cyrilzakka/clinical-trials huggingface dataset:
Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies

The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addition the incidence and severity of side effects and of graft vs. host disease (GVHD) will be monitored.

* In order to undergo transplant procedure, patients will be admitted to the hospital for approximately 10-14 days.
* To prepare patient's bone marrow to accept donor stem cells, they will receive fludarabine and busulfex. Fludarabine will be given intravenously once daily for 4 days. Busulfex will be given once daily for the same 4 days.
* One day before patients receive busulfex and fludarabine, they will also be given alemtuzumab intravenously once daily for 5 days.
* Three days after the end of chemotherapy, patients will receive the infusion of donor stem cells.
* If patients have thalassemia, they will receive subcutaneous injections of filgrastim starting on day one after the donor stem cell transfusion and will continue receiving filgrastim every day until it appears that the donor stem cells have been accepted. If the patient has sickle cell disease, filgrastim will not be given,
* Additional drugs will be given to help prevent infection (i.e. antibiotics).
* After stem cell infusion patients will be examined and have blood tests weekly for 1 month. Bone marrow biopsies, and blood work will also be performed 1 month, 3 months, 6 months and 1 year after stem cell infusion.
* Patients will be on the study for about 12 months. After study is completed progress will be monitored on an annual basis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sickle cell disease should have one or more of the following: acute chest syndrome requiring hospitalization; nonhemorrhagic stroke or central nervous system event lasting longer than 24 hours; recurrent caso-occlusive pain or recurrent priapism; sickle neuropathy; bilateral proliferative retinopathy and major visual impairment of at least one eye; osteonecrosis of multiple joints; transfusion dependence; vaso-occlusive.
* Patients with thalassemia should have one or more of the following: transfusion dependence; iron overload; presence of 2 or more alloantibodies against red cell antigens.

Exclusion Criteria:

* Pregnancy
* Acute hepatitis
* Cardiac ejection fraction \< 30%
* Severe renal impairment
* Severe residual functional neurologic impairment
* Evidence of HIV infection
Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis

The randomized clinical study aimed to assess the efficacy and safety of standard anticoagulation with rivaroxaban in combination with diosmin compared to the isolated use of standard rivaroxaban for prolonged therapy of acute femoro-popliteal deep vein thrombosis reflected the speed of deep vein recanalization and incidence of post-thrombotic syndrome.

Deep vein thrombosis is an acute inflammatory disease that affects vein wall and leads to the structural changes in the wall and valves reflected with chronic venous insufficiency that called postthrombotic syndrome (PTS).

Diosmin as a flavonoid agent has properties to reduce leukocyte-endothelial interaction and inflammatory response, that could reduce the damage to venous wall and valves.

The hypothesis of the study is based on assumption that diosmin combined with standard anticoagulation can improve outcomes of femoro-popliteal DVT due to increase speed of veins recanalization, decrease of vein wall inflammation and finally decrease the incidence of PTS at 6 month and 1 year after index DVT.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* The first episode of femoro-popliteal deep vein thrombosis (DVT)
* Verification of DVT by duplex ultrasound
* Informed consent signed

Exclusion Criteria:

* Suspicion of pulmonary embolism (PE)
* Verified PE
* Bilateral DVT
* Contraindications for rivaroxaban (in accordance with the official instructions)
* Contraindications for diosmin (in accordance with the official instructions)
* Active cancer
* Verified severe thrombophilia (antiphospholipid antibodies, deficiency of proteins C, S, antithrombin 3)
* Use of other anticoagulants for more than 7 days from the DVT verification
* Impossibility of using compression stocking after 3 days from DVT verification
* Performed surgical intervention on the superficial or deep veins of the lower extremities (thrombolysis, thrombectomy, vein ligation, implantation of the inferior cava filter)
* Continuous use of other drugs that affect the hemostasis system (except for acetylsalicylic acid in a dose of not more than 100 mg).
* Low compliance
Subjective Wearing Experience of the Total30 for Astigmatism Lens Among Satisfied Biofinity Toric Lens Wearers

To subjectively evaluate wearing experience in the T30fA lens among subjects who were already satisfied with their Biofinity Toric lenses.

This study is a single site, prospective, observational study of the subjective performance of T30fA in symptomatic patients. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include measurement of visual acuity, manifest refraction, and patient questionnaires.

Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Subjects who are currently wearing and can answer in the affirmative the following question: "I am satisfied with my current Biofinity toric monthly replacement lenses" prior to and after habitual lens optimization.
* Subjects between the ages of 18-45 who wear their Biofinity Toric lenses at least 5 days per week, at least 10 hours per day.
* Prescription with a sphere value between +4.00D and -6.00D inclusive, and a cylinder value between -0.75D and -2.25D.
* Vision Correctable to 20/20 (0.0 logMAR) or better in each eye at 6M with their Manifest refraction.
* Willing to attend all study visits.

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined the investigator.
* Monocular (only 1 eye with functional vision) or fit with only 1 lens (and those patients that cannot be successfully fit with the T30fA lens design).
* Fitted with monovision.
* Prior ocular surgery.
* History of herpetic keratitis, ocular surgery, or irregular cornea.
* Pregnant or lactating.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic Approach

Ultrasound-guided suprazygomatic maxillary nerve block (SMNB) will be performed in paediatric patients with or without the aid of ultrasound guidance. Magnetic resonance imaging (MRI) is used to visualize the spread of the local anaesthetic (LA) spread after suprazygomatic injection and to verify LA contact with the maxillary nerve in the pterygopalatine fossa (PPF).


Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients scheduled for cleft palate (CP) surgery with SMNB as part of their perioperative pain treatment
* American Society of Anesthesiologists physical status 1 - 2
* Age 10 to 24 months
* Given informed written consent by legal guardian

Exclusion Criteria:

* American Society of Anesthesiologists physical status \> 2
* Patients with cranial deformation
* Patients with concomitant medical treatments or medical conditions interfering with peripheral nerve block treatment
* Patients with concomitant medical treatments or medical conditions interfering with MRI
* Patients that are allergic to bupivacaine or other local anaesthetic agents.
TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation

The primary goal of the TCD-REDUCE study is to demonstrate the effectiveness of continuous transcranial Doppler sonography ("sonolysis") on the reduction of the ischemic stroke volume during MitraClip implantation.

Cardiac procedures are associated with new cerebral ischemic lesions detected on diffusion-weighted MRI (Bendszus et al., 2006).

A previous study suggests that sonolysis (continuous transcranial Doppler sonography using a 2-MHz diagnostic probe) can reduce the risk of new cerebral ischemic lesions during carotid endarterectomy and carotid angioplasty / stenting (Skoloudik et al., 2015).

Currently, it is unknown whether sonolysis can also reduce the risk of new cerebral ischemic lesions during MitraClip implantation - a percutaneous treatment option in patients with moderate / severe mitral regurgitation.

In this study, patients will receive cerebral MRI and clinical neurological / neuropsychological examination before and after MitraClip implantation. During MitraClip implantation, all patients will receive continuous transcranial Doppler sonography using a 2-MHz diagnostic probe with maximal diagnostic energy administered through either the left or the right transtemporal window (computer-generated 1:1 randomization).

The primary endpoint is the median ischemic lesion volume detected on diffusion-weighted MRI after MitraClip implantation in the sonolysis group and in the control group.

Eligibility Criteria:
Inclusion Criteria:

Patients with mitral regurgitation that are assigned to the MitraClip implantation by an interdisciplinary heart team according to current guidelines.

Exclusion Criteria:

* contraindication to MRI examination (e.g. pace-maker, implanted metal material, claustrophobia)
* pregnancy
* unable to consent
* no transtemporal window
Peripheral Vascular Function in Obstructive Sleep Apnoea

Peripheral vascular function is impaired in people with obstructive sleep apnoea who are untreated compared with age-, weight- and sex-matched healthy controls.

Obstructive sleep apnoea (OSA) is a chronic respiratory disorder associated with endothelial dysfunction, increased sympathetic activation and increased cardiovascular risk. The standard treatment paradigm is continuous positive airway pressure (CPAP), however, patient adherence to CPAP is variable. It is unclear to what extent that poor adherence to CPAP therapy augments vascular endothelial function and reduces cardiovascular risk compared to excellent adherence. The main aim of this research is to investigate vascular endothelial function in OSA patients who are poorly-adherent to CPAP therapy. Nitric oxide (NO)-mediated, endothelium-dependent macrovascular and microvascular function (by brachial artery flow-mediated dilatation and forearm cutaneous thermal hyperaemia, respectively) and generalised microvascular function (by post-occlusion reactive hyperaemia) will be assessed in three obese OSA patient populations (high-adherence (n=20); low adherence (n=20); and, untreated (n=20)) and age-/BMI-matched OSA-free controls. We will also assess body composition, cardiovascular risk, lipid status and functional capacity. This research will evaluate treatment efficacy in patients who are poorly-adherent to CPAP treatment and could identify whether an alternative approach to their care should be explored.

Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnoea diagnosed using overnight polysomnography
* Age 18-90 years

Exclusion Criteria:

* Unable to perform the tests involved in the study
* Unable to provide written informed consent
Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients

The optimal plasma concentration range of adalimumab in Chinese patients with active ankylosing spondylitis remains unknown, the aims of this study is to determine the concentration-effect relationship, and explore the effect of anti-drug antibody or biomarkers on clinical outcomes in a real-world setting.

This prospective observational study will include Chinese adult patients with active ankylosing spondylitis receiving adalimumab treatment. The primary outcome is the mean change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS).

Eligibility Criteria:
Inclusion Criteria:

1. Consent of the patient.
2. Patient who meets the definition of Ankylosing Spondylitis based on the 1984 Modified New York Criteria, has a diagnosis of active Ankylosing Spondylitis (BASDAI ≥ 4, Back pain ≥ 4).
3. Patients who have indication of adalimumab.
4. Patients on NSAIDs treatment need to be on a stable dose for at least 4 weeks.

Exclusion Criteria:

(1) Hepatitis B or tuberculosis patients
The Effect of Mental Fatigue on Lower Limb Functional Performance Tests and Brain Activity in a Healthy Population

Objective of the study

The main objectives of this project are:

1. To assess the influence of mental fatigue on a return-to-play test battery in healthy population
2. To assess the influence of mental fatigue on brain functioning during a balance and reaction time task in healthy population In a later stage, these experiments could be carried out in a clinical context (e.g. in an ankle sprain population).

The researchers will use a randomized, placebo controlled, counter-balanced, cross-over design.

Thirteen healthy subjects will visit the lab 3 times. On the first visit (familiarisation trial), the investigators will collect the participants' characteristics. The participants will also be familiarized to the procedures and materials of the experiment during this first visit. The second and third visit contain the experimental setup and will proceed as follows: first, the participants will fill in a mental fatigue scale (M-VAS) and motivation scale. Next, the subjects will carry out a functional test battery (hop test, vertical jump test, Y-balance test, and a balance reaction-time test). Session rate of perceived exertion (RPE) is measured to indicate how fatigued the participants feel because of the test battery; also, M-VAS is collected once more. Then, a short cognitive task (Flanker task) is followed by either a long intensive cognitive task (90 minutes Stroop task) or control task (90 minutes documentary). Afterwards, participants have to carry out the Flanker task, fill in M-VAS (2x), perform the same test battery, fill in session RPE and one final fatigue scale (Nasa TLX). Heart frequency and EEG will be measured continuously during the trials.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (No neurological/cardiorespiratory/psychological disorders)
* Male and female
* No medication
* Non-smoker
* Between 18 and 35 years old

Exclusion Criteria:

* Back and/or lower extremity injuries during the past 6 months
* Bone/joint abnormalities
* Dizziness, history of loss of consciousness, any inner ear disorders
* Nervous system disorders or dysfunctions
* Uncorrected eye disorders/dysfunctions
* Illness
* Use of medication or any kind of drugs
* Use of alcohol, caffeine and heavy efforts 24 hours before each trial
* Not eating the same meal the night before and the morning of each trial
A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

This study compared the safety and efficacy of a generic fluticasone furoate (Lek Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of fluticasone furoate, 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Veramyst® nasal spray (GlaxoSmithKline) in the relief of the signs and symptoms of seasonal allergic rhinitis. Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 110 mcg was 4 actuations, each containing 27.5 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female 12 years of age or older with a minimum of 2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
* Signed informed consent (assent) form.
* Documented positive allergic skin test to local pollen.
* An average score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum score of at least 2 for "nasal congestion" and at least 4 on the reflective Total Ocular Symptom Score (rTOSS).

Exclusion Criteria:

* History of asthma that required chronic therapy (with the exception of occasional acute or mild exercise induced asthma).
* Some other past and concomitant medical conditions, prohibited medications.
* Upper respiratory tract infection or any untreated infections.
* Patient has started immunotherapy/changed the dose.
* Any known allergy to any of the components of the study nasal spray.
A Study to Evaluate HB0034 in Healthy Adult Participants

The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose.

This is a first-in-human (FIH) study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects age ≥ 18 and ≤ 55 years.
* Body Mass Index (BMI) ≥ 17.5 and ≤ 32 kg/m².
* Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion Criteria:

* History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
* Current or history of malignancy.
* Family history of premature Coronary Heart Disease (CHD)
* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
* Pregnant or Breasting feeding subject. Women with a positive pregnancy test (HCG).
* Further exclusions criteria apply.
Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
* Have active AS defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and the spinal pain (back pain) score ≥4 on a numeric rating scale (NRS)
* Participants should have been on nonsteroidal anti-inflammatory drugs (NSAIDs) with an inadequate response
* Participants who are regularly taking NSAIDs or cyclooxygenase-2 (COX-2) inhibitors as part of their AS therapy are required to be on a stable dose
* Participants who have been on a tumor necrosis factor alpha (TNF) inhibitor (not more than one) must have experienced an inadequate response
* Total duration of prior therapy (NSAIDs and/or adequate physical therapy) should be at least 12 weeks
* Men must agree to use a reliable method of birth control or remain abstinent during the study
* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

* Participants with a total ankylosis of the spine
* Prior or current treatment with adalimumab
* Participants previously treated with any biological or other immunomodulating agents except for those targeting TNF
* Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than ankylosing spondylitis
* Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
* Serious disorder or illness other than ankylosing spondylitis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
Serum Fibroblast Growth Factor-21 Levels During Prolonged Fasting

The investigators hypothesized that serum FGF21 levels would increase with prolongation of the fasting period. The investigators also hypothesized that food intake and body composition would change. The study was conducted with 12 healthy male adults. A questionnaire was administered at the beginning of the study. Anthropometric measurements, dietary intake and physical activities were recorded and blood samples were taken before, during and after Ramadan.

The aim of this study was to determine the effects of hunger on serum Fibroblast Growth Factor 21 (FGF21) levels, nutritional status and anthropometric measurements of adult males during fasting. FGF21 is a significant protein in the process of adaption to fasting due to its effects on liver, adipose tissue, and brain. A total of 12 healthy individuals with normal body mass index, between the ages of 18 to 35 participated to this cross-sectional study. All participants provided written informed consent. Sample size determined with power analysis. A questionnaire was administered in order to determine individuals' general characteristics, nutrition habits, and smoking and alcohol habits. Anthropometric measurements, 24 hours dietary recall and physical activities were recorded and blood samples were taken four times in following periods; before Ramadan, first week of Ramadan, third week of Ramadan and two weeks after Ramadan. Serum FGF21 levels were determined by ELISA (Enzyme-Linked Immunosorbent Assay). Mean energy and nutrient intake were calculated by BEBIS (Nutrition Information System) and results were compared with Recommended Dietary Allowances (RDA). Paired samples t-test and Wilcoxon-signed rank test were used to explore differences. The study was approved by Hacettepe University Non-Interventional Clinical Research Ethics Board.

Eligibility Criteria:
Inclusion Criteria:

* Being healthy male,
* Being between the ages of 19-35,
* Fasting regularly during Ramadan.

Exclusion Criteria:

* Being females,
* Being younger than 19 years and older than 35 years of age,
* Having a BMI less than 18.5 kg/m2 and greater than 24.9 kg/m2,
* Having any chronic metabolic disease,
* Individuals who not fast regularly during Ramadan.