cyrilzakka/clinical-trials huggingface dataset:
Antiangiogenic Therapy for Children with Recurrent Medulloblastoma, Ependymoma and ATRT

Patients with relapsed medulloblastoma, ependymoma and ATRT have a very poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or combinations of these modalities. Antiangiogenetic therapy has emerged as new treatment option in solid malignancies. The frequent, metronomic schedule targets both proliferating tumor cells and endothelial cells, and minimizes toxicity. In this study the investigators will evaluate the use of biweekly intravenous bevacizumab in combination with five oral drugs (thalidomide, celecoxib, fenofibrate, and alternating cycles of daily low-dose oral etoposide and cyclophosphamide), augmented with alternating courses of intrathecal etoposide and cytarabine. The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma and ATRT, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The primary objective of the MEMMAT trial is to evaluate the activity of this multidrug antiangiogenic approach in these heavily pretreated children and young adults. Additionally, progression-free survival (PFS), overall survival (OS), as well as feasibility and toxicity will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or progressive medulloblastoma, ependymoma or ATRT (at least one site of untreated recurrent disease)
* Histological confirmation of medulloblastoma, ependymoma or ATRT at diagnosis or relapse
* Female or male, aged from 0 to \<20 years (at time of original diagnosis)
* Participants must have normal organ and bone marrow function (ALT \<5x institutional upper limit of normal, creatinine \<1.5x institutional upper limit of normal for age, WBC \>1000/mm3, platelets \> 20,000/mm3. Patients with values less than WBC 2000/mm3 or platelets 50,000/mm3 will require initiation of treatment with etoposide and cyclophosphamide at a lower starting dose as defined within the protocol.
* Karnofsky performance status ≥50. For infants and children less than 12 years of age, the Lansky play scale ≥50% will be used
* Written informed consent of patients and / or parents

Exclusion Criteria:

* Active infection
* VP-shunt dependency
* Pregnancy or breast feeding
* Conventional chemotherapy, antiangiogenic treatment or complete irradiation of all disease for current relapse (surgery may be performed before antiangiogenic treatment; patients with sites of disease not irradiated are still eligible for the protocol)
* Known hypersensitivity to any of the drugs in the protocol
* Active peptic ulcer
* Any significant cardiovascular disease not controled by standard therapy e.g. systemic hypertension
* Anticipation of the need for major elective surgery during the course of the study treatment
* Any disease or condition that contraindicates the use of the study medication/treatment or places the patient at an unacceptable risk of experiencing treatment-related complications
* Non-healing surgical wound
* A bone fracture that has not satisfactorily healed
Long-Term Study of the Effects of Navarixin (SCH 527123, MK-7123) in Participants With Moderate to Severe COPD (MK-7123-019)

Neutrophils are thought to play an important role in the pathophysiology of chronic obstructive pulmonary disease (COPD). Navarixin (SCH 527123, MK-7123) is an antagonist of the cysteine-X-cysteine chemokine receptor 2 (CXCR2) and is thought to reduce neutrophil migration to the diseased lung. It is theorized that reducing neutrophil migration to the diseased lung will improve a participant's symptoms and the natural history of the disease.

The study will consist of a 2-week screening period followed by a 2-year (104-week) double-blind treatment period. The 2-year Treatment Period will be made up of two phases: a 26-week (6-month) dose range-finding phase with 3 active arms and 1 placebo arm (Period 1), followed by a 78-week (18-month) long-term safety and efficacy phase (Period 2). Participants participating in the original 6-month study (Period 1) may elect not to continue into the 18-month extension study (Period 2).

Hypothesis: navarixin, 50 mg, or the highest remaining dose if the 50-mg dose is discontinued, is superior to placebo with respect to improving airflow.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD for at least 2 years based on American Thoracic Society/European Respiratory Society (ATS/ERS) current guidelines or symptoms consistent with COPD for at least 2 years.
* \>40 to \<=75 years of age, of either sex, and of any race.
* No exacerbation or respiratory infection in the past 6 weeks.
* Smoker or ex-smoker with more than 10 pack-year history.

Exclusion Criteria:

* Diagnosis of asthma or other clinically relevant lung disease (other than COPD), i.e., sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis, or lung cancer.
* Significant X-ray findings.
* Use of supplemental oxygen for \>12 hours/day.
Identification of an Atypical acetabuLar frActure With an Independent Roof Component: Incidence and Description

Treatment of acetabular fractures needs a perfect diagnosis to anticipate surgical difficulties. E. Letournel described a rare atypical both-column fracture which " introduces enormous surgical difficulties ". Its particularity is a sagittal comminution interesting the acetabular roof.

In this experience the particular fracture is probably under-diagnosed. The purpose of this study is to give the exact incidence and a precise description of these fractures to improve their surgical management.


Eligibility Criteria:
Inclusion Criteria:

* patient with acetabular fracture

Exclusion Criteria:

* other type of fracture
Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

This will be a randomized non-dispensing study comparing the overnight corneal swelling of an eye while wearing no contact lens to the Ultra contract lens.


Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 40 years of age (inclusive)
* Not a current contact lens wearer (have not worn extended wear, and not worn in lenses in 6 months)
* Able to read, comprehend and sign an informed consent
* Willing to comply with the wear and study visit schedule
* Monocular best-corrected distance visual acuity \>/-20/25 in each eye

Exclusion Criteria:

* Any active corneal infection, disease, injury, inflammation, past surgery, or ocular abnormality which may interfere with contact lens wear
* Systemic or ocular allergies, which might interfere with contact lens wear
* Systemic disease or condition, which might interfere with contact lens wear
* Use of prescription sleep aids or alcohol within 24 hours of study appointment
* Inability to wear contact lenses
* Under 18 years of age
Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss

This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is approved for this device. Participants receive interventions as part of routine medical care.

This study is set up to document any adverse events and comparing pre- to post-implant benefit to subjects. Any adverse events associated with the device will be documented via Advanced Bionics complaint handling system for the lifetime of the device. A within-subjects repeated-measures design will be employed. Speech perception will be evaluated preoperatively with conventional amplification to determine candidacy and to establish baseline performance. Efficacy parameters are speech perception data which will be collected according to clinical routine with a 6 month follow up period. Subjects will be implanted unilaterally with the Ultra X according to standard clinical care.

The primary efficacy objective is to demonstrate that mean monosyllabic word recognition score with the Ultra X used in combination with a sound processor programmed with the latest fitting software six months after activation is at least 20% better than the mean word score at baseline with conventional amplification in the same ear.

The primary efficacy endpoint is reached six months after device activation.

Eligibility Criteria:
Inclusion Criteria:

* No previous experience with any auditory implant
* 18 years of age or older
* Postlingual onset of severe hearing loss (≥ 4 years of age)
* Limited benefit from appropriately fitted hearing aids, defined as scoring 60% or less in Freiburger Monosyllabic word test
* German language proficiency
* Willingness to participate in all scheduled procedures outlined in the protocol

Exclusion Criteria:

* Cochlear malformation or obstruction that would preclude full insertion of electrode array.
* Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
* Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures
* Evidence of central auditory lesion or compromised auditory nerve
* Pregnancy at time of surgery.
A Trial of SHR2285 in Healthy Subjects

This is a phase 1 open-label study

This is a phase 1 open-label study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral administered SHR2285 in healthy subjects

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent.
* Be able to comply with all the requirements and able to complete the study.
* Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
* No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.
* Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration.

Exclusion Criteria:

* Receipt of any other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form).
* History of illicit or prescription drug abuse or addiction within one year of screening, or positive urine drug screen at screening and Day-1. The urine drug screen may be repeated at the discretion of the investigator and the reason for repeat needs to be documented clearly (e.g., suspicion of false positive due to diet).
* Receipt of any other investigational drugs or medical devices within 3 months prior to screening (from the date of signed consent form).
Compared With Different Method for Postcesarean Section Analgesia

The aim of this study is compare the efficacy of local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation and intrathecal injection of morphine with local anesthesic to reduce pain in women undergoing elective cesarean section under spinal anesthesia. The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.

Secondary purpose; Pain scores at 2,4,6,12,and 24 hours during movement ( moving back and forth in bed ) and rest ( lying motionless in bed )

This prospective randomized double-blind study will be planned on 46 pregnant women aged 18-50 who will undergo cesarean section with Pfannenstiel incision under spinal anesthesia with American Society of Anesthesiologists Classification (ASA) II,fullterm singular pregnancy after receiving the approval of the ethics committee of Ataturk University Medical Faculty Hospital and written approval of the patients

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* 18-50 age
* ASA II
* Fullterm singular pregnancy

Exclusion Criteria:

* Neuraxial anesthesia is contraindicated,
* Allergy to the drugs to be used in the study,
* Refused to participate in the study,
* BMI\>35 kg/m2
* ASA≥3
* Diabetes
* Preeclampsia,
* Cardiovascular disease
* Chronic pain and neuropathic pain,
* Given opioids in the operation due to intraoperative pain,
* Switched to general anesthesia,
* Excessive bleeding during the operation,
* Uterine atony
* Drain placed in the area to be infiltrated,
* History of drug addiction and psychiatric illness,
* Understand Visual analog pain scale
Evaluation of Musculoskeletal System Symptoms and Biochemical Parameters in COVID-19

The neutrophil-lymphocyte ratio (NLR) used to demonstrate inflammatory status in recent years can be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count at routine blood tests.

Dysregulation in immune responses has been reported in association with hyperinflammation in COVID-19 patients, NLR has been linked to the severity of the patient's clinical status, and an increase in NLR is reported to be an independent risk factor for in-hospital mortality. Pain is a frequently seen symptom at the onset of viral infections and throughout the course of the disease. Although the pain mechanisms triggered by viral pathogens are not yet entirely understood, pain is thought to arise as a result of direct activation of nociceptor neurons by pathogens and their interaction with molecular ligands. Toll-like receptor 7 (TLR7), a pathogen recognition receptor that plays an important role in immune responses to viruses by binding to viral RNA, is known to be involved in pain development in different RNA virus infections. Park et al. showed that extracellular micro RNAs activate nociceptive neurons via the TLR7 pathway. Although these mechanisms have been demonstrated for different viral infections, the viral pathogenesis leading to pain in COVID-19 is still unclear. The purpose of this study was to investigate the prevalence of headache and muscular pain in patients diagnosed with COVID-19 and to determine the relationship between these symptoms and inflammatory parameters.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-70
* Diagnosed with COVID-19

Exclusion Criteria:

* Patients with suspected SARS-CoV-2 infection, with two negative RT-PCR tests, hospitalized in the intensive care unit during inclusion in the study
* Musculoskeletal pains in the previous three months, with diseases capable of causing myalgia prior to diagnosis (such as fibromyalgia and inflammatory muscle disease)
* Cognitive disorders capable of preventing history-taking and physical examination such as mental disability and dementia,
* previous history of headache (migraine, tension type headache)
Prospective Assessment of the Efficacy of Hyaluronate Knee Injections in Patients With Osteoarthritis

This study looks at the effect of an injectable medication called Hyalgan on the cartilage of the knee in people who have osteoarthritis ("wear and tear arthritis") of the knee. Hyalgan is a medication which is injected into the knee, and is FDA approved to treat knee arthritis. We will be using magnetic resonance imaging (MRI) and x-rays to look at knee cartilage to see how it responds over the course of a year to the injections. A comparison to patients taking oral pain medication will be made.


Eligibility Criteria:
Inclusion Criteria:

* age 45-90
* seeking medical care for painful knee osteoarthritis
* alignment based on AP standing radiographs of neutral to 10º of valgus
* no prior surgery on the ipsilateral knee
* no history of major trauma to either knee or either hip
* no history of congenital hip dysplasia
* No history of inflammatory synovitis or crystalline arthropathy
* No history of systemic rheumatic disease
* cruciate and collateral ligament stability, defined by clinical examination
* meniscus intact (MRI grade II degenerative signal acceptable)
* Noyes compartment score: no greater than 50% of cartilage thickness over an area greater than 15mm
* If bilateral OA, the most painful knee, (as documented by VAS scale for pain) which qualifies for the study will be entered.
* If taking glucosamine chondroitin sulfate, discontinue at least one month prior to HA injections

Exclusion Criteria:

* previous IA HA injection in the ipsilateral knee
* IA steroid in the ipsilateral knee in the past 3 months
* MR evidence of inflammatory or hypertrophic synovitis
* Large joint effusion with a ballotable patella on baseline clinical exam
* Inability to safely perform MR imaging
* Active systemic infection
* Active malignancy (except non-melanomatous skin cancer)
* Allergies to HA or chicken products
* Clinical symptoms of an acute meniscal tear (locking, new acute mechanical symptoms etc...)
* A recent injury to the knee
* Radiographic evidence of Grade III or IV Kellgren and Lawrence OA
* Chondrocalcinosis on radiographs
* Unwilling to discontinue or avoid glucosamine chondroitin sulfate for the 12 month study period
* People taking blood thinners or who have bleeding problems
* Anticipated lower extremity surgery during the next 12 months
* BMI \>30 kg/m2
Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism.

The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism. This is a prospective, randomized, participant masked, crossover, bilateral dispensing study.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 42 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Self reports having a full eye examination in the previous two years;
4. Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
5. Is willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wears soft contact lens for the past 3 months minimum;
7. Has refractive astigmatism of at least -0.75DC;
8. Is presbyopic and requires a reading addition of at least +0.75D;
9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (sphere +4 to -6; cylinder -0.75 to -1.75DC; near addition +0.75 to +2.50).

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Habitually wears one of the study contact lenses;
3. Has any known active\* ocular disease and/or infection;
4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
5. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
6. Has known sensitivity to the diagnostic sodium fluorescein and/or the care product Opti-Free PureMoist being used in the study;
7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
8. Has undergone refractive error surgery. \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography

Prospective, observational, single-center study about the use of indocyanine green angiography during total thyroidectomy.

The main objective of the study is to identify a quantitative score of parathyroid vascularization as an outcome of angiography that correlates with the absence of postoperative hypoparathyroidism.

It is planned to enroll 66 patients.

Postoperative hypoparathyroidism and subsequent hypocalcemia are the most frequent complications after thyroid surgery. The incidence ranges from 19-38%, depending on the definition of hypoparathyroidism and hypocalcemia.

Although the cause of postoperative hypoparathyroidism is multifactorial, one of the most important factors is vascularization of parathyroid glands left in situ that is insufficient or impaired by surgical manipulation. Therefore, one of the goals of thyroid surgery is not only to recognize the parathyroid glands during dissection but also to respect their vascularization in order to preserve well perfused and viable glands.

The general objective of this study is to quantitatively assess the vascularization of the parathyroids following total thyroid removal.

In particular, the investigators intend to obtain data regarding parathyroid vascularization during total thyroidectomy with indocyanine green angiography. During standard surgery, angiography will be performed using a special camera after having administered intravenously indocyanine green. This technique is used to objectively assess the degree of fluorescence of the parathyroid glands.

Eligibility Criteria:
Inclusion Criteria:

* Able to sign informed consent
* Indication to total thyroidectomy
* No contraindication to indocyanine green administration

Exclusion Criteria:

* Evidence of parathyroid disease
* Allergy to iodinated contrast
* Chronic kidney failure
* Pregnancy or lactation
Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections

This study will determine whether cranberry juice is effective in reducing recurrent urinary tract infections (UTIs) in women who have had a UTI within the past year.

UTIs are a common problem among young women, resulting in considerable morbidity and health care costs. Increasing resistance to antibiotics is making treatment of these infections even more problematic. Therefore, safe and effective nonantimicrobial prevention strategies are needed. One approach that appears to be effective is the use of cranberry products. However, data on the safety and effectiveness of cranberry products are limited. This study will determine whether cranberry juice can reduce UTIs in women.

Participants will be randomly assigned to receive either cranberry juice or a placebo drink daily for 6 months. Study visits will occur every month for the 6-month treatment phase of the study. At study entry and at each study visit, urine collection will occur and vaginal swabs will be taken. A rectal swab will be taken at study entry and at the Month 2 and 4 visits. Participants will be asked about medication usage, any side effects they may be experiencing, and diet at each study visit. If participants develop a UTI at any time during the study, they will be asked to visit the study site within 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* At least one UTI within 12 months prior to study entry
* Premenopausal
* Agree to avoid all foods that contain plants from the genus Vaccinium (related to cranberries) for the duration of the study

Exclusion Criteria:

* Anatomic abnormalities of the urinary tract
* History of kidney stones
* Bacteria in the urine (bacteriuria)
* Use of prophylactic antibiotics within 7 days prior to study entry
* Use of investigational drugs within 30 days prior to study entry
* Current use of warfarin
* Diabetes
* Cancer. Participants with skin cancer are not excluded.
* Allergy or intolerance of cranberry products
* Symptomatic vaginitis
* Pregnant or breastfeeding