cyrilzakka/clinical-trials huggingface dataset:
Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer

The purpose of this study is to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis at baseline.

Participants were randomized to receive denosumab 120 mg or placebo every 4 weeks (Q4W) until approximately 660 participants developed bone metastasis or died and the primary efficacy and safety analyses were completed.

All participants undergoing scheduled assessments were offered open-label denosumab 120 mg subcutaneous (SC) until they either developed a bone metastasis, obtained access to commercially available product in this setting, or for up to 3 years, whichever came first. For participants who ended participation before the open-label extension (OLE) phase or withdrew from investigational product during the OLE phase, their survival data was to be collected every 6 months for up to 3 years after their last dose of investigational product.

Participants in the Czech Republic and United Kingdom were enrolled under a separate protocol for the OLE phase per Health Authority request, and are reported separately (Study 20080585; NCT01824342).

Eligibility Criteria:
Inclusion Criteria:

* men with histologically confirmed prostate cancer
* bilateral orchiectomy at least 6 months before randomization or continuous androgen-deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) agonist or antagonist for at least 6 months before randomization
* total testosterone level less than 50 ng/dL,
* hormone refractory (androgen independent) prostate cancer demonstrated during continuous ADT/post-orchiectomy defined as: 3 consecutive prostate-specific antigen (PSA) values with PSA1 \< PSA2 \< PSA3, each PSA value must be separated by at least 2 weeks, PSA2 and PSA3 greater than or equal to 1.0 ng/mL,
* high risk for development of bone metastasis defined as PSA value greater than or equal to 8.0 ng/mL, obtained no more than 3 months before randomization OR PSA doubling time less than or equal to 10.0 months

Exclusion Criteria:

* prior or current evidence of radiographically detectable bone metastasis
* known prior or current evidence of any metastatic involvement of distant organs (lymph node metastases in any region is acceptable)
* prior or current intravenous bisphosphonate administration
The Effects of Video Training Given to Individuals With Type 2 Diabetes

The goal of this randomised control type of study is to examine the effects of Video Diabetes Training given to individuals with Type 2 Diabetes through smartphones on self-care and metabolic control.

The Hypotheses of the Study:

H1: Video Diabetes Training given to individuals with Type 2 Diabetes through smartphones has a positive impact on individuals' self-care.

H2: Video Diabetes Training given to individuals with Type 2 Diabetes through smartphones has a positive impact on individuals' metabolic control variables.

Participants will answer the data collection tools in the first and second interviews and metabolic control variables will be record. Diabetes training videos will sent to the Training Group through smartphones after the first meeting as two episodes a week.

Video Diabetes Training given to training group will be examine the effects of on self-care and metabolic control.

The study will conduct to examine the effects of Video Diabetes Training given to individuals with Type 2 Diabetes through smartphones on self-care and metabolic control.

This experimental, randomized, and controlled study will conduct with a total of 112 individuals with Type 2 Diabetes (56 in the Training Group, and 56 in the Control Group), who apply to the Internal Medicine Clinic of a state hospital in the Mediterranean Region of Turkey between February and August 2022, who volunteered to participate in the study and met the inclusion criteria.

A total of 112 individuals with Type 2 Diabetes, who volunteered to participate in the study, and met the inclusion criteria, will select with the Simple Random Sampling Method and will randomize with the help of a computer program.

Participants will answer the data collection tools in the first and second interviews and metabolic control variables will be record. Diabetes training videos will sent to the Training Group through smartphones after the first meeting as two episodes a week.

Video Diabetes Training given to training group will be examine the effects of on self-care and metabolic control.

Eligibility Criteria:
Inclusion Criteria:

* agreed to participate in the study voluntarily,
* were diagnosed with Type 2 Diabetes for at least 6 months,
* were 18 years of age or older,
* were literate, had smartphones with video playback features and internet,
* without a physician diagnosis that would prevent communication, and psychiatric problems and hearing problems
* those who did not have sensory losses such as vision or hearing.

Exclusion Criteria:

-Individuals who did not meet the inclusion criteria.
Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson Disease

The study will evaluate the efficacy and safety of ALXN1840 (formerly called WTX101) administered for 48 weeks compared to standard of care (SoC) in Wilson Disease (WD) participants aged 12 and older in the Primary Evaluation Period. In addition, efficacy and safety will be evaluated during an optional 60-month Extension Period.

The study consists of 2 cohorts. Cohort 1: Participants who have received SoC therapy for \> 28 days and Cohort 2: Participants who are treatment-naïve or who have received SoC therapy for ≤ 28 days.

All enrolled participants were randomized by cohort in a 2:1 ratio to treatment with ALXN1840 or SoC (either as continued therapy in Cohort 1 or as continued or initial therapy in Cohort 2).

Eligibility Criteria:
Key Inclusion Criteria:

* Established diagnosis of WD by Leipzig-Score ≥ 4
* Female participants of childbearing potential, if heterosexually active, must be willing to follow protocol-specified guidance for highly effective contraception starting at least 6 weeks before the Day 1 visit and continuing through 28 days after the last dose of either ALXN1840 or SoC
* Male participants, if heterosexually active, must be willing to follow protocol-specified guidance for highly effective contraception beginning at Day 1 visit and continuing through 90 days after last dose of either ALXN1840 or SoC

Key Exclusion Criteria:

* Decompensated hepatic cirrhosis
* MELD score \> 13
* Modified Nazer score \> 7
* Clinically significant gastrointestinal bleed within past 3 months
* Alanine aminotransferase \> 2 X upper limit of normal (ULN) for participants treated for \> 28 days with WD therapy (Cohort 1)
* Alanine aminotransferase \> 5 X ULN for treatment-naïve participants or participants who have been treated for ≤ 28 days (Cohort 2)
* Marked neurological disease requiring either nasogastric feeding or intensive inpatient medical care
* Hemoglobin \< 9 grams/deciliter
* History of seizure activity within 6 months prior to informed consent
* Pregnant (or women who are planning to become pregnant) or breastfeeding women
* Active infection with hepatitis B virus (positive hepatitis B surface antigen) or C virus or seropositivity for human immunodeficiency virus (HIV)
* Previous treatment with tetrathiomolybdate
* Participants with end-stage renal disease on dialysis (chronic kidney disease stage 5) or creatinine clearance \< 30 milliliter/minute
Clinical Evaluation of Intraocular Caliper-assisted Capsulotomy for Age-related Cataract

The purpose of this study is to compare the accuracy of capsulotomy assisted by intraocular caliper and Verion navigation system in phacoemulsification surgery and postoperative visual quality of patients.

Continuous curvilinear capsulorhexis (CCC) is an important and technically challenging procedure in cataract surgery. However, most surgeons perform CCC by experience or referring to the pupil size, which is highly subjective and the accuracy of capsulorhexis is unsatisfactory. The investigators developed a new modified intraocular caliper with standard calibration on the rinse needle, which can measure and locate the position of capsulorhexis. The surgeon can gently use the blunt needle in the front of the intraocular caliper to further make corresponding markers on the lens anterior capsule, and then carry out capsulotomy according to the marks. We found intraocular caliper-assisted capsulotomy can obviously improve the accuracy of capsulorhexis. The purpose of this study is to compare the accuracy and postoperative visual quality of intraocular caliper-assisted capsulotomy with those of digital image projection device VERION navigation system.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 55 to 80 years with age-related cataract;
* Pupil diameter ≥ 6.5mm after pupil dilation;
* Lens nuclear opacity grading score (LOCS III) lower than 4.0.

Exclusion Criteria:

* Patients had previous intraocular surgery;
* Patients with a diagnosed eye disease that may affect the functions of lens suspensory ligament such as previous ocular trauma, lens subluxation, pseudoexfoliation syndrome, retinal pigment degeneration;
* Patients had other ocular diseases that impair visual function include optic neuropathy, uveitis, and tumor.
* Refused to participate the study.
Effects of the Pilates Method Versus Home Exercise in Individuals With Chronic Non-specific Back Pain

The aim is to compare the effectiveness and cost-effectiveness of a Pilates program versus home-based exercises in individuals with chronic non-specific low back pain. This is a randomized controlled trial with economic evaluation. Participants will be sequentially enrolled and randomly allocated into two groups: 1) Pilates: Mat Pilates sessions, supervised by a physiotherapist (2x/week for 6 weeks); 2) Home-Based Exercise: face-to-face familiarization (two sessions), supervised by another physiotherapist. After familiarization, the exercises will be prescribed using a booklet containing descriptions of sets/repetitions, as well as guidelines and precautions, to be performed during 6 weeks (2x/week) and monitored in a diary. Participants will be supervised by the physiotherapist (telephone/text messaging). Participants will be evaluated in three different moments: 1) Baseline (pre-intervention); 2) At the end of the intervention (post-intervention, 6 weeks); and 3) After six months follow-up (from post-intervention). Primary outcomes: pain intensity and disability. Secondary outcomes: perception of recovery, postural balance, and quality of life. Concurrently, a cost-effectiveness study will be conducted comparing the Pilates vs Home-Based Exercise, from the perspectives of public healthcare and society. In the first perspective, only costs incurred by the public healthcare system will be included (direct costs related to consultations, medications, tests, hospitalizations, and professional fees). In the second perspective, private health care expenses, costs incurred by patients (transportation and support by caregivers, when applicable), as well as indirect costs (missed workdays and loss of productivity) will be included. The incremental cost-effectiveness ratios for the primary outcomes and cost-utility ratios will be calculated for both perspectives. The cost-utility ratio will express the incremental costs per quality-adjusted life year (QALY). In addition, the absolute and incremental net monetary benefit will be calculated. Sensitivity analyses will be conducted. Data normality assumptions will be evaluated using the Shapiro Wilk test. If confirmed, a mixed model will be used, for the comparisons between groups and moments. It is hypothesized that the Pilates will be more cost-effective compared to the home-based exercise program.


Eligibility Criteria:
Inclusion Criteria:

* Presence of chronic non-specific back pain for more than 12 consecutive weeks;
* Not having attended Pilates or physiotherapy sessions for at least 6 months prior to enrollment.

Exclusion Criteria:

* History of trauma or fractures in the spine;;
* Diagnosis of osteoarthritis, disc herniation or spondylolisthesis;
* Referred pain (visceral, abdominoplasty, appendicitis, abdominal and pelvic surgeries);
* Previous surgery on the spine;
* Presence of root symptoms;
* Pregnancy.
Pudendal Block Versus Penian Block For Circumcision In Children

The authors study the efficacy of the pudendal versus penile block for the relief of postoperative pain in children receiving ambulatory circumcision.

In this prospective, double-blind, randomized, parallel-arm trial, 60 children recruited during the anesthesia consultation will be allocated a general anesthesia with a pudendal block (PUD group) or a penile block (PEN group).

Each block will be made with equal parts lidocaine 1% and ropivacaine 0.75% (0.3 ml/kg).


Eligibility Criteria:
Inclusion Criteria:

* circumcision in day surgery hospital

Exclusion Criteria:

* allergy to amino-amide local anesthetics
* parental consent not received
* infection at injection site
Multimodal Equipment for Teleophthalmology Assessment (META)

We have developed a Multimodal Equipment for Teleophthalmology Assessment (META) device. This novel device is compact, portable and suitable for packaging and express delivery. With this device, there is a potential to implement a new concept of "hospital-at-home" eye care model. The present study is designed to validate the META device for future clinical usage and investigation. We will compare the performance of the META device with those provided by commercial devices in terms of image quality of optical coherence tomography (OCT), anterior segment and fundus camera, and evaluate the level of agreement in lesion detection and quantitative measurements between META and other commercial devices (e.g., Heidelberg Spectralis OCT, Haag-Streit BQ900 Slit-lamp imaging, Canon CR-2 fundus imaging, Zeiss IOL Master 500).

The META is an innovative and non-invasive examination instrument for a variety of common eye diseases. The integrated multimodality device combines digital slit lamp, fundus camera, OCT, refractometer, optical biometry and visual acuity test (near and distance) that facilitate a comprehensive ophthalmic examination. In the current study, all participants will undergo the measurements provided by the META and by traditional examination modalities (including digital slit lamp, fundus camera, OCT, refractometer, optical biometry and visual acuity test) in a random order. The participants will need to complete several questionnaires to investigate their preference and confidence to receive the META exams in the future.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older.
* Participants with healthy eyes, or patients diagnosed with one or more common eye diseases, including anterior segment eye diseases (conjunctivitis, keratitis, corneal opacity or cataract), fundus diseases (age-related macular degeneration or diabetic retinopathy) and/or refractive error (myopia, high myopia, hyperopia, anisometropia, or presbyopia).
* Willing and able to participate in all examinations related to this study
* Visual acuity of 20/400 or better in the study eye(s).

Exclusion Criteria:

* Ocular trauma or postoperative eyes within 3 months.
* Study eye(s) with dilated pupil.
Role of TIRADS and Bethesda Scoring Systems in Management of Thyroid Nodules

role of TIRADS and Bethesda scoring system in management of thyroid nodules as these methods are ultrasound clasification that helps increase the diagnostic effectiveness of thyroid nodules and reduces the use of preopeative FNA .that nodules are usually divided into diffent categories based on TIRADS and are then referred to FNA and follow up according to variable risk of maligneny.

this study is an observational study will be conducted on patiend with thyroid nodules will be admitted to general surgical department at sohag university hospital . patients will be approved to have single or multinodular goitre and thyroid nodules more than 1 cm . thyroid nodules are very common disease with great clinical importance although most cases are benign and only 4.5% to 6.5% are malignant ... itis necessary to distinguish those cases to reduce frequency of unnecessary thyroidectomies ... ultrasound classification and Fine needle aspiration (FNA) are first line diagnostic procedures and help in decrease cases undergoing unnecessary thyroidectomies as 50% of the nodules removed recently are malignant and the number of patients undergoing surgery is significantly reduced.

Eligibility Criteria:
Inclusion Criteria:

* patients will proved to have single or multinodular goitre thyroid nodules more than 1cm

Exclusion Criteria:

* thyroid nodules less than 1 cm history of thyroid surgery history of radiotherapy
Clinical Study of Solo Tympanostomy Tube Device (TTD)

This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)


Eligibility Criteria:
Basic Inclusion Criteria:

* Listed for bilateral tympanostomy tube insertion only

Basic Exclusion Criteria:

* Anatomy that precludes sufficient visualisation of both the left and right eardrum with the Solo TTD in place.
* Anatomy that precludes safe access to both the left and right eardrum with the Solo TTD
* Patients in whom a reliable audiogram is not possible
Treatment of Chronic Migraine Headaches.

The purpose of the study is assessment of the safety and efficacy of the De-Novo therapy in the treatment of craniofacial neuralgia and migraine headaches.This is an open-label study of simultaneous administration of combination of dexamethasone, lidocaine, and thiamine into the trigeminal nerve branches as well as greater and lesser occipital nerve bilaterally in one session.

Patients who meet the exclusion and inclusion criteria are eligible for trial if they have experienced chronic migraine and craniofacial pain not responding to other prior therapies.

A combination of dexamethasone, lidocaine and thiamine (pat.), may bring changes in the pattern of sympathetic and parasympathetic nerve signaling at the level vasa nervorum. These changes may down-regulate the hyperexcitable sympathetic signals at the level of adventitia and consequently the medial layer of vasa nervorum and providing long term relief from migraine headaches. However, a bilateral and simultaneous treatment of trigeminal and occipital nerves in migraine and craniofacial neuralgia using a combination of dexamethasone, thiamine and lidocaine has been rarely studied.

The objective of this study is to assess the safety and efficacy of concomitant administration of dexamethasone, lidocaine, and thiamine compounds into the trigeminal nerve branches, the greater and lesser occipital nerve for the treatment of chronic migraine, and craniofacial neuralgia.

Eligibility Criteria:
Inclusion Criteria:

* • Age: 10-90 years

  * Ability to describe headache and its symptoms
  * Ability to read, comprehend, and legibly and reliably record information
  * Ability to provide written, informed consent, and respond to pre and post treatment questionnaires, children's guardian accepts responsibility. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures
  * Already diagnosed with chronic craniofacial neuralgia and chronic migraine headache
  * Exhausted all or most of available abortive and preventive treatment modalities.

Exclusion Criteria:

* • Uncontrollable hypertension, acute Myocardial Infarct within last 6 months

  * History of cerebral vascular aneurysm/known atherosclerosis of cerebral system, brain tumor
  * Implanted of neuro-stimulator, trigeminal tractotomy, neurectomy partial or complete, history of gamma knife treatment, microsurgical decompression procedure.
  * Hypersensitivity or allergy to any components of De-Novo formula
  * Presence or known anatomic craniofacial deformities or severe spondylosis/spondylolisthesis of cervical spine, profound dental caries, Maxillofacial deformities
  * Pregnancy and current breast feeding status
  * Headaches attribute to acute head and neck injuries, chronicity of cervicogenic headaches
  * Skin infection or micro abscesses dermatogen or dental, ongoing treatment for Methicillin Resistant Streptococcus Aureus ( MRSA) unless treatment completed.
Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders

The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d) versus placebo to sleep latency with electronic sleep diaries.

This study will be a multicenter, double-blind, randomized, placebo-controlled parallel group trial. The trial has five phases; the pre-screening phase, the screening phase, double-blinded treatment phase, open label treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During double-blinded treatment phase, patients who meet all entry criteria for the trial will be randomized into three groups, and they will be assigned NPC-15 1 mg, 4 mg or placebo before going to bed for 2 weeks. During open label treatment phase, all patients will be administered NPC-15 1 mg, 2 mg or 4 mg on the basis of their doctors' judgements.

Eligibility Criteria:
Inclusion Criteria:

* Female or male patients aged 6 to 15 years.
* Patients with "autism spectrum disorder" diagnosed by using DSM-5.
* Patients with average of daily sleep latency persisted over 30 min and the condition is continuous over 3 months
* Patients who are out-patient, not hospitalized patient.
* Signed informed consent obtained from rearer(s)/parent(s)/guardian(s) of the patient, or signed IC or informed assent obtained from the patient themselves.

Exclusion Criteria:

* Patients with at least severity in either Conceptual area, or Social area, or Practical area of intellectual disability have judged more than "severe" by using DSM-5.
* Patients who took melatonin (including supplement) in history.
* Patients who had taken Ramelteon within 4 weeks before clinical study starts.