cyrilzakka/clinical-trials huggingface dataset:
A Study of Daratumumab

The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R\&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be actively receiving daratumumab (either as monotherapy or in combination with other study treatment) in certain Janssen research and development (R\&D) studies or receiving other study treatment in a Janssen R\&D daratumumab study for participants with multiple myeloma or smoldering multiple myeloma which has reached clinical cutoff for final analysis continue to benefit from study treatment, not have experienced disease progression or unmanageable toxicity while receiving daratumumab, not have met the withdrawal criteria set forth in the parent study, and have had the last dose of study treatment within the previous 3 months
* Investigator's assessment that the benefit of continued study treatment will outweigh the risks
* A female participant of childbearing potential must have a negative pregnancy test at screening and must agree to further serum or urine pregnancy tests during the study
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study treatment
* Must sign an informed consent form (ICF; or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

* Has taken any disallowed therapies or treatment for the disease under study between the completion of the parent study and the planned first dose of study treatment
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Known allergies, hypersensitivity, or intolerance to study treatments or their excipients (refer to the daratumumab investigator brochure (IB) and local country prescribing information for dexamethasone, carfilzomib, pomalidomide, and lenalidomide)
* Vaccinated with an investigational vaccine (except for Coronavirus disease \[COVID-19\])or live attenuated or replicating viral vector vaccines within 4 weeks prior to enrollment
Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")

Evaluation of decellularized human heart valves for aortic heart valve replacement in comparison to current valve substitutes.

Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and explantation.

Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.

This is a prospective, non-randomized, single-arm, multi-centre surveillance study to be conducted in Europe.

The Surveillance is designed as a study, where

* ARISE AV is prescribed in the usual manner in accordance with the terms of the approval.
* Assignment of the patient to a particular therapeutic strategy is not decided in advance by this Surveillance Protocol but falls within current practice and the prescription of ARISE AV is clearly separated from the decision to include the patient in the Surveillance.
* No additional diagnostic or monitoring procedures shall be applied to the patients.
* and epidemiological methods shall be used for the analysis of collected data.

Eligibility Criteria:
Inclusion Criteria:

i. Indication for aortic valve replacement according to current medical guidelines in valvular heart disease

ii. Informed consent of legal guardians or patients, assent of patients

Exclusion Criteria:

i. The patient has not provided Surveillance informed consent.

ii. The patient shall not suffer from:

* generalized connective tissue disorders (eg, Marfan syndrome), or .
* active rheumatic disorders, or
* severe asymmetric calcification of the valve ring.

iii. The coronary arteries of the patient shall not be in abnormal position or heavily calcified.

iv. Patients shall not show hypersensitivity against sodium dodecyl sulphate (SDS), sodium desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.
Miniscrews Primary Stability

Orthodontic Miniscrew primary stability is essential for success and long term results.

The aim of the present study is to evaluate Bone Properties and Torque insertion values and how they could be related to primary stability and success rate of miniscrew.

Orthodontic miniscrews are intraoral anchorage devices designed to support biomechanics during orthodontic tooth movement. Also known as miniscrews, mini-implants, microscrews, or temporary anchorage devices, they are made of a head, a neck, and a threaded shank. The head may show different designs (bracket-like, rounded with slot, etc.) the threaded shank is generally cylindrical, tapered or a combination of the two, and may be self-tapping (i.e. requiring a pre-drilled pilot hole) and/or self-drilling (not requiring a pilot hole). Because of their small diameter, they may be implanted in a wide variety of anatomic sites, such as the alveolar interradicular spaces or the palatal cortical bone, in order to attend to treatment anchorage needs. The loading protocol for miniscrews loading can be as immediate as delayed; in the beginning in literature was indicated a non-specific period of healing and osseointegration before a screw inserted in the mandible could be loaded; the importance of a healing period was derived by several studies on Branemark protocol on implants. Further experimental studies on orthodontic load were not able to demonstrate loaded implant loosening, even when loads were applied immediately, so that an immediate loading protocol for orthodontic miniscrews appeared as reasonable. Costa and Melsen studied the tissue reaction around the immediately loaded screws in an animal model and suggested the use of immediately loaded screws as an intra-oral extra-dental anchorage. Histomorphometric analyses have shown that the immediate loading of miniscrew implants may help to activate bone remodeling and increase the mineral contents at the loaded region. Compared to traditional endosseous implants, orthodontic miniscrews have relatively high failure rates, varying from 16.4% to 39% ; according to recent reviews, the average failure rate is believed to be less than 20%. Many factors have been proposed to be associated to success rate; among these age, gender, jaw (maxilla or mandible), placement site, tissue mobility (firm or movable tissue), inflammation, distance to the root, insertion torque, loading time, type, length, and diameter of the miniscrew. Recently, an experimental study on primary stability found that bone properties are more important than the screw geometry in establishing primary mechanical retention. Thus the aim of this study is to deeply analyze the bone role related to the success of miniscrews analyzing both insertion/removal torque values, both bone characteristics by the mean of x-rays.

Eligibility Criteria:
Inclusion Criteria:

* patient who need ortho treatment with miniscrew
* permanent dentition

Exclusion Criteria:

* bone pathologies
* systemic disease
The Effect of Patient Optimism & Pessimism on Recovery From Elective Cardiac Surgery

Before a heart operation, patient outlook may be either pessimistic or optimistic. Previous research on this topic has focused on patient reported quality of life but has never examined measurable clinical outcomes such as length of hospital stay.This pilot study hopes to establish whether patient outlook (optimistic or pessimistic) before a heart operation can influence recovery and length of hospital stay. If there is a difference, then a case can be made for providing psychological support before an operation in the hope of modifying outlook and thus improving patient care and reducing hospital stay and NHS costs. Patients will be recruited over a 12month period. Their outlook (pessimistic or optimistic) will be ascertained using two standardised questionnaires. Their recovery and length of stay will be recorded. The study will answer the research question and determine whether outlook has an impact on recovery. Depending on the results, this study could provide opportunities for additional future research into modifying outlook with a view to improving patient care and recovery.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Elective planned cardiac surgery
* Consent to participate

Exclusion Criteria:

* Patients diagnosed with clinical depression
* Patients deemed not competent to provide consent
Crystalloids for AKI in Shock Patients

Fluid resuscitation is important in shock therapy, but the choice of fluids, especially the choice of crystalloid is under debate. It is said that normal saline is related to hyperchloremia， which might lead to acute kidney injury. Thus the hypothesis of the study is to explicit whether balanced salt solution could reduce the incidence of acute kidney injury when compared with normal saline.


Eligibility Criteria:
Inclusion Criteria:

* Shock patients

Exclusion Criteria:

* History of chronic renal failure
Gabapentin Treatment of Cannabis Dependence

This is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.

This is a 12-week, double blind, placebo controlled study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. After an initial phone screen, a comprehensive screening visit is scheduled to determine eligibility. Upon enrollment, counseling, medication dispensation and research assessments occur 1 time per week for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Males or females from 18-65 years of age
* Meets DSM IV criteria for current cannabis dependence
* Seeking research-based outpatient treatment for cannabis dependence that involves daily medication
* Smoked MJ daily at least 25 days per month during the 90 days prior to randomization
* At least a 2-year history of regular MJ use

Exclusion Criteria:

* Abstinent from cannabis more than 2 days at the time of randomization
* Active suicidal ideation
* Currently meets DSM IV criteria for abuse or dependence on other substances, or has urine drug screen positive for substances, other than cannabis or nicotine
* Significant medical disorders that will increase potential risk or interfere with study participation,
* Sexually active female participants with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
* Meets DSM IV criteria for a major AXIS I disorder other than cannabis and nicotine dependence,
* Inability to understand and/or comply with the provisions of the protocol and consent form
* Treatment with an investigational drug during the previous month
* Sensitivity to study drug as evidenced by adverse drug experiences with gabapentin or its ingredients
* Ongoing treatment with medications that may affect study outcomes
Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease

Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release.

In this study, it was aimed to investigate the effects of non-invasive vagus nerve stimulation to be applied to patients with Parkinson's disease on tremor and vagus nerve activity in patients.

The tremor and autonomic activations of the participants will be evaluated at pre and post treatment.

Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release.

5 patients who meet the inclusion criteria will be included in this prospectively planned study. As a vagus stimulation protocol, noninvasive auricular stimulation and stimulation frequency of 10 Hz, pulse width of 300 µs, biphasic application for 20 minutes will be applied to each patient 3 times on different days. Stimulations will be performed 3 times on 3 different days as the right ear, left ear and bilateral ear.

The tremor of the patients participating in the study will be evaluated with the smartphone application. After opening the phone application (G-Sensor), which is used to measure tremor, the patients will be asked to hold the phone in each hand at rest for 30 seconds and the tremor will be recorded. In this application, the maximum amplitude and frequency of the tremor in the 3D plane are calculated automatically.

The effect of vagus nerve stimulation on autonomic nervous system activity is evaluated using heart rate variability with Polar device.

The participants will be evaluated pre and post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 40-65.
* Diagnosed with Parkinson's Disease by a specialist neurologist.
* Hoehn-Yahr stage 2-3.
* Having bilateral resting tremor of the hands.
* Being agreed to participate in the study.

Exclusion Criteria:

* Bilateral or unilateral previous injury to the vagus nerve (eg injury during carotid endarterectomy).
* Severe depression (Beck Depression Scale \> 29)
* Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug.
* Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from following the protocol timeline.
* Pregnancy or planning to become pregnant or breast-feed during the study period.
* Botox injections or any other upper extremity rehabilitation within 6 months prior to treatment.
Cardiac Output Measurement With NICCOMO and PiCCO Devices at Different PEEP Levels

Thermodilution cardiac output measurement is a reliable method, but it is an invasive one. PiCCO device requires cannulation of central vein and peripheral artery. Impedance method requires only attachment of special electrodes. Non-invasive methods are less accurate. Aim of study is to assess accuracy and reliability of impedance method ( using NICCOMO device) in comparison of thermodilution method ( using PiCCO device) at different PEEP levels.

Echocardiography is performed prior to measurement to exclude patients with heart valve abnormalities.

Patients without spontaneous ventilation ( deeply unconscious, sedated or sedated and paralysed), ventilated with controlled mechanical ventilation mode with tidal volume 6-8 ml/ideal body weight, resulting in EtCO2 35-45 mmHg, with PiCCO catheters implemented have additionally NICCOMO device attached. Fraction of inspired oxygen (FiO2) is set to achieve saturation \>96% at positive end expiratory pressure (PEEP) 0 cmH2O.

Measurement of cardiac output are performed on expiration at PEEP 0, 5, 10, 15 20 cmH2O and at optimal PEEP (obtained from P-V curve). Simultaneously CO value from impedance device is noted. Other haemodynamic parameters, calculated by both devices are also noted - stroke volume (SV), stroke volume variation (SVV), Cardiac index (CI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI).

Eligibility Criteria:
Inclusion Criteria:

* critically ill patients
* patients on mechanical ventilation
* circulatory insufficiency (present or in the past) monitored with with PiCCO device

Exclusion Criteria:

* morbid obesity,
* short neck,
* severe pneumonia,
* inability to NICCOMO electrodes attachment,
* massive tissue oedema,
* non-sinus cardiac rhythm,
* tachycardia,
* low cardiac output,
* septic shock,
* heart valve pathologies,
* severe atherosclerosis,
* aortic prosthesis,
* severe hypertension,
* extremes of height and weight,
* intraaortic pump
Relaxation and Meditation Techniques on Pain, Fatigue and Quality of Life

Patients with painful diabethic peripheral neuropathy will be entered.. Participants will be randomized to one of three study arms: Arm 1: relaxatio; Arm 2:meditation Arm 3: Attention matched control Hypothesis: Progressive muscle relaxation and mindfullness meditation will decrease severity of neuropathc pain and fatigue and improve quality of life.

Previous reports have revealed that progressive muscle relaxation and meditation are promising for glycemic control in type 2 diabetes patients. On the other hand, research examining effects of these approaches on painful diabetic peripheral neuropathy, fatigue and quality of life is limited. The present study investigates the effects of progressive muscle relaxation and mindfullness meditation in a single-site, 3-arm, assessor blinded randomized, controlled study of 77 type 2 diabetes patients with painful diabetic peripheral neuropathy. Arm 1: relaxation; Arm 2: mindfulness meditation; Arm 3: Attention matched control. The investigators hypothesize that Progressive muscle relaxation and mindfulness meditation will decrease severity of neuropathic pain and fatigue and improve quality of life.

Eligibility Criteria:
Inclusion Criteria:

* being diagnosed with painful diabethic peripheral neuropathy ,
* being at least primary school graduates,
* not using any other complementary or integrative therapy during the study period

Exclusion Criteria:

* neuropathy history due to any other causes such as megaloblastic anemia, fibromyalgia, autoimmune diseases, hypothyroidism, and lumbar disc hernia
* having end-stage of renal failure, chronic obstructive pulmonary disease, advanced cardiac failure, musculoskeletal disorders or depression
* having a diabetic foot ulcer or amputation.
Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia

Videolaryngoscopy can lead to superior airway conditions and to the possible higher success compared to standard direct laryngoscopy. Patient will be randomized to the interventional group (videolaryngoscopy) and control group (direct laryngoscopy). The first attempt success rate, time to first end-tidal CO2 (ETCO2) wave, overall success rate, incidence of aspiration, bradycardia, desaturation a overall complications will be monitored.

Videolaryngoscopy is specialized equipment for airway management, where a camera located at the tip of the laryngoscope blade can visualize also structures that can´t be seen on direct laryngoscopy, co the operator can obtain superior view of aditus laryngis during intubation. Currently videolaryngoscopy is not routinely used for intubation and it is reserved for patients with difficult airway. The aim of the trial is to compare the elective use of videolaryngoscopy versus direct laryngoscopy for elective airway management (tracheal intubation). Patients after informed consent approval will be randomized to the interventional group (videolaryngoscopy) and control group (laryngoscopy). The randomization will be managed by the Institute of Biostatistics and Analyses by the Faculty of medicine, Masaryk university. The primary aim will be the first intubation attempt success rate, the secondary aims will be time to successful intubation (time to first ETCO2 wave), overall success rate, number of intubation attempts, incidence of aspiration, desaturation and incidence of overall complications in all operators, in trainees, residents (5-10 years of practice), consultants (10-15 years of clinical practice) and consultants with over 15 years of clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients scheduled for elective surgery
* Planned tracheal intubation for airway management during surgery
* Signed informed consent

Exclusion Criteria:

* Emergency surgery
* Other airway management plan
* age outside the predefined limits
* Informed consent not signed
Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005

The purpose of this study is to determine the extent of systemic absorption of PEP005 when applied topically for the treatment of actinic keratoses.

Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients at least 18 years of age.
2. A contiguous 100 cm2 treatment area containing at least 5 AK lesions, on the either the right or left extensor (dorsal aspect) forearm.
3. Written informed consent has been obtained.
4. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study package.
STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function

The primary objective of this study is to compare the function results between two methods for surgically repairing rectoceles: vaginal versus endo-anal surgery. Our working hypothesis is that the relatively new type of endo-anal surgery will result in better voiding function compared to the traditional vaginal surgery.


Eligibility Criteria:
Inclusion Criteria:

* patient is not under any type of guardianship
* patient has a rectocele \> 3 cm during defecography
* patient has persistent defecatory troubles depite medical treatment (laxatives for at least 1 month) and an ODS score \> 10
* patient recieved information and signed the consent form

Exclusion Criteria:

* patient cannot read French
* patient has an asymptomatic rectocele
* patient with an enterocele at rest upon defecography, with opacification of the small bowel
* patient with non-rehabilitated anorectal asynchrony (anism)
* patient with anal incontinence, Wexner score \> 7
* patient has a rectal lesion
* patient has previously had rectal surgery including a colorectal anastomosis
* patient has previously had a surgery involving disection of the rectovaginal wall, except for myorraphy of relever muscles
* patient has previously had pelvic radiotherapy
* anal sphincter insufficiency detected by rectomanometry
* megarectum detected by rectomanometry and defecography
* granule transit anomaly: \> 70h
* exteriorized rectal prolapse
* rectovaginal fistule
* intestinal inflammatory disease
* anal stenosis
* anal or rectal tumor
* patient refuses to participate or refuses to sign consent
* patient is enrolled in another study
* contra indication for general or localized anesthesia
* patient does not have social security coverage