cyrilzakka/clinical-trials huggingface dataset:
Efficacy on Anxiety of the Digital Music Application Versus Equimolar Mixture of Oxygen and Nitrous Oxide in Patients Receiving CT-guided Lumbar Infiltration

Since the Covid-19 crisis, patients appear more stressed, with increasing fear of exams and the hospital environment, in particular for CT scan teams, which require injections. Currently, an equimolar mixture of oxygen and nitrous oxide (EMONO) is used to calm patients. However, the patient's prone position complicates its use, with patients sometimes in painful position and the discomfort of gas inhalation (nausea, dizziness, etc.), as well as reduced lung capacity. Greater patient anxiety increases the risk of complications, or even failure, (unexpected movement, stiffness, refusal to complete the procedure, etc.). In this study, music therapy using Music Care® tablets, was tested to replace EMONO. The study authors hypothesize that the use of the Music Care® device will have a comparable efficacy to that of EMONO (non-inferiority) in reducing patient anxiety during CT-guided lumbar infiltration. Furthermore, the study authors hypothesize that this simple, non-invasive method, with no contraindications for the patient, will be better tolerated and appreciated by both the patient and the paramedical team in charge of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patient with low back pain and an indication for CT-guided foraminal, posterior joint, or pudendal injection
* Patient with an anxiety score ≥ 35/100 based on the STAI-ETAT questionnaire

Exclusion Criteria:

* The subject is participating in another drug or category I interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient who has already received a CT-guided posterior articular, foraminal, epidural, or pudendal injection
* Indication for epidural or cervical injection
* Patient who is deaf or hard of hearing
* Contraindications to EMONO
* Facial or head trauma making it impossible to wear a nasofacial mask or headphones
* Patient who has taken an anxiolytic medication within 24 hours prior to the injection
A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser Among Patients With Chronic Haemodialysis

This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.

This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off(MCO) Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.

Patients who are initially on High Flux Dialyser will be randomised into either MCO Dialyser (modality A) or High Flux Dialyser (modality B) dialysate. The dialysate flow (QD) and blood flow (QB) remains unchanged throughout study period. After 12 treatments (4 weeks) a 4-weeks wash-out phase using High-flux dialyzers was performed to minimize carry-over-effects. After the 4-weeks washout phase, the modality is switched to the alternative one for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or above
2. End stage kidney failure receiving hemodialysis for at least 3 years
3. Currently receiving hemodialysis at our center regularly
4. Written informed consent

Exclusion Criteria:

1. Patients with hemodiafiltration
2. Catheter-related blood stream infection in the preceding 4 weeks
3. Malfunctioning of HD catheter
4. Planned transfer to peritoneal dialysis or transplant within 90 days
5. Pregnancy
6. History of active alcohol or substance abuse in the previous 6 months
7. Concurrent participation in another interventional study
8. Other medical condition which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Hemiparesis

This study will compare the effectiveness of different polarities of transcranial direct current stimulation paired with intensive motor training in recovery of upper extremity function in individuals with severe post-stroke hemiparesis. The hypothesis is that more severely impaired individuals will derive greater benefit from anodal stimulation of the ipsilesional hemisphere or cathodal stimulation of the contralesional hemisphere than dual stimulation (anodal applied to the ipsilesional hemisphere and cathodal applied to the contralesional hemisphere.)

This study has 2 aims: 1) determine which transcranial direct current stimulation (tDCS) electrode configuration is most effective in combination with motor training to promote motor recovery from severe post-stroke hemiparesis; and 2) begin to clarify the extent to which baseline transcranial magnetic stimulation (TMS) measures predict response to tDCS, as well as the effects of tDCS paired with motor training on TMS measures of motor cortical organization.

To accomplish these aims, the investigators will recruit 36 human subjects with severe post-stroke hemiparesis and assign each subject to 1 of 4 tDCS conditions (anodal excitatory ipsilesional; cathodal inhibitory contralesional; a combination of anodal excitatory ipsilesional during cathodal inhibitory contralesional; or sham). Each subject will undergo a 20-minute stimulation session once a day for 10 days over a 2-week period. Each session will be followed by 3 hours of intensive, task-oriented upper extremity motor training.

Outcome measures for this study include TMS motor cortical maps and standardized tests of motor performance. The investigators hypothesize that all groups will show improvement in all measures; however, both the anodal excitatory ipsilesional group and the cathodal inhibitory contralesional group will show significantly greater improvement compared with the other 2 groups. The investigators will also find evidence clarifying whether the presence or absence of motor-evoked potentials (MEPs) has predictive value regarding which tDCS configuration would be most effective for a particular subject.

Eligibility Criteria:
Inclusion Criteria:

* Chronic stroke patients
* Single stroke
* Chronic (more than 12 months after from stroke)
* At least 18 years old, but there is no upper age range for this project.
* Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.

Exclusion Criteria:

* History of head injury with loss of consciousness, seizure, severe alcohol or drug abuse, psychiatric illness
* Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
* Cognitive deficit severe enough to preclude informed consent
* Positive pregnancy test or being of childbearing age and not using appropriate contraception
* Participants with history of untreated depression.
Multicomponent Intervention on Lifestyle, Anthropometric Measurements, Glycemic Control and Quality of Life in Patients Obese People With Type II Diabetes

The main objective of this study will be to evaluate the effectiveness of a multicomponent intervention on nutritional recommendations and physical activity on glycemic control in obese patients with Type II Diabetes (DM2) in three places at the Algodonera Health Center of the Care Management Integrated in Talavera de la Reina.

Diabetes Mellitus (DM) is a chronic process that is not only important for its incidence and prevalence, but also for its complications. DM is responsible for cardiovascular complications that have high and premature mortality and a significant impact on quality of life. Diet control is one of the most effective therapeutic measures at all stages of diabetes management. It is important to promote healthy eating patterns that increase the consumption of foods with high nutritional value, in appropriate proportions, to improve overall health.

The objective of this study will be to evaluate the effectiveness of a multicomponent intervention on nutritional recommendations and physical activity on glycemic control in obese patients with Type II Diabetes (DM2) in three places at the Algodonera Health Center of the Integrated Care Management. from Talavera de la Reina.

For this purpose, a clinical trial will be carried out with two parallel arms, random assignment and blind evaluation by third parties. The study will be carried out on obese patients with DM2 between 40 and 75 years old at the "Algodonera" Health Center of the Integrated Care Management of Talavera de la Reina over a period of 1 year, from the subject's admission to the hospital. study until the last follow-up evaluation at one year. Selected patients must have a Barthel index \> 90 and must travel to the health center independently.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a known diagnosis of DM2.
* Obese patients with a BMI \> 30.
* Patients with Barthel index \> 90
* Possibility of walking to the Health Center.
* Know how to read and write
* That they agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* Patients with Type I DM.
* Inability to perform physical exercise, defined as such, that appears in your current medical history or that your PCP considers.
* Patients with complete deafness.
* Patients with blindness.
* Moderate or severe cognitive impairment.
* Participation in another clinical trial.
* Pregnant or breastfeeding women
* Any condition, laboratory parameter or concomitant therapy that, in the opinion of the investigator, may be a risk to the potential participant or that participation in the study is not in the best interest of the patient.
Natural Disease Progression in Participants With Choroideremia

The primary objective of this study is to quantify disease progression measured by best corrected visual acuity (BCVA) in the real-world setting among Choroideremia (CHM) participants. The secondary objectives are to describe demographic and baseline clinical characteristics among CHM participants and to match CHM participants in the Intelligent Research in Sight (IRIS®) Registry to Biogen's investigator sponsored trial (IST) study population using propensity score matching.

This study is a retrospective cohort study of CHM eyes and participants which will include all eligible participants and eyes with the first documented diagnosis of CHM from July 1st, 2013 to December 31st, 2019 that meet the study criteria. This study will be conducted using data from American Academy of Ophthalmology's (AAO) IRIS® Registry which captures CHM participant's demographics, clinical characteristics and clinical outcomes from 2013.

Eligibility Criteria:
Key Inclusion Criteria:

Cohort 1: All CHM Participants

* Participants with a documented diagnosis of CHM identified by the presence of International Classification of Diseases (ICD)-9/10 or SNOMED coding:

  1. ICD-9: 363.55
  2. ICD-10: H31.2
  3. SNOMED-CT: 75241009

Cohort 2: Trial-Matched CHM Participants

* Male participants with a documented diagnosis of CHM identified by the presence of ICD-9/10 or SNOMED coding:

  1. ICD-9: 363.55
  2. ICD-10: H31.21
  3. SNOMED-CT: 75241009

Key Exclusion Criteria:

* N/A

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Anti-aging Efficacy of Food Supplement and Cosmetic Routine

The aim of this study is to investigate the impact of a topical and an oral product alone and in combination compared to placebo on skin aging


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent to participate in the study
* Willingness to actively participate in the study and to come to the scheduled visits
* Female
* From 40 to 70 years of age, in order to include sufficient subjects for the study, if necessary, the age may be gradually increased to 70 years or decreased to 40 years
* Healthy skin in the test areas
* Visible wrinkles in the face (grade 3 to 6 according to proderm wrinkle score)

For biopsy subpanel:

- Vaccination of tetanus within the last 10 years

Exclusion Criteria:

* Female subjects: Pregnancy or lactation
* Drug addicts, alcoholics
* AIDS, HIV-positive or infectious hepatitis
* Conditions which exclude a participation or might influence the test reaction/evaluation
* Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
* Active skin disease at the test area
* Documented allergies to face/eye care products and food supplements or their ingredients
* Intake of dietary supplements within the last 3 months before the start of the study
* Diabetes mellitus
* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
* One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension (if not adjusted with medication), cardiovascular diseases
* Epilepsy
* Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation
* Regular use of tanning beds
* Any topical medication at the test area within the last 3 days prior to the start of the study
* Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) and/or within the last 7 days prior to the start of the study
* Therapy with antibiotics within the last 2 weeks prior to the start of the study
* Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
* Cosmetic surgery procedure in the test area, e.g. IPL (Intensed Pulsed Light), botox, chemical peel, dermabrasion within the last 2 years prior to the start of the study and/or throughout the entire course of the study
* Medical treatment for wrinkle reduction (e.g. peeling with vitamin A or fruit acids) on the face within the last 2 weeks prior to the start of the study

For biopsy subpanel:

* Regular medication with anti-coagulating drugs like Aspirin®, Macumar®, etc. (e.g. for thrombosis prophylaxis) within up to 15 days prior to the taking of the biopsies
* History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)
* Known intolerance to local anaesthetics
* Known Sensitivity to any dressing systems
Krill Oil and Muscle Weakness in Type 2 Diabetes

The age-related loss of muscle mass and function, sarcopenia, has several deleterious effects, such as a reduction in the quality of life and an increase in the incidence of falls, often leading to hospitalisation. The prevalence of sarcopenia is unclear but is estimated to be between 4.6 and 7.9% and the loss of skeletal muscle mass and function is accelerated in people with type 2 diabetes. With the percentage of older people and the percentage of people with type 2 diabetes predicted to rise in coming years it is crucial to develop therapies to increase muscle mass and function. Alterations in nutrition have also been suggested to be of therapeutic use in sarcopenia. Epidemiological data showed that the consumption of fatty fish is positively associated with muscle function in older population, indicating a potential role for long-chain n-3 polyunsaturated fatty acids (LCn-3 PUFA) in increasing muscle mass and function in older people. The aim of the current study, therefore, is to determine the effects of krill oil supplementation on muscle size and function in adults with muscle weakness and type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Physician confirmed type 2 diabetes.
* Age \>/= 40 years
* No changes in anti-diabetic medication in the last 3 months.
* Muscle weakness (grip strength \<27kg and females \<16kg)

Exclusion Criteria:

* BMI of 45 or higher
* BP of 160/100mmHg or higher
* Cancer or cancer that has been in remission \<5 years
* Any medical condition that prevents participants from exercising safely
* On anticoagulant therapy
* Allergies to seafood
* Regular consumption of more than 2 portions of oily fish per week
* Currently consuming omega-3 supplements
Facial Block for Outpatient Rhinoplasty Analgesia

A bilateral facial block (infraorbital and infratrochlear) will be performed immediately after intubation in patients undergoing outpatient rhinoplasty with 2.5% levobupivacaine (intervention group) or saline as control. Intravenous saline or morphine will be administered at the end of surgery in intervention or control groups, respectively. In case of pain in post-anesthesia care unit (numerical pain score \>3 on a 0-10 scale), both groups will receive intravenous morphine titration. The total perioperative morphine consumption (intraoperative and in post-anesthesia care unit) will be compared between groups. Pain intensity, presence of nausea/vomiting and patient's satisfaction will be compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient rhinoplasty
* American Society of Anesthesiologists (ASA) classification I-II
* Affiliated to Social Security
* Written informed consent

Exclusion Criteria:

* Allergy to levobupivacaine
* Incapacity to give consent
* Chronic pain
Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects

The purpose of this study is to compare two biologic methods for the treatment of articular cartilage defects in the knee. The first method, microfracture, is the standard of care and is routinely used to recruit cells from the subchondral bone marrow to the site of cartilage loss. The second method is the application of adipose-derived stem cells (ADSCs) to the defect site. In theory, ADSCs on a collagen scaffold should enable the delivery of more specific progenitor cells to the site of injury, resulting in better regeneration and integration of articular cartilage at the site of a defect as compared to the microfracture method.

Patients enrolled in the ADSC cohort will undergo the following procedures: arthroscopic resection of approximately 5cc of the infrapatellar fat pad using a motorized shaver (standard use in arthroscopy). Fat will be collected in a sterile Aquavage Collection System (AV1200, MD Resources, Livermore, CA) and kept sealed until processing. Fat will then immediately be processed in the Harvest Adiprep System to separate a population of ADSCs. This system concentrates an average of 5 x 105 cells/ml. All specimens will be processed using routine sterile procedures within the operating room; cells destined for implantation will not leave the operating room. Concurrently, patients will undergo arthroscopy and similar preparation of the chondral defect and removal of the calcified cartilage layer. However, no puncture of the subchondral bone will be performed. A layer of fibrin glue (Tisseel) will be placed at the base of the defect to seal off any bleeding from the subchondral plate followed by the application of the acellular dermal matrix (Allopatch HD, MTF Corporation, Edison, NJ, USA)and ADSCs. An additional layer of Tisseel will then be applied over the cells and matrix. No additional fixation will be applied. The matrix and cells will be recessed below the articular surface by an average of 1mm.

They will then complete outcome questionnaires and additional MRI scans at 6, 12, and 24 months post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Must be between ages 18 and 50 years.
* Must have a discrete, contained chondral defect less than 400mm\^2 located on the medial or lateral femoral condyle
* Must have overall neutral lower limb mechanical alignment (\<5 degrees varus or valgus).

Exclusion Criteria:

* Ages younger than 18 years and older than 50 years.
* If they have undergone previous chondral procedures
* If they have pre-existing osteoarthritis (Kellegren-Lawrence Grade ≥2)
* If they have a BMI \>30.
A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy

The purpose of this study is to evaluate the safety and effectiveness of bortezomib in combination with a standard regimen of cyclophosphamide and dexamethasone.

This is open-label (both the participant and the investigator know what treatment participants will receive), prospective (participants are identified and then followed forward in time for the outcome of the study), multi-centre, and non-randomized (participants are assigned to different treatment groups by the investigator) study. The study will be conducted into 2 parts (Part 1 and Part 2). Approximately 400 participants will be enrolled (30 in Part 1 and 370 in Part 2). In Part 1 the optimum dose of cyclophosphamide will be evaluated and in Part 2 the selected dose of cyclophosphamide from Part 1 will be administered. Part 2 will include a screening period of a maximum of 14 days followed by chemotherapy (bortezomib, cyclophosphamide, and dexamethasone) of a maximum of three 21-day cycles. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, electrocardiogram, and clinical laboratory tests which will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologically diagnosed with multiple myeloma stage II/III
* Participants without preceding cytostatic (tending to retard cellular activity and multiplication) treatment (pretreatment with radiation or dexamethasone is allowed)
* Agree to use one of the contraception methods as defined in the protocol
* Karnofsky performance status 60 percent or more
* Adequate laboratory test values

Exclusion Criteria:

* Non-secretory multiple myeloma
* Estimated life expectancy less than 3 months
* History of cancer (except basal cell carcinoma) in the last 5 years
* Peripheral neuropathy (disorder of the peripheral nerves) grade 2 or more
* Positive human immunodeficiency virus test and active hepatitis B and/or hepatitis C
* Pregnant or breast-feeding female participants
The Use of Brace to Retrain Hemiparetic Gait

The purpose of this study is to verify if the incorporation of a new brace, which assists in gait rehabilitation, can contribute to the rehabilitation process for stroke patients.

Objective To compare the behavior of plantar pressure peak distribution, before and after training using a brace for gait rehabilitation.

Method The brace was developed with the aim of promoting better biomechanical alignment, as well as providing proprioceptive information in order to stimulate action in the knee's flexor muscle groups, thus facilitating the activation pattern contrary to what occurs during genu recurvatum. We conducted a quasi-experimental "before and after" study with twelve hemiparetic adult patients who had genu recurvatum in the gait. The plantar pressure peaks were compared at the various moments of the study.

Eligibility Criteria:
Inclusion Criteria:

* the presence of hemiparesis after the stroke, with an evolution time of between 6 and 24 months, the ability to walk without using assistive aids, and the presence of genu recurvatum during the mid-stance in the gait.

Exclusion Criteria:

* conditions that would preclude evaluation and training with the brace; for example, the presence of contractures or fixed deformities in the lower limbs, and moderate to severe impairments related to cognition, perception, attention, or language