cyrilzakka/clinical-trials huggingface dataset:
Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19

A randomized, double-Blind, placebo-controlled trial aimed to investigate the safety and efficacy of sivelestat on treating adult patients with COVID-19-related acute respiratory distress syndrome (ARDS)

This study is designed as a randomized, double-blind, placebo-controlled clinical trial, and is planned to be conducted at 3 clinical centers in China from January 1, 2023, to January 31, 2024. During the study period, we intend to enroll a total of 238 eligible patients. These patients will be randomly assigned in a 1:1 ratio to receive either sivelestat sodium or placebo via continuous intravenous infusion (0.2mg/kg/h) over a 24-hour period for 7 days (or to the day of death or ICU discharge if it occurs before day 7). Both the patients and investigators are blinded to the treatment assignment. Subsequent follow-ups will be performed in person at 7,14 and 28 days after randomization. The primary endpoint will be at 7 days post randomization and secondary endpoints will be at 14 and 28 days post randomization. Also, endpoint assessors are masked to the treatment allocation. Lastly, these endpoint variables will be compared between the treatment groups to investigate the efficacy and safety of sivelestat for COVID-19-associated ARDS

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Confirmed SARS-CoV-2 infection as determined by Polymerase Chain Reaction (PCR) in sputum, nasopharyngeal swabs, or oropharyngeal swabs
* Diagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin Definition criteria
* Onset of ARDS less than 72 hours before randomization
* Written informed consent

Exclusion Criteria:

* ARDS potentially caused by extra-pulmonary reasons, including non-pulmonary sepsis, pancreatitis, multiple trauma and massive transfusion, etc.
* Leukopenia (leukocyte count \<4,000/μL/) and/or thrombocytopenia (platelet count \<100,000/μL)
* Significant hepatic dysfunction, defined as elevated AST and ALT ≥ 3 times the normal limits, or total bilirubin ≥ 1.5 mg/dL
* Severe renal insufficiency with serum creatinine \> 3.0 mg/dL
* History of moderate to severe chronic lung disease requiring home-based oxygen therapy, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), asthma and bronchiectasis, etc.
* Pre-existing peripheral nerve injury, spinal cord trauma, or neuromuscular disorder that may impair spontaneous ventilation (e.g., high cervical spinal cord injury, Guillain-Barré Syndrome, and myasthenia gravis, etc.)
* Current diagnosis of pulmonary embolism
* Coexisting multi-organ failure, affecting more than 3 systems
* Combined with burn injury
* Life expectancy less than 6 months (e.g., due to an an end-stage malignant disease)
* Moribund and expected to die within 48 hours
* Known allergy to sivelestat or any of the study drug excipients
* Pregnancy or lactation, or the possibility of conception
* Current or recent (last 3 months) participation in any other clinical trial
A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes

The primary objective of this study is to compare two post operative drop regimens for the management of dry eye and control of healing using FDA-approved ophthalmic solutions.

This comparison will be made between bilateral eyes of the same patient following excimer laser ablation using the FDA-approved LADARVision 4000 Excimer Laser System or the WaveLight ALLEGRETTO WAVE™ Excimer Laser System. Post operative questionnaires regarding the use of the drops will be compared. Tear osmolarity and tear breakup time will be evaluated using Tear Lab and OQAS II.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be a suitable candidate for FDA Approved LASIK.
* Subjects must have a stable refraction as documented by previous clinical records.
* Subjects who wear soft contact lenses must discontinue wear at least 3 days prior to preoperative exam or surgery.
* Subjects who wear gas permeable contact lenses must discontinue wear at least 3 weeks prior to preoperative exam or surgery.
* Subjects must be at least 18 years of age.
* Subjects must be willing and able to return for scheduled follow up examinations each day after surgery at the specified time.
* Subjects must sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

* Subjects for whom either eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
* Subjects with clinically significant dry eye syndrome or clinically significant blepharitis in either eye.
* Subjects with clinically significant anterior segment pathology, including clinically significant cataracts, corneal scarring or neovascularization in either eye.
* Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
* Subjects who have a history of Herpes zoster or Herpes simplex keratitis.
* Subjects on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing, any immunocompromised subjects, and subjects with clinically significant atopic disease, connective tissue disease, or uncontrolled diabetes.
* Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP\>25 mm Hg in either eye.
* Subjects with macular pathology in either eye.
* Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
* Subjects with known sensitivity to planned study concomitant medications.
* Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
* Use of ocular drugs, other than study medications, during the study and within 30 days prior to study entry or any other ocular medication.
Comparison of Two Treatments on Nonspecific Neck Pain

The purpose of this study was to evaluate the impact of Ischemic Compression (IC) and Instrument Assisted Soft Tissue Mobilization (IASTM) on pain, functionality, cervical range of motion, pressure pain threshold, and quality of life in patients suffering from nonspecific neck pain.

Chronic nonspecific neck pain affects approximately 67% of the global population at least once in their lifetime. This type of neck pain, which is not linked to any specific cause or disease but often associated with the musculoskeletal system, can result from muscle strain or spasms in the neck. It causes functional limitations and decreases quality of life for those affected. Individuals frequently turn to healthcare services and pain-relieving medications in their efforts to manage this discomfort. Chronic nonspecific neck pain is recognized as a significant public health challenge due to its considerable socioeconomic impact. Several studies have indicated that myofascial trigger points in the neck region are associated with nonspecific neck pain and that myofascial trigger point therapy can reduce pain. Therefore, the role of myofascial trigger point therapy in the treatment of nonspecific neck pain has been emphasized in studies.

Eligibility Criteria:
Inclusion Criteria:

1. Having nonspecific neck pain and at least 3 myofascial trigger points in the back and neck muscles,
2. Pain duration exceeding 3 months,
3. Working with a computer for at least 20 hours per week for at least 1 year,
4. Pain intensity rated as at least 3 on the Visual Analog Scale (VAS),
5. Age between 18 and 50 years

Exclusion Criteria:

1. Use of anti-inflammatory, analgesic, anticoagulant, muscle relaxant, or antidepressant medications at the start of the study or within 1 week prior to the study,
2. History of cervical spine surgery or trauma,
3. Neck pain, including inflammatory rheumatic diseases,
4. Malignancy or structural deformity,
5. Coagulation disorders,
6. Presence of cervical radiculopathy or myelopathy,
7. Individuals who have undergone any physical therapy and rehabilitation interventions to the neck and back regions in the last three months
Cross-sectional Examination of the Reliability of Oral Implants

Aim of the multi centrical, cross-sectional study is the registration of the prevalence and incidence of mucositis and periimplantitis.

Aim of the multi centrical, cross-sectional study is the registration of the prevalence and incidence of mucositis and periimplantitis. Additional clinical examination of the tolerance of titanium using cytosine analysis of periimplant sulcus smear and of blood lymphocytes on titanium plates in vitro. In total 10 centers will examine clinical, genetic and microbiological parameters in 200 patients during 12 months.

Study hypothesis: The incidence of mucositis and periimplantitis during a time period of 10 years in patients is less than 30%

Eligibility Criteria:
Inclusion Criteria:

* Patients with oral implants inserted after 01.04.2002
* Periodical recall

Exclusion Criteria:

* No other titanium implants inside the body
Association Between Vitamin D and the Risk of Uterine Fibroids

The aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could reduce the risk of uterine fibroids in reproductive stage women.

A total of 1160 hypovitaminosis D patients (12 ng/ml ≤ serum 25-hydroxyvitamin D3 \< 20 ng/ml) without uterine fibroids will be randomly assigned in a ratio of 1:1 to two groups: intervention group and control group. The intervention group will receive 1600 IU/d of vitamin D3; the control group will receive regular follow-up. Patients will be followed up at the same time points for 24 months. The outcome measure is the incidence of uterine fibroids in different groups.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in the study with informed consent;
2. Females aged 35-50 who are confirmed with a normal, fibroid-free uterine structure, by means of transvaginal or abdominal ultrasonography;
3. Serum25-hydroxyvitamin D3 \<20 ng/ml, ≥ 12ng/ml.

Exclusion Criteria:

1. Use of sexual hormone, mifepristone, gonadotropin-releasing hormone agonist (GnRHa), or other medication which is likely to interfere with uterine fibroids within 3 months;
2. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
3. Allergic to vitamin D3;
4. Suspected or identified as other tumors of genital tract;
5. History of hysterectomy or myomectomy;
6. History of osteoporosis or vitamin D deficiency taking vitamin D supplements within previous one month;
7. History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
8. Alanine aminotransferase (ALT) or aspartate transaminase (AST) more than 3 times of the normal upper limit, total bilirubin (TBIL) more than 2 times of the normal upper limit;
9. Creatinine levels ≥ 1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 ml/min;
10. History of malignant tumors;
11. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer

To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.

Inclusion Criteria

* Males over 18 with documented advanced or metastatic prostate cancer

Outcome measures

* Comparative castration rates one week after starting therapy
* Degree of testosterone surge in the first month of treatment.
* Maintenance of medical castration during one year of therapy.
* Comparison of the treatments on QTc prolongation

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate cancer and not previously treated with hormones
* Evidance of advanced disease or metastases
* Life expentancy of at least 3 months
* Normal serum testosterone levels
* Written informed consent

Exclusion Criteria:

* Previous endocrine or cytoxic theapy for prostate cancer
* Known tumour complication of prostate cancer which owuld require immediate treatment
* Another malignancy other than basal cell cancer
* History of significant drug hypersensitivity to either LHRH agonists or GnRH antagonists.
* Congenital or acquired coagulation disorders contraindicating intramuscular injections
* Pagets disease of the bone
* QTcB \> 450 msec at Day - 14
Registry Construction for Perioperative Data in Patients Undergoing Cardiovascular Surgery

The purpose of this registry is to obtain perioperative data in patients undergoing cardiac or thoracic aortic surgery and find out relations between the data and investigate several causes affecting postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cardiac or thoracic aortic surgery

Exclusion Criteria:

* refused to participate
Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study

The purpose of the study is to compare outcomes of laparoscopic versus open liver resection for colorectal metastases in a prospective and randomized study. The study will include all non-anatomic liver resections in our institution.

The primary end point is that the use of laparoscopic technique significantly can reduce the frequency of complications to liver resection. Secondary end points are 5-year survival, immediate surgical outcomes, quality of life and degree of impairment of the immune system.

Full protocol is published open access in Trialsjournal:

http://www.trialsjournal.com/content/16/1/73

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for radical liver resection without formal liver resection or without assistance of radiofrequency ablation

Exclusion Criteria:

* Inability to give written informed concent
* Patients with tumors that can't be resected without reconstruction of vessels or bile ducts
* Patients with tumors that can't be resected without 1)formal liver resection 2)combination with radiofrequency ablation
* Patients with extrahepatic metastasis except resectable metastasis in lungs and adrenals
* Pre- and peroperative diagnosis of non radically treatable disease
Machine Learning Miscarriage Management Clinical Decision Support Tool Study

Machine learning used to develop an algorithm to determine chance of success with expectant or medical management for an individual patient. Taking into account the following objective measures:

* Demographics: Maternal Age, Parity
* History: Previous CS, Previous SMM/MVA, Previous Myomectomy
* Gestation by LMP
* Presenting symptoms: Bleeding score, Pain score
* USS Measurements: CRL, GS, RPOC 3 dimensions, Vascularity
* Discrepancy between gestation by CRL and LMP

Audit to collate 1000 cases and identify features contributing to an algorithm that can predict outcome of miscarriage management for individualized case management.

* Artificial intelligence discovery science: Algorithm Development based on a retrospective Audit of approximately 1000 cases of miscarriage
* To determine the reliability of the tool with test data sets
* To increase the sensitivity and specificity of the decision aid by widening the data collection to multiple sites and testing the algorithm with prospective data

The study will be conducted at Queen Charlotte's and Chelsea Hospital at Imperial College Healthcare NHS Trusts (Primary Centre of the study).

This is a multi-centre retrospective, cohort observational study.

The study will be conducted over a minimum of three years to enable sufficient time to go through the retrospective data and collate test data sets.

Retrospective annonymised cases of missed miscarriage and incomplete miscarriage managed at Imperial College Healthcare NHS Trust will be analyse:

For each case the following clinical features will be collated and outcomes:

* Demographics: Maternal Age, Parity
* History: Previous CS, Previous SMM/MVA, Previous Myomectomy
* Gestation by LMP
* Presenting symptoms: Bleeding score, Pain score
* USS Measurements: CRL, GS, RPOC 3 dimensions, Vascularity
* Discrepancy between gestation by CRL and LMP

All data will be collected retrospectively and annonymised.

Following data collection, machine learning models and feature reduction methods will be applied to determine the best performing model to predict success or failure of expectant or medical management of miscarriage respectively.

The next phase will include a prospective audit to collect data and test the predictive power of the MLM clinical decision support tool.

Eligibility Criteria:
Inclusion Criteria:

* Missed miscarriage and incomplete miscarriage less than 14weeks gestation
* Follow-up recorded at 2 weeks

Exclusion Criteria:

- Final outcome data unavailable
The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases

Thyroid hormone autoantibodies(THAA) in serum can Interfere radioimmunoassay for the determination of free thyroid hormones. Thyroid function test plays a key role in the diagnosis and treatment of autoimmune thyroid disease (AITD), and abnormal examination results in misdiagnosis and mistreatment. At present, the epidemiological results of THAA in AITD are inconsistent, and the pathogenesis has not been clarified. However, there is no relevant research on THAA in China. This project intends to collect AITD patients and healthy people, detecting THAA, at the same time testing thyroid function and thyroid autoantibodies, definiting positive rate of THAA in AITD patients, observing the effect of common therapeutic drugs for AITD on THAA, investigating the rule of THAA influencing thyroid function test results .This project will provide the basis and method for how to effectively avoid THAA interfering with thyroid function test.


Eligibility Criteria:
Inclusion Criteria:

* male or female with Hashimoto thyroiditis or Grave's disease aged for 18 to 65 years old

Exclusion Criteria:

* Had a thyroidectomy Had a thyroid fine needle puncture biopsy Autoimmune diseases Take drugs that affect the immune system
Changes in Brain Structure Related to Systemic Chemotherapy Treatment: A Prospective Study in Individuals Diagnosed With Non-small Cell Lung Cancer Utilizing High-resolution Structural Magnetic Resonance Imaging

The purpose of this study is to learn about the effects of cancer treatment on the brain. Some cancer patients report changes in their memory or thinking after treatment. These changes could be a result of changes in brain structure, such as a change in size or thickness of different parts of the brain. The investigators will look to see if these changes in brain structure happen through the results of magnetic resonance imaging (MRI). The investigators will do this by looking at the brain structure of lung cancer patients who have surgery and chemotherapy versus those who have surgery only.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 80 years old
* As per self report and/or medical record female patients are either postmenopausal or not able to become pregnant
* Patients with biopsy proven or suspected non-small cell lung cancer planned to undergo induction chemotherapy and surgery, OR with biopsy proven or suspected non-small cell lung cancer planned to undergo immediate surgical resection
* No clinical/neurological symptoms suggestive of brain metastases by attending's judgment as documented in the medical record and/or correspondence with the research team
* In the judgement of the consenting professional, patient is able to understand English, through verbal and written communication
* Patient is able to undergo MRI scanning (verified with pre-MRI Safety Screening form (Appendix A) used in MSKCC MRI Centers) completed at screening and again prior to having the MRI.

Exclusion Criteria:

* Patients with history of significant neurological diagnoses including stroke, tumor, dementia, epilepsy, or multiple sclerosis as indicated by medical records and/or self report
* History of head injury with evidence of brain injury or loss of consciousness for \> 60 minutes as per EMR or self-report
* No prior treatment with chemotherapy
* Participant has dentures, body jewelry or wig that they are unable to remove as per self-report
* Patient reports that he/she cannot undergo MRI scanning without significant distress or discomfort
* Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the study (i.e., schizophrenia).
Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects

Two movement illusion techniques can currently be used in clinical practice for motor rehabilitation after stroke hemiplegia: visual illusion (mirror therapy) and proprioceptive illusion (tendon vibration). Mirror therapy, in its computerized version (IVS3, Dessintey, Saint-Etienne, France), is based on the substitution of the deficient visual feedback by a visual feedback of a correctly realized movement. The proprioceptive illusion is based on the external application of a vibrator on muscle tendons at a frequency between 50 and 120 Hz. These two techniques are currently used independently. They are, in theory, complementary and additive. No study has described the combinatorial properties of the illusions generated by these 2 techniques in hemiplegic subjects and healthy subjects.

The study hypothesis is that the administration of mirror therapy together with vibration will increase the perception of movement in a subjective scale.

Eligibility Criteria:
Inclusion Criteria:

Hemiplegic subjects :

* Male or female
* Aged 18 to 70 years,
* First ischemic or hemorrhagic stroke causing hemiplegic
* Having signed the written consent
* Affiliated or entitled to a social security scheme

Healthy subjects :

* Male or female, aged 18 to 70 years,
* Matched in sex, age and laterally with hemiplegic subjects
* Having signed the written consent
* Affiliated or entitled to a social security scheme

Exclusion Criteria:

Hemiplegic subjects :

* With complete lesion of the primary motor cortex
* With an addiction to alcohol or drugs
* With psychiatric illness, cognitive impairment, uncontrolled disease/epilepsy, malignant illness severe kidney or lung disease
* With history of associated general disabling disease
* With cerebellar syndrome
* With clinical brain stem involvement
* Under legal protection
* Pregnant or breastfeeding women

Healthy subjects :

* Neurological, cardiovascular, musculoskeletal diseases
* Taking medication that can affect attention
* Unable to understand instructions of the study
* Under legal protection
* Pregnant or breastfeeding women