cyrilzakka/clinical-trials huggingface dataset:
Association Between Vitamin D and the Development of Uterine Fibroids

the aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could inhibit the growth of uterine fibroids in reproductive stage women.

180 patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 20 ng/ml) and uterine fibroids will be randomly assigned in a ratio of 1:1 to two groups: intervention group A and control group B. 180 patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 30 ng/ml) and uterine fibroids will be also randomly assigned in a ratio of 1:1 to two groups: intervention group C and control group D. The intervention group A will receive 1600 IU/d of vitamin D3; The intervention group C will receive 800 IU/d of vitamin D3; the control group B and the control group D will receive regular follow-up. Patients will be followed up at the same time points for 24 months. The outcome measure is the growth of uterine fibroids in different groups.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients are willing to cooperate with the follow-up and sign informed consent;
* 2. Females aged 35-50 who are diagnosed as having uterine fibroids by transvaginal or abdominal ultrasonography;
* 3. The maximum average diameter of intramural myoma is ≤ 4cm，≥ 1cm; The amount of myoma is less than 4;
* 4. Serum 25-hydroxyvitamin D3 \< 30 ng/ml, ≥ 12 ng/ml.

Exclusion Criteria:

* 1. Patients with heavy menstrual bleeding (\>80.0 mL), menstrual disorders, pelvic discomfort, infertility, or other indications for operation;
* 2. Patients complicated with myoma degeneration and adenomyosis that were suspected or diagnosed by ultrasound or gynecologic examination;
* 3. Allergic to vitamin D3;
* 4. Use of sexual hormone, mifepristone, gonadotropin-releasing hormone agonist (GnRHa), or other medication which is likely to interfere with uterine fibroids within 3 months;
* 5. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
* 6. Suspected or identified as other tumors of genital tract;
* 7. History of osteoporosis or vitamin D deficiency taking vitamin D supplements within previous one month;
* 8. History of autoimmune diseases, infectious diseases (tuberculosis, AIDS), autoimmune diseases, digestive system diseases (malabsorption, crohn disease, and dysentery);
* 9. Alanine aminotransferase (ALT) or aspartate transaminase(AST) more than 3 times of the normal upper limit, total bilirubin (TBIL) more than 2 times of the normal upper limit;
* 10. Creatinine levels≥1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 mL/min;
* 11. History of malignant tumors;
* 12. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor

This study aims to study the efficiency of using a single injection of Corifollitropin alfa for ovarian stimulation by initiating administration late and without further administration of follicle-stimulating hormone after the 7th day of stimulation compared to conventional ovarian stimulation using Corifollitropin alfa (drug administration 5 days after cessation of hormonal contraceptive and supplementation with follicle-stimulating hormone daily administration from the 8th day of stimulation).

This a controlled randomized clinical study and 180 patients will be recruited (90 per arm) and the primary study outcome is the number of obtained oocytes.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for oocyte donation program
* Age between 18 and 32 years old
* BMI \>18 and \<30
* Antral follicle count \>12 (summing both ovaries)
* Presence of both ovaries
* Ability to participate in and comply with study protocol
* Signed informed consent
* No treatment with ovulation stimulators in the 3 months prior to the start of stimulation.

Exclusion Criteria:

* Diagnosis of endometriosis at any stage
* AFC \>20
* Polycystic ovary syndrome
* Concurrent participation in another study
Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency

Effects of modified fixed twin block versus removable twin block on skeletal class 2 growing patients with mandibular deficiency:

A Randomized Clinical Trial

The main objective of the study is to evaluate the effects of the modified fixed TB on class 2 growing cases and to compare its effect to the conventional removable TB

Research question Does the modified fixed twin block have the same effects as removable twin block during treatment of skeletal class 2 growing patients with mandibular deficiency?

PICO P: Growing skeletal class 2 patients with deficient mandible I : Modified Fixed Twin block C: Conventional removable Twin block

O :

Primary outcome:

Overjet

Secondary outcome:

Soft tissue Profile Antro-posterior mandibular position Mandibular length Antro-posterior maxillary position Upper and lower Incisors inclinations Durability of the appliance Patient Acceptance

Hypothesis:

There is no difference between the modified fixed or removable Twin block appliance regarding overjet reduction, dentoskeletal effects and patient perception.

8. Trial design: Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.

Eligibility Criteria:
Inclusion Criteria:

* Skeletal Class 2 malocclusion cases (ANB ≥ 5 degrees)
* Overjet ≥ 5 mm
* Growing patients (CVMS 3 or 4)

Exclusion Criteria:

* Skeletally mature patients 15 years old or above
* Patients with normal mandible and only protruded upper incisors.
* Syndromic, cleft patients and patients with dental anomalies
* Previous orthopaedic or orthodontic treatment
* No sex predilection.
Restless Legs Syndrome in People With Neuromyelitis Optica Spectrum Disorder

Restless legs syndrome (RLS) is a neurological movement disorder characterized by uncomfortable and uncontrollable sensations, usually in the legs, that increase at rest, and an urge to move the legs or other affected extremities. The exact cause of RLS is unknown, but there are idiopathic and secondary forms of RLS associated with various medical conditions such as anemia, pregnancy, uremia, neuropathies, rheumatoid arthritis, parkinson's disease, spinocerebellar ataxia, and neurological disorders such as multiple sclerosis.

Neuromyelitis optica (NMO) is a severe inflammatory disease of the central nervous system.

NMO, once considered a variant of multiple sclerosis, is now recognized as a separate disease entity. In 2004, the water channel protein-specific antibody called aquaporin 4 (AQP4) was found to cause NMO, leading to the identification of NMO as a separate disease. When initially described, the disease was thought to show only necrotic and demyelinating lesions in the optic nerve and spinal cord. It was therefore thought that NMO would preferentially only attack the optic nerves and spinal cord, not the brain. However, over the years, evidence from various studies has proven that various parts of the brain are also affected during the course of the disease. In addition, some patients showing features of the disease were found to be seronegative for anti-AQP4 antibodies. These findings necessitated the need to introduce a new term "neuromyelitis optica spectrum disorders (NMOSD)" to describe all the features of the disease. Although the feeling of restlessness in the legs is frequently reported as a sensory symptom by people with NMOSD, there are limited publications to investigate the relationship between RLS and NMOSD.

The primary aim of the study is to determine the frequency and severity of RLS in people with NMOSD. The second aim of the study is to compare the presence and severity of RLS, sleep quality, daytime sleepiness level, quality of life, fatigue and Magnetic Resonance Imaging (MRI) results in people with NMOSD. The third aim of the study is to compare the cognitive functions of people with RLS positive and negative NMOSD.

People with NMOSD who came to Dokuz Eylul University Medical Faculty Hospital Neurology Department MS Polyclinic for their routine check-ups, who volunteered to participate, will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with NMOSD by a neurologist
* To be willing to participate in the study.

Exclusion Criteria:

* Diagnosed severe cognitive and/or psychiatric impairment
* Having any of the conditions known to be associated with RLS, such as anemia \[hemoglobin (Hb) levels \<12 mg/mL\], pregnancy, uremia, neuropathies, rheumatoid arthritis, and neurological diseases other than NMOSD
Non-Invasive Biomarkers in Prostate Cancer Disease Management

This study is an observational retrospective/ prospective study with diagnosed low/intermediate risk (no-surgery) \& high risk (surgery) prostate cancer that are eligible and willing to undergo standard of care (SOC) assessment, annually along with biopsies, bio-fluid collection. Participants will obtain genomic and histological evaluation on their biopsied samples. Study follows SOC collection with additional body fluid collection (blood, urine). Biopsy/surgery will not require additional sample collection


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients who had received primary diagnosis at Moffitt or outside the cancer center with available records (radiology, pathology, access to samples).
* No-Surgery (Intermediate risk) group: patients diagnosed with pre-biopsy mpMRI, blood plasma: the biopsy must consist of a pathological diagnosis with a Gleason pattern score.
* Surgery (High risk) group: patients who had radical prostatectomy (RP) with (or with-out) mpMR imaging, bio fluids available for research will be accrued for this group. We follow the NCCN recommendations for high-risk (Unfavorable intermediate risk or High-risk) groups inclusion and follow-up criteria (58, 89, 90).
* ≥ 4 ng/ml and ≤ 20 ng/ml and PSA ≤ 10 ng/ml (for late disease), within 3 months of study enrollment.
* Age 35 through 85 years.
* Zubrod/ECOG performance status \<2;
* Ability to understand and willingness to sign a written informed consent document.
* Patients who agree to have a multiparametric MRI with targeted/template biopsy.
* Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life.
* Availability of Bio-samples (blood plasma, urine) for exosomal, proteomic, genomic and pathology (H\&E slides, IHC slides).
* Quantity of bio-samples; Blood, Urine, tissue sections (including FFPE) for each region of interest.

Exclusion Criteria:

* Subject is not a candidate for multiparametric MRI with contrast. Some reasons may include (but are not limited to): renal insufficiency, foreign body or pacemakers.
* No prior pelvic radiotherapy
* No prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment)
* No concurrent, active malignancy, other than non-metastatic skin cancer of any type, superficial bladder cancer, or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma) or \> Bilateral hip replacement.
The RESPOND Registry

The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.

The purpose of this study is to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings as it leads to an improvement in wound bed condition (i.e increase in healthy granulation tissue, reduction in bioburden, and reduction in amount of exudate).

The RESPOND Registry is a prospective, non-interventional research initiative to collect information on patients who are eligible to receive PuraPly™ AM, and no interventional procedures will be mandated by this protocol.

Enrolled and eligible patients will receive standard wound care clinical assessments and any additional care as determined by the treating wound care clinician. Although multiple wounds may be treated simultaneously, one wound will be identified as the target wound, and characteristics regarding this wound will be consistently documented.

The case series is being undertaken to better understand PuraPly™ AM utilization and subsequent healing outcomes as well as to evaluate the effects of concomitant wound therapy on healing. Patient's participation may involve follow-up for up to 24 weeks following application of PuraPly™ AM.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age.
* Patient, or their legally authorized representative (LAR), has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).
* Patient has a wound appropriate for receiving PuraPly™ AM, including:

  * Partial or full-thickness wound
  * Pressure ulcer
  * Venous ulcer
  * Diabetic ulcer
  * Chronic vascular ulcer
  * Tunneled/undermined wound
  * Surgical wound (e.g., donor sites/graft, post-Mohs' surgery, post-laser surgery, podiatric surgery wound, wound dehiscence)
  * Trauma wound (abrasions, lacerations, second degree burns, and skin tears)
  * Draining wound

Exclusion Criteria:

* Patient has a known sensitivity to porcine materials.
* Patient has a third-degree burn.
* Patient has a known sensitivity to polyhexamethylenebiguanide hydrochloride (PHMB).
* Patient's target wound was previously treated with PuraPly™ AM.
Interest of Hypnosis When Setting up Non-invasive Ventilation in a Conscious Patient With COPD and/or Obesity With a BMI Greater Than 30, Suffering Fromacute Respiratory Distress in Adult Intensive Care

Discomfort during respiratory decompensation of a patient with chronic obstructive pulmonary disease (COPD) and/or obesity with a BMI greater than 30, in intensive care and the establishment of non-invasive ventilation (NIV) is frequent and a source of failure. this therapy. Pharmacological treatments may be impossible due to the pathology, the risk of it worsening and adverse effects. In this context, hypnosis appears to be a tool that would promote comfort and thus increase tolerance of NIV.


Eligibility Criteria:
Pre-inclusion criteria

* Man or woman, aged 18 or over, admitted to medical intensive care
* Glasgow score = 15
* Patient with acute respiratory failure decompensating COPD and/or having obesity with a body mass index (BMI) greater than 30
* Patient having given free, informed and written consent
* Patient affiliated to a health insurance system

Inclusion Criteria:

* Glasgow score = 15
* Need during use of non-invasive ventilation

Exclusion Criteria:

* Procedure to be carried out in extreme urgency (PaCO2 too high and leading to an immediate vital risk, and / or PaO2 too low) on medical decision
* Confusional state making hypnosis impossible
* Decompensated psychiatric illness
* Patient entering with an NIV in place already installed in another department. The subject becomes included again at the end of the treatment with NIV if however he needs it again.
* Patient already included in the study during previous non-invasive ventilation
* Patient participating in research involving an interventional human person (category 1) on an analgesic / sedative medication
* A person of full age subject to legal protection (safeguard of justice, curators, guardianship) or deprived of liberty
Urethrocutaneous Fistula Rate After Double Dartos and Single Dartos Tubularized Incised Plate Urethroplasty

The subjects were divided into two groups. Each group comprised 30 children. Children were randomly allocated in two groups via computer generated tables. Children in group-A underwent single dartos tubularized incised plate urethroplasty while those in group-B underwent double dartos tubularized incised plate urethroplasty.

In group A dartos flap is raised from foreskin of the patient and applied as a single layer after tubularization in between neourethra and skin . In group B dartos flap is raised from the foreskin of patient and divided in two equal halves.Both flaps are placed as two layers in between skin and neourethra.After surgery patient is kept in ward for 10 days with stent.Patient is followed up in OPD on after 7th day after discharge for outcome.

Eligibility Criteria:
Inclusion Criteria All the patients above one year of age All patients having distal and mid penile hypospadias. -

Exclusion Criteria Severe chordee Previously operated cases Patient with undescended testis Circumcised patient

-
Policy on Optimal Epilepsy Management

This study examines the use of an online social media platform (PatientsLikeMe) to assist Veterans with epilepsy. The hypothesis is that the online social media platform, PatientsLikeMe, will improve selected patient-reported outcomes on perceived self-management skills for patients who engage in the website functions.


Eligibility Criteria:
Inclusion Criteria:

* US Veteran
* Epilepsy (Seizure Disorder)
* \>18 years

Exclusion Criteria:

-
Procedural Pain in Children: Intervention With the Hospital Clown

This study evaluates the effect of an intervention with a hospital clown compared to standard care on pain experience for acute hospitalized children receiving venipuncture. Half of the children will receive an intervention with the hospital clown while the other half will receive standard care.

Background: Hospitalized children describe the pain associated with painful procedures as one of the worst experiences during hospitalization. These experiences can be traumatic for children and their families. Most children are acutely hospitalized with no chance to prepare the child for painful procedures, while others experience repeated hospitalizations. Previous negative pain experiences are known to have major consequences for future admissions and procedures. Therefore, there is a need for different interventions for pain relief. In 2004, hospital clowns became a part of the team on pediatric wards in Denmark. International studies have shown positive effects of hospital clowns on preoperative anxiety in children, but there is limited knowledge of the impact on the child's experience related to painful procedures.

The overall purpose of this study is to investigate the effect and impact of the hospital clown as a non-pharmacological intervention on hospitalized children's pain experience and ability to cope during painful procedures in both short and long-term treatment and care.

Methods: A two-faced mixed methods study design with merging and connecting results and findings.

1. A prospective, randomized open-label trial to identify whether exposure to the hospital clown has an effect on pain experience in acute hospitalized children receiving venipuncture.
2. An ethnographic study to uncover the pain experience and ability to cope during painful procedures in short-term hospitalization.
3. An ethnographic study to uncover the influence related to repeated painful procedures, as well as uncover if a relationship may have a potential long-term impact.

Eligibility Criteria:
Inclusion Criteria:

* Acutely admitted to the hospital
* Scheduled for the venipuncture procedure
* Not prepared for the procedure before coming to the hospital
* Accompanied by at least one parent

Exclusion Criteria:

* Subjects with developmental disorders who could not cooperate with self- reporting of pain
* Subjects who were unable to speak Danish or English
Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.

This is an ascending dose study evaluating the cardiovascular safety of dexmedetomidine bolus/infusions in acutely burned pediatric patients. The study entails a bolus of dexmedetomidine, followed by 2 hours of increasing infusion doses. Cardiovascular parameters including EKG, heart rate, oxygen saturation, blood pressure, are recorded.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patient
* \>25% total body surface area (tbsa) burn and \< 90% tbsa
* opioid requirements \> 0.1 mg/kg/hour of morphine (or equivalent)
* midazolam requirement \> 0.1 mg/kg/hour
* treatment team determined that patient should be started on dexmedetomidine

Exclusion Criteria:

* hemodynamically unstable patients (epinephrine \> 1.0 ug/kg/min, levophed \> 0.75 ug/kg/min, dopamine \> 10 ug/kg/min)
* pregnant patients
* patients with history of heart block
* patients with congenital heart disease
* patients with significant hepatic dysfunction
* patients with urine output \< 0.5 ml/kg/hour \[averaged\] over past 24 hours
An Observational Study in Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)

This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for up to 12 months from start of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis
* Patients for whom the treating physician has made the decision to commence RoActemra/Actemra treatment. In Group A RoActemra/Actemra has been prescribed within 8 weeks prior to the enrolment visit. In Group B RoActemra/Actemra has been started more than 8 weeks before inclusion in the study, but not before January 2011

Exclusion Criteria:

* RoActemra/Actemra treatment more than 8 weeks prior to inclusion visit for Group A, before January 2011 for Group B
* Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Post-marketing Study to Supplement Data on Safety, Tolerability and Efficacy of Micardis® With Special Emphasis on the Control of Blood Pressure

This post-marketing surveillance study is designed to supplement under conditions of normal clinical practice data on safety, tolerability and efficacy of Micardis® collected in clinical studies with special emphasis on the control of blood pressure in the morning before intake of the next antihypertensive drug


Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension
* At least 18 years of age

Exclusion Criteria:

* NA