cyrilzakka/clinical-trials huggingface dataset:
Adductor Canal Blockade vs Femoral Nerve Blockade on Muscle Strength, Mobility and Pain After TKA

The purpose of the study is to compare the effect of a Adductor Canal Blockade (ACB) vs a Femoral Nerve Blockade (FNB), on muscle strength, mobility and pain in patients with severe pain (VAS pain score \> 60) after Total Knee Arthroplasty (TKA.

The patients will be included after surgery (the first 2 postoperative days). Patients reporting VAS \> 60 during active flexion of the knee can be included. All included patients will receive 2 blockades at the same time - an ACB and a FNB, one blockade with 30ml ropivacaine 0,2% and the other with 30ml saline according to randomization.

Prior to, and after, the blockades VAS pain scores will be obtained, muscle strength (quadriceps and adductors) will be measured using a handheld dynanometer and a Timed Up and Go test will be performed.

The study is registered at clinicaltrials.gov after inclusion of the first patient. The reason for this is that we recently became aware of that some journals do not accept a EudraCT registration. The study was registered at EudraCT (2012-004554-28)prior to enrollment of patients.

Eligibility Criteria:
Inclusion Criteria:

* TKA within 72 hours and VAS\>60 during 45 degrees active flexion of the knee despite conventional pain medication
* informed consent
* ASA 1-3
* BMI 18-40

Exclusion Criteria:

* Unable to communicate in Danish
* Allergic reactions toward ropivacaine
* Alcohol and or drug abuse
* Unable to cooperate
* Known sensory disturbances in the lower limbs
Three-dimensional Changes in Free Gingival Grafts Around Dental Implants

The purpose of this study is to evaluate the stability of the free gingival graft dimensions around dental implants and to compare three-dimensional changes according to smoking status. Its primary goal is to provide an answer to:

Is this grafting procedure stable around dental implants? Are there any differences in tissue stability between smoker and non-smoker patients?

Our study consists of 2 groups:

The first group includes smoker patients who need free gingival grafts around their dental implants (n=16).

The second group includes non-smoker patients who need free gingival grafts around their dental implants (n=16).

Clinical measurements will be recorded at the baseline, 1st month, 3rd month, and 6th month of the study. An intraoral digital scanner will be used to measure the dimension changes of the graft at the baseline, after the surgery, 1st month, 3rd month, and 6th month of the study. Wound healing will be evaluated on postoperative days 10, 1 month, 3 months, and 6 months. Visual Analog Scale will be used to measure postoperative pain, and the number of painkillers taken will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Periodontal and peri-implant tissue health
* Good oral hygiene (plaque accumulation \<20%)
* Either around the functioning implant or in patients scheduled for second-stage surgery following implant surgery \<2 mm keratinized gingiva on the vestibular side of the implant
* No systemic disease and medication use that may affect soft tissue healing.
* Volunteering to participate in the study

Exclusion Criteria:

* Systemic disease that is a contraindication to the surgical procedure,
* Uncontrolled diabetes (HbA1c \> 7),
* Being pregnant or breastfeeding,
* Autoimmune and/or inflammatory diseases of the oral cavity,
* Active periodontal disease,
* Incorrectly positioned implants
The Effect of Embryo Transfer Technique on Pregnancy Outcomes in HRT-FET Cycles

The positions of the air bubble and the tip of catheter will be measured by transabdominal utrasonography among patients who have undergone high-quality frozen blastocyst transfer. The aim of this study is to compare pregnancy rates according to air bubble's final location in endometrial cavity. It is expected that the ET technique will be improved and live birth rates will increase by determining the optimal position of the embryo in the endometrial cavity during ET in patients who have achieved pregnancy.

Only patients who have high-quality blastocyst stage embryos will be included in the study. Since the implantation potential of high-quality embryos is high, possible embryo-induced implantation failure will be minimized. The positions of the air bubble and the catheter in the endometrial cavity in patients with and without pregnancy will be compared.

In patients participating in the study, the transfer catheter will be loaded using a "three drop technique," in which the drop of medium containing the embryo(s) is/are separated from a preceding and a following drop of the medium by an air bubble.

In hormonally prepared frozen embryo cycles, during embryo transfer in each patient, endometrial thickness, uterine cavity dimensions, distance of transfer catheter to the fundus, distance of released air bubble to the fundus, and distance of air bubble to side walls will be systematically measured and recorded under the guidance of transabdominal ultrasonography.

If the position of the embryo in the endometrial cavity is determined during ET in patients who have achieved pregnancy, an ET technique can be defined that predicts the optimum for the physician who will perform the transfer. Therefore, an increase in implantation and pregnancy rates can be achieved.

Eligibility Criteria:
Inclusion Criteria:

* Exogenous hormone preparation of the endometrial lining
* High embryo quality ((≥2BB) according to Alpha criteria
* Embryo transfer at the blastocyst stage

Exclusion Criteria:

* Patients whose treatments were canceled for any reason before the embryo transfer procedure
* Patients who underwent embryo transfer in the cleavage stage
* Presence of low-quality (\<2BB) blastocysts
* \>15% loss of viability of the embryo during embryo thawing,
* Patients with congenital uterine malformations,
Translational Approaches to Septic Cardiomyopathy

This translational study will assess the association between septic cardiomyopathy (measured via left ventricular global longitudinal strain) and (a) inflammatory cytokine profiles, and (b) the behavior of cardiomyocytes derived from inducible pluripotent stem cells.


Eligibility Criteria:
INCLUSION CRITERIA

At least 18 years of age Admitted to the ICU

SEPSIS PATIENTS:

Sepsis patients must have:

1. Suspected or confirmed infection AND
2. Organ dysfunction as defined by a SOFA \>= 2 above baseline (if no baseline data available, SOFA assumed to be 0)

OR

SEPTIC SHOCK PATIENTS:

AFTER INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, septic shock patients must have:

1. Suspected or confirmed infection AND
2. Lactate \> 2 mmol/L AND
3. Receiving vasopressors

EXCLUSION CRITERIA Known pregnancy Primary diagnosis of acute coronary syndrome Known preexisting heart disease Known severe valvular disease (regurgitation or stenosis)

Major cardiac dysrhythmia such as:

* Ventricular tachycardia (V-tach)
* Ventricular Fibrillation (V-fib)
* Third degree heart block (complete hear block or complete AV block)
Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF

The purpose of this study is to determine the safety and effectiveness of the endoscopic ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF) with pulmonary vein isolation (PVI).


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic, Paroxysmal atrial fibrillation (AF)
* 18 to 70 years of age
* Failure of at least one AAD
* Others

Exclusion Criteria:

* Generally good overall health as determined by multiple criteria
* Willing to participate in a study
* Others
Quality of Life Study in Participants With IPF Under Pirfenidone Treatment

This multicenter, post-marketing, observational study will evaluate quality of life in participants with Idiopathic Pulmonary Fibrosis (IPF) under treatment with pirfenidone (Esbriet).


Eligibility Criteria:
Inclusion Criteria:

* Adult participants for whom pirfenidone has already been prescribed for IPF no more than 4 weeks prior to enrollment, according to their physicians' clinical decision and the terms in the SmPC

Exclusion Criteria:

* Participants who are participating in an interventional study or have received any investigational agent in the past 4 weeks
Testosterone Therapy for Pubertal Delay in Duchenne Muscular Dystrophy

"Observational study of clinical outcomes for testosterone treatment of pubertal delay in Duchenne Muscular Dystrophy" is a single centre observational study that aims to follow the progress of 20 adolescents with Duchenne Muscular Dystrophy (DMD) and delayed puberty who are treated by the Newcastle muscle team, as they are treated with testosterone to induce puberty. The participants will all be treated with the standard stepwise regimen of testosterone injections every 4 weeks and data will be collected to help determine the effectiveness and tolerability of the current treatment regimen. The investigators will use the data to explore the effect of testosterone on pubertal development, growth, muscle strength and function, bone mineral density and body composition and characterise any side effects. Semi-structured interviews will also be carried out to learn the boys' views on the tolerability of the regimen. The study will last up to a maximum of 27 months in total for each participant, but may be less if they are happy with pubertal development before this time. It is important to do this study because from the investigator's limited experience in this group, testosterone treatment seems to be well liked and tolerated but the best treatment regimen to use remains unknown and there is no current consensus. It is not currently part of the standard of care in DMD but it would be important to include it if this study can show that it is an effective treatment for pubertal delay.


Eligibility Criteria:
Inclusion Criteria:

* A molecular diagnosis of Duchenne Muscular Dystrophy.
* Males aged between 12 and 17 years of age at time of first dosing
* Prepubertal (Tanner stage 1, testicular volume \<4 mls, initial testosterone level of \<2.0 nmol/l)
* Subjects are receiving the standard of care for DMD as recommended by the NorthStar UK and TREAT-NMD guidelines
* Patients are capable of sitting upright in a wheelchair for at least an hour
* Patients have stable respiratory function. Artificial ventilation with either Bipap/continuous positive airways pressure (CPAP) or tracheostomy is not a contraindication to the study.
* Informed consent/assent signed by the patient (or parent/guardian if under 16 years of age)

Exclusion Criteria:

* Severe learning difficulties that would preclude them from cooperating with examination.
* Anticipated surgery during the study period.
* Symptomatic cardiac failure.
* Participants/families who may have emotional or psychological problems if recruited to a study
* Hypersensitivity to the active substance or to any of the excipients, including arachis oil or derivatives (including hypersensitivity and allergy to peanuts or soya.)
* Any contra-indication to receiving an intramuscular injection
* Any additional chronic disease that affects androgen production
* Anti-coagulant therapy
* If participation in the study is not recommended in the opinion of the investigators
Immunomonitoring of Breast Cancer Patients During Systemic Treatment

This study aims to constitute a most complete biological collection for patients treated for localized or metastatic breast cancer (in different cohorts depending on the type of systemic treatment received), in order to describe the basal immune response of patients treated for a breast cancer according to the stage of the disease, but above all to study how the different systemic treatments used in the management of breast cancer modulate this immune response.

The main objective of this study is to describe, depending on the type of systemic treatment received, the blood immune response before treatment and its evolution under treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Woman aged between 18 and 85.
2. Patient with histologically proven infiltrating breast cancer.
3. Triple negative breast cancer or RH + / HER2- (OR and RP \<10% and HER2 negative (0 or 1+ in IHC or 2+ in IHC and FISH negative)
4. Patient receiving treatment corresponding to one of these cohorts:

   * In a metastatic situation with establishment of treatment with Paclitaxel regardless of the treatment line
   * In a metastatic situation with establishment of treatment with Epirubicin - cyclophosphamide (EC) regardless of the treatment line
   * In a metastatic situation with establishment of treatment with Eribulin regardless of the line of treatment
   * In a 1st line metastatic situation with initiation of treatment with Palbociclib or Abemaciclib, or Ribociclib in combination with hormone therapy (aromatase inhibitor)
5. Patient who signed the informed consent for the study.
6. Patient fit and able to adhere to protocol for the duration of the study, including visits, scheduled specimens and follow-up.
7. Patient affiliated to the social security system.

Exclusion Criteria:

1. Patient unable to understand, read and / or sign informed consent.
2. Presence of cerebral or meningeal metastasis
3. Current or previous use of an immunosuppressive drug in the 14 days preceding inclusion (except intranasal corticosteroids, systemic corticosteroids at physiological doses not exceeding 10 mg per day of prednisone or its equivalent, corticosteroids for antiemetic purposes, corticosteroids used as premedication for hypersensitivity reactions (injected CT scan, taxanes, etc.)
4. Patient participating in another research that may modify the systemic treatment administered in the framework of the cohort in which she will be included.
5. Pregnant or breastfeeding woman.
6. HIV and / or HBV and / or HCV serology positive.
7. Life expectancy estimated at less than 3 months.
8. Patient's refusal.
9. Person benefiting from a protection system for adults (including tutorship and curatorship).
10. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
Thoracic Spine Manipulation for Patients With Thoracic Spine Pain

The study includes two phases. In phase one the reliability of thoracic spine mobility measurements are studied in subjects with thoracic spine pain. In phase two the reliable measurements are used to measure the effects of thoracic spine manipulation in subjects with thoracic spine pain. The changes in pain is measured as well.

In second phase the control group receives TNS treatment six times at home as a placebo so that the power of TNS is limited to very low level. The number of treatments are controlled as well as the time of treatment. The treatment group receives six manipulation treatments within 3 week period. The effects are measured immediately after the treatment weeks, and 3 and 8 week follow-up. Moreover the one year follow-up will be performed by mail questionnaire.

Outcome measures are intensity of pain (VAS, Roland-Morris questionnaire) thoracic mobility (measured with computer, tape measurements, inclinometer and manually).

Eligibility Criteria:
Inclusion Criteria:

* Thoracic spine pain,
* 18-55 years old

Exclusion Criteria:

* Inflammatory spine disease,
* previous surgery on thoracic spine area,
* osteoporosis
Analysis of naïve Patients With Age-related Macular Degeneration Neovascular Type and Treated With Ranibizumab (Lucentis®) in Treat-and-extend at the CHU Brugmann.

Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50 years old. Neovascular AMD, the most severe form and the most severe is characterized by the appearance, spread and growth of subretinal neovessels. One of the major molecular mediators is the endothelial growth factor vascular (VEGF).

Intra-vitreous (IVI) injection of an anti-VEGF may slow the progression of Neovascular AMD and stabilize vision in the majority of cases. Ranibizumab (Lucentis®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD.

At the start of its use, ranibizumab was first injected monthly and then according to the "reactive" protocol. Over time, a new strategy of treatment was born: the "treat-and-extend" (T\&E). This is 'made to measure' protocol for each patient aiming to reduce the frequency of injections while guaranteeing inactivity of the disease. It starts with the loading dose, i.e. 3 injections given 4 weeks apart. Subsequently, the interval is lengthened by slices of 1 or 2 weeks provided that the visual and anatomical results remain stable. In the event of deterioration, the interval is shortened while keeping a minimum of 4 weeks between each IIV.

The efficacy and safety of ranibizumab, when used in a proactive regimen of T\&E, has been shown in the CANTREAT randomized controlled trial. However, there is a lack of more data on T\&E used in current practice, and particularly on the number of injections and treatment intervals over a minimum treatment period of 24 months.

The aim of this retrospective study carried out at the CHU Brugmann Hospital is to determine the number of injections and the intervals necessary to have encouraging results in visual acuity over a treatment period of at least two years.


Eligibility Criteria:
Inclusion Criteria:

* Patients\> 50 years old diagnosed with neovascular age related macular degeneration,
* Patients who have never received anti-VEGF treatment,
* Patients who started intra-vitreous injections of ranibizumab between 01 January 2014 and November 30, 2019,
* Treatment by "treat-and-extend" directly after the loading dose of ranibizumab,
* Availability of the medical file reporting treatment with ranibizumab.

Exclusion Criteria:

* Participation in an interventional clinical study during treatment with ranibizumab,
* Patients suffering from ocular pathologies and having required surgery during the first 24 months of treatment with ranibizumab (for example advanced glaucoma or cataract).
Investigation of Laser Assisted Drug Delivery of NanoDOX®

This is a self-controlled single-site study of healthy subjects receiving an ablative fractional CO2 (carbon dioxide) laser procedure followed by topical application of NanoDOX® Hydrogel (1% doxycycline). The study includes skin biopsies to evaluate the effects of NanoDOX® Doxycycline Monohydrate Gel on wound healing after the ablative laser procedure. Study subjects will be asked to do 2 visits of 4 hours in total over approximately 1 week. An optional third visit will take place approximately 6 weeks after Visit 1. In this study, 20 subjects are expected to enroll with a goal of 12 healthy subjects to enroll and complete the study.

Effective topical delivery of any pharmaceutical agent requires small molecule drugs to penetrate the epidermis, yet the absorption of topical products through the epidermis is limited.

In this study, the investigators are looking for healthy volunteers who are eligible to help us to determine the safety and efficacy of ablative fractional laser therapy combined with NanoDOX. The investigators are doing the research to evaluate drug delivery of topical NanoDOX® Hydrogel following ablative fractional CO2 laser treatment and our secondary objective is to evaluate the efficacy of NanoDOX® for wound healing.

Subjects will have a screening visit to determine eligibility, 2 study visits when they will receive CO2 ablative fractional laser treatment, NanoDOX® Hydrogel application, and skin biopsies, and 1 optional study visit for wound healing assessment. Laser procedure will happen only during visit 1, visit 2 will happen 2 days after visit 1, and visit 3 will happen approximately 6 weeks after visit 1. In total, 7 skin biopsies will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
* Subject must be able to read and understand English;
* Any gender and any Fitzpatrick skin type;
* Age equal to or greater than 18 years old;
* Willing to sun protect treated area (sunscreen or cover the area with clothes) for the duration of enrollment in the study and 1 year after treatment.
* Subjects must be willing to undergo skin biopsies

Exclusion Criteria:

* Participation in another investigational drug or device clinical trial in the past 30 days;
* Are pregnant or lactating;
* History of allergic reaction to topical or local anesthesia;
* History of allergic reaction to Doxycycline or other tetracyclines;
* Regular intake of high doses of anti-inflammatory drugs (aspirin \>81 mg/day, ibuprofen, corticosteroids, etc.) , immunosuppressive drugs or biologics;
* Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study;
* Laser treatment in past six months; History of poor wound healing;
* History of keloids; History of extreme photosensitivity;
* History of severe hyperpigmentation; History of tattoos on thighs.
Evaluation of Repetitive Transcranial Magnetic Stimulation as an Adjunct to Modified Constraint Induced Movement Therapy in Improving Upper Limb Function in Children With Hemiparetic Cerebral Palsy Aged 5 - 18 Years

The investigators aim to evaluate efficacy of TMS as an adjunct to CIMT, assess its safety and tolerability and study cortical excitability with help of TMS which are both rehabilitative therapies for hemiplegic cerebral palsy.

Cerebral palsy is the most common motor disability of childhood and Hemiparetic cerebral palsy accounts for about one third of cases. Improving spasticity and upper limb function in these children can lead to better functional outcome and quality of life. TMS is an upcoming rehabilitative modality which has shown promising results in western studies. It has benefits of being non-invasive and has shown to have additive effect when used with CIMT which is standard of care in hemiparetic CP. However, randomized controlled clinical trials comparing it with CIMT alone in hemiparetic CP are very few, none from India so far. The dose, type and duration of TMS and its feasibility in resource limited set up needs to be investigated in children .Therefore, the investigators aim to evaluate efficacy of TMS as an adjunct to CIMT, assess its safety and tolerability and study cortical excitability with help of TMS.

Eligibility Criteria:
Inclusion Criteria:

* • Age 5 - 18 years

  * Hemiparetic Cerebral Palsy (perinatal brain injury)
  * Intelligence Quotient \>70 (Binet Kamat Test/Malin's Intelligence Scale for Children)
  * Modified Ashworth scoring 1-3 for affected limb
  * Can sit independently or with support (GMFCS stage : 1-4 and Manual Ability Classification System stage: 1-3)
  * Preserved vision and hearing (with or without correction)

Exclusion Criteria:

* • Uncontrolled epilepsy as defined by seizure frequency \>1/month for preceding 3 months

  * Severe concurrent illness or disease not associated with CP or unstable medical conditions like pneumonia
  * Genetic or syndromic associations
  * Children diagnosed with Autistic Spectrum Disorders
  * Modified Ashworth Scale Score more than 3 at shoulder/elbow/wrist
  * Contractures of affected limb
  * Severe movement disorder like dystonia, choreo-athetosis or ballismus interfering with purposeful limb movement
  * Any congenital brain malformation detected on conventional MRI brain
  * Recent surgery/cast/splint in affected limb
  * Botulinum toxin/phenol block in affected limb in past 6 months or planned to receive in study period
  * Those receiving tone modifying agents within two weeks before enrolment (Tizanidine, baclofen, benzodiazepines, dantrolene)
  * mCIMT received in last 6 months
  * Any contraindications for TMS - implanted electronic device and non-removable metallic objects near coil e.g. Pacemaker, cochlear implant