cyrilzakka/clinical-trials huggingface dataset:
Genetic Predisposition to Severe Forms of COVID-19 (SARS-CoV2 Infection)

The main objective of this part of the project is to identify the germline genetic factors which discriminate the benign and severe forms of SARS-CoV2 (CoVID-19) infection in the context of the ongoing SARS-CoV2 (HCOVID-19) epidemic. The scientific arguments of the project are described in APPENDIX. We hypothesize that pathogenic variants in genes coding for crucial factors involved in the HOST PATHOGEN interaction could explain the susceptibility of some patients to severe disease, even in the absence of comorbidities. The challenge is to identify those of the genetic factors who may be related respiratory distress and potentially further death. Based on our previous experience in sarcoidosis, a multifactorial disease predisposing to opportunistic infections, we will focus particularly the regulation of apoptosis and autophagy, immune response to viral infection, and endoplasmic reticulum stress response (ER STRESS) which is closely linked to apoptosis. Genetic defects in such pathways may decrease the clearance of viral particles and induces the progressive invasion by SARS-CoV2 and destruction of lung parenchyma. Our strategy will be similar to that described in our previous studies on sarcoidosis, recently published. We will combine a comparative genotype analysis by WHOLE EXOME SEQUENCING (WES) of benign and severe forms of SARS-CoV2 infection through clinical subgroups defined by the infectious diseases experts and a bioinformatics analysis of the functional networks identified by the panel of genes sharing pathogenic variants and discriminating the severe forms of the diseases. WES data will be carefully analyzed and related to all the intracellular physiological process and also the functional pathways involved in host-pathogen interaction: viral targets on the cell surface and downstream signaling, viral genomic RNA replication and translation, production and release of new viral particles. Finally, our main objectives are the definition of a gene panel more specifically related to severe forms of infection and the characterization of defective pathways involved in pejorative forms of SARS-COv2 disease in order to identify putative therapeutic targets.


Eligibility Criteria:
Inclusion Criteria:

* Patients affected by COVID-10 Age: 18-70 (values included) Without any co morbidities (analysis of the clinical files in our hospital) Without any regular treatments

Exclusion Criteria:

* below 18yr and higher than 70yr old
* With comorbidities - ex: diabetes, obesity, hypertension, ischemic heart, neurological disorders, autoinflammatory / autoimmune diseases ...
* Not agreeing the protocol (absence of informed consent)
Therapeutic Targeting of Sex Differences in Pediatric Brain Tumor Glycolysis

The investigators will develop the concept of a sex-specific therapeutic intervention for gliomas that is based upon dietary carbohydrate restriction. The investigators will integrate metabolomics tools and FDG-PET imaging to validate the ketogenic diet on a sex-specific basis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a recurrent primary brain tumor with no curative therapy available.
* Measurable disease using pediatric Response Assessment in Neuro-Oncology Criteria (RANO) criteria.
* Life expectancy \> 12 weeks
* Prior treatment with radiation alone, chemotherapy alone or combined radiation and chemotherapy is allowed.
* Patient is \< 21 years of age
* Normal bone marrow and organ function as defined below:

  * Leukocytes ≥ 3,000/mcL
  * Absolute neutrophil count ≥ 1,500/mcl
  * Platelets ≥ 100,000/mcl
  * Total bilirubin ≤ 1.5 x IULN
  * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  * Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  * Normal room air oxygenation must be documented. If room air oxygen saturation is less than 97%, a diffusion capacity of carbon monoxide (DLCO) of greater than 80%, must be demonstrated.
* Karnofsky or Lansky performance score of ≥ 60
* Patients of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

* Patient does not have any of the following conditions as they are contraindicated for ketogenic diet:

  * Primary and secondary carnitine deficiency
  * Carnitine palmitoyltransferase I or II deficiency
  * Carnitine translocase deficiency
  * Mitochondrial β-oxidation defects
  * Pyruvate carboxylase deficiency
  * Glycogen storage diseases
  * Ketolysis defects
  * Ketogenesis defects
  * Porphyria
  * Prolonged QT syndrome
  * Liver insufficiency
  * Renal insufficiency
  * Pancreatic insufficiency
  * Pulmonary insufficiency
  * Hyper insulinism
* Pregnant and/or breastfeeding. Female patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.
A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.

This study will investigate the safety and tolerability of inhaled doses of GSK233705 with a new formulation.

A single-centre, randomized, double-blind placebo-controlled, dose-ascending, cross-over study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of GSK233705 (50, 100 and 200Âµg), formulated with the excipient magnesium stearate, in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects 18-55 years old
* Non-Smokers

Exclusion Criteria:

* Any subject with breathing problems.
* High blood pressure and heart abnormalities.
* Any subjects currently taking prescription and non-prescription medications.
Genetic Screening and Assisted Oocyte Activation in Couples with Diminished/aberrant Embryonic Development.

This is an interventional comparative study at the Department of Reproductive Medicine at Ghent University Hospital. Patients with previous embryo developmental problems are eligible for the study. Patients will undergo an ICSI-AOA treatment and will also be screened for genes important in the oocyte activation and embryonic development process. Also, the calcium releasing pattern of the patients' spermatozoa will be investigated.

Assisted Oocyte Activation (ICSI-AOA) will be the treatment for these patients to overcome their previous embryo developmental problems. This protocol artificially induces calcium rises in the oocyte, which mimics the natural oocyte activation process induced by the sperm factor PLCzeta. If 6 or more mature oocytes are collected at oocyte retrieval, 50%ICSI and 50% ICSI-AOA will be applied to all oocytes. The best embryo(s) will be transferred back. Rest embryo(s) will be vitrified for future cycles. Patients will be followed up.

Furthermore, an additional sperm sample will be produced to investigate the calcium inducing pattern of the patients' spermatozoa. Thereby, mouse and/or human (research-donated control oocytes) will be pre-incubated with a Ca2+ sensitive dye. Next, human spermatozoa will be injected into these mouse/human oocytes and the calcium pattern will be recorded under an inverted epifluorescence microscope.

Both partners will give a saliva sample to screen for mutations possible genes involved in oocyte activation and embryo development.

Eligibility Criteria:
Inclusion Criteria:

* patients with one or more previous ICSI cycles (UZ Gent) AND
* patients with:
* complete developmental arrest (no transfer), or
* complete developmental delay (no morula/blastocyst on Day 5), or
* significantly reduced blastocyst formation (≤15%)
* willing and able to give informed consent

Exclusion Criteria:

* patients which went for oocyte or sperm donation
* patients with severe male infertility or low fertilization (\<33%) after ICSI
* cycles requiring surgical sperm recovery procedures
The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts

The purpose of this study is to test the hypothesis that one-time application of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for pre-medication to reduce discomfort during screening mammography does not result in adverse effects, electrocardiogram (EKG) changes, or systemically toxic plasma concentration of lidocaine or its principal metabolite, monoethylglycinexylidide (MEGX).


Eligibility Criteria:
Inclusion Criteria:

* 35 years and older
* intact skin on breasts and chest wall

Exclusion Criteria:

* sensitivity or allergy to lidocaine
* liver or kidney dysfunction
* pregnant
* breast feeding
* currently smoke or chew tobacco
* used lidocaine products within 48 hours of baseline lab, EKG, or gel application
* exhibit neurological or cardiac signs or symptoms prior to gel application
* are taking antiarrythmic medications, ciprofloxacin, erythromycin products, or oral contraceptives
* history of Wolffe-Parkinson-White Syndrome (WPW) or congestive heart failure
* heart rate below 60 or above 100 beats per minute
* systolic blood pressure below 95 or above 180 mm Hg
* PR interval greater 200 msec, QRS duration greater than 120 msec, QTc greater than 450 msec, or evidence of WPW on EKG
* have an automatic implantable cardioverter defibrillator (AICD) or cardiac pacemaker
* have had cancer, surgery, trauma, or myocardial infarction in the past 6 months
Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema

The best treatment strategy for refractory DME is not known, options include switching between anti-VEGF agents, corticosteroids, and vitrectomy. In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.

Purpose: In this study, authors describe a new surgical technique for the treatment of refractory DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.

Methods: This is a prospective interventional non-comparative study including patients with refractory DME. Included patients were subjected to the new surgical technique of pars plana vitrectomy with sub-retinal injection of Ranibizumab.

Eligibility Criteria:
Inclusion Criteria:

* refractory diffuse non tractional DME.
* Central retinal thickness (CRT) should exceed 350 µm despite undergoing multiple anti-VEGF therapy.
* Decimal best corrected visual acuity (BCVA) must be ≥0.01 and ≤0.5.

Exclusion Criteria:

* Previous vitrectomy, recent cataract surgery less than 6 months,
* evident RPE atrophy, proliferative diabetic retinopathy, massive foveal hard exudation, foveal traction on OCT,
* glaucoma and one eyed patients.
Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement

In this prospective case series study, 20 patients with an implant-borne single crown following early implant placement with simultaneous contour augmentation will be followed for 10 years. Clinical, radiologic, and esthetic parameters will be assessed. In addition, cone beam computed tomography (CBCT) will be used at 10 years to examine the facial bone wall and compared to the 6 year data.


Eligibility Criteria:
Inclusion Criteria:

* Single tooth gaps post extraction in the esthetic zone
* Written informed consent

Exclusion Criteria:

* Heavy smoking (more than 10 cigarettes per day)
Rib Raising for Post-operative Ileus

We are conducting a randomized controlled trial the use of rib raising for post-operative ileus. Rib raising is an osteopathic manipulative technique (OMT). We will recruit all patients undergoing major abdominal surgery and once they have been enrolled, we will randomize them to receive daily rib raising or a control technique where we place hands on the back but do not apply any pressure. In preliminary studies, Rib raising has been shown to reduce post-operative ileus and hospital length of stay by up to 50%.


Eligibility Criteria:
Inclusion Criteria:

* Major abdominal surgery (laparotomy, laparoscopy excluding simple laparoscopic appendectomy or laparoscopic cholecystectomy)

Exclusion Criteria:

* Open abdomen for \>72 hours
* Prior history of major post-operative complications
* Intolerance to anesthesia
* Co-morbidities including osteoporosis and osteopenia
* Spine or rib fractures
* Pregnancy
* Prisoners
* History of osteopathic manipulation
* Recruitment delayed beyond 48 hours
* Surgeon requested exclusion
Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients

The purpose of this study is to determine if lamotrigine therapy is associated with improvement in mood, memory and hippocampal size and function in patients receiving chronic corticosteroid therapy. Standard care for mood changes associated with corticosteroid therapy, if severe, includes antidepressants or other medications which can influence mood. No therapies, other than dose reduction or discontinuation, are currently available for memory loss associated with corticosteroid treatment. However, very little information is available on the treatment of either mood or memory changes associated with corticosteroid treatment, thus the proposed project may improve standard care.


Eligibility Criteria:
Inclusion Criteria:

* Current Corticosteroid Use of 7 mg or more for 6+ months
* 18-65 years of age

Exclusion Criteria:

* Primarily non-English speaking
* Pregnant/nursing woman
* Currently taking Depakote
* Currently taking Rifampin
* Has diagnosis of major depressive disorder, schizophrenia, PTSD, bipolar I or bipolar II (not related to corticosteroid use)
* Diseases with CNS involvement
* Is to start a brief steroid taper
* History of Alcohol/drug abuse/dependence
Identification of Genetic Polymorphisms Related to Propofol Requirement and Recovery Through Genome-wide Association Study (GWAS) in Total Intravenous Anesthesia for Clipping of Unruptured Cerebral Aneurysm in Korean Population

In neurosurgical anesthesia, propofol based total intravenous anesthesia (TIVA) is frequently used due to brain relaxation and less effect on electrophysiologic monitoring. Response to propofol can vary between individuals and be associated with clinical factors including age and weight, and genetic polymorphism. Because the importance of rapid recovery in neurosurgery with long operation time is emphasized recently, the choice and dose adjustment of anesthetics should be determined according to clinical and genetic factors. Recently, researches about genetic variations have been performed with single nucleotide polymorphism (SNP). The aim of this study is to find SNPs associated with propofol recovery and response through genome-wide association study (GWAS) in Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm.


Eligibility Criteria:
Inclusion Criteria:

* Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm

Exclusion Criteria:

* Patients not able to read, or understand the consent form
* Ethnicity, other than Korean population
* Patients refusal
* Patients not to perform total intravenous anesthesia
* Patients currently taking psychiatric medication
Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis

Some parents may be more protective of children with CF due to concerns about worsening of the disease due to infection, which can affect their functional level. The goal of this observational study is to learn about the family's protective approach to the functioning and disease course of children with cystic fibrosis (CF) to determine whether there are possible negative effects. There will be an alternative viewpoint offered to clinicians regarding the management of CF with outputs of this study.

Cystic fibrosis (CF) is an inherited disease characterized by pulmonary involvement. Children with CF may have low levels of physical activity, physical fitness and functional capacity, and peripheral muscle weakness. Parents who take care of children with CF may be protective of their children's social environment due to reasons such as the risk of infection. Based on the idea that parents may have potential limitations on their children with CF, the aim of this study was to examine the effect of parental illness beliefs and anxiety levels on the functional and physical level of the child. Children with CF will be administered Modified Shuttle Walking Test, Munich Physical Fitness Test, quadriceps muscle strength and hand grip strength test, respiratory function and respiratory muscle strength test, Child Physical Activity Questionnaire, Shortness of Breath Beliefs Questionnaire, Revised Cystic Fibrosis Questionnaire, Parental Attitude Scale, Perceived Social Support Scale. Parents will be administered the Shortness of Breath Beliefs Questionnaire (Parent version), Revised Cystic Fibrosis Questionnaire (Parent version), Parent Attitude Scale, Fear of Disease Progression Questionnaire for Parents. The level of correlation between the outcomes of the scales administered to parents and the assessment outcomes administered to children will be examined.

Eligibility Criteria:
* Inclusion Criteria:

  1. For a child

     1. To be between 7-17 years old,
     2. Living with family or caregiver.
  2. For the parent

     1. Being the mother, father or other caregiver of the child,
     2. Voluntarily agreeing to participate in the study on behalf of both the child and oneself.
* Exclusion Criteria:

  1. For the child

     1. Having cognitive impairment that would prevent participation in the study or being able to cooperate with the measurements and not being able to adapt,
     2. History of previous lung or liver transplantation,
     3. History of hospitalization within the last 1 month,
     4. Having a neurological or orthopedic comorbidity that affects mobility.
  2. For the parent

     1. Having cognitive impairment at a level that prevents participation in the study
     2. Not living in the same household with the child.
Could Colour Dopper Improve the Diagnosis of Retained Placental Fragments After Second Trimester Miscarriage ?

Value of pelvi- abdominal ultrasound and Doppler in diagnosis of retained products of conception after second trimester miscarriage to select who will benefit from surgical evacuations or conservative management.

This is a study for diagnostic accuracy test where all patients will undergo US and Doppler examination after second trimester miscarriage. Then all patients with endometrial mass on US will undergo colour Doppler then surgical evacuation and results of histopathology will be recorded.

Now, pathological examination of suction evacuation products is considered the gold standard so sensitivity, specificity, PPV and NPV of US and Doppler are the primary outcome

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy duration: early mid-trimester from 14 to 20 weeks
* Endometrial mass upon ultrasound examination after second trimesteric miscarriage

Exclusion Criteria:

* Uterine congenital anomaly
* Patients with signs of sepsis.
* Negative scan after second trimesteric miscarriage
Study of Surgical Technique With Use of Single-radius Prosthesis in Total Knee Replacement

The purpose of this study is to clinically demonstrate a phenomenon of measurement error that can occur during placement of a specific type of total knee replacement prosthesis (single radius femoral component) using a certain type of surgical technique (flexion/extension gap balancing).


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo primary total knee arthroplasty performed by the principal investigator
* Use of a single radius posterior-stabilized TKA prosthesis is planned
* Spinal anesthetic is planned
* Diagnosis of osteoarthritis
* Has normal knee ligaments with no history of previous injury or surgery to ligaments, or other pathologic condition
* Has at least 100 degrees knee flexion preoperatively (measured by long goniometer)
* Gives valid informed consent
* Age 18 years or older

Exclusion Criteria:

* Patient receives general anesthetic
* Diagnosis other than osteoarthritis (e.g., rheumatoid arthritis, avascular necrosis, post-traumatic arthritis)
* History of any prior knee ligament injury, or any surgery to ligaments
* Any connective tissue disease affecting integrity of the ligaments (must have normal ligaments)
* History of long bone fracture in the affected leg
* Flexion contracture that would interfere with ability to establish extension gap reliably (judgment of investigator)
* Maximum pre-operative knee flexion is less than 100 degrees.
* Patient is non-ambulatory
* Any preclusion or inability to use navigation
* Treatment with single radius posterior stabilized TKA prosthesis is not indicated
* Participation is not in best interest of patient for any reason
* Cannot or does not give valid informed consent
* Female patient who is currently pregnant
* Age less than 18 years
* Body mass index greater than 40 kg/(m\*m)
* Incarcerated
Community Testing of Wearable Assistance

This feasibility study looks to evaluate ankle exoskeleton assistance in community settings for individuals with cerebral palsy.

Participants will undergo consent (if not done over the phone), history/physical/activity questionnaire, and orthotic device fitting. Following device fitting, the participants will practice walking with powered assistance.

Next, participants will complete "pre" walking tests with and without the device (order randomized) on a 15-minute pre planned community walk in close proximity with their own home. Distance, time, heart-rate, and perceived exertion will be recorded. The expected duration is 1-2 hours.

Next, participants will be asked to complete (under parental supervision for minors) the pre-determined walking route every day for 1 week with or without ankle exoskeleton assistance (block randomized). Following the first week of independent walking practice, participants will complete "post" walking tests with and without the device on the same walking route. Distance, time, heart-rate, and perceived exertion will be recorded. The expected duration is 1-2 hours.

Participants will then have a 2-6 week washout period.

Following this washout, the pre- and post-assessments will be completed before and after, respectively, another week of identical community walking practice completed under the remaining condition (either exoskeleton or no exoskeleton).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cerebral palsy
* Gross Motor Function Classification Level I, II, or III
* Able to walk for at least 20 minutes with or without a walking aid
* Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking
* Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.

Exclusion Criteria:

* Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than cerebral palsy that would affect the ability to walk as directed for short periods of time.
* Participant or parent report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.
Transgastric Peritoneoscopy and Appendectomy

This study is a feasibility study. Patients with acute abdominal pain who are planning to undergo a diagnostic laparoscopy are asked to participate in the study. The aim of the study is to evaluate if transgastric peritoneoscopy is feasible.


Eligibility Criteria:
Inclusion Criteria:

* Patient with acute abdominal pain

Exclusion Criteria:

* Patient under 18
* Patient who cannot understand information in Swedish
* Patients previously operated in upper part of the abdomen