cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Thioctacid Oral Tablets 600mg to Treat Chinese Diabetic Patients With Distal Symmetric Polyneuropathy

The purpose of the study is to evaluate the efficacy on overall neuropathic sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with distal symmetric polyneuropathy (DSP).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must fulfil all of the following criteria to be appropriate to enter into Registry (Visit 2)

  1. Provision of informed consent
  2. Females and males aged from 18 to 75 (inclusive), who were definitely diagnosed with diabetes
  3. HbA1C\< 10％
  4. Moderate neuropathy according to Neuropathy Disability Score (NDS) \>= 4 points. Difference in score between left and right foot is not to be higher than 2 points
  5. Total Symptom Score (TSS) \> 6.5 points
  6. At least one of the four symptoms of the TSS has occurred continuously over the last 3 months before screening
  7. Other concomitant treatments (the drugs and their dosage) have been stable over 1 month before screening Subjects must fulfil all of the following criteria before randomization：
  8. TSS \> 5 points
  9. TSS range (maximum TSS - minimum TSS during Run-in Period) \< 3 points during the Run-in Period
  10. Compliance in Run-in Period \> 85%

Exclusion Criteria:

1. Neurologic disease other than diabetic neuropathy that may produce weakness, sensory loss, or autonomic symptoms or test abnormality
2. Peripheral vascular disease severe enough to cause intermittent claudication or ischemic ulcers
3. Patients who have been hospitalized due to glucopenia or ketoacidosis in the last 3 month
4. Present ulcers on lower limbs of any cause
5. Antioxidant therapy within the last 1 month before screening (Vitamin E\> 400IU, Vitamin C\> 200mg once daily for continuous 2 weeks)
6. Any ALA therapy within the last1 month before screening
7. Opioid analgesic therapy within the last 1 month before screening
8. History of mental, psychological or behavioral conditions rendering the patient unable to follow the protocol
9. History of malignant tumors in the past 5 years except for basal cell carcinoma
10. Any severe systematic diseases, at the investigator's discretion, which will make it undesirable for the patient to participate in the trial or which could jeopardize compliance with the trial protocol,
11. ALT or AST \> 2.5 ´ upper limit of reference range
12. Cr \> 1.8mg/dL ( \> 159µmol/L) for males or \> 1.6mg/dL ( \> 141µmol/L) for females
13. History of hypersensitive to the active ingredients or excipients of ALA
14. Participation in a clinical study or treatment with a non-approved experimental medication in the last 1 month
15. Pregnant or breast-feeding women, or women of childbearing age without appropriate contraception measures
Diffusion Tensor Imaging in Predicting Development of Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer (CIPN)

This pilot early phase I trial studies how well diffusion tensor imaging works in predicting development of chemotherapy induced peripheral neuropathy in patients with breast cancer. Diffusion tensor imaging may help to get better pictures of the nerves of feet and lower legs before and after chemotherapy treatment and may help to predict the risk of developing peripheral neuropathy.

PRIMARY OBJECTIVES:

I. To assess the changes in the fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values of the lower extremity nerves by diffusion tensor imaging (DTI) before initiation and after completion of taxane chemotherapy in patients with breast cancer.

SECONDARY OBJECTIVES:

I. Establish normal and abnormal FA and ADC values of the lower extremity nerves.

II. Evaluate relationship of DTI findings of chemotherapy induced peripheral neuropathy (CIPN) with self-reported Patient Neurotoxicity Questionnaire (PNQ) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-neurotoxicity questionnaire (FACT-GOT-NTX) questionnaires.

III. Assess inter-reader variability in measuring FA and ADC values.

OUTLINE:

Patients undergo non-enhanced magnetic resonance imaging (MRI) of both lower extremities using magnetic resonance neurography (MRN) and DTI prior to initiation and after completion of standard of care chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
* Be capable of signing and providing written consent in accordance with institutional and federal guidelines
* Have a histologically-confirmed diagnosis of breast cancer
* Need to be treated with taxane containing chemotherapy as determined by their treating physician
* Be able to undergo magnetic resonance (MR) imaging
* Be willing and able to comply with scheduled visits, treatment plan, and MR imaging

Exclusion Criteria:

* Have non-MRI compatible metallic objects on/in body
* Have metallic hardware in the lower extremity which is MR compatible however would create too much artifact for MR examination
* Are unable to lay still in the MR scanner for length of examination
* Have severe claustrophobia
* Have pre-existing peripheral neuropathy from other medical conditions or due to cancer
* Have diagnosis of diabetes
* Pregnant patients
* Prior exposure to neurotoxic chemotherapy
Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX

Phase II prospective single-institutional study.

The aim of this Phase II prospective single-institutional study is to assess feasibility and early complications rate of Telelap ALF-X surgical treatment in obese patients affected by gynecological disease.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* 30 ≤ BMI \< 40
* ASA \< III
* Ovarian Cyst
* Prophylactic bilateral salpingo-oophorectomy
* Ectopic Pregnancy
* Pelvic Inflammatory Disease
* Sterility/Infertility
* Benign uterine disease (fibromatosis, adenomyosis)
* Endometrial hiperplasia
* Early-stage Endometrial Cancer
* Preneoplastic lesions of the cervix
* IA1 Cervical Cancer
* Pelvic endometriosis

Exclusion Criteria:

* Pregnancy
* Liver disease
* Coagulopathies
* Clinical conditions contraindicating laparoscopy
The Ability of Adipose Flap Over the NVB to Improve Sexual and Urinary Function Following Radical Prostatectomy

Despite technological advances, incontinence and impotence remain significant side effects of radical prostatectomy (RP). Strategies have been developed to reduce the injury to the erection nerves (i.e. neurovascular bundle - NVB)during surgery to further improve functional outcomes after RP. Adipose tissue is known for its stabilizing and even healing potential. These features include reducing the inflammatory process and improving blood supply to an injured nerve. We hypothesized that covering the NVB with periprostatic fat during surgery may potentially improve neural recovery and enhance functional recovery after RP. We sought to examine our hypothesis in a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

1. Male aged 18 years and older.
2. Patients diagnosed with prostate cancer.
3. Patients should be potent (IIEF erectile function domain score of 26 and above) and have a sexual partner.
4. Patients scheduled for Radical Prostatectomy with NVB preservation (at least unilateral).

Exclusion Criteria:

Patients who did not undergo NVB preservation or technical inability to create flap
Testing A Visual Thermometer in Newborns and Young Infants

"Severe neonatal jaundice and acute bilirubin encephalopathy are a major cause of death and disability among newborns in LMICs. Filtered sunlight phototherapy (FSPT) was developed, tested and shown to be safe and efficacious in the treatment of jaundice, because effective electric-powered conventional phototherapy is often unavailable10,11. However, FSPT currently requires at least hourly temperature monitoring by healthcare providers (HCPs) because infants receiving FSPT are prone to both hypothermia and hyperthermia.

20 years ago, a liquid crystal thermometer, ThermospotTM (Maternova, Providence, RI) was developed primarily for use in LMICs. It was designed to detect hypothermia and is most sensitive in cold infants and not as sensitive as needed for detecting hyperthermia or fever. The purpose of this pilot study is to determine the accuracy and useability of this LCTD for a wider spectrum of temperatures when used in a large group of infants in a high-income country. If the device performs well in this study, we plan to study it in a low- and middle-income country in Africa."


Eligibility Criteria:
Inclusion Criteria:

* Infants 0-6 months (\<7 months) presenting to Masonic Emergency Room or inpatient ward, their parent or caregiver who provide verbal consent in English or through a medical interpreter.

Exclusion Criteria:

* Any infant undergoing active resuscitation
* any infant for whom physician deems study enrollment would interfere with their care
* any infant whose parents or caregiver decline enrollment
* any nurse or other healthcare provider who declines participation
* Parents who do not understand English, and do not have a medical interpreter at the bedside.
A Remote, 9-week Insomnia Treatment Trial to Collect Real World Data for a Digital Therapeutic

The purpose of the study is to collect data in a real-world environment, for a digital therapeutic that delivers CBT-I through a decentralized clinical trial, open to participants with chronic insomnia.

This is an open-access, open-label, decentralized clinical trial to collect real-world evidence for PEAR-003A, a digital therapeutic delivering CBT-I.

Potential participants will answer an online prescreening questionnaire to determine eligibility. Qualifying participants will proceed to complete 6 weekly modules through their personal mobile phone or tablet in nine weeks. A series of the assessment and questionnaires will be administered at set points during the study. Participants will be asked to complete a follow-up module about 26 weeks, and at Days 243 (6-month), 428 (12-month), 610 (18-month) and 793 (24-month) after completing treatment.

A subset of approximately 34 participants may be asked to partake in a optional user experience sub study. The participant will be asked to provide study feedback by either completing a five-day diary or an interview.

Eligibility Criteria:
Inclusion Criteria:

1. Provide electronic informed consent prior to any study specific assessments being performed
2. Between 22 and 75 years old, inclusively
3. Insomnia as defined by an ISI score of 8 or above
4. Insomnia symptoms for at least 3 months
5. \< or = 6.5 hours of sleep per night
6. Access to a mobile device
7. Resident of the United States and currently living in the United States for the duration of the trial.

Exclusion Criteria:

1. Presence of an active and/or progressive physical illness (e.g., congestive-heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorder (e.g., epilepsy) or neurological degenerative diseases (e.g., dementia, multiple sclerosis)
2. Unstable medication regimen (change to schedule or dosage within the past 3 months)
3. Diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction
4. Have family or work schedules that prevent them from having normal sleep schedules defined as bedtime between 8:00 pm and 2:00 am and/or waking times between 4:00 am and 10:00 am.
5. Individuals who need to be alert or cautious to avoid serious accidents in their job or daily life. Examples include: Long-haul truck drivers, Long-distance bus drivers, Air traffic controllers, Operators of heavy machinery, some assembly line jobs.
6. Pregnant or planning to become pregnant during the course of the trial.
7. Other untreated sleep disorders as self-reported by the participant (e.g., obstructive sleep apnea, periodic leg movements, parasomnias)
8. Participated in an investigational research study in the past 30 days
ADRN Barrier/Immunoprofiling Exploratory Pilot Study

The purpose of this study is to look at how defects in the skin barrier and immune response affect risk for skin infections.

Participants will be classified into 4 groups based on Atopic Dermatitis (AD)/Non-Atopic (NA) status and Staphylococcus aureus (S. aureus) colonization (negative or positive):

* AD S. aureus negative
* AD S. aureus positive
* NA S. aureus negative and
* NA S. aureus positive.

Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with severe itching. People with atopic dermatitis have defects in the skin barrier as well as defects in the immune system which fights off skin infections. People who have atopic dermatitis often have complications from viral and bacterial skin infections, such as recurring Staphylococcus aureus (S. aureus), or Staph infections.

The study will compare the skin barrier and immune response of people with and without atopic dermatitis in relation to whether Staph bacteria is growing on their skin.

Eligibility Criteria:
Inclusion Criteria:

Participants fulfilling all of the following criteria are eligible for enrollment-

* Non-Hispanic Caucasian males and females 18 to 60 years of age, inclusive, at the time of Enrollment
* Who are enrolled in the ADRN Registry study
* Who have active AD (lesions present) with or without a history of Eczema Herpeticum (EH) as defined in the ADRN Standard Diagnostic Criteria OR who meet criteria for the NA diagnostic group as defined in the ADRN Standard Diagnostic Criteria
* Who are willing to sign the informed consent form prior to initiation of any study procedures.

Exclusion Criteria:

Participants fulfilling any of the following criteria are not eligible for enrollment-

* Who are pregnant
* Who have an active systemic malignancy. Uncomplicated non-melanoma skin cancer and melanoma in situ with documentation of complete excision are not exclusionary
* Who have any skin disease other than AD that might compromise the SC barrier (e.g., bullous disease, psoriasis, cutaneous T cell lymphoma \[also called Mycosis Fungoides or Sezary syndrome\], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease)
* Who have a history of systemic immunological illness (e.g., human immunodeficiency virus \[HIV\] or systemic lupus erythematosus \[SLE\]) other than the condition being studied
* Who have active EH or eczema vaccinatum (EV)
* Who have a history of serious or life-threatening reaction to latex, tape, or adhesives
* Who are determined to be not eligible based on the opinion of the Investigator.
Development of a Deep Learning System for Identification of Neuro-Ophthalmological Conditions on Color Fundus Photographs in Emergency Department

In recent years, artificial intelligence (AI) has been widely integrated into the medical field, contributing in particular to improved patient diagnosis. The BONSAI study, Brain and Optic Nerve Study with AI, in which our team is participating, has successfully demonstrated the ability of AI to identify individual neuro-ophthalmological or neurological pathologies affecting the optic nerves and/or brain, from a simple fundus image.

While this is a promising advance, it remains limited in current clinical practice. Our major challenge is to be able to identify a wider range of optic nerve and/or brain pathologies simultaneously in the same analysis, so as to improve patient management, especially for those referred to emergency departments. Indeed, in the absence of a precise diagnosis, complications can be irreversible and life-threatening.

Among the most alarming clinical signs in the emergency department is papilledema of stasis, which, accompanied by acute headaches, may indicate the presence of intracranial hypertension, inflammatory or ischemic pathology. The latter may be a manifestation of Horton's disease. Our team has developed an AI algorithm to diagnose retinal and optic nerve abnormalities based on retinophotographs taken under ideal conditions during scheduled consultations, and not on images of patients presenting to the emergency department. In hospitals without ophthalmology emergency departments, it is essential that emergency physicians (emergency physicians, general practitioners, neurologists) are able to assess the fundus in the absence of an ophthalmology specialist. This assessment, although part of the general examination, often presents challenges for non-ophthalmologists. The aim of our study is to improve the performance of our AI algorithm so that it can discriminate between different retinal and optic nerve pathologies in the emergency department. We therefore plan to build a database of fundus images by prospectively including patients presenting to the ophthalmology and neurology emergency departments of the Fondation Adolphe de Rothschild Hospital. The performance of the algorithm developed will be evaluated according to standard criteria of sensitivity, specificity, area under the curve (AUC) and accuracy.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 and over
* Presenting to the emergency department of the Fondation Adolphe de Rothschild hospital
* Express consent to participate in the study
* Member or beneficiary of a social security scheme

Exclusion Criteria:

* Patient under legal protection
* Pregnant or breast-feeding women
A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

The purpose of this study is to evaluate the safety of FCX-007, evaluate Type VII collagen (COL7) expression and the presence of anchoring fibrils and to analyze wound healing as a result of FCX-007 administration in subjects with recessive dystrophic epidermolysis bullosa (RDEB). Funding Source- FDA OOPD

RDEB is a rare skin and connective tissue disease characterized clinically by skin fragility with easy blistering, erosion and scarring of skin and mucous membranes, and caused by the deficiency of the protein type VII collagen (COL7). The objective of this study is evaluate the safety of FCX-007 intradermal injections in RDEB subjects. Additionally, the trial will evaluate COL7 expression, the presence of anchoring fibrils, as well evidence of wound healing.

Approximately twelve subjects are expected to enroll in the Phase I/II trial. Phase I will enroll approximately six adult subjects. Phase II will enroll approximately six subjects both adults and pediatric (aged seven (7) years or older). All subjects will receive FCX-007 to one or more paired target RDEB wounds. Proof of mechanism will be monitored through digital photography of target wounds and assays conducted on biopsies taken from intact skin sites where FCX-007 is administered.

Eligibility Criteria:
Key Inclusion Criteria:

1. Age

   1. Phase I: Eighteen (18) years or older.
   2. Phase II: Seven (7) years or older.
2. Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB)

Key Exclusion Criteria:

1. Medical instability limiting ability to travel to the investigative center.
2. Active infection with HIV, hepatitis B or hepatitis C or evidence of other systemic infection
3. Current evidence of metastatic squamous cell carcinoma at the site to be injected
4. Clinically significant abnormal laboratory result or other significant clinical abnormalities
5. Receipt of a chemical or biological study product for the specific treatment of RDEB in the past six months
Community Resilience to Acute Malnutrition

The study evaluates the impact of a multi-sectoral intervention (water, sanitation, and hygiene; training on climate smart activities; care groups for mothers; market gardens) on the prevalence of acute malnutrition as the primary outcome using a randomized intervention trial between 2012-2017 with four points of data collection (2012, 2014, 2015, and 2017).

Concern Worldwide has developed a model of intervention called Community Resilience to Acute Malnutrition (CRAM). This model is based on the need for (a) the introduction of longer-term programming to build community resilience to shocks, while recognising that there may be a need for humanitarian intervention, and (b) a multi-sectoral package of activities given experience in programming from other settings. The goal of the study is to rigorously test the impact of the model and associated activities on community resilience to shocks in the Goz Beida area of Chad. Where community resilience is proxied by the primary outcome variable: acute malnutrition.

In order to answer this question, 69 villages had been randomized to either receive the full multi-sectoral program or not. In each village, approximately 20 households were surveyed (randomly selected from a household list from a previous emergency distribution) for a total of 1420 households. Those households were then surveyed in November/December 2012 (prior to the intervention), and again a the same time period in 2014, 2015, and 2017.

Data was collected on household demographics, livelihoods, child health, and nutrition, including child (6-59 months) anthropometry.

Eligibility Criteria:
Inclusion Criteria:

* child is from household with B, C, or D wealth ranking (wealth ranking is from A-D with A being the highest wealth and D being the lowest wealth)
* child is between the ages of 6-59 months
* child is present in the selected household at the time of the survey

Exclusion Criteria:

* child has a skin disorder
* too ill to be measured on height board or weight scale
Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan

This study seeks to evaluate the clinical performance of a recently released contact lens designed to correct astigmatism to an established contact lens that has historically been used in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is 18 to 39 years of age. (Parental consent is required for a minor child i.e. under the age of 20.)
2. The subject has signed an informed consent with his/her own judgement for participation in the study.
3. The subject currently is a habitual wearer of spherical or toric daily-wear soft contact lenses, excluding daily disposables, in daily wear bases.

Exclusion Criteria:

1. The subject has any ocular or systemic allergies that interfere with contact lens wear.
2. The subject has dry eye and lacrimal apparatus disease that could interfere with contact lens wear.
3. The subject has any systemic disease or autoimmune disease that interferes with contact lens wear.
4. The subject has corneal edema, neovascularization, corneal staining or other ocular abnormalities (Grade 3 or above) that clinically apparently interfere with contact lens wear.
5. The subject has any anterior segment eye disease (palpebral abnormalities, corneal hypesthesia, corneal epithelial defect, bulbar conjunctival hyperemia, etc.) that clinically apparently interferes with contact lens wear.
6. The subject has a history of solution reactions to the chemical cleaner/disinfectant to be used in this study, as far as known to the subject.
7. The subject has ocular infection.
8. The subject has ocular inflammation (including acute/subacute anterior segment inflammations and uveitis).
9. The subject has corneal distortion resulting from previous experience of hard contact lens wear.
10. The subject has infectious disease (pneumonia, tuberculosis, etc.) or immunosuppressive disease (HIV positive etc.), as far as known to the subject.
11. The subject has diabetes, as far as known to the subject.
12. The subject is pregnant or in the lactation period, as far as known to the subject.
13. The subject uses any eye remedies (excluding artificial tear substitutes or hyaluronic acid drops for reducing dryness while wearing contact lenses).
14. The subject had any ocular trauma or surgery within 8 weeks prior to participation in the study.
15. The subject is a wearer of hard contact lenses (including rigid gas permeable).
16. The subject is exposed to a dry environment on a constant basis.
17. The subject is exposed to a living environment where dust, chemicals, etc. can easily enter the eye.
18. The subject is unable to follow the principal investigator's instructions.
19. The subject is unable to follow lens hygiene procedures necessary for contact lens wear.