cyrilzakka/clinical-trials huggingface dataset:
Productivity Study of Presbyopia Improvement in Textile Workers

To establish, using a randomized, controlled design, the impact of near vision correction on the productivity of presbyopic textile workers in China, as measured by the change of monthly income.

Sustainable development is considered to be a major development strategy to meet rapid economic and social development in China. China is one of the biggest manufacturing hubs in the world. With the rapid development of economy, the health of manufacturing workers is closely related to productivity. In some low-income developing countries, studies have focused on improving the health of manufacturing workers to improve productivity .Most of the studies focused on improving the nutritional intake of workers has a significant effect on improving work efficiency and productivity .

As the global aging is becoming an critical issue for both health and economics, the health of the working population over the age of 45 is of greater concern in low - and middle-income developing countries. China has a workforce of 980 million people (aged 15 to 60). Urban workers and blue-collar workers account for nearly 310 million. With the aging population increased, presbyopia is becoming more and more serious, and it also affects the labor group that needs to work in close proximity. Studies have proved that refractive correction for tea pickers with old vision can effectively improve the yield of tea pickers and increase personal income.Because Guangdong area textile industry is developed, textile worker population is large. Most front-line textile workers need to work in close proximity for a long time, and the problem of aging productivity is increasingly obvious. At present, no relevant studies have explored whether presbyopia affects the work efficiency of textile workers who work in close proximity.

In this study, a randomized controlled clinical study will be conducted on front-line textile workers with presbyopia to explore whether refractive correction can improve labor income and relieve symptoms of visual fatigue for textile workers aged 40 years or above who work in the front-line.

Eligibility Criteria:
Inclusion Criteria:

* Employee of E-square for 6 months;
* Aged \>= 40 years;
* Quantifiable near visual task workers;
* Habitual near visual acuity of \>= 0.8M (\<=6/12) at 40cm in both eyes, correctable to \<=0.5M (\>=6/7.5);
* Near correction spherical equivalent refractive error \>= +0.50D or astigmatism \<-1.00D;
* Asthenopia symptoms reported ( Asthenopia questionnaire score \>= 16) Ability to give informed consent

Exclusion Criteria:

* Ocular surgery done in the past 3 months;
* Eye disease detected on baseline eye exam
* Current ownership of near correction capable of improving near visual acuity to \<= 0.8M (\>= 6/12) in either eye
* Unlikely to complete follow-up due to unsatisfactory work performance, plans to move out of the area, etc.
the Effect of Vitamin D on the Serum Thioredoxin, TBP-2, Thioredoxin Reductase, Gene Expression of TBP-2 in Patients With Type II Diabetes

The aim of this study is the comparision between the effects of vitamin D or placebo supplementation for 2 months in serum level of thioredoxin, TBP-2 and thioredoxin reductase activity in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

literate, willingness to participation, diabetic patients 30- 60 years old, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention -

Exclusion Criteria:

people who have used vitamin D supplements in last 3 months, having chronic renal disease , GI disease, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or Thiazolidinediones, Smokers

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A Study to Investigate the Safety and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Male and Female Participants Aged 18 to 75 With Autoimmune Disease

The goal of this clinical trial is to assess the safety and tolerability profile of belantamab. The study will also assess how the levels of belantamab change over time and body's reaction to it in participants with stable but active autoimmune disease.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) from 18 to 40 kilograms per square meter (kg/m\^2) (BMI = weight/height\^2), inclusive, and body weight of \>=40 kilogram (kg)
* IgM \>= lower limit of normal (LLN) (40 milligram per deciliter \[mg/dL\]) at initial screening visit (ISV)

Participants with systemic lupus erythematosus (SLE) must also meet the following inclusion criteria:

* Documented clinical diagnosis of SLE according to the European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria
* Positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) autoantibody and/or positive antinuclear antibody (ANA) test results, using central lab test, at ISV.
* SLE Disease Activity Index 2000 (SLEDAI-2K) total score of \>=6 at ISV.
* Failure to adequately respond to at least two immunosuppressive therapies.

Participants with Rheumatoid Arthritis (RA) must also meet the following inclusion Criteria:

* Meets ACR/EULAR 2010 RA Classification Criteria with a duration of RA disease of \>=6 months at time of ISV
* Positive rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) test results, using central lab test, at ISV.
* Have moderate to severe active disease as defined by \>=3/68 Tender and \>=3/66 Swollen joint count at ISV and Baseline.
* Failure to adequately respond to at least two immunosuppressive therapies.

Participants with antiphospholipid syndrome (APS) must also meet the following inclusion criteria:

* Documented diagnosis of APS meeting the 2023 ACR/EULAR APS classification criteria
* Positive lupus anticoagulant test or moderate to high titers of positive IgG/IgM anticardiolipin (aCL) or moderate to high titers of IgG/IgM anti-beta2-glycoprotein I antibody using central lab test, at ISV
* Clinical features attributable to antiphospholipid antibodies that are resistant to warfarin and/or heparin:

  * Thrombotic event within last 18 months despite adequate anti-coagulation therapy and/or
  * Persistent thrombocytopenia and/or
  * Persistent autoimmune hemolytic anemia
* Sex and Contraceptive /Barrier requirements for females.

Exclusion criteria:

SLE specific exclusion:

* Any acute, severe lupus related flare during the Screening Period that needs immediate treatment
* Has any unstable or progressive manifestation of SLE
* Significant, likely irreversible organ damage related to SLE

RA specific exclusions:

* RA functional status class IV according to the ACR 1991 revised criteria
* Adult Juvenile RA

APS specific exclusions:

* Acute thrombosis (arterial or venous acute thrombosis diagnosis) less than 30 days before study ISV
* Catastrophic APS classification within the prior 90 days of ISV
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care

The emergency setting, frequently associated with pain and the feeling of loss of control, can cause anxiety in patients.

Reaction anxiety may be an appropriate response to an emergency; Nevertheless, attention must be paid to the evaluation and management of the latter especially as anxiety and pain are closely linked.

There is a definite interest in the management of patients' pre-hospital anxiety. The literature reports a strong association between anxiety, post-traumatic stress and chronic pain. A study conducted at SAMU 31 also found that anxiety on arrival at the emergency department was a negative factor in the treatment of pain. Anxiety can reduce the pain threshold and promote hyperalgesia.

The management of patient anxiety in pre-hospital offers interesting results in terms of analgesia and satisfaction of users of care and should not be neglected.

MEOPA has recently been available in SMUR vehicles (emergency and resuscitation mobile service) at SAMU 31 (urgent medical assistance service); its availability can lead teams to change their practices. More and more emphasis is placed on the importance of positive communication and comfort for which MEOPA, with its conscious sedating effect, could be a facilitating factor.

The aim of our study is to evaluate the level of anxiety of patients treated by SMUR teams in Toulouse and receiving MEOPA following the usual indications for pain-induced pain or pain alleviation.

This is a pilot study, which focuses on the assessment of anxiety in patients treated in pre-hospital care by SMUR Toulouse and receiving MEOPA as part of their care. No data exists in the literature on this subject.

This descriptive study based on qualitative data collected by the FAS1 scale will provide us with the first data on this population. It does not change the usual management of the patient since only patients who must receive MEOPA following the usual indications for pain relief or pain-induced care will be included in the study

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18
* Patient supported by a SMUR team from Toulouse
* Patient receiving MEOPA during pre-hospital care (in the usual indications for pain relief or pain-induced care)
* Patient having given his non-opposition to participate in the study

Exclusion Criteria:

* Any patient with a contraindication to MEOPA:
* Patient requiring pure oxygen ventilation
* Intracranial hypertension
* Any alteration of the state of consciousness preventing the patient's cooperation
* Traumatic brain injury
* Pneumothorax
* Emphysema bubbles
* Gas embolism
* Diving accident
* Abdominal gas distension
* Patient who received an ophthalmic gas for ocular surgery less than three months old
* Known and unsubstituted vitamin B12 deficiency
* Patient under legal protection
* Refusal of the patient to participate in the study
* Barrier of the language or alteration of the communication
* Patient in vital distress
Retrospective Analysis of Veritas in Breast Reconstruction

Retrospective data collection of the use of Veritas in breast reconstruction surgery

This is a multi-center study to retrospectively collect data on the use of Veritas Collagen Matrix in breast reconstruction. Data will be collected on post-operative complications in immediate breast reconstruction and then be compared to literature reported post-operative complication rates associated with the use of acellular dermal matrix in immediate breast reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patients who underwent mastectomy with immediate breast reconstruction using Veritas collagen matrix
* Patients who underwent mastectomy with single stage procedures or two-stage procedures using Veritas collagen matrix

Exclusion Criteria:

* Patients who underwent delayed breast reconstruction
* Reconstruction with something other than Veritas collagen matrix
* Breasts that were created with DIEP or TRAM procedures
An Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures

The goal of this clinical trial is to compare Dermabond with non-absorbable sutures in skin closure after brow ptosis surgery. The main questions it aims to answer are:

* if Dermabond provides equivalent wound healing compared to conventional non-absorbable skin suture techniques
* if Dermabond provides equivalent scar appearance compared to conventional non-absorbable suture techniques
* if Dermabond results in equivalent complication rates compared to conventional non-absorbable suture techniques Participants will have be randomly selected to have either Dermabond or non-absorbable suture closure methods. Scar analysis and both participant and provider surveys will be performed to assess the differences between groups, if any.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing bilateral direct excision brow lift for brow ptosis at the University of Kentucky Medical Center.
* Patients \> 18 years of age.
* Patients must be able to follow up at the specified intervals.
* Patients who are able to give their own informed consent.
* Health Status: Variable health status reflective of general population of Kentucky. Patients will be healthy enough to be seen in an office setting.
* All patients will need to be proficient in the English language to understand the scale used for scar assessment

Exclusion Criteria:

* Patients \<18 years of age or \>100
* Allergy to Dermabond
* Adults with impaired consent capacity
* Incarcerated individuals
Increasing Availability of Lower Energy Meals on Food Choice and Intake

This study will examine the effectiveness of a structural intervention (baseline proportion of lower energy ready meals vs increased proportion of lower energy ready meals) on calories (kcal) ordered and consumed. The study will use a within-subjects design, meaning all participants will be exposed to both conditions (baseline vs increased lower energy meal menus). The procedure will involve participants placing orders for supermarket ready meals, which are then delivered to their homes for their consumption. This study will also investigate whether the effectiveness of the intervention varies, depending on socioeconomic position (SEP). The primary hypothesis is that increasing proportion of lower energy options will decrease total kcal ordered and consumed, and that there will be no difference between higher and lower SEP. To address the limited evidence on longer term impacts of dietary interventions on daily energy intake, the present study will also examine post-meal energy consumption up to midnight on the following day. Finally, this study will explore the psychological processes that might underlie the effectiveness of the intervention among individuals with higher and lower SEP; namely, food choice motives, satiety responsiveness, plate clearing tendencies, and food waste concerns.

See attached protocol documents.

Eligibility Criteria:
Inclusion Criteria:

* UK (United Kingdom) residents, aged 18 or over
* Fluent in English
* Have access to a phone/tablet/computer device which has access to Internet and a functioning camera
* Willing to consume two supermarket ready meals
* Have access to a functioning microwave and oven for the preparation of the ready meals

Exclusion Criteria:

* Taking part more than once
* Another member of the same household has participated in the study (Multiple members of the same household will not be allowed to take part)
* Current or historic diagnosed eating disorders
* Currently on any medication which affects appetite
* Any of the following dietary restrictions, intolerances, or allergies (Vegetarian, vegan, gluten-free, sugar-free, dairy/lactose-free, food allergy - such as milk, eggs, nut, wheat, fish, etc)
* History of severe childhood allergies, anaphylaxis or anaphylactic shock
Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help in Treatment for Breast Cancer

Integrative approaches to promote wellness and reduce the distress associated with cancer are considered as essential components of cancer care. In case, exercise training has been shown to produce many positive physiological and psychological benefits. Mindfulness-based stress reduction program shows similar beneficial effects, and especially in emotional distress management. The aim of the study is to examine the cumulative effect of an 8 week-exercise-training program combined with an MBSR program on cardio-respiratory fitness and quality of life in women with breast cancer. These effects are thought to be mediated in part through changes in underlying brain processes, that investigators will be put in light. Through telomerase activity, oxidative stress, mitochondrial respiration and blood cytokine level measurements, investigators could expect to better understand the effect of these combined training in breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer
* Having completed the chemotherapy period
* Undergoing radiotherapy and/or hormono therapy

Exclusion Criteria:

* Regular physical activity higher than 4 hours per week.
* Any disease cardiac, respiratory, neurological or articular disease, which counteract the muscular training )
Study of the Safety and Efficacy of Ruxolitinib Cream for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease

The purpose of this study is to compare the safety and effects of ruxolitinib 1.5% cream with those of standard moisturizers in people with non-sclerotic chronic cutaneous GVHD.


Eligibility Criteria:
Inclusion Criteria:

* Patients (≥ 12 years)
* History of allogeneic hematopoietic stem cell transplantation
* BSA of at least 2% of clinically or histologically confirmed non-sclerotic cutaneous chronic graft-versus-host disease (diagnosed and BSA calculated in accordance with the National Institutes of Health Chronic Graft-versus-Host Disease Consensus for Clinical Trials: I. The 2014 Diagnosis and Staging Working Group Report)
* Patients age ≥ 18 years must provide written informed consent; or patients age ≥12 years and \<18 years must provide assent and have at least one guardian provide written informed consent to participate in the study.
* Able to self-administer topical interventions or provide for another person to apply the topical interventions (while wearing nitrile gloves)
* If on systemic therapy for GVHD, systemic therapy must be stable for past 4 weeks; however, any planned systemic corticosteroid taper during the study will be permitted.Changes in systemic therapy during the study period will be allowed for the management of non-skin GVHD.
* Any concurrent topical therapies including topical corticosteroids, topical calcienurin inhibitors, moisturizers, phototherapy (narrowband UVB or UVA1); or excimer laser therapy must be discontinued on Study Day 0.

Exclusion Criteria:

* Known history of allergy to any ingredient of the study medication
* Patients with deep sclerotic cutaneous graft-versus-host disease including deep sclerotic subtypes of chronic cutaneous GVHD
* Use of concurrent topical therapy including topical corticosteroids, topical calcienurin inhibitors, moisturizers, phototherapy (narrowband UVB or UVA1); or excimer laser therapy after Study Day 0 up to and including Study Day 28.
* Changes in systemic therapy during study period for the purpose of treating skin GVHD.
* Special populations:

  * vulnerable populations e.g. decisionally impaired (cognitive, psychiatric), terminally ill, prisoners
  * patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent
* Concurrent participation in another topical trial of a drug(s) or medical device, or the subject is in an exclusion period after a previous trial of drug(s) or medical device
* Pregnancy or lactation
* Patients with inadequate liver function (ALT above 4 × upper limit of normal \[ULN\] for the patient's age or direct bilirubin 4 × ULN for the patient's age and the laboratory abnormalities are considered to be due to underlying liver dysfunction) unless attributed to GVHD (if direct bilirubin is not in the medical record, it is acceptable to use total bilirubin x4 ULN).
* Active uncontrolled infection requiring systemic therapy. Subjects with a controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible.
A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).


Eligibility Criteria:
Inclusion Criteria:

* Participants who have had a diagnosis of type 2 diabetes mellitus before screening
* Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG, TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been on a stable dose for at least 8 weeks before screening
* Participants must have a qualifying HbA1c value of 7.0% to 11.0% at screening
* Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2)

Exclusion Criteria:

* Participants who have a diagnosis of type 1 diabetes
* Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog within the 3 months before screening
* Participants who are currently taking insulin or have had previous insulin treatment within the 3 months before screening
* Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening
* Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)
Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback

Deep Brain Stimulation of the subthalamic nucleus (STN) has become a standard of care, FDA-approved treatment for Parkinson's disease, with stimulation delivered at a constant amplitude and voltage, operating in an open-loop fashion that does not respond to a patient's current state. Although gait deficits and freezing of gait may initially respond to continuous open-loop deep brain stimulation (olDBS) and medication, the symptoms often recur over time.

The episodic and predictable nature of FOG makes it well suited for adaptive DBS (aDBS) and a device that overcomes the limitations of traditional high frequency olDBS and is capable of adapting therapy either in the frequency or intensity domain transiently to treat FOG while also treating other PD signs such as tremor and bradykinesia.

The purpose of this study is to determine the feasibility of an adaptive DBS system, that responds to patient-specific neural and kinematic variables with customized DBS parameters.


Eligibility Criteria:
Inclusion Criteria:

* Clinically-established PD
* Meets criteria for STN DBS eligibility as part of patient's standard medical care or already implanted in the STN with Percept(TM) PC
* The presence of complications of medication such as wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication due to these factors.
* Ability and willingness to return for study visits, at the initial programming and after three, six and twelve months of DBS.
* Age \> 18
* Freezing of gait questionnaire (FOG-Q) score ≥ 1 and/or gait sub-score (Item 3.10) of MDS- UPDRS III ≥ 1
* Greater than or equal to 1.2 microVp between 8-35 Hz on either the LSTN or RSTN (Percept (TM) PC cohort only)

Exclusion Criteria:

* Dementia
* Untreated psychiatric disease
* Hoehn and Yahr stage 5 on or off medication (non-ambulatory)
* Age \> 80
* Major surgical morbidities such as severe hypertension, coagulopathy and certain metabolic conditions that might increase the risk of hemorrhage or other surgical complications
* Presence of a cardiac pacemaker/defibrillator
* Inability to understand/sign consent
* Requires rTMS, ECT, MRI (Summit(R) RC+S cohort only), or diathermy
* Are pregnant or lactating
* Has a cranial metallic implant
* History of seizures or epilepsy