cyrilzakka/clinical-trials huggingface dataset:
NA-AION Risk Factors: New Perspectives

The purpose of the study is to use new diagnostic methods (OCT and OCT-A) to shed light on risk factors for the development of NA-AION. The risk factors we are focusing on are comorbidities along with anatomical and vascular characteristics of the optic nerve.

Non-arteritic anterior ischemic optic neuropathy (NA-AION) is the most common acute optic neuropathy in the middle-aged and elderly population and can also occur in children and young adults. NA-AION leads to irreversible vision loss, and there is currently no effective treatment. In recent years, acellular calcified deposits in the optic nerve head called optic disc drusen (ODD) have been investigated as an important risk factor for NA-AION in patients under the age of 50.

The purpose of the study is to use new diagnostic methods optical coherence tomography (OCT) and OCT-angiography (OCTA) to shed light on risk factors for the development of NA-AION. We will perform two sub-studies:

1. Characteristics of the optic nerve head anatomy including the presence of ODD as risk factors for the development of NA-AION.
2. Vascular comorbidities and in vivo vasculature as a risk factor for developing NA-AION.

The study is an international prospective multicenter study including 20 sites in 9 different countries. The study population is patients diagnosed with NA-AION in a 1.5-year inclusion period. Each included patient gets 1-2 follow up visits during a 3-month follow up time.

Included patients will be examined as per standard clinical care for that site including OCT and OCT-A. Standard clinical care includes at least: obtaining medical history, measurement of visual acuity, slit lamp examination, and automated perimetry.

Characteristics and risk factors in NA-AION patients with ODD (ODD-AION) will be compared with NA-AOIN patients without ODD (nODD-AION).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of first episode of NA-AION in study eye with symptom onset within 1 month prior
2. Subject age: Age \>10
3. NA-AION diagnosis requires:

   * disc edema seen by site PI or by referring doctor
   * visual field defect in the study eye consistent with NA-AION and mean deviation worse than 3.0 dB using the study visual field examination protocol
   * relative afferent pupillary defect (unless the fellow eye had previous NA-AION or other optic nerve or retinal disease that is not exclusionary)

Exclusion Criteria:

1. Previous episode of NA-AION in the study eye only
2. Intraocular pressure of \>21 mm Hg in the study eye
3. Clinical or pathological evidence of giant cell arteritis
4. Diseases that may affect the optic nerve: glaucoma, multiple sclerosis, Alzheimer disease, and Parkinson disease. Evidence of optic disc drusen and optic nerve hypoplasia are not exclusion criteria given they are important parts of the study. We will not exclude significant retinal diseases, since they may be related to underlying etiologies giving rise to ODD, such as macular degeneration, retinal dystrophies, but eyes with significant retinal diseases will be analyzed separately.
Different Learning Methods of Motor Control Exercises

This study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.

For see the full effect of exercise treatment, exercise adherence should be high. In patients with chronic non-specific low back pain, the complex nature of the core-stabilization exercises decrease the exercise adherence. Some novel studies show that multimedia learning can increase efficiancy of complex skill learning and can be better from classic face to face learning.

So this study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Chronic (\>3 month), non-specific low back pain
* 25- 55 years old
* Have a capacity can understand exercise instructions (Montreal Cognitive Assessment \> 21)
* Being a computer literate

Exclusion Criteria:

* Root nerve signs
* Cauda equina syndrome
* Fracture in the vertebra
* Tumour
* Have a neurologic disease
* History of spine surgery
* Knowing motor control exercises
* Visual impairment
* Hearing loss
Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy

This trial is being conducted to assess the effects of Rotigotine over Placebo on improvement of Apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson´s Disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with early or advanced idiopathic Parkinson's Disease
* Patients with advanced idiopathic Parkinson's Disease: intake of Levodopa on a stable dose of at least 200 mg/day
* Unsatisfactory control of Parkinson's Disease motor symptoms under current treatment
* Patients experiencing Apathy associated with Parkinson's Disease
* Hoehn and Yahr stage score of I to IV
* Mini-Mental State Examination score ≥ 25
* If an antidepressant drug is taken, the dose must be stable

Exclusion Criteria:

* Therapy with a Dopamine agonist
* Discontinuation from pervious therapy with a dopamine agonist after an adequate length of treatment, at adequate dose, due to lack of efficacy
* Any medical or psychiatric condition that jeopardizes / compromises patient's ability for participation
* Patient has received Neuroleptics, Dopamine releasing substances, Dopamine modulating substances, Alpha-Methyldopa, Metoclopramide, MAO-A inhibitors, Budipine, or Tolcapone
* Electroconvulsive therapy
* Patient has a

  * current/anticipated psychotherapy or behavior therapy
  * history of deep brain stimulation
  * history of suicide attempt or has suicidal ideation
  * impulse control disorder
  * severe Depression
Maternal and Neonatal Microbiome

The aim of the study is to characterize and monitor the microbiome of premature infants born in the investigators facility until discharge from the NICU. The investigators will also examine the relationship between mode of delivery and the microbiome of the infant, while exploring various possible factors that may affect it. In addition, the investigators will compare the microbiome of premature infants to the microbiome of term babies born at the same time in the same facility.


Eligibility Criteria:
Inclusion Criteria:

* Premature infants ≤ 34 weeks of gestation admitted to the Neonatal Intensive Care Unit at Hadassah University Hospital, Mount Scopus and their mothers.

The control group:

* Neonates ≥ 37 weeks gestation of which 50 were delivered vaginally and 50 by Caesarean section at Hadassah University Hospital, Mount Scopus and their mothers.

Exclusion Criteria:

* Neonates with congenital anomalies or metabolic conditions.
A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients

The primary objective of this study is to determine the dose of aflibercept to be further studied in combination with docetaxel in Japanese cancer patients.

The secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cancer patients without standard of care
* ECOG performance status 0 or 1
* Adequate organ and bone marrow function

Exclusion Criteria:

* Need for a major surgery or radiation therapy during the study
* History of hypersensitivity to docetaxel or polysorbate 80
* Treatment with chemotherapy, hormonal therapy, radiotherapy within 28 days
* Uncontrolled hypertension
* History of brain metastases
* Ascites requiring drainage
* Pregnancy or breastfeeding
* Patients who have previously been treated with aflibercept.

The investigator will evaluate whether there are other reasons why a patient may not participate.
Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

This study is being conducted to decrease the rate of surgical wound complications. The investigators are studying the effects that caloric restriction has on decreasing the rate of surgical wound complications.

The goal is to decrease the chance of having wound complications after surgery. Caloric Restriction has been found to be a natural modifier of surgical outcomes. Participants will be randomize into the arms Caloric Restriction Diet or Normal Diet.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Biopsy proven soft tissue sarcoma located in the lower extremities
* Patient to be treated with radiation therapy for a primary lower extremity soft tissue sarcoma or recurrent tumor after surgery, followed by surgical resection
* Karnofsky Score ≥ 60%
* Body Mass Index (BMI) ≥ 20 kg/m2
* Protein levels within normal limits within 45 days of enrollment
* Normal kidney and liver function within 45 days of enrollment
* Normal blood counts within 45 days of enrollment
* Normal chemistries within 45 days of enrollment

Exclusion Criteria:

* Current pregnancy and breast feeding
* Other cancers diagnosed within the last 5 years (in situ and/or invasive)
* Diabetes mellitus
* Current metformin therapy
* Other conditions may exclude participants from the study (e.g. intractable nausea/emesis, allergic reaction to shake, patient decides not to have surgery, any medical condition that prevents patient from having surgery)
A Study to Investigate Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis

The study is designed to investigate efficacy and safety of KBL697 in patients with Moderate Plaque Type Psoriasis. KBL697 has been developed as a potential new treatment for Psoriatic Plaque.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 75 years (inclusive)
* Have a diagnosis of plaque type psoriasis for ≥ 6 months
* Must have chronic plaque type psoriasis of moderate severity
* All subjects must agree and commit to the use of a reliable contraceptive regimen.

Exclusion Criteria:

* Current diagnosis of forms of psoriasis other than chronic plaque type only
* Drug-induced psoriasis
* Other inflammatory skin disease that may confound the evaluation of plaque psoriasis
* Failed 2 or more systemic treatments for plaque psoriasis
* Medicinal shampoos that contain tar and/or salicylic acid within 2 weeks prior to Baseline Visit
Study on Wood-plastic Composite for Circumferential Casting

The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.

An ecologically friendly and biodegradable wood-plastic composite-cast is studied. The purpose of the study is to verify that WOODCAST Circular system performs safely and effectively in its intended use. Patients, who need immobilization of extremity (including for example scaphoid fracture of the wrist or ankle fracture) will be participating in the study. Various casting techniques with novel WOODCAST material will be studied.

Eligibility Criteria:
Inclusion Criteria:

* patient treatment involves circular casting;
* age 0-90 years;
* mother tongue finnish or swedish

Exclusion Criteria:

* open fracture;
* other fractures or a previous fracture;
* a previous or simultaneous tendon-, nerve-, or vascular injury to the extremity yo be treated;
* a multiple injured extremity;
* decreased co-operation of the patient;
* malignancy;
* an illness affecting the general health.
Observing the Relationship of Fibroblast Growth Factor and Fibroblast in Thyroid Eye Disease

Graves' orbitopathy (GO) affects about 50% of patients with Graves' disease (GD), and some cannot be cured by current treatments. Orbital fibroblasts involves in the pathogenesis of GO by producing glycosaminoglycans and inflammatory cytokines. Since fibroblast growth factors (FGFs) binding to FGF receptors (FGFRs) can induce proliferation and differentiation of fibroblasts, investigators would like to measure the expression of FGFs and FGFRs in GO patients to see if inhibition of FGF-FGFR pathway has potential in treatment.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed as thyroid eye disease
* suggested to accept orbital decompression

Exclusion Criteria:

* age below 20 or above 80
* pregnancy
Return to Play Criteria After Shoulder Dislocation in Upper Limb Athletes: Critical Analysis Between the Habits of Medical Professionals and the Literature

Purpose: Identify the criteria employed by sports medicine specialists in assessing the aptitude/inaptitude of an overhead athlete to return to competition following an antero-internal dislocation of the glenohumeral joint that has been operated or not.

Materials and methods: The target population consisted of French-speaking physicians in orthopedic surgery, physical medicine and rehabilitation or sports medicine. This study was conducted by the means of a questionnaire. The list of the most relevant criteria to be included in the questionnaire was established following a literature review.


Eligibility Criteria:
Inclusion Criteria:

* Professions: physicians in orthopedic surgery, physical medicine and rehabilitation or sports medicine.
* Language: French

Exclusion Criteria:

* Other professions
The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy (CP)

The purpose of this study is to compare the Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scale Gastrointestinal Symptoms Scale (GI-PedsQL) differences , to assess the differences in stool microbiome and stool metabolomics , to assess differences in salivary cytokine profile , to assess differences in weight change , to compare the use of antacid medications and to compare the use of laxative medications in patients on commercial formulas (CF) versus commercial blenderized tube feed (CBTF).


Eligibility Criteria:
Inclusion Criteria:

* Patients with CP receiving \>75% of total daily caloric requirements from commercial formulas (CF) via a gastrostomy tube 12french or greater
* Patients' insurance covers a CBTF
* Diagnosis of cerebral palsy

Exclusion Criteria:

* Receiving enteral nutrition by transpyloric feeds or jejunal tube.
* Receiving \<75% of total daily energy requirements from a commercial formula
* Weight or weight for length or body mass index less than the 5th percentile for age or greater than the 85th% percentile for age when plotted on the cerebral palsy growth chart
* Rapidly progressive neurodegenerative disease diagnosis
* Use of monomeric formulas
Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.

The study was designed to evaluate the efficacy and safety of different forms of neoadjuvant intense androgen deprivation therapy (ADT) compared with ADT alone, followed by prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

1. All patients must have been histologically diagnosed of prostate cancer and must be eligible for radical prostatectomy.
2. All patients must undergo thorough tumor staging and meet one of the following criteria: a) multi-parameter MRI or PSMA PET/CT shows clinical staging of primary tumor ≥ T3; b) Gleason score of primary tumor ≥ 8; c)prostate specific antigen(PSA) ≥20 ng/ml; d) Imaging evaluation shows regional lymph node metastases (N1).
3. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
4. Patients must have adequate hematologic function, hepatic function, renal function and cardiac function.
5. Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must bewilling to obey the prohibitions and restrictions specified in the research protocol.
6. Fertile patients must be willing to use highly effective contraception during the study period and within 120 days of the last dose of treatment.

Exclusion Criteria:

1. Patients with neuroendocrine, small cell, or sarcoma-like pathologic features are not eligible.
2. Patients with low-risk or medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: a) multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor \< T3; b) Gleason score of primary tumor \< 8; c) prostate specific antigen (PSA) \<20 ng/ml.
3. Patients with clinical or radiological evidence of extra-regional lymph node metastases or bone metastases or visceral metastases (any M1) are not eligible.
4. Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment, radiotherapy, chemotherapy for prostate cancer are not eligible.
5. Patients with severe or uncontrolled concurrent infections are not eligible.
6. Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
7. Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
8. Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
9. Patients with mental illness, mental disability or inability to give informed consent are not eligible.
Tocilizumab for Relapsing Polychondritis

This is a study for one patient with severe relapsing polychondritis which has been unresponsive to other more conventional medications including prednisone, methotrexate, anakinra and TNF inhibitors. Tolerability, and efficacy of the drug, Tocilizumab will be monitored by clinical assessment and bloodwork.


Eligibility Criteria:
Inclusion Criteria:

* A single patient with unremitting inflammatory relapsing polychondritis

Exclusion Criteria:

* As this is a study in a single patient, there are no exclusions
Prognostic Value of Serum Cholesterol and Triglyceride in Septic and Non Septic Patients

The primary outcome of this study is to evaluate the difference between the level of serum cholesterol and triglyceride in septic and non septic patients in the ICU. .

The secondary outcome will be to find correlation between the level of serum cholesterol and triglyceride and both Acute physiology And Chronic Health Evaluation Score (APACHE) II(19) and quick Sequential Organ Failure Assessment (qSOFA) score (20) and their relation to mortality.

Type and Site of The study:

This study will be be done at Beni-Suef university hospital SICU after approval of the local ethics and research committee and anesthesia department of Beni-Suef University.

DATE AND PERIOD OF THE STUDY:

The study will be done between June 2017 and June 2018

Study population:

The study population will include the patients (age range between 20 and 70)of both sex (septic and non septic patients e.g. trauma patients, post surgical patients) who will be admitted to the surgical intensive care in Beni Suef University hospital.

Sample size estimation:

Sample technique:

The patients will be randomly assigned into two groups, septic patients (groups) according to established consensus definitions (21) or non septic patients (NS) as post surgical and trauma patients.

The following data will be recorded for each patient: age, sex,weight, cause of ICU admission, administration of vasoactive drugs, length of ICU stay, 28-day mortality, administration of vasoactive drugs, days on mechanical ventilation, Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, quick Sequential Organ Failure Assessment (qSOFA) scores will be recorded.

The following laboratory data will be measured:

cholesterol, triglyceride on days 0 (ICU admission), 1, 3, and 7, 10 and 14.

Eligibility Criteria:
Inclusion Criteria:

* The study population will include the patients (age range between 20 and 70) of both sex (septic and non septic patients e.g. trauma patients, post surgical patients) who will be admitted to the surgical intensive care in Beni-Suef University hospital

Exclusion Criteria:

* Age less than 20
* Pregnancy
* ICU readmission
* Dyslipidemia
* Patients with liver disease e.g.hepatitis B,hepatitis C , liver cirrhosis, and hepatocellular carcinoma)
* Concomitant of use immunosuppressive therapy
* Using statin or steroid (≥15mg/day) within the previous 7 days
* Patients who had been treated with corticosteroid therapy for septic shock prior to admission to ICU
* Patients sedated by propofol
Exercise and Nutrition Interventions for Platinum Chemotherapy-induced Neuropathy R21

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.


Eligibility Criteria:
Inclusion criteria (subjects must...)

1. Have a diagnosis of cancer
2. Be scheduled to receive platinum chemotherapy (specifically oxaliplatin or cisplatin) without other neurotoxic chemotherapy (taxanes, bortezomib, thalidomide). Patients may be enrolled before their first (preferred), second, or third infusion of neurotoxic chemotherapy
3. Be able to read English
4. Be ≥18 years

Exclusion criteria (subjects must not...)

1. Be performing regular exercise, which is any planned physical activity (e.g., brisk walking, aerobics, jogging, bicycling, swimming, rowing, weight lifting, resistance training, yoga, pilates, etc.) performed to increase physical fitness. To be considered exercise, physical activity should be performed 3-5 times per week for 20-60 minutes per session and should be done at a level that increases your breathing rate and causes you to break a sweat.
2. Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.
3. Have planned surgery or radiation treatment in the 12 weeks after baseline.

Additional exclusion criteria only for patients completing MRI (approximately 40 of 60 enrolled subjects; subjects must not...)

1. Have current or prior cancer in the spine, brainstem, or brain (to allow standard brain MRI analysis)
2. Have contraindications for MRI scanning (pacemaker, ferrous metal implants, pregnancy, etc. note that most port-a-caths are safe for MRI scanning)