cyrilzakka/clinical-trials huggingface dataset:
Study of Visual Mecanisms Involved in Face Recognition

Since the 19th century, perception has been regarded as an inferential process in which sensory input is compared with prior knowledge, namely the internalised representation of the visual environment. This notion is central to the understanding of everyday perception and cognition in general, and is attracting much attention in various areas of psychology and cognitive neuroscience. However, it is unclear whether and how the primary visual refinement that is thought to underlie the convergence of bottom-up inputs with top-down prior knowledge applies to the processing of meaningful stimuli in our everyday lives. The investigators have shown that human face processing mechanisms are shaped by prior knowledge that the horizontal range of face information conveys the richest and most reliable cues. Furthermore, investigators' previous data suggest that the primary visual cortex is recruited during the progressive refinement of face representation. Using very high field neuroimaging, the present project proposes to follow the neural mechanisms underlying the cortical refinement of horizontal information in human face processing, and to study their contribution to behaviour.


Eligibility Criteria:
Inclusion Criteria:

Participants will be screened (see annex 2) to ascertain they fit with all these inclusion criteria:

* Be between 18 and 50 years old,
* have normal eyesight or eyesight corrected with contact lenses,
* Have no neurological disorder,
* Not have had a skull fracture or head surgery,
* Have no chronic progressive illness or mental deficiency,
* Have no metal parts in their body (dental braces or pins, metal plates, pacemakers, implanted prostheses, etc.),
* Have no tattoos containing metallic particles or implanted jewellery (e.g. piercings) that cannot be removed,
* Not to have worked with metals,
* Do not take any medicines or substances that may affect brain function (e.g. drugs, energy drinks, alcohol),
* Not to be pregnant or breastfeeding.
* Do not be claustrophobic.

Exclusion Criteria:

Participants presenting a counter-indication (responding yes to one of the questions of the screening questionnaire, see annex 2) to participate will be excluded from participation.

Participants will be screened to ascertain they do not present any of these counter-indications to the participation to the MRI measurement. We will exclude people with these characteristics:

* Be younger than 18 or older than 50 years old,
* have poor eyesight,
* Have neurological disorder,
* have had a skull fracture or head surgery,
* Have a chronic progressive illness or mental deficiency,
* Have metal parts in their body (dental braces or pins, metal plates, pacemakers, implanted prostheses, etc.),
* Have tattoos containing metallic particles or implanted jewellery (e.g. piercings) that cannot be removed,
* have worked with metals,
* take medicines or substances that may affect brain function (e.g. drugs, energy drinks, alcohol),
* pregnant or breastfeeding.
* claustrophobic.
Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-concept)

SynABPM 2 proof-of-efficacy is a retrospective, multicentre, observational study performed in patients affected by hypotensive reflex syncope who had performed two ABPMs, one before and another after any therapeutical intervention aimed to increase arterial blood pressure

24-hour ambulatory blood pressure monitoring (ABPM) is able to detect systolic blood pressure (SBP) drops that allow to discriminate patients with reflex syncope from controls. One episode of daytime SBP \<90 mmHg or one episode of daytime SBP \<100 mmHg, if mean 24-hour SBP is \<125 mmHg, is the best cut-off for the identification of reflex syncope patients with hypotensive susceptibility.

The hypothesis of the present proof-of-concept study is that a therapeutic strategy aimed to increase arterial blood pressure can prevent SBP drops and (hopefully) reduce syncope recurrences.

If the study hypothesis will be confirmed, the magnitude of increase of SBP needed to abolish SBP drops will be also assessed.

Eligibility Criteria:
Inclusion Criteria:

Eligible patients were those who fulfilled all the following criteria:

* had received a diagnosis of reflex syncope
* had undergone an ABPM as part of the routine work-up of syncope in use in these hospitals that had shown one or more daytime SBP drop \<90 mmHg or one or more daytime drops \<100 mmHg in patients with average 24-hour SBP ≥125 mmHg
* had received instructions in order to abolish/reduce their antihypertensive therapy with the aim to prevent syncopal recurrences or had received active drug therapy, i.e., fludrocortisone, in order to increase their arterial blood pressure.
* had performed a second ABPM within 6 months from ABPM 1 in order to verify the effect of the prescribed change in therapy

Exclusion Criteria:

* Age \<18 years
* Symptomatic orthostatic hypotension (defined as a symptomatic fall in SBP ≥20 mm Hg or a SBP decrease to \<90 mmHg, as per the ESC guidelines;
* competing causes of syncope (i.e., syncope due to arrhythmias and structural cardiac diseases and non-syncopal causes of transient loss of consciousness as defined by ESC guidelines on syncope
* Severe structural heart disease, previous stroke or transient ischaemic attack
Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome

In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI) treatment is able to improve IVF outcomes.

In particular, retrieved oocytes will be randomly divided in two groups, one group will be inseminated with MI treated semen while the other will be inseminated with untreated semen.

Myo is synthesized from glucose-6-phosphate, it is a precursor of second messengers in the cell signaling pathways and it is involved in the regulation of intracellular calcium.

Literature data have demonstrated the MI play a crucial role in reproduction, indeed, oocyte and spematozoa are nursed in a medium congaing hig MI concentration.

Furthermore, it has been demonstrated that, in oligoasthenoteratozoospermic patients, in vitro incubation with 2 mg/ml of myo increase significantly the number of spermatozoa with high mitochondrial membrane potential (MMP). Moreover, it has been found that the in vitro fertilization rate is correlated with the percentage of high MMP spermatozoa.

Eligibility Criteria:
Inclusion Criteria:

* couple counselled for IVF

Exclusion Criteria:

* cryopreserved sample
Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury

The main objective of this placebo-controlled randomized double-blinded study is to investigate the effect of vitamin D supplementation on vitamin D status (25(OH)D concentration in the blood) among individuals with a chronic spinal cord injury (SCI). Further, the effects of vitamin D supplementation on several other parameters (e.g. bone density and mood) are investigated, which could reveal positive secondary effects of supplementation that are especially relevant for clinical practice.

The purpose of this study is to evaluate the influence of vitamin D supplementation among individuals with chronic SCI. The primary aim is to study whether different dosages (24'000 IU/month or 48'000 IU/month) of vitamin D supplementation over 12 months will lead to differences in vitamin D status as well as differences in several other outcomes. The use of a placebo group supports the evaluation of dose-response effects of vitamin D supplementation on the primary outcome (vitamin D status) and secondary outcomes (including bone density and mood) that are not only supported by randomized controlled trial standards but also informative in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent to the present study as documented by a signature
* Chronic (\> 3 years) traumatic or non-traumatic spinal cord injury with a sub-C4-level lesion
* Wheelchair dependency during activities of daily living
* vitamin D status \<75nmol/L

Exclusion Criteria:

* Contraindications to the investigational product
* Clinically relevant disorders,
* Pressure ulcer grade 3 or 4
* Pregnancy, breastfeeding
* Vitamin D supplementation (\> 400 IU/day) within the last 12 months
* Visiting a country with increased sun exposure (below the 37th parallel north) within the last month before study enrolment or during the study
* Fractures in both arms and/or both legs within the last five years
Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)

The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.

The current trial was designed to evaluate the dialysability of the sugammadex-rocuronium complex in participants with severe renal impairment. A dose of 4.0 mg/kg sugammadex was administered 15 minutes after administration of 0.6 mg/kg rocuronium. Blood and dialysate samples were collected before, during and after hemodialysis/filtration, for calculation of clearance of sugammadex-rocuronium complex and assessment of rebound.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* American Society of Anesthesiologists (ASA) Class \>=4
* Creatinine clearance (CLCR) \< 30 mL/min and clinical indication for dialysis
* Hospitalization at Intensive Care Unit (ICU) and scheduled for a (surgical) procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium
* Scheduled for a (surgical) procedure in supine position
* Written informed consent (of the legal representative)

Exclusion Criteria:

* Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic dysfunction
* Known or suspected to have a (family) history of malignant hyperthermia
* Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
* Have already participated in a sugammadex trial
* Have participated in another clinical trial, not preapproved by NV Organon, within 30 days of study entry
* Females who are pregnant\*
* Females who are breast-feeding \* In females pregnancy will be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy.
Respiratory Physiotherapy and Neurorehabilitation in Patients With Post-covid19 Sequelae.

The objectives are to reduce dyspnoea, increase exertional capacity, increase vital capacity and respiratory muscle strength.

vital capacity and respiratory muscle strength. In addition to increasing the sensibility of smell and taste, observing if there is a relationship between the decrease of these senses with the senses with appetite and whether appetite has normalised in post-SARS-CoV-2 patients. It is a randomised and blinded experimental study with a control group where the sample recruited will be 30 patients, with a range of of 30 patients, with an age range of 19-42 years, where they carried out an assessment of spirometry, modified Borg dyspnoea scales and modified Medical Research Council (MMRC), Singapure (MMRC), Singapore Smell and Taste Questionnaire (SSTQ) and weekly smell and taste questionnaire.

taste questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* age range between 18 and 42 years.
* patients with respiratory sequelae post Covid-19.
* patients with smell and taste sequelae post Covid-19.

Exclusion Criteria:

* Under 18 years old.
* Over 42 years old.
* Patients not diagnosed with Covid-19 (PCR positive).
Utility of Lung Ultrasound in the Estimation of Extravascular Lung Water in Pediatric Population

Increased extravascular lung water (EVLW) may increase mortality and morbidity in cardiopulmonary pathology. Many factors can cause increased extravascular lung water and pulmonary edema after cardiac surgery. This includes left ventricular failure, acute mitral regurgitation; systemic inflammatory response post-cardiopulmonary bypass, left to right shunts, transfusion associated acute lung injury, acute respiratory distress syndrome(ARDS) and sepsis.

The clinical assessment of lung water ranges from auscultation to radiological methods to invasive measurements like dye dilution or thermodilution studies.

Lung ultrasonography is the newest modality for noninvasive assessment of extravascular lung water. Lung ultrasound has been validated against auscultation, chest X-rays, CT chest as well as the bedside gold standard, transpulmonary thermodilution in adults.

Critically ill children are more susceptible to complications and worsened outcomes from increased EVLW.

Lung ultrasound correlates with clinical and radiological endpoints, but has not been validated against invasive objective measures like transpulmonary thermodilution.

Evaluation of transpulmonary thermodilution setups in the pediatric population has shown different normal values and cutoffs compared to adults, possibly due to differential rates growth and development.

It is aimed to investigate the correlation of Lung ultrasound based indices of extravascular lung water to invasive measures, assess optimum cutoffs to appropriate clinical endpoints and evaluate their sensitivity and specificity.


Eligibility Criteria:
Inclusion Criteria:

* aged under 12 years,
* undergoing elective cardiac surgery for cyanotic or acyanotic congenital heart disease,
* Aristotle score ≤9,
* with prior written informed consent

Exclusion Criteria:

* Neonates,
* Children with any chest wall deformity,
* children with known lung disease, active infection,
* those weighing less than 3.5 kg.
Acupuncture in Treating Hot Flashes in Women With Breast Cancer

RATIONALE: Acupuncture may help relieve hot flashes in women with breast cancer. It is not yet known whether acupuncture is more effective than a placebo in treating hot flashes in women with breast cancer

PURPOSE: This randomized clinical trial is studying acupuncture to see how well it works compared to a placebo in treating hot flashes in women with breast cancer.

OBJECTIVES:

Primary

* Determine whether acupuncture, compared to placebo, reduces the incidence of hot flashes in women with breast cancer.

Secondary

* Determine the long-term effects of acupuncture on hot flashes.

OUTLINE: This a randomized, placebo-controlled, multicenter study. Patients are stratified according to concurrent treatment with selective estrogen receptor modulators, gonadotropin-releasing hormone analogs, or aromatase inhibitors (yes vs no), concurrent use of hot flash medication or selective serotonin reuptake inhibitors (SSRIs) (yes vs no), baseline hot flash frequency (\> 7 per day), and menopausal status at diagnosis (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.

* Arm I (treatment): Patients receive 8 acupuncture treatments over 4 weeks.
* Arm II (control): Patients receive 8 placebo acupuncture treatments over 4 weeks. Beginning at week 7, patients are offered 8 true acupuncture treatments over 4 weeks.

Patients in both arms complete a "hot flash" diary for 1 week before treatment and then periodically during and after treatment.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer (including in situ disease)
* Must be receiving treatment for breast cancer at Memorial Sloan Kettering Cancer Center (MSKCC) or its regional site (Commack)
* Has an average of 3 or more hot flashes a day during 1 week of baseline diary recording
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Pre- or postmenopausal
* Karnofsky performance status 70-100%
* Ambulatory
* No skin infection

PRIOR CONCURRENT THERAPY:

* More than 3 weeks since prior and no concurrent treatment with any of the following during the 6 week evaluation period of the trial:

  * Surgery
  * Initiation of a new chemotherapy regimen
  * Initiation of immunotherapy
  * Initiation of radiotherapy
  * Initiation or cessation of hormonal therapy
* More than 6 weeks since prior acupuncture treatment (6 months for acupuncture specifically for the treatment of hot flashes)
* No concurrent pharmacological treatment for hot flashes unless dose has been stable for 4 weeks
* No concurrent selective serotonin reuptake inhibitors (SSRIs) unless dose has been stable for 4 weeks
Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation

The purpose of this study is to investigate whether the combination of cyclophosphamide and abatacept versus the treatment used in standard of care will reduce the incidence of moderate and severe chronic graft-versus-host disease (GVHD) following hematopoietic stem cell transplantation. GVHD occurs when the cells from your donor (the graft) see your body's cells (the host) as different and attack them.

The experimental GVHD prophylaxis arm consists of cyclophosphamide and abatacept. Cyclophosphamide induces apoptosis of activated T cells and abatacept (CTLA4Ig) blocks activation of T cells by inhibiting the co-stimulatory signal.

Compared to the standard-of-care control arm, the experimental arm is much more convenient and expected to be associated with fewer toxicities.

In addition there is a great theoretical potential for immunological synergy between cyclophosphamide and abatacept for inducing post-transplant immunologic tolerance that clinically might translate into less GVHD without increase in relapse Patients will be randomized 1:1 to the experimental vs the standard of care arm. Randomization will be done prior to the use of any conditional therapy.

The two arms will be stratified by disease (acute leukemia vs others) and donor type (MRD vs MUD/MUD vs Haplo) in an effort to keep them balanced.

The conditioning regimen for both arms will be mainly Busulfan/Fludarabine (A Total Body Irradiation based conditioning regimen will be allowed for diseases such as ALL)

The GVHD prophylaxis regimen on the experimental arm will consist of high dose Cyclophosphamide on Days +3 and +4 followed by abatacept for 6 months.

The GVHD prophylaxis regimen on the standard of care arm will consist of methotrexate on Days +1,+3, +6 and +11 and tacrolimus for patients with a 10/10 matched related or unrelated donor and of high dose cyclophosphamide on Days +3 and +4 followed by tacrolimus and mycophenolate for patients with a haploidentical donor.

Eligibility Criteria:
Inclusion Criteria:

* High risk hematologic malignancy justifying the need for an allogeneic hematopoetic stem cell transplantation: AML, ALL, CML in accelerated or blast phase, MDS/MPN, NHL, Hodgkin lymphoma, and multiple myeloma
* Creatinine clearance \> 40
* Adequate hepatic function
* Normal cardiac function (EF \> 50%)

Exclusion Criteria:

* Patients with hematologic malignancies for which transplant is not the only curative option, such as AML with good or intermediate cytogenetics or molecular markers in CR1 or CML in chronic phase
* Inability to identify an 10/10 HLA-Matched Donor (related or unrelated) or a haploidentical donor
* Active malignant disease relapse
* Active, uncontrolled infection, uncontrolled cardiac angina, symptomatic congestive heart failure
* Life expectancy \<3 months
* Pregnancy or lactation
* Patients may not be receiving any other investigational agents in the last 28 days
* Patients with chronic myeloid leukemia in first chronic phase
Management of Popeye Sign With Botulinum Toxin After Bicepstenotomy

Double-blinded randomized controlled trial with 20 people of whom 10 will receive a placebo infiltration and 10 an infiltration with botulinum toxin type A for cramping pain after arthroscopic tenotomy of the long head of the biceps tendon.

Title: Management of Popeye sign with botulinum toxin after tenotomy of the long head of the biceps tendon: a double-blinded randomized controlled trial Précis: Double-blinded randomized controlled trial with 20 people. Randomization in 2 arms of 10 people. 3 visits will be planned with a meantime of 3 months after the infiltration with botulinum toxin type A (BTX-A) or placebo that will be administered at the 2nd visit.

Objective: The primary objective is to assess the effectiveness of an infiltration with botulinum toxin in the biceps muscle after tenotomy of the long head of the biceps tendon for pain and disability reduction.

Endpoint: The primary endpoint is a pain reduction as measured by the Visual Analogue pain scale (VAS) and a reduced disability as measured by the quick DASH (Disabilities of the Arm, Shoulder and Hand).

Population: 20 people who underwent an arthroscopic tenotomy of the long head of the biceps tendon and are having post-operative pain in the biceps muscle.

Phase: 4

Number of Sites enrolling participants: single center study in AZ Delta Roeselare

Description of Study Agent: botulinum toxin type A (Botox®) 100 International Units by intramuscular injection

Study Duration: From March 2021 till December 2022

Participant Duration: 3 months

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Have had arthroscopic tenotomy of the long head of the biceps tendon without rotator cuff repair, acromioclavicular joint resection or glenoid labrum repair
* Having bicipital pain that started after the tenotomy

Exclusion Criteria:

* under 18 years of age
* over 65 years of age
* pregnancy or lactation
Double Randomized and Placebo Controlled Trail of Tianqi Pingchan Granule to Prevent Levodopa-Induced Dyskinesia

A randomized, double-blind, placebo-controlled multicenter clinical trial was used to observe the effectiveness, safety and side effects of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia, so as to determine the clinical efficacy of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia.

The aim of this clinical trail is to evaluate the effect of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia in adults. All patients included in the study should meet the inclusion criteria. Half of participants will receive Tianqi Pingzhan Granule, while the other half will receive a placebo of Tianqi Pingzhan Granule. All participants will be assigned to either the active group or the control group randomly. During the clinical trail both doctors and patients are double-blind except serious adverse events occurred.

Eligibility Criteria:
Inclusion Criteria:

Patients with PD aged 30-85，have at least the following two conditions:

1. Dosage of Levodopa ≥ 400mg/d;
2. Grade of H\&Y≥3;
3. risk score of dyskinesia\>4;

Exclusion Criteria:

1. PD patients with dyskinesia;
2. Taking other Chinese medicines against Parkinson's disease;
3. pregnant and lactating women;
4. Impaired cognitive function (according to pre-entry MMSE score):

   secondary education level: MMSE \<24 points; primary education level \<20 points; illiterate \<17 points;
5. accompanied by a history of mental illness;
6. impaired liver and kidney function;
7. accompanied by severe other systemic diseases;
8. Previous traditional Chinese medicine preparations or serious adverse reactions
9. Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention.
10. PD related brain surgery
11. Patients who are participating in other clinical studies or has participated other clinical studies within 30 days before
12. Patients unable to cooperate with the survey