cyrilzakka/clinical-trials huggingface dataset:
Study on AUNIP as a Novel Tumor Marker for Cervical Cancer

To detect the expression of AUNIP in cervical cancer serum, and to clarify its diagnostic and prognostic value.

Blood of all study participants of cervical cancer patients are collected to detect the expression of AUNIP, analyze the statistical correlation between the expression of cervical cancer AUNIP and clinicopathological parameters of patients, and preliminarily understand the expression of AUNIP in cervical cancer tumor tissues and its clinical diagnostic and progniostic value.

Eligibility Criteria:
Inclusion Criteria:

Study group inclusion criteria:

* Women aged 20-60
* There is a definite pathological diagnosis of cervical cancer

Healthy control group:

* Women aged 20-60
* No tumors in the uterus or other parts of the body
* No inflammatory disease
* Blood routine and blood biochemical tests are normal

Exclusion Criteria:

Exclusion criteria of the study group:

* There are other lesions in the uterus and uterine adnexa

Exclusion criteria of healthy control group:

* Pregnant, lactating or menarche women
* Women who are undergoing human papillomavirus (HPV) vaccination
Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers

Alzheimer disease is hard, long and expensive to diagnose. In order to help the clinician, a new biomarker in Alzheimer disease seems to be very useful. The retina, as a window of the brain, could offer a new way to diagnose this common disease. Indeed, a retinal atrophy could especially appear in Alzheimer disease. Besides, many aspects about retinal alteration, visual function and their link with the disease deserve to be more explored. So as to fill these gaps, a new study about retinal specificity in Alzheimer disease appears to be relevant.


Eligibility Criteria:
Inclusion Criteria:

* Patients having a consultation in the Research and Resources Memory Center of Amiens (RRMC) ,
* patients registered in the Alzheimer National Bank and having an Alzheimer Disease based on NIA-AA (McKahnn2011)and IWG2 (Dubois et al, 2014) criteria or, having a Lewy body disease based on revised criteria of McKeith et al 2020
* patients having a complete neuropsychological evaluation including a visual inspection time.
* patients having a MMSE ≥ 18/30 so as to ensure a good homogeneity of the group and to have an adequate ocular exam's quality.
* patients having an available MRI in the CHU's database including a 3DT1 sequence
* patients having a visual acuity better than 5/10, spherical refraction of +/- 5D, an astigmatism \< 3D and an applanation IOP \<22mmHg

Exclusion Criteria:

* Any other neurocognitive disorder
* Any other optical neuropathy including glaucoma
* All kind of retinal disease (diabetic retinopathy, age-related macular degeneration...)
* Diabetes mellitus
* Uncontrolled hypertension blood pressure
* Any ophthalmological conditions interfering with a good ocular examination or OCT quality (cataract, corneal opacity..)
* Severe dementia preventing a good ophthalmological examination
* Not consenting patient
* Patient with guardianship or curatorship having symptoms preventing a good ophthalmological examination (agitation, unstable ocular fixation)
Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy

The development of Immune Checkpoint Blockade (ICB) is a revolution in medical oncology as ICB have changed the standard treatments of several metastatic tumor types. However, the response rate to ICB is low, and the biological bases for this response heterogeneity are poorly understood.

In the frame of Immunosup study, we will collect blood (at baseline, post infusion of ICB n°2/4/8 and at progression) and tumor samples (optional: at baseline and progression) from patients with locally advanced or metastatic cancer, treated with ICB, in order to determine if the dynamics of immunosuppressive actors (MDSC, TReg, Immunosuppressive cytokines) predicts response to these immunotherapies.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Diagnosis of locally advanced or metastatic solid tumor or lymphoma treated with Immune check blockade
* Signed informed consent
* Affiliated to(or beneficiary of) the French Social Security

Exclusion Criteria:

* Pregnant or breastfeeding woman or woman who does not apply effective contraception
* Emergency
* Vulnerable person or unable to provide informed consent
* Emergency
* Person unable to comply with required study follow up
* Contraindication to the study procedure
Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome

Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment. This study will enroll approximately 90 male and female pediatric subjects clinically diagnosed with Tourette Syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Have a clinical diagnosis of Tourette Syndrome (TS)
2. Have at least moderate tic severity
3. Have TS symptoms that impair school, occupational, and/or social function
4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder \[OCD\], Attention-Deficit Hyperactivity Disorder \[ADHD\]), be on stable doses
5. Be in good general health
6. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen
7. Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study

Exclusion Criteria:

1. Have an active, clinically significant unstable medical condition within 1 month prior to screening
2. Have a known history of long QT syndrome or cardiac arrhythmia
3. Have a known history of neuroleptic malignant syndrome
4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
6. Have a blood loss ≥250 mL or donated blood within 30 days prior to screening
7. Have a known history of substance dependence, substance (drug) or alcohol abuse
8. Have a significant risk of suicidal or violent behavior
9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
10. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
Trimetazidine Efficacy in Attenuating Paclitaxel-Induced Peripheral Neuropathy

This proof-of-concept study evaluated the effect of Trimetazidine on the incidence of paclitaxel-induced peripheral neuropathy in patients with breast cancer.

Chemotherapy-induced peripheral neuropathy (CIPN) is a major adverse effect of many commonly used chemotherapeutic agents that greatly affect patient quality of life. Paclitaxel (PTX), one of the main neurotoxic classes of anticancer drugs, is used to treat several types of solid tumors, including breast cancer. Development of PTX-induced peripheral neuropathy (PIPN) during cancer treatment requires dose reduction limiting its clinical benefits.

The only currently recognized prophylactic measure for chemotherapy-induced peripheral neuropathy (CIPN) is monitoring for pre-existing neuropathies and then the early detection of clinical symptoms of neuropathy in subjects undergoing neurotoxic chemotherapy treatment.

Preclinical data has shown that the neuroprotective effect of trimetazidine (TMZ) can attenuate PIPN.

TMZ has preclinical evidence about its preventive capacity against peripheral neuropathy. Which represents a possible prophylactic strategy for attenuating PIPN. TMZ is commercially available in various preparations that are relatively affordable and well-tolerated, making it a valid candidate for clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients who will receive paclitaxel.
* Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
* Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin \<1.5 mg/dl), renal function (creatinine \< 1.5 mg/dl).

Exclusion Criteria:

* Patients with signs and symptoms of clinical neuropathy at baseline.
* Patients with diabetes mellitus, alcoholic disease, heart failure, pregnant or lactating women.
* Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
* Patients with contraindications to trimetazidine including Parkinson's disease, Parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
Intra-op vs Pre-op Transbronchial Localization for Small Lung Nodule

Comparing pre-operative transbronchial localization under augmented fluoroscopy and intra-operative transbronchial localization using electromagnetic navigation bronchoscopy system for small lung nodules.

Using electromagnetic navigation bronchoscopy (ENB), transbronchial localization can be performed in the operating room (OR) under general anesthesia without extra radiation exposure, which is expected to reduce the discomfort for the patient during localization. This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital. It is expected that 40 patients with pulmonary nodules will be randomly assigned into two groups. One group will receive bronchoscopic dye localization in the hybrid examination room equipped with cone-beam computed tomography, and the other group will receive ENB-guided dye localization in OR. The primary goal of the study was to compare the localization duration of the two groups of patients, the total dose of radiation exposure during localization and the incidence of location-related complications, and the secondary goals were the results of the surgical procedure, including the surgical duration.

Eligibility Criteria:
Inclusion Criteria:

A. One of each: lung nodule size less than 1 cm; depth more than 2 cm; GGO lesion B. 20\~90 years old C. sign permit

Exclusion Criteria:

A. Previous emphysema, TB, COPD B. Previous ipsilateral thoracic surgery C. Bleeding tendency D. Heart failure, cirrhosis, CKD E. Pregnancy or breast feeding F. Immunocompromised G. Severe infection H. Unable to sign permit
Balance in Children With Cochlear Implants

Cochlear implantation is performed in children with sensorineural hearing loss to restore hearing. Fifty percent of children with sensory neural hearing loss, who are candidates for cochlear implant, have vestibular (inner ear) dysfunction prior to surgery. Anatomically, the cochlea, semicircular canals, and otolith organs are located in close proximity in the inner ear and any procedure in the cochlea may affect the vestibular system, resulting in subsequent balance impairment. In addition, the process of implantation often results in further suppression of vestibular function necessary to develop normal balance. Vestibular dysfunction predisposes these children to balance impairments that can affect the normal development of gross motor skills such as sitting, standing, and walking. These balance and gross motor deficits may predispose the child to difficulties with safe community participation resulting in lower quality of life for the child and family.

Evidence in the literature suggests that children with vestibular loss do not recover to the same levels as their peers, especially in the area of activities requiring vestibular input for balance.

The purpose of this descriptive study is to examine balance, vestibular function, and gross motor skills in children following cochlear implantation over a period of one year. Children, ages 1 year to 5 years will be tested post cochlear implant , and at 6 and 12 months subsequent to initial testing, using clinically based tests of vestibular impairment (head impulse test, post rotary nystagmus or head shake nystagmus), balance (Pediatric Balance Scale) and gross motor skill development (Peabody Developmental Motor Scales, 2nd edition). Quality of life will be assessed using the Life-H (Assessment of Life Habits).


Eligibility Criteria:
Inclusion Criteria:

1. The Child must be a child between 12 months and 71 months of age.
2. The child should have received a cochlear implant within the previous year.
3. The child should be able to stand unsupported for 4 seconds.
4. Follow simple one step directions.

Exclusion Criteria:

1. Uncontrolled seizures
2. Any physician-recommended activity limitations that would preclude performing activities in the testing protocol.
3. Testing will not occur when the child is or has been acutely ill (i.e. fever, ear infection, etc.) within the previous week.
4. The participant must not have a known medical or developmental diagnosis that impacts his or her motor skills (i.e.

cerebral palsy, Down Syndrome) -
Does Vascular Endothelial Growth Factor (VEGF) or Complement Factor H Gene Polymorphism Play a Role in the Treatment Success With VEGF Inhibitors in Patients With Choroidal NeoVascularization (CNV)?

Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic component. Most importantly a genetic polymorphism in the gene encoding for the complement factor H (CFH) has been recently identified which is highly associated with an increased risk of developing AMD. This Tyr402His polymorphism located on chromosome 1q31 has been implicated to play a role in the development of the disease.

For this purpose a total of 200 patients with wet AMD will be included in the study. As described in detail below, the current study aims to identify potentially non-responders to anti-VEGF therapy based on genetic analysis of VEGF polymorphism and complement factor H polymorphism.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 50 years
* Angiographically verified neovascular AMD
* Active primary or recurrent subfoveal lesion with CNV secondary to AMD
* Activity to be proven by fluorescein angiography
* Best corrected visual acuity assessed using ETDRS charts of 20/40 to 20/320 in the study eye
* CNV to be treated with intravitreal ranibizumab
* Signed informed consent

Exclusion Criteria:

* Prior treatment with any intravitreal drug in the study eye
* Prior treatment with verteporfin photodynamic therapy in the study eye
* Prior treatment with systemic bevacizumab
* Prior treatment with any intravitreal drug or verteporfin photodynamic therapy in the non-study eye within the 3 moths before the study entry
* Laser photocoagulation within 1 month before study entry in the study eye
* Previous participation in any clinical trial within 1 month before the entry of the study
* Subfoveal fibrosis or atrophy in the study eye
* CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathological myopia
* Retinal pigment epithelial tear involving the macula in the study eye
* Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss of best corrected visual acuity over the 12 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma). The decision on exclusion is to be based on the opinion of the local principal investigator.
* Active intraocular inflammation
* Acute angle-closure glaucoma or narrow angle glaucoma due to the risk of IOP elevation caused by the administration of tropicamide
Mohs Micrographic Surgery and Reconstruction in the Optum Insurance Claims Database

Mohs micrographic surgery (MMS) followed by skin reconstruction has been widely accepted for treatment of many skin cancers. To further characterize the trends in MMS and reconstruction for skin cancer, a retrospective analysis will be performed using the Optum© Clinformatics® DataMart de-identified commercial claims database from 2001-2016. The findings may provide critical data for future prospective studies in skin cancer treatments.


Eligibility Criteria:
Inclusion criteria:

- All patients in the Optum© Clinformatics® database who have an ICD9 or ICD10 code for skin cancer and a corresponding CPT code specific for interpolated flap reconstruction

Exclusion criteria:

- All patients for whom cost data is missing in the Optum© Clinformatics® DataMart
Avastin for CNV Secondary to Pattern Dystrophy

The natural history of subfoveal CNV secondary to Pattern Dystrophy is little understood, but it seems that visual function may be preserved only in the short-term follow-up, with progressive deterioration thereafter.

Photodynamic therapy with verteporfin is the most studied therapeuthic option for this kindf of lesion, but unfortunately, this approach does not appear to guarantee long-term vision stabilization, and alternative therapies should be investigated.

Diagnosis of Pattern Dystrophy Diagnosis of subfoveal CNV Intravitreal injection of avastin (1.25 mg) in operating room under sterile condition.

Retreatment on the basis of the detection of disease progression and of lack of central retinal thickness reduction on OCT.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of RPD (hyperpigmented yellowish-greyish network, other family members sharing RPD, normal electroretinogram and normal/subnormal electrooculogram)
* classic or occult CNV involving the foveal avascular zone's geometric centre

Exclusion Criteria:

* conditions other than RPD
* intraocular surgery or capsulotomy within the last 2 or 1 months
* pregnancy
An Intervention With Weighted Blankets for Children With ADHD and Sleep Problems

The aim of the study is to evaluate a sleep intervention with weighted blankets for children with ADHD and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness.

The study is an RCT with cross-over design. The participants will be randomized to start with an active or placebo blanket, and then change blankets during the 16 week study period.

There is limited evidence about health outcomes or health-economic benefits of sleep interventions with weighted blankets for children with neuropsychiatric syndromes (NPS).

The aim of the study is to evaluate a sleep intervention with weighted blankets for children with ADHD and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness.

The participants, n=100 children between 6 and 13 years old, will be recruited from the ADHD unit in Child and Adolescent Mental Health Service (CAMHS) and randomly assigned into two groups: Fiber Weighted Blankets (intervention 1) and Control Blankets (controls).

The children will use each blanket respectively for 4 weeks, then change blankets. A long term follow-up will be conducted 16 weeks from baseline.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with ADHD with sleep problems (defined by screening instrument). -
* Being a patient at child and adolescent mental health service (CAMHS) in Region Halland, Sweden.
* Parents and children should understand (written and spoken) Swedish language.

Exclusion Criteria:

* Already used weighted blankets as a sleep intervention,
* If they have received a new prescription or change of pharmacological treatment for sleep problems
Bringing Advocacy Via Digital Guide to the Emergency Department (Project BADGE)

The pilot study of Project BADGE will focus on emergency department (ED) patients with diabetes, which has significant disparities in prevalence and mortality for underserved populations. The objective is to determine the effect of a text-based resource referral platform with diabetes educational materials on patient diabetes knowledge, diabetes distress, diabetes self-care activities, and acceptability and feasibility of the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (18+) ED/observation unit patients
2. Have poorly controlled or new onset diabetes (hyperglycemia or Diabetic ketoacidosis (DKA))
3. Speak English or Spanish
4. Has a cell phone able to send and receive text messages

Exclusion Criteria:

1) Intubated patient
Using the Blood Pressure TRU in Clinical Settings: a Knowledge Translation Study

Context: Use of automated blood pressure (BP) measurement devices in the office setting is increasingly recognized as superior to manual BP measurement. Current recommendations are to have the patient alone in a quiet room, with no interactions with health care professionals during the readings. However, this may not be practical in primary care offices where the exam rooms are constantly being used.

Objective: To compare measurements with an automated BP device in private examination rooms with measurements in non-private areas of a primary care office.

Design: Randomized controlled trial with cross-over.

Setting: Community based primary care office participating in the NorTReN Practice Based Research Network in Toronto, Ontario.

Participants: Fifty consecutive consenting patients over the age of 18 having their BP checked as part of their routine care.

Intervention: Patients will be randomly allocated to either automated BP measurement in an exam room, or in a non-private area of the clinic. After being tested in the first location they will subsequently be tested in the second location with the same device.

Main outcome measure: The primary outcome measure is a comparison between the mean systolic values of the automated BP measurements in the two office areas. The investigators will use the t-test for paired samples. The secondary outcome is a comparison of systolic values for patients with previously documented hypertension. The investigators define a clinically meaningful result as a difference of 5 mmHg or more in systolic BP.

Conclusion: New technology is more readily adopted if barriers to use are minimized. If the investigators find no differences in BP readings between office locations, physicians will then have the convenience of an additional office area to implement the automated BP measurement device.


Eligibility Criteria:
Inclusion Criteria:

* Able to consent
* Over the age of 18
The Clinicopathological and Prognostic Factors of Hepatocellular Carcinoma; 10 Years' Tertiary Center Experience in Egypt

This study aimed at study the clinical and pathological criteria of Hepatocellular carcinoma to keep with new challenging in diagnosis and morpho-molecular classifications


Eligibility Criteria:
Inclusion Criteria:

* All pathologically proven Hepatocellular Carcinoma

Exclusion Criteria:

* Other malignant tumors than Hepatocellular Carcinoma
* Benign tumor
AZD5672 Absolute Bioavailability Study

The purpose of the study is to estimate the absolute bioavailability at steady state of 2 doses of AZD5672 (50 mg and 150 mg administered orally once daily)


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Females should not be of childbearing potential
* Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate
* Unsuitable venous access for intravenous studies
* Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).