cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF : Double Blinded, Randomized Control Trial

Researchers are considering Dexamethasone as preemptive medication before minimally invasive spine fusion surgery to minimize postoperative back pain with minimal side effects, aiming to enhance the effectiveness of surgery and improve patient outcomes.

Surgery for spine fusion through a minimally invasive technique called MIS-TLIF has become increasingly popular nowadays due to various reasons such as lower blood loss and reduced need for blood transfusions, less postoperative back pain, and shorter surgical duration compared to the traditional technique known as TLIF. However, even after MIS TLIF, patients still experience issues such as wound or back pain, which can affect their physical activity and increase the risk of infection. Prolonged hospital stays lead to resource wastage.

In the Enhanced Recovery After Surgery (ERAS) program for spine surgery, preoperative medication, including Acetaminophen, NSAIDs, and Gabapentinoids, is recommended to alleviate postoperative back pain. However, even after implementing ERAS, patients undergoing MIS TLIF still experience pain, suggesting that further pain reduction strategies are needed. The use of Dexamethasone as preemptive medication has shown promising results in various surgeries, with minimal side effects and a manageable cost. Dexamethasone, administered via injection, has a longer duration of action compared to other steroids, making it suitable for preemptive use.

The main objective is to study the effectiveness of using Dexamethasone via intravenous injection before minimally invasive spine fusion surgery, known as MIS-TLIF, in reducing postoperative back pain.

The secondary objectives are to compare the rate of morphine usage for pain management after surgery between two groups.

To compare the side effects and adverse reactions of the medication, such as nausea and vomiting, surgical site infection rates, and blood sugar levels post-surgery.

To compare the fusion rates of the spinal bones. To compare the length of hospital stays after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age range: 50-80 years old.
* Undergoing MIS TLIF surgery at 1-2 spinal levels.

Exclusion Criteria:

* Previously undergone spine surgery.
* HbA1C greater than or equal to 7.5 mg%
* Allergic to all types of experimental medication.
* History of using systemic steroids.
Acute Treatment of Migraine Using the CEFALY Device

The purpose of this study is to investigate the efficacy of e-TNS with the Cefaly® device as an acute treatment for a migraine attack. This open clinical trial will study the acute treatment of migraine using the Cefaly® device, prior to development of a sham-controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a history of episodic or chronic migraine with or without aura, meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine- recurrent painful ophthalmoplegic neuropathy, migrainous infarction)
* The patient must be experiencing a migraine attack lasting for at least 3 hours, with pain intensity stabilized for at least 1 hour. The location of the headache should be frontal, retro- or peri- orbital, on one or either side.

Exclusion Criteria:

* Pregnant women
* Patients having received treatment with onabotulinum toxin (e.g., Botox, Dysport, Xeomin) to the head in the prior 4 months
* Patients having received supraorbital nerve blocks in the prior 4 months
* Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
* Patients with only temporal or occipital headaches
* Patients taking opioid medications
* Patients having taken abortive migraine medication in the prior 3 hours
* Allodynia: intolerance to supraorbital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded while the neurostimulation has already started).
* Implanted metal or electrical devices in the head
* Cardiac pacemaker or implanted or wearable defibrillator
Surgery Versus Non-surgical Treatment for Esophageal Squamous Cell Carcinoma in Patients Older Than 70 Years

To determine whether older patients who underwent esophagectomy had better outcome survival than those who were non-surgically treated.


Eligibility Criteria:
Inclusion Criteria:

1. Pathology confirmed ESCC,
2. Patients with esophagectomy or radiotherapy (RT)/chemotherapy (CT),
3. Age ≥ 70.

Exclusion Criteria:

1. Having other malignant tumours,
2. Missing of required data.
Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia

Randomized Controlled Trial Comparing Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia. The control strategy will be based on ARDSNet approach. The intervention group will receive a different ventilatory strategy based on positive end-expiratory pressure tailored according to compliance and limited driving pressure.

There is no consensus on the optimal ventilatory management of patients with community-acquired pneumonia that require mechanical ventilation and have acute respiratory distress syndrome. The traditional ventilatory approach (ARDSNet) is based on a fixed table for both end respiratory positive end-expiratory pressure according to inspired oxygen fraction. Alternatively, a strategy that tailors positive end-expiratory pressure according to compliance and limits driving pressure may be beneficial, but evidence is lacking.

We will perform an open label randomized controlled trial comparing both strategies.

Eligibility Criteria:
Inclusion Criteria:

* Patients with community acquired pneumonia requiring invasive mechanical ventilation
* Bilateral pulmonary infiltrates on chest imaging not fully explained by fluid overload in the opinion of the attending physician
* One of the criteria below:
* Oxygen inspired fraction above 50% with a positive end-expiratory pressure of at least 8 cmH2O to main peripheral oxygen saturation above 93%, OR
* Arterial partial pressure of oxygen divided by inspired fraction of oxygen lower than 200 with PEEP values of at least 5 cmH2O

Exclusion Criteria:

* Patients with inclusion criteria for more than 36 hours
* Refusal of the patient´s legal representative
* Acute neurologic disease (stroke, brain trauma, or any disease that may cause intracranial hypertension)
* Patients with current airway fistula or barotrauma
* Patients on chronic home use of oxygen due to underlying lung disease
* Patients younger than 18 years
* Patients not on full code status
HsCRP in the Prognosis of Patients After PCI：a Multi-center Study

Coronary heart disease (CAD) is caused by myocardial ischemia, hypoxia or necrosis due to coronary artery stenosis, spasm or obstruction. Although standard drug therapy can greatly improve the prognosis of patients with CAD after percutaneous coronary interventions (PCI), these patients are still at high risk of major adverse cardiovascular and cerebrovascular events (MACCE). At present, the concept of residual inflammation risk (RIR) has aroused widespread concern. RIR is an important independent risk in patients with CAD. Previous studies indicated that hsCRP ≥ 2mg / L was the definition standard of RIR in CAD in European and American people. In China, the impact of dynamic changes of hsCRP on MACCE in PCI population remains unclear. Therefore, in this study, the investigators plan to recruit patients undergoing PCI, and observe the impact of RIR by serial hsCRP measurements on the prognosis of these patients followed up for 1 years at 14 hospitals in China.


Eligibility Criteria:
Inclusion Criteria:

* Participants who understand and sign the informed consent voluntarily;
* Age ≥ 18 years old and ≤ 80 years old, regardless of sex;
* The hospitalized patients with coronary heart disease undergoing PCI;
* Complete all planned PCI during hospitalization.

Exclusion Criteria:

* Acute, chronic or recurrent infectious diseases;
* Immune diseases or immune-related diseases;
* Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapy drugs;
* Pregnant women, lactating women or women of childbearing age who do not use effective contraceptive measures;
* The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.
Efficacy and Safety Study of JTT-705 in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia

The purpose of this study is to evaluate the effect of two dose levels of JTT-705 when co-administered with pravastatin 40 mg on HDL-C and LDL-C and the inhibition rate of CETP activity and to document short term safety.


Eligibility Criteria:
Inclusion Criteria:

* Patients having lipid values as indicated below:
* HDL-C less than 1.6 mmol/L (60 mg/dL)
* TG less than 4.5 mmol/L (400 mg/dL)
* LDL more than 4.0 mmol/L (160 mg/dL)
* Patients with CHD or CHD risk equivalent
* Male and females between 18 and 65 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

* Body Mass Index of ≥ 35 kg/m2
* Females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception
* Concomitant use of medications identified in the protocol
Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage

Diabetic retinopathy (DR) is one of the most serious microvascular complications of diabetes. Early diagnosis and treatment of diabetes is the key to prevent visual impairment in DR patients. This study aims to use a non-targeted metabolomics detection technique combined with ultra-high performance liquid chromatography time-of-flight mass spectrometry to analyze the metabolomics profile in aqueous humor sample of DR patents, and further explore the mechanism of the relationship between differential metabolites and their metabolic pathways with NLRP3 activation in DR inflammatory damage. DR patients with macular edema will receive anti-vascular endothelial growth factor (anti-VEGF) treatment; these patients will be divided into two groups: responders group and non-responders group.


Eligibility Criteria:
Inclusion Criteria:

1. Patients \> 40 years old.
2. CON (non diabetes control group)：patients undergoing phacoemulsification surgery.
3. NDR (non diabetes retinopathy diabetes patients): patients with diabetes history and undergoing phacoemulsification surgery.
4. NPDR (non proliferative diabetes retinopathy): patients with history of diabetes, fundus microangiopathy shown by fundus fluorescein angiography, including microangioma, hard exudation, wadding exudation and other non proliferative diabetes retinopathy signs, and did not receive invasive ophthalmic treatment within 3 months.
5. PDR (proliferative diabetes retinopathy): patients with a history of diabetes, fundus neovascular lesions shown by fundus fluorescein angiography, and did not receive invasive ophthalmic treatment within 3 months.
6. Patients voluntarily signed informed consent.

Exclusion Criteria:

1. CON (non diabetes control group)：patients with a history of other ophthalmic operations.
2. NDR (non diabetes retinopathy diabetes patients): patients with fundus changes of diabetes retinopathy or other ophthalmic surgery history.
3. NPDR (non proliferative diabetes retinopathy): patients with fundus neovascular lesions shown by fundus fluorescein angiography.
4. PDR (proliferative diabetes retinopathy):patients undergoing vitrectomy。
5. Patients with active ocular inflammation, high myopia, pregnancy.
Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%

The aim of this study is to investigate the utility of a technological based rating scale for assessing improvement in plaque psoriasis with Clobex spray treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age or older.
* Subjects with a board certified dermatologist clinical diagnosis of active moderate to severe psoriasis lesions affecting up to 20% of the body surface area at the baseline visit, and in the opinion of the investigator, is otherwise a good candidate for treatment with clobetasol propionate 0.05% spray.
* Subjects with a target lesion of at least 1 cm x 1 cm
* Subjects who agree to be photographed at each visit

Exclusion Criteria:

* Subjects with any condition or presentation that may, in the opinion of the investigator, may put the subject at risk, may confound study results, or may interfere with participation in the study.
* Subjects with any known allergies to any of the ingredients listed on the test article label or surgical ink.
* Subjects who are pregnant or breast-feeding, or who plan to become pregnant or breast feed during the course of the trial.
* Subjects that are relatives of the investigator, or are themselves or a relative of any study staff or any Galderma employee.
* Subjects who have participated in an investigational study within 30 days of enrollment; participated in biologic investigational studies within 90 days of enrollment, or subjects planning to participate in any other interventional clinical research study while enrolled in this trial.
Radiation Dose Escalation Study for Advanced Liver Cancer

The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of 3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy (IMRT) for locally advanced hepatocellular carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed or clinically diagnosed HCC
* Surgically unsectable or medically inoperable diseases, or surgery declined by the patient
* Solitary intrahepatic lesion with diameter bigger than 5 cm, without extrahepatic and/or distant metastases
* Associated with cirrhosis of Child-Pugh A
* Karnofsky performance status (KPS) of ≥ 70
* Normal renal function and adequate bone marrow reservation
* Tolerate active breathing control (ABC)

Exclusion Criteria:

* Child-Pugh B or C liver cirrhosis score
* Previous radiotherapy to the liver
* Indistinct tumor boundary in CT/MRI image
Pharmacogenomics Results Affect Patients' Plan of Care and Changes in Medication Prescription(s)

Current providers' standard operating procedures on pharmacogenomic testing patients

The general design of this study is collecting data and reviewing Principal Investigators' Standard Operating Procedures on Pharmacogenomic testing and changes made to their specific SOP.

Eligibility Criteria:
Inclusion Criteria:

* Must be a Medical Practitioner

  * Medical Doctor (MD)
  * Doctor of Osteopathic (DO)
  * Physician Assistant (PA)
  * Advanced Practice Registered Nurse (APRN)
  * Nurse Practioner (NP)
* Must have a current standard operating procedure that includes obtaining/reviewing medical history.

Exclusion Criteria:

* Government-funded insurance data cannot be included in the study.
CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease

The purpose of this study is to examine the safety and efficacy of the addition of BMS-986004 to standard of care Sirolimus (SIR)-based immune suppression.

The approach builds upon extensive evidence supporting the benefit of CD40L blockade in disrupting key signaling events associated with immune activation. The trial addresses a pressing clinical need, namely prevention of Graft-Versus-Host Disease (GVHD) after hematopoietic cell transplantation (HCT) and promotion of donor-recipient immune tolerance. The safety profile of this anti-CD40L antibody overcomes major prior limitations, and the planned biologic studies will provide significant mechanistic insight.

Eligibility Criteria:
Inclusion Criteria:

* Hematologic malignancy or blood disorder requiring allogeneic HCT
* Adequate vital organ function as defined per protocol
* Karnofsky Performance Status Score (KPS) ≥ 80%
* Participants must have an available 8/8 HLA-A, -B, -C, and -DRB1 matched-related or unrelated donor

Exclusion Criteria:

* Active infection not controlled with appropriate antimicrobial therapy
* HIV, hepatitis B or C infection or known history of HIV, hepatitis B or C(all patients will be tested for HIV, hepatitis B and C as part of standard pre-transplant testing, and will be excluded from this trial if positive)
* Anti-thymocyte globulin, or cyclophosphamide administered within 14 days before or planned to receive with HCT conditioning or as part of GVHD prophylaxis in the 14 days after HCT
* Known allergic reactions to components of the study drug
* Concurrent treatment with another investigational drug
* History of thromboembolism, transient ischemic attack, stroke, myocardial infarction within 3 months preceding the transplant, or uncontrolled congestive heart failure or cardiac arrhythmias.
* Post-transplant maintenance therapies such as FLT3 inhibitor, tyrosine kinase inhibitor, JAK inhibitors etc. are not allowed if plan is to initiate such therapies \<90 days post-transplant. Patient will be eligible if plan to initiate maintenance therapy is after day 90 post-transplant.
Overnight Fasting After Completion of Therapy: The OnFACT Study

The purpose of this study is to test whether regularly not eating for at least 14 hours overnight ("intermittent fasting") is feasible and can improve blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index is ≥ 18.5 kg/m\^2
* History of treatment for cancer or related illness diagnosed at ≤ 25 years old
* Off cytotoxic therapy for primary cancer ≥ 2 years
* Not receiving cytotoxic therapy (chemotherapy, external beam radiation therapy) at the time of study enrollment
* History of radiation to the chest, abdomen or total body
* Current age ≥18 years
* English-speaking
* Personal phone with SMS text messaging capability
* Willingness to wear an mHealth device, such as a FitBit, for two 7-day periods
* Able to perform all study requirements

Exclusion Criteria:

* Use of any antidiabetic, weight loss, or appetite control medication
* Use of any other medication that could impact dietary intake, such as prednisone
* Currently fasts 12 hours or more by self-report
* Unable to fast due to medical reason such as pregnancy
Quality of Life (QoL) in Subjects With Acromegaly Under Lanreotide Autogel® Treatment.

The purpose of the protocol is to evaluate and describe QoL, in the population of Polish acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term observation).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with acromegaly treated for at least three months and no longer than three years with Lanreotide Autogel® 120 mg just before inclusion.
* Patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form.

Exclusion Criteria:

* Active participation in any interventional or any other non-interventional acromegaly clinical study. (Previous participation in any interventional or any observational / post marketing study (PMS) of other somatostatin analogue should not be an exclusion criteria).
* Any medical or psychological condition, according to investigator judgement, that might compromise the ability to give informed consent.
3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China

The thirty-six-month immunogenicity evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese female subjects aged 9 to 45 years and male subjects aged 9 to 15 years.

All eligible subjects will be enrolled for one visit. A medical history and physical examination will be conducted on all subjects. A 10 mL blood specimen will be collected. All Sera should be shipped to PPD Vaccines and Biologics Laboratory in the US. The serum specimen will be tested at PPD Laboratory with competitive Luminex immunoassay (cLIA) and multiplexed HPV immunoassay. The purpose of the quadrivalent HPV cLIA and multiplex is to detect neutralizing antibody and total IgG to HPV virus-like particles (VLPs), serotypes 6, 11, 16, 18, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese subject who participated in V501-030 in Per-protocol population.
* Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
* Subject is willing to give consent/assent.

Exclusion Criteria:

* Subject is concurrently enrolled in clinical studies of investigational agents which may interfere with the evaluation of the study objectives.
* Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
* Subject has a history of known prior vaccination with a HPV vaccine, either active agent or placebo after receiving the vaccination during V501-030
Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds

This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF (20 mg/mL) and an other concentration in the other NLF (24 mg/mL).

Interventional, monocentric, double blind, randomised study Evaluation of safety the 1st month (primary criteria) and until 12 month Evaluation of performance at baseline, month 3, month 6, month 9 and month 12 : WSRS (wrinkle scale), profilometry (image measuring wrinkle depth and area), GAIS : satisfaction scale

Eligibility Criteria:
Inclusion Criteria:

* Is at least 19 years of age.
* Has Fitzpatrick Skin Type IV, V, or VI.
* Has a WSRS score \> or = to 3 for both NLF
* Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months

Exclusion Criteria:

Has keloid formation, or hypertrophic scarring or dyschromic scaring. Has hypersensitivity to hyaluronic acid, Chlorhexidine lidocaine or local anaesthetic drugs

* Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
* Has nasolabial folds that are too severe to be corrected in one treatment session.
* Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold during the last year.
* Is pregnant, lactating, or not using acceptable contraception.