rheumatoid arthritis. The primary purpose of this study is to estimate the incidence of serious adverse experiences and adverse experiences of interest in patients with rheumatoid arthritis (RA) treated with ENBREL®.


Eligibility Criteria:
Inclusion Criteria:

* Fulfillment of the 1987 American Rheumatism Association criteria for RA
* Currently requiring the addition of ENBREL® therapy (to be taken alone or in addition to their current DMARD therapy)

Exclusion Criteria:

* Currently or previously enrolled in RADIUS 1
* Currently enrolled in a clinical trial where treatments or patient visits are imposed by a protocol
* Active infections
* Known allergy to ENBREL® or any of its components
* Current treatment with ENBREL®
* Patients who have previously been demonstrated to be intolerant of or refractory to ENBREL® therapy
* Nursing or pregnant women
Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery

This study is conducted in order to evaluate the effect of remote ischemic preconditioning on children undergoing cardiac surgery, especially focusing on possible differences according to preoperative cyanosis.


Eligibility Criteria:
Inclusion Criteria:

* open heart surgery under cardiopulmonary bypass: ventricular septal defect, tetralogy of Fallot

Exclusion Criteria:

* chromosomal defect
* airway and parenchymal lung disease blood disorder
* isolated atrail septal defect
* immunodeficiency