cyrilzakka/clinical-trials huggingface dataset:
Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture

It is believed, that Non Steroidal Antiinflammatory Drug (NSAID) drugs slows bone healing, but the knowledge is based only on animal studies, and the results are automatically raised for the people.

Many patients with bone fracture must therefore avoid the formerly so popular and good painkillers, although no clinical trial evidence is, that this medicine is really harmful for patients with fractures.

The purpose of this study is to investigate whether these drugs slows bone healing, and what the relationship is between various bone studies - DEXA scanning, biochemical bone marker tests, radiographic controls and tissue examination of newly formed bone under a microscope. How sensitive and specific, each of the above study methods? If they are just as sensitive, the cheapest of them recommended as a routine investigation on suspicion of bone effects. Furthermore, to compare the benefit (pain-relieving effect, influence on rehabilitation) of these drugs and their possible harmful side effects (affected and delayed bone healing).

The expectation is that the study may contribute to increased knowledge about NSAIDs effect do pain management, rehabilitation and the entire treatment process significantly easier and safer, so that patients recover faster and return to usual activities.


Eligibility Criteria:
Inclusion Criteria:

* written acceptance to participate in the study
* immobilisation or reposition or surgery demanding Colles fracture (which needs to be fixed with external fixation).

Exclusion Criteria:

* age - younger than 50 years or older than 80 years
* treatment with prednisolon
* NSAIDs - treatment
* previous fracture or surgery at the wrist
* lack of mental and physical capacity to follow studies' instructions
* lack of informed consent
* other diseases can affect bone substance (oncology, endocrine diseases)
* medical contraindications to NSAIDs use
* smoking, alcohol consumption of more than 14 drinks per week
* secondary dislocation of fracture also apply as exclusion criterion.
Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers

This study will compare the pharmacokinetics of the Phase 3 simufilam 100 mg oral tablet when taken fasted versus following a high-fat or low-fat meal. Additionally, the Phase 3 oral tablet will be compared to the Phase 2 oral tablet for bioequivalence under fasted conditions.

This is a single-center, randomized, four-treatment, four-sequence crossover study in healthy volunteers to estimate the effect of food on the pharmacokinetics of simufilam following oral 100 mg Phase 3 oral tablets. Additionally, the relative bioavailability of the Phase 3 100 mg tablet will be compared to the earlier Phase 2 100 mg tablet in the fasted state. A total of twenty four (24) healthy volunteers (12 male and 12 female) will be enrolled into this study. Subjects will be randomly assigned to one of four treatment sequences (6 subjects/sequence).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, Ages ≥ 18 and ≤ 45 years
2. BMI of 18 - 30 Kg/m²
3. Informed consent form (ICF) signed by the subject
4. General health status acceptable for participation in the study as determined by medical history, review of current medication, physical examination, and laboratory results
5. Fluency (oral and written) in English
6. The patient must agree to comply with the drawing of blood samples for the PK assessments, laboratory assessments and plasma biomarkers
7. The subject is willing and able to remain at the study site for the duration of the study

Exclusion Criteria:

1. The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
2. The subject has had a clinically significant illness within 30 days of this study.
3. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
4. Subject is taking prescription CNS medication.
5. The subject has used alcohol, grapefruit, grapefruit juice, caffeine or xanthinecontaining products 48 h before dosing or intends to use any of these products during the study.
6. The subject has a history of substance abuse or a current positive ethanol breath test or positive urine drug screen.
7. The subject has a positive serum hepatitis B surface antigen or positive HCV antibody test.
8. The subject has a positive HIV test.
9. The subject has a current positive urine cotinine test.
10. The subject has participated in another drug study in the past 30 days.
11. The subject has donated or lost a significant volume of blood (\>450 mL) within 4 weeks of the study.
12. The subject is unwilling to reside in the study unit for the duration of the study or to cooperate fully with the investigator or site personnel.
13. Covid-19 infection within the past 3 months
Simultaneous MEG or fMRI And INtracranial EEG

The SEMAINE project will investigate intracranial EEG (icEEG) simultaneously recorded with either fMRI or MEG to 1) improve identification of the epileptogenic zone in patients suffering from drug-resistant partial epilepsy, and 2) define the functional organization of neural networks underlying human perception and cognition in order to prevent inadvertent deficits resulting from neurosurgical resection. In particular, high-frequency activity (HFA), as measured with icEEG, has been demonstrated in recent years as a relevant index for both epileptogenic tissue and healthy cortical processing, but its correlates in fMRI and MEG require further investigation. This will be a pioneering effort in several respects, as the first to directly measure high-frequency neural activity in tandem with fMRI, and among the first to do so with MEG. In addition to their attractiveness as noninvasive imaging techniques, fMRI and MEG have the potential to examine whole-brain networks that are not accessible to icEEG's necessarily limited spatial coverage. Furthermore, such a campaign of simultaneous recordings will take unprecedented advantage of icEEG as the bridge between the two noninvasive techniques, providing compelling evidence for the links between all three measurements with respect to underlying high-frequency neural activity in both health and disease. This project will therefore lead to improved selection of epilepsy surgery candidates and improved neurosurgical outcomes from the precise mapping of epileptogenic and healthy brain networks. The same techniques will be immediately applicable to functional mapping of other types of neurosurgery populations as well as diagnostic neuroimaging of neurological and psychiatric populations.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 60 years, not subject of any measure of legal protection
* Patients suffering from drug resistant partial epilepsy
* Patient undergoing intracranial video EEG
* Patients with electrodes implanted in orthogonal
* no MRI cons-indication
* Patients who signed a consent form
* Intellectual capacity to perform cognitive tasks and to sign an informed consent.
* Affiliation to social security

Exclusion Criteria:

* Pregnant women
* Elderly patients under 18 or over 60 years Patient not suffering from drug resistant partial epilepsy, or not scheduled for a SEEG
* MRI cons-indication
* Patients taking psychotropics drugs
* Claustrophobia
* Inability to perform cognitive tasks or to give informed consent.
Role of Rotational Guided Growth in Management of Increased Femoral Anteversion

Efficacy of guided growth in coronal plane deformity correction and limb length discrepancy has been well-established. Recently, studies have explored the validity of guided growth in correction of rotational deformity through a modified method of application.

This concept has been validated in animal studies, biomechanical studies and two limited human case series through different methods.

This study evaluates the efficacy of rotational guided growth in management of increased femoral anteversion using three different constructs.

The purpose of this study is:

1. Evaluate the efficacy of different constructs in correcting increased femoral anteversion clinically and radiographically.
2. Asses possible complications of this new concept including LLD, undesired coronal, sagittal plane deformity and stiffness.

Eligibility Criteria:
Inclusion Criteria:

* Children with increased femoral anteversion causing in-toeing with decreased agility.
* Aged 8 years and above with at least two years of bone growth remaining.

Exclusion Criteria:

* Any patient who underwent previous femoral osteotomy.
* Any patient with sick physis (skeletal dysplasias, post traumatic / post infective physeal damage, active rickets).
* Cerebral Palsy (CP) patients
Study of an Interposition Supraciliary Implant in Patients With Open Angle Glaucoma

The purpose of this study is to prolong observational follow-up up to 36 months of patients already implanted with a novel interposition supraciliary implant.

19 patients with primary open angle glaucoma (POAG) refractory to topical medical therapy were operated in late 2020 and a novel interposition supraciliary device implanted.

These patients reached 6 months follow-up and the original study had to be interrupted.

This observational study prolonges follow-up to 36 months

Eligibility Criteria:
Inclusion Criteria:

* All patients who were implanted in this center with the novel supraciliary interposition device under the scope of clinical trial NCT03736655

Exclusion Criteria:

* if cannot assist to all future follow-up visits
Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

The purpose of this study is to compare the incidence rate of infection in surgical patients with closed fractures treated prophylactically with Cefazolin versus Vancomycin in the peri-operative period.

The hypothesis of this study is that patients undergoing surgical treatment for closed fractures who are treated prophylactically with Vancomycin will have a lower incidence rate of infection than patients who are treated prophylactically with Cefazolin.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 years old and 85 years old
* Closed fracture
* Fracture treatment plan is for one operation on one day (one surgical setting)
* Likely to follow-up with surgeon until fracture is healed
* Ability to understand and agree to Informed Consent

Exclusion Criteria:

* Under 18 years old or over 85 years old
* Open fracture(s)
* Fracture requires multiple operations
* Other injuries requiring operations
* Documented allergy to Cefazolin or Vancomycin
* Previous history of Methicillin-resistant Staphylococcus aureus infection
* Previous surgery on the injured extremity within 1 year
* Use of antibiotics within 2 weeks before or after injury
* Use of antibiotics within 2 weeks before surgery
* Unlikely to follow-up until fracture is healed
* Unable to understand and agree to Informed Consent
Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature

This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained from subject's parents or legally acceptable representative before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
* Pre-pubertal status (males aged from 4 to 11 \[both inclusive\], females aged from 4 to 9 \[both inclusive\]): an absence of breast development in females (Tanner 1 only) and testicular volume below 4 mL in males
* Growth hormone level above 10 ng/mL following a stimulation test (test result within 6 months from screening can be used)
* Height below 3 percentile
* Bone age below or equal to 12 year
* Epiphyses confirmed as open in patients at least 10 years or more of age

Exclusion Criteria:

* Known presence of one or more pituitary hormone deficiencies (ACTH (adrenocorticotropic hormone), ADH (antidiuretic hormone), FSH (follicle-stimulating hormone), LH (luteinising hormone), TSH (thyroid-stimulating hormone))
* Known primary hypothyroidism, adrenal insufficiency or hypogonadism (treated or untreated)
* Specific types of growth failure including, but not limited to, known chromosomal abnormalities associated with growth failure and altered sensitivity to growth hormone
* Bone age is advanced over chronological age more than 3 years
* Active malignancy, CNS (central nervous system) trauma, active chemotherapy or radiation therapy for neoplasia
* Prior history of intracranial hypertension
* Hypertrophic cardiomyopathy
Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude

Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing sleep related breathing disturbances in lowlanders with chronic obstructive lung disease travelling from 700 m to 3200 m.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of dexamethasone prophylaxis in sleep related breathing disturbances in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (700m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Dexamethasone 2x4mg/day (or placebo), will be administered before departure at 700 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m

Eligibility Criteria:
Inclusion Criteria:

* Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2
* Living at low altitude (\<800m)

Exclusion Criteria:

* COPD exacerbation
* severe COPD, GOLD grade 3 or 4
* arterial oxygen saturation \<92% at low altitude (\<800 m)
* Diabetes, uncontrolled cardiovascular disease such as systemic arterial hypertension, coronary artery disease; previous stroke; pneumothorax in the last 2 months, untreated or symptomatic peptic ulcer disease, glaucoma, obstructive sleep apnea.
* Internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day).
* pregnant or nursing patients
Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer

The objective of this study is to assess the effect Of zoledronic acid on circulating and bone marrow-residing prostate cancer cells in patients with clinically localized prostate cancer


Eligibility Criteria:
Inclusion Criteria

* Prostate cancer
* Radical prostatectomy or external beam irradiation therapy within 6 months before study entry.
* No bone metastases according to bone scan

Exclusion Criteria

* Metastatic prostate cancer
* Hormone ablation therapy for more than 3 months before/after radical prostatectomy and external beam irradiation therapy
* Treatment with bisphosphonates or other drugs known to affect the skeleton within the past year.

Other protocol-defined inclusion / exclusion criteria may apply.
Preimplantation Genetic Testing for Aneuploidy of Polar Bodies

This study intends to randomly group the patients with advanced maternal age and poor ovarian response, and the study group will undergo polar body biopsy, and the next-generation sequencing(NGS) technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores. In the control group undergo routine culture and the transfer priority is determined according to the morphological score only. The transfer of frozen embryos at the cleavage or blastocyst stage was permitted. Cumulative live birth rate, miscarriage rate and time required to obtain a live birth up to two ovulatory cycles in a year.


Eligibility Criteria:
Inclusion Criteria:

* patients between their 36th and 42st birthdays;
* absence of any type of genetic abnormality in the patient's personal and family history;
* MⅡ oocytes: 2-9 .

Exclusion Criteria:

* treatment involving donor oocytes;
* any type of genetic abnormality or family history of genetic abnormality in subject or partner;
* with assisted reproductive technology and pregnancy contraindications and with diseases that have a definite effect on pregnancy;
* poor embryo quality in previous cycles;
* Preimplantation genetic testing for aneuploidy(PGT-A) cycles;
* MⅡ oocytes ≥10 or ≤ 1;
* three or more previous failed IVF or Intracytoplasmic sperm injection(ICSI) cycles.
Physical Capability Outcomes After Single-Level PD-L vs Single-Level ALIF: a Multi-Center Clinical Trial

The purpose of this study is to compare the physical capability outcomes of patients who undergo single-level ProDisc-L disc replacement with those of patients who undergo stand-alone, single-level anterior lumbar interbody fusion (ALIF). This study will be the first multi-center clinical study to use clearly measurable outcomes from physical tests to compare the results of lumbar disc arthroplasty with disc fusion.

Physical capability testing will be conducted once before surgery and at 6 months and 1 year after surgery. Physical capability testing assesses the ability to perform a number of common tasks: the distance a subject can walk comfortably in 6 minutes; the amount of weight a subject can lift, push, pull, and carry; and the ability to squat and work bending forward in the kneeling and standing positions. The results of this testing will be evaluated to determine whether the subject's physical capability meets the physical requirements of their job, based on their responses to a pre-study questionnaire. Each physical capability testing session will require from 1 to 1 ½ hours of the subject's time. Physical capability testing will be provided without charge.

Eligibility Criteria:
Inclusion Criteria:

Eligible patients will meet the following criteria based on clinically appropriate criteria per standard of care at individual institutions which may include but are not limited to

* skeletally mature; BMI \< 40
* suffered from low-back pain with or without leg pain for 6 months or longer
* no evidence of spinal deformity on plain radiograph
* no evidence of angular instability on flexion extension radiographs
* severe and incapacitating low-back pain, defined as a score of 40% or greater on the Oswestry Disability Questionnaire
* a single level of degenerative disc disease at L34, L45, or L5-S1 on magnetic resonance imaging (MRI) scan
* discography, if indicated, reproduces pain at the level of degeneration noted on the MRI scan and is negative for pain reproduction at adjacent levels
* bone mineral density T-Score by DEXA Scan \>-1.0 for any skeletal region
* computed tomographic (CT) scan demonstrates the absence of pars defect at the index level
* CT scan demonstrates the absence of significant facet arthropathy at the index level
* considered reasonable candidates for surgery in regard to psychological factors as determined according to the standard of care at each participating center

Exclusion Criteria:

* active systemic infection
* evidence of alcoholism
* spondylolisthesis of greater than grade 1
* clinically significant lumbar spinal stenosis
* allergy to implant materials
* isolated radicular syndrome
* vertebral body compromised by trauma at the index level.
The Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients

The purpose of this study is to assess the efficacy and safety of Hyalgan after proximal tibial osteotomy in treatment of knee osteoarthritis patients. Normally, OA patients who were treated with osteotomy will not be treated with any SYSADOA after operation, even though their cartilage's not completely loss, so osteotomy plus HA injection should provide more benefit to patients than osteotomy alone.


Eligibility Criteria:
Inclusion Criteria:

1. Patients between 35 and 65 years with primary knee OA with malalignment
2. Mild to moderate OA of grade II or III severity on the Kellgren-Lawrence scale with require treatment by osteotomy
3. Malalignment is not exceed 15 degree (+,-)
4. Pain on walking (15 m) ≥ 40 mm.
5. Range of motion \> 90 degree
6. Evidence of adequate contraceptive methods in women of childbearing age

Exclusion Criteria:

1. Previous surgery on affected knee
2. Previous intraarticular intervention within the last 3 months (eg. Steroid, anaesthetic, Sodium hyaluronate)
3. Oral SYSADOA treatment (chondroitin, glucosamine, diacerein) within 2 months prior to study start
4. Known or suspected infection of the affected joint
5. Painful knee condition due to another cause than chondral lesions, such as Sudeck's atrophy, intraarticular neoplasm, pigmented villonodular synovitis, chondromatosis
6. Poor general health or other conditions which would make regular hospital attendance difficult
7. Ascertained hypersensitivity to any component used in the study (eg. Hyaluronic acid, diclofenac, morphine, omeprazole and paracetamol)
8. Hypersensitivity to avian protein
9. Ongoing or previous participation in a clinical study within the last 3 months
A Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus

The primary objective of this study is to evaluate, for the visual correction of aphakia and presbyopia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) to provide an extended depth of focus (improve intermediate and near visual acuity without compromising distance visual acuity) in subjects who have undergone bilateral implantation with the LAL and subsequent light treatments for refractive and presbyopia correction (LAL group).


Eligibility Criteria:
Inclusion Criteria:

* Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of either the LAL or SofPort LI61AO intraocular lens (IOL) (Bausch + Lomb).
* Must be willing to be randomized to either the LAL group (bilaterally implanted with the LAL and receive light treatments for refractive and presbyopia correction) or the Control group
* Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
* Cataractous lens changes as demonstrated by best corrected distance visual acuity (BCDVA) of 20/40 or worse with or without a glare source in both eyes.
* Willing and able to comply with the requirements for study specific procedures and visits.
* Able to complete a written questionnaire in English.

Exclusion Criteria:

* Pre-existing macular disease in either eye.
* Patient with sufficiently dense cataract that precludes examination of the macula in either eye.
* Diabetes with any evidence of retinopathy in either eye.
* Evidence of glaucomatous optic neuropathy in either eye.
* History of uveitis in either eye.
* Keratoconus or suspected of having keratoconus in either eye.
* Has undergone previous corneal or intraocular surgery in either eye, except eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
* Subjects taking systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and methoxsalen. LDD treatment in patients taking such medications may lead to irreversible phototoxic damage to the eye. This is only a partial list of photosensitizing medications. Please evaluate all medications that the patient is taking for this effect prior to consideration for implantation.
* Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
* History of ocular herpes simplex virus in either eye.
* Subject who has participated within another ophthalmic clinical trial within the last 3 months.