cyrilzakka/clinical-trials huggingface dataset:
Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis

Although the use of bortezomib has reported efficacy in amyloid light chain (AL) amyloidosis, the role of bortezomib with dexamethasone (BD) in the first-line treatment of patients with AL amyloidosis should be determined. In this study, the investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.

This study included patients with newly diagnosed AL amyloidosis who were treated with a BD regimen in Jinling hospital. The AL amyloidosis diagnosis was confirmed by renal biopsy, and the assessment of organ involvement were based on consensus criteria. The clinical and laboratory data were collected at the beginning of each cycle and every 3 months thereafter. The initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.) twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period (days 12-21). The investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.

Eligibility Criteria:
Inclusion Criteria:

* Female or male patients aged between 18 to 80 years
* Renal or other type biopsy was used to diagnose AL amyloidosis
* Understand and voluntarily sign an informed consent form
* ECOG score 0-3 points
* Adequate residual organ function

Exclusion Criteria:

* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
* Grade 3 sensory or grade 1 painful peripheral neuropathy
* Known hypersensitivity to bortezomib, boron or mannitol
* Cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure
* Clinically overt multiple myeloma
* Pregnant or nursing women.
Use of Large Field of View During Image Acquisition for Coronary Angiography

Coronary angiography exposes patients and physicians to ionizing radiation. The purpose of this study is to evaluate the routine use of large field of view during image acquisition for coronary angiography. Patients with indication of diagnostic coronary angiography will be randomized for the use of either large field of view during image acquisition or medium field of view. Patients, physician and nurse radiation exposure will be measured by digital dosimeter.


Eligibility Criteria:
Inclusion Criteria:

* Indication of diagnostic coronary angiography for suspected coronary artery disease
* Sign written consent form

Exclusion Criteria:

* Therapeutics procedures
* Urgency/emergency procedures
* Previous CABG
* Severe valvular disease
Predictive Tools for the Presence of Significant Coronary Artery Disease Requiring Intervention in Chronic Hemodialysis Patients

Medical record data of all HD patients undergoing coronary angiography (CAG) at King Chulalongkorn Memorial Hospital between January 2017 and March 2021 were retrospectively reviewed as a discovery cohort to identify factors discriminating patients with and without significant CAG-established CAD. HD patients receiving CAG between April 2021 and March 2023 were assigned as a validation cohort.

Background: Hemodialysis (HD) patients have increased cardiovascular risk. Coronary artery disease (CAD) may not typically manifest in these patients and the investigational results can be confounded by the fluctuation of body fluid and electrolytes. This study explored the accuracy of these findings in identifying CAD in HD patients.

Methods: Medical record data of all HD patients undergoing coronary angiography (CAG) at King Chulalongkorn Memorial Hospital between January 2017 and March 2021 were retrospectively reviewed as a discovery cohort to identify factors discriminating patients with and without significant CAG-established CAD. HD patients receiving CAG between April 2021 and March 2023 were assigned as a validation cohort.

Eligibility Criteria:
Inclusion Criteria:

* All adult HD patients undergoing CAG at King Chulalongkorn Memorial Hospital of all indications between January 2017 and March 2021 with complete data

Exclusion Criteria:

* Those resinged for using their clinical data for the research
Complementary/Alternative Medicine for Abnormality in the Vestibular (Balance) System

The purpose of this study is to determine the relative merits of vestibular rehabilitation and Tai Chi for patients with inner ear (vestibular) disorders.

It is proposed a randomized, blinded, controlled trial comparing vestibular rehabilitation (VR) to Tai Chi (TC). Our overall goal is to explore whether, and if so, how TC can improve functional, dynamic stability in persons with vestibulopathy (VSP). It is hypothesized that the TC group will demonstrate significantly greater improvement in performing functional activities than the VR group.

Sixty subjects will be randomly assigned into either TC instruction or VR. Both treatment groups will receive identical duration treatment once a week for 10 weeks, with supplemental home exercises. It is hypothesized that 1) TC improves whole-body dynamic locomotor stability more than does VR; 2) TC improves gait coordination during planned and unplanned obstacle encounters more than does VR; 3) TC improves whole-body speed related movement control more than does VR.

Eligibility Criteria:
Main inclusion criteria:

* vestibulopathy and locomotor unsteadiness

Main exclusion criteria:

* diseases/impairments that prevent rehab participation.
Primovist / Eovist in Renally Impaired Patients

Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate.

The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Primovist/Eovist.

Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.

Adverse events data will be reported in Adverse Events section.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be scheduled for Contrast enhanced magnetic resonance imaging (CE-MRI) of the liver with Primovist/Eovist based on careful risk/benefit evaluation at the recommended dose in one of the approved indications
* Patient must fulfill criteria for moderate (Estimated glomerular filtration rate \[eGFR\] 30 - 59 mL/min/1.73 m\^2) to severe (eGFR \< 30 mL/min/1.73 m\^2) renal impairment.

Exclusion Criteria:

* Gadolinium based contrast agent (GBCA)-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Primovist/Eovist within 12 months prior to administration of Primovist/Eovist
* History of existing NSF
Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Acute Ischemic Stroke (ANAIS)

This study will have acupuncture intervention in acute ischemic stroke patients and evaluate the effect in neurological function improving by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS), Barthel Index, and antiinflammatory actions by biomarkers.

Acupuncture Treatment in Stroke is a widely practiced in Taiwan, mainland China, and around the world. The using in stroke group is countless. Numerous clinical trials have been conducted in the medical community to assess efficacy, and the results mostly suggest that acupuncture may be an effective, low side effects adjuvant therapy. Ischemic stroke is also associated with chronic inflammation-related diseases. In recent years, the anti-inflammatory effect of acupuncture was gradually found. So, whether in the basic or in clinical, the investigators can deduce that acupuncture may be helpful for stroke as an adjuvant therapy.

This study evaluates the neurological function of patients with acute stroke by using the widely used National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS) and Barthel Index. Also, the investigators assess the degree of inflammation by biomarkers. Therefore, the purpose of this study is to explore the effect of acupuncture intervention on acute ischemic patients and its relationship in anti-inflammatory actions.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed acute ischemic stroke
* Initial NIHSS between 4\~20
* Aged 45 \~ 85

Exclusion Criteria:

* Hemorrhagic transformation after cerebral infarction, the hemorrhage size estimated to be ≥ 2cm in diameter by brain imaging.
* Any intracranial hemorrhage , except hemorrhagic transformation after cerebral infarction
* Any intracranial operation during acute stage
* Patient using anticoagulants
* Cerebellar infarction
* Special causes of stroke, such as coagulation abnormalities, or arteriovenous malformations
* Epileptic seizures after stroke
* Combined with infection diseases at the time of assessment
* Pregnant or breastfeeding women
* Present mental illness or symptoms and cannot cooperate with the study
* Cannot sign the inform consent
Menstrual Cycle Study

A data collection study to develop algorithms to estimate menstrual cycle phases.


Eligibility Criteria:
Inclusion:

* Adults who are between 18 - 42 years old at enrollment and menstruate
* Capable of giving informed consent in Spanish or English
* Menstrual cycle lengths between 21- 45 days
* Have tracked menstruation for at least 3 menstrual cycles out of the prior 6 months
* Willing to wear a wrist-worn wearable device continuously for 6 months
* Willing to use an ovulation predictor kit for 6 months
* Willing to report vaccine history
* Owns a smartphone compatible with the study and has access to wi-fi

Exclusion:

* A citizen of the European Union or United Kingdom
* Trying to conceive during the six-month study period
* Have used specific forms of birth control in the 3 months prior to the study or planning on using specific birth control methods during the study duration
* Participant has undergone hormonal treatment in the past 3 months or planning to do so during the study
* Known history of health-related issues that affect their menstrual cycle, history of pelvic radiation, vasomotor symptoms, endometriosis, fibroids, polyps, ovarian cysts or known history of health-related issues that affect the physiology
* Currently (or within the past 3 months) engaged in health impacting behaviors
* Have been breastfeeding or pregnant in the past 6 months prior to the study
* On medications or taking substances that could affect their menstrual cycle or physiology
* Travel frequently such as crossing more than two time zones at least once every 2 weeks
* Have a known sleeping disorder or consistently work night shifts
Functional Assessment of a Vibration Feedback on the Gripping Pressure in the Territory of the Median Nerve

The objective of this study is to investigate the effect of vibration feedback on the gripping pressure in the territory of the median nerve.


Eligibility Criteria:
Inclusion Criteria:

* person between 18 and 45 years old
* affiliation to the french social security system or equivalent
* person signed a consent to participate
* for the patient group: person with post-traumatic sensory deficit in the territory of the right median nerve above the wrist (\<S3 according Zachary modified Dellon).

Exclusion Criteria:

* person with a cognitive pathology incompatible with the use of the device, understanding and implementation of the protocol
* person with a concomitant nerve injury of any other nerve territory,
* person with pain or stiffness inconsistent with the achievement tests
* person with an allergy to any component of the device: polyamide, cotton, nickel, textile glue, rubber, plastic or latex,
* person with an infectious disease or dermatology of the right hand
* person deprived of freedom by judicial or administrative decision
* person hospitalized without their consent
* person under legal protection
* person hospitalized for psychiatric care
* pregnant and parturient women
Examining the Attitudes of Physiotherapists on Patient Psychology

To examine the psychology methods used by physiotherapists on patient psychology and to investigate their attitudes about psychology education.

The answers will be collected by asking questions to the participants with an online survey. The scales and surveys to be used are as follows:

* Working Alliance Inventory (Therapeutic Alliance Scale)
* Attitude Towards Psychiatry-30 Scale
* Questionnaires prepared by the researcher.

surveys will be sent to the participants via e-mail or phone message applications.The obtained data will be analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* Being a physiotherapist
* Having access to a computer/tablet/phone and internet
* To have accepted the voluntary consent form that requires participation in the survey study.

Exclusion Criteria:

* Those who do not meet the participation criteria
* Those who do not approve the voluntary consent form
Rosuvastatin for Preventing Deep Vein Thrombosis

Deep vein thrombosis (DVT)is devastating disease which influencing the mortality and morbidity of patients at-risk like those undergoing orthopedic surgery.

Recent publication suggested HMO-co-A reductase inhibitor (statin) may reduce the occurrence rate of venous thromboembolism in apparently healthy persons.

The pleiotropic property of statin like antioxidant, antithrombotic, anti-inflammatory may have effect on the positive results.

We are investigating whether rosuvastatin is associated with lower incidence of deep vein thrombosis (DVT) in patients undergoing total knee replacement arthroplasty(TKRA)who are at-high risk for developing DVT


Eligibility Criteria:
Inclusion Criteria:

* Patients who are going to receive total knee replacement arthroplasty from any cause.
* \< 19 years old

Exclusion Criteria:

* patients with cancer
* Patients receiving anticoagulant agents from any cause
* current statin users
* expecting survival from other co-morbidity \< 1year
* Bed ridden patient
* AST, ALT \> 3times of upper normal limit
* CK\> upper normal limit
* pregnancy
* patients who receives hormone replacement therapy
Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

Eligible eyes are randomized to two groups. Group A will receive three intravitreal injections of bevacizumab at 4 week intervals. In group B, three intravitreal injections of combined bevacizumab and fasudil will be performed with the same frequency.

Best corrected visual acuity (BCVA) and central macular thickness (CMT) will be evaluated prior to injections and then every 4 weeks for 6 months. Fluorescein angiography will be performed at baseline and at weeks 12 and 24. The two groups will be compared in terms of BCVA and CMT changes.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with diabetic macular edema (DME) and:
* Central macula thickness\> 250μm
* Visual acuity \< 20/40
* No active proliferative diabetic retinopathy
* No history of intravitreal anti-VEGF drug injection or macular laser photocoagulation (MPC) within the past 3 months

Exclusion Criteria:

* History of vitrectomy
* History of cataract surgery within the past 6 months
* History of glaucoma or uveitis
* Presence of any macular disorder other than DME
* Presence of traction on the macula
* Significant media opacity
* Serum creatinine\>3mg/ml
The Impact of the Implementation of BIS on the Incidence of Postoperative Delirium

This study will investigate the incidence of postoperative POD in patients undergoing non cardiac surgery under general anesthesia with and without the implementation of the BIS monitoring.T

This study will compare the incidence of POD after elective non cardiac surgery conducted under general anesthesia before and after the implementation of BIS monitoring in our University Hospital.

The POD will be evaluated with the CAM and Nu-DESC tools, which have been adapted for the greek population.

Eligibility Criteria:
Inclusion Criteria:

1. adult patients over 60 years of age
2. an American Society of Anesthesiologists (ASA) physical status I to III
3. undergoing elective non cardiac surgery under general anaesthesia
4. native speakers of the Greek language
5. eligible to leave the post-anaesthesia care unit
6. an expected in-hospital stay at least 24 hours following surgery

Exclusion Criteria:

1. refused to participate or sign the informed consent form
2. surgery or anaesthesia within the last 30 day
3. any prior or current history involving an affliction of the central nervous system
4. severe hearing or visual impairment
5. psychiatric disorders
6. a score less than 5 according the Geriatric Depression Scale (GDS-15)
7. a score less than 4 for females and less than 2 for males according to the Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
8. alcohol consumption less than 35 units/week
9. drug dependence
10. previous neuropsychological testing
11. haemodynamical instability
12. peri-procedural desaturation (one or more events of SpO2\<80% for more than 2 minutes)
Study to Compare Standard Perimetry With the New Scotoma-Oriented Perimetry (SCOPE) Using a New Fast German Adaptive Threshold Estimation (GATE) in Glaucoma Patients

The purpose of this study is to compare the two psychophysical perimetric techniques regarding progression of the visual field.


Eligibility Criteria:
Inclusion Criteria:

* primary open angle glaucoma (POAG)
* spherical ametropia max. ± 8 dpt
* cylindrical ametropia max. ± 3 dpt
* distant visual acuity \> 10/20
* pupil diameter \> 3 mm

Exclusion Criteria:

* diabetic retinopathy
* asthma
* history of epilepsy or significant psychiatric disease
* medications known to effect visual field sensitivity
* infections (e.g., keratitis, conjunctivitis, uveitis)
* severe dry eyes
* miotic drug
* squint
* nystagmus
* albinism
* any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields
* keratoconus
* intraocular surgery (except for uncomplicated cataract surgery) performed \< 3 month prior to screening
* history or signs of any visual pathway affection other than glaucoma
* history or presence of macular disease and/or macular edema, ocular trauma, medications known to affect visual field sensitivity
Thromboelastography-derived Functional Fibrinogen Levels

This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF or FLEV) levels obtained during the rewarming phase of cardiopulmonary bypass can provide information on coagulation status sooner, allowing for anticipation of post-bypass bleeding and transfusion requirements


Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery patients who are undergoing primary cardiac surgery

Exclusion Criteria:

* Emergency surgery
* Re-operative cardiac surgery
* History of hypercoagulable state as defined in medical record
* Anticoagulated status at time of surgery
* Plasma requirement prior to discontinuation of bypass (alters fibrinogen level)
Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 1

The investigators study aims to test the correlation between the CoaguChek point-of-care testing (POCT) device (Roche, Switzerland) and low plasma levels of all three currently approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in real-life stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events
* Age ≥ 18 years

Exclusion Criteria:

* Vitamin K antagonists or direct oral anticoagulants ≤ 14 days prior to study participation
* Low-molecular weight heparin ≤ 24 hours
* Unfractionated heparin ≤ 12 hours
* Abnormal coagulation values at baseline (Quick \< 70% or activated thromboplastin time (aPTT) \> 40sec.)
* History of coagulopathy
A Cognitive Intervention to Manage 'Brain Fog' in Menopause Transition: Feasibility Study

Cognitive complaints at menopause transition (MT), often described as 'brain fog'; can include difficulty recalling words and numbers, misplacing items, trouble concentrating and forgetfulness. Whilst these difficulties resolve for most people, several years of reduced cognitive functioning can be highly damaging and result in problems including leaving work, depression and relationship breakdown.

Study Aims: This project aims 1) to develop and finalise a cognitive intervention for the menopause, 2) To evaluate the feasibility, acceptability and preliminary effects of the intervention. 3) To evaluate the interventions preliminary effects on subjective and objective cognition

Relevance: Traditionally Menopause Hormone Therapy (MHT) is offered to women with cognitive complaints due to its beneficial effect. However, many women are unable to take it due to medical reasons or choose not to. If this intervention is concluded as feasible and acceptable it may then be appropriate to conduct a full RCT of this intervention. It could reduce excess disability, potentially enabling people to remain at work and function better in daily life. Costs to the NHS might be reduced through decreased service and medication use.


Eligibility Criteria:
Inclusion Criteria:

* people with ovaries (women, trans-men and non-binary people) aged 40-60
* late-reproductive, early-late perimenopause or early post-menopause stages according to the Stages of Reproductive Aging Workshop (STRAW+10; Harlow et al., 2012)
* stable dose of hormonal (oestrogen, progesterone, testosterone) or antidepressant (SSRI, SSNI) medication for 6 months or more
* self-reported cognitive difficulties impacting on quality of life
* ability to communicate in English

Exclusion Criteria:

* diagnosis of dementia
* new regimen (under 6 months) of medication likely to impact on cognition (i.e. hormonal or anti-depressant)
Comparison of Two Laryngoscopes: Single-use Device Laryngobloc ® (SU) Versus Reusable Handle With Disposable Metal Blade (R)

Reduce the risk of nosocomial transmission of germs related to the reusability of the laryngoscope handle. The alternative is to replace it with a disposable device, provided that it is as effective as the reference strategy at a reasonable cost.


Eligibility Criteria:
Inclusion Criteria:

* Men or women over 18 years·
* Hospitalized for elective surgery and targeted for orotracheal intubation under direct laryngoscopy under general anesthesia with neuromuscular blockade resolved·
* Subject has signed informed consent·
* Suject affiliated to a social protection·
* Subject informed of the results of medical examination

Exclusion Criteria:

* Contraindication to general anesthesia or one of its components·
* General anesthesia without a competitive muscle relaxant·
* Patient with criteria for difficult intubation·
* Patient targeted for special care of the airway (fiberoptic or vidéolaryngoscopy), whatever the indication as Mallampati class 4·
* Subject in class 4 Mallampati·
* Acts performed in the emergency setting·
* Pregnancy and obstetric procedures·
* Breastfeeding·
* Difficulty in communication with the patient (including obtaining informed consent, evaluation of pain in the recovery Room ·
* Subject in exclusion period (determined by a previous study or a study in progress)