cyrilzakka/clinical-trials huggingface dataset:
Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

Venous thromboembolism (VTE) is an important cause of post-operative morbidity and mortality in women undergoing surgery for gynecologic malignancies. Although the benefit of thromboprophylaxis in reduction of post-operative VTE events after surgery for gynecologic cancers has been well documented around the world, the evidence for Chinese women is rare. The investigators designed this prospective and randomized study to assess the benefit of pharmacologic prophylaxis for patients received surgical treatment for gynecologic malignancies in China.


Eligibility Criteria:
Inclusion Criteria:

* Patients of ovarian cancer, cervix cancer or endometrial cancer;
* Age ≤ 70 years; female, Chinese women;
* Initial treatment is surgery;
* Laboratory tests: WBC ≥ 4×10(9)/L, NEU ≥ 2×10(9)/L, PLT ≥ 100×10(9)/L, serum bilirubin ≤ 1.5 times the upper limit of normal, transaminase ≤ 1.5 times the upper limit of normal, BUN, Cr ≤ normal
* No prior pharmacologic prophylaxis;
* Provide written informed consent.

Exclusion Criteria:

* PLT ≤ 75×10(9)/L
* Vascular injury
* History of thrombosis
* Liver and kidney dysfunction
* Concurrently participating in other clinical trials
* Unable or unwilling to sign informed consents;
* Unable or unwilling to abide by protocol.
Measuring Parkinson's Disease Progression

The Measuring Parkinson's Disease Progression study aims to use MRI scans and a controlled dose of levodopa to find a biomarker (objective measurement) of Parkinson's disease (PD). Biomarkers would help determine the effectiveness of therapies in slowing or stopping PD progression, and accelerate the pace of research.

Early in the course of Parkinson's disease, a small dose of levodopa (L-DOPA) provides benefit for many hours. The body responds as if the levodopa in the plasma filled a reservoir and then slowly leaked out to produce benefit. With disease progression, even though the same amount of levodopa circulates in the blood, the benefit wears off much faster, as if the reservoir had become leakier. This wearing off of benefit can be characterized by a single number, the effect site rate constant Ke. On average, patients with more severe disease and longer disease duration have a larger ("leakier") Ke when the response to drug is measured using clinical features like tapping speed. Unfortunately, clinical measurements are influenced by confounding factors such as patient fatigue and comfort. A direct, objective brain measure of response to levodopa may improve the reliability of this measurement. Fortunately, we can assess the effect of levodopa on the brain directly, using an MRI machine to measure blood flow in different parts of the brain. For instance, the midbrain has a robust blood flow response to a single, clinically sensible dose of levodopa. This study's goal is to validate MRI measurement of Ke in the brain as an objective, quantitative measure of disease severity in PD. We will do this by comparing MRI-based Ke values from people with PD across a wide range of disease duration and severity. In a subgroup of participants, we will do this measurement twice, once before treatment and once after 6 weeks of treatment with carbidopa-levodopa (Sinemet® and other brand names).

Eligibility Criteria:
Inclusion Criteria:

* Age 40-79 at screening
* Meet accepted diagnostic criteria for Parkinson disease

Exclusion Criteria: Key exclusion criteria:

* Deep brain stimulator (DBS)
* Pregnancy
* Patients taking a dopamine antagonist (like quetiapine) or dopamine partial agonist (like aripiprazole)
* Metal in the head or eye, or other contraindication to MRI
* Claustrophobia
* Serious neurologic disease other than PD
* Head trauma with loss of consciousness for more than 5 minutes
* Severe or unstable systemic illness
* Certain psychiatric illnesses (dementia, psychosis, current major depression)
* Current alcohol use disorder
* Subjects who feel that going without nicotine for 3-4 hours would be uncomfortable
* Currently taking an extended-release formulation of a dopamine agonist (like Mirapex ER or Requip XL)
A Safety and Efficacy Study of Xolair in Peanut Allergy

This is a 38-week, randomized, double-blind, placebo-controlled, parallel group trial of approximately 150 patients who have a history of immediate hypersensitivity reaction to peanut protein.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a diagnosis of acute peanut allergy
* The patient meets the Xolair dosing table eligibility criteria by having a serum baseline IgE level between 30 and 1300IU/mL, and a body weight between 20 and 150 kilograms
* The patient is six to 75 years of age
* The patient reacts to peanut flour but not wheat (placebo) flour during the first Oral Food Challenge (OFC)
* The patient has a positive skin prick test to peanut or detectable serum peanut-specific IgE level
* The patient is able to swallow capsules

Exclusion Criteria:

* Have FEV1 value \<80% predicted or any clinical features of moderate persistent asthma, as defined by the NHLBI guidelines
* Have other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions
* Have a history of allergy to wheat protein
* Have previously been exposed to monoclonal antibody treatment
Cognitive Dysfunction in People Who Are Obese But Metabolically Healthy

There is some evidence to suggest that obesity is a risk factor for the development of cognitive dysfunction, although this is not a universal finding. This discordance might be ascribed to the existence of a 'healthy obese phenotype'- that is, obesity in the absence of metabolic risk factors. We examined whether the association of obesity with cognitive dysfunction is dependent on the individual's metabolic health.

60 obese patients' undergoping liver fibroscan and blood tests will be enrolled. Obesity was defined as body mass index ≥ 30 kg/m2. Based on blood pressure, HDL-cholesterol, triglycerides, glycated haemoglobin, and C-reactive protein, participants were classified as 'metabolically healthy' (0 or 1 metabolic abnormality) or 'unhealthy' (≥ 2 metabolic abnormalities). Cognitive dysfunction will be assessed by moca and minimental score. Results: Cognitive dysfunction prevalence is expected in 30% , but 50% of this group was categorized as metabolically healthy. Relative to non-obese healthy participants, after adjustment for baseline covariates, the metabolically unhealthy obese participants had elevated risk of cognitive dysfunction although the metabolically healthy obese did not. The association between obesity and risk of cognitive dysfunction appears to be partly dependent on metabolic health, although further work is required to confirm these findings.

In obesity there is an increase in oxidative stress due to metabolic syndrome . Thus obese patients suffer from higher incidences of cardiovascular complications such as atherosclerosis as compare to non- obese population. Haptoglobin (Hp) is a plasma protein which binds free hemoglobin and prevents it from heme- iron mediated oxidation. There are three different types of Hp which differ in their antioxidant ability. Several clinical studies have shown that Hp 2-2 genotype is associated with higher incidence of cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

Freely given written informed consent BMI\>=30

Exclusion Criteria:

Evidence of Chronic Liver Diseases Pregnant Women
COVID-19 And Geko Evaluation: The CAGE Study

The primary objectives of this pilot study protocol are to assess safety and feasibility of using the geko™ device in COVID-19.

Regarding safety to patients, we will measure the rate of adverse events, primarily local site irritation or discomfort. Feasibility will be measured on the basis of recruitment; ability to enroll sufficient number of patients meeting criteria. Protocol adherence will be observed as the ability to deliver the study intervention to the patients randomized to the treatment arm within the prescribed timeline and ability to complete the course of treatment. Additionally, we plan to measure patient outcomes such as ICU admission and death. The findings of this study have the potential to decrease the complications seen in COVID-19 infections.

On March 11, 2020, a global pandemic was declared by the World Health Organization. A novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the cause of the COVID-19 pandemic. SARS-CoV-2 infection has quickly become one of the fastest growing and deadliest diseases to surface due to its high death rate and ability to replicate and spread readily from people without symptoms. Recent evidence indicates that critically ill patients with COVID-19 experience a high risk of blood clots. Deep leg vein blood clots can travel to the lungs and cause severe lung failure and death. The geko™ device is a simple device that increases the return of blood flow from the lower legs and potentially decrease the risk of lung blood clots. Investigators believe the geko™ device may have an important benefit in COVID-19 patients by decreasing the risk of lung clots and decrease the risk of respiratory failure which is often the cause of death in COVID-19 patients. In this study, Investigators plan to study the effect of using the geko™ device in COVID-19 patients and measure patient outcomes such as ICU admission and death. The findings of this study have the potential to decrease the complications seen in COVID-19 infections.

Eligibility Criteria:
Inclusion Criteria:

* Patients who test positive for Covid-19

Exclusion Criteria:

* Patients who are unlikely to be adherent or cannot tolerate the therapy (self-report)
* Prior above or below knee amputation
* A history of prior Deep Venous Thrombosis (DVT) or Venous Thromboembolism (VTE),
* Those patients being treated with full dose therapeutic anticoagulation.
* Patients with pacemakers
Retropubic vs. Transobturator Tension-free Vaginal Tape

The so-called tension-free vaginal tape (TVT), first described in Sweden in 1996, has become a standard operation worldwide for the treatment of women with stress urinary incontinence. This tape is placed from the vagina behind the pubic bone and exits through the skin of the lower abdomen, just above the pubic bone. In 2001 a urologist in France proposed passing a similar tape laterally (as opposed to behind the pubic bone). This tape is passed through a window of the pelvic bones (the so-called obturator foramen), by what is called a transobturator approach. It is passed through the skin of the thigh (as opposed to the lower abdomen). The reason for this modification was to avoid injuring the bladder and, possibly, provide a more physiologic restoration of the continence mechanism. However, it is unclear whether the lateral (so-called transobturator approach) is as good as or better than the initial approach behind the pubic bone.

The purpose of the present study is to compare the standard (retropubic) and the newer (transobturator) approach for the placement of a tape for treating women with stress urinary incontinence.

After informed consent women scheduled for surgery for stress urinary incontinence are randomized to receive a tension-free vaginal tape either by the retropubic or the transobturator approach.

Eligibility Criteria:
Inclusion Criteria:

* Planned surgery for primary stress incontinence (positive stress test at bladder filling of 300 ml) without concomitant prolapse surgery or hysterectomy
* Patient able and willing to participate in follow-up
* Informed consent

Exclusion Criteria:´

* Detrusor overactivity, predominant complaint overactive bladder (OAB)
* Major concomitant surgery
* Prolapse beyond introitus or any prolapse necessitating surgery
* Previous incontinence surgery other than colporrhaphy
* Residual urine \>100 ml
* Neurologic disease
* Allergy to local anesthetic agents
* Coagulation disorders
Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis

The study is being done to determine if venous angioplasty is an effective treatment for chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or blockages are present in the internal jugular or azygos veins (veins which drain blood from the central nervous system) and these blockages may be associated with symptoms classically attributed to MS. Therefore, angioplasty may help to improve the symptoms associated with CCSVI and multiple sclerosis (MS). In this study, the investigators will evaluate the effectiveness of angioplasty in the treatment of CCSVI by comparing two the outcomes of two groups of patients: one group with CCSVI diagnosed on a venogram and treated with angioplasty and one group with CCSVI diagnosed on a venogram but not treated. The patients enrolled in this study, and the neurologist evaluating patients after the procedure, will not know whether or not they were treated with angioplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are willing to comply with the protocol requirements and can be contacted by telephone
* Patients 18-60 years of age
* Patients with clinically definite multiple sclerosis by Polman criteria
* Patients with a history of MS as defined above with an EDSS between 3-6.
* Patients with a significant stenosis of the internal jugular or azygos vein on the basis of magnetic resonance venography or Doppler ultrasound.

Exclusion Criteria:

* Patients with renal insufficiency based on an estimated GFR \<45
* Patients with a known severe allergy to iodine or gadolinium-based contrast agents which cannot be adequately pre-medicated
* Patients with a known allergy to nickel
* Patients who pregnant
* Patients with a contraindication to anticoagulation or anti-platelet medication
* Patients with a contraindication to drugs used for conscious sedation during interventional procedures, including Versed and Fentanyl
* Patients with a history of deep venous thrombosis of the lower extremities
* Patients with occlusion of the right and left common femoral veins
* Patients who have had any changes in their disease modifying drug regimen for MS during the 6 months prior to enrollment in this trial. This would include the addition of any new medications, a change in the dosage of any medications, or the removal of any medications from a patient's drug regimen
* Patients with a life expectancy \<18 months
* Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial
Comparison of Bioactive Glass and Beta-Tricalcium Phosphate as Bone Graft Substitute

This study is designed to perform a head-to-head comparison of two synthetic ceramic bone graft substitutes, bioactive glass (BAG) and beta-tricalcium phosphate (TCP), in filling of contained bone defects following surgical evacuation of benign bone tumor or tumor-like conditions. Based on the investigators' previous preclinical research and an ongoing single-center randomized clinical trial on bioactive glass filling, the investigators expect BAG filling to be more efficient compared to TCP in promotion of defect healing and functional recovery after surgery.

This study is designed to perform a head-to-head comparison of two synthetic ceramic bone graft substitutes, bioactive glass (BAG) and beta-tricalcium phosphate (TCP), in filling of contained bone defects following surgical evacuation of benign bone tumor or tumor-like conditions. Small metacarpal and phalangeal enchondromas (Stratum I) and large long-bone lesions (Stratum II) will be evaluated separately. Aside with the head-to-head comparison of the two synthetic bone graft substitutes, autologous bone graft (Stratum I) and allogeneic bone graft (Stratum II) will be used as the standard of care controls.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary or recurrent benign bone tumor or tumor-like condition that requires operative treatment by means of tumor evacuation and defect filling
* Pathological fractures of patients in Stratum I are treated by means of conservative treatment for three months before tumor surgery

Exclusion Criteria:

* History of acute or chronic local infection
* History of malignancy (excluding carcinoma basocellular) within past 5 years
* A history of local radiotherapy
* A known metabolic skeletal disease (such as osteoporosis, Paget's disease or osteomalacia)
* Medication affecting bone turnover (oral bisphosphonates, PTH, sodium fluoride, strontium ranelate, calcitonin, testosterone, systemic cortico- or anabolic steroids)
* Any plans to use phenol or other chemical/thermal method of local tumor control
* Pregnancy
* Any other condition that in the judgment of the investigator, would prohibit the subject from participating in the study or may hinder the collection of data and interpretation of the results
ALS Study Determining Various Biomarkers and Strength Comparison After Exercise

The purpose of this study is to determine the muscle strength of a muscle in the thigh after 12 weeks of home exercise.

Study participation lasts a total of three months and includes two study visits. Subjects are asked to undergo strength testing, physical exams, lab draws, and muscle biopsies at each study visit. Muscle biopsies are done in the quadriceps muscle. In between study visits, subjects are asked to maintain a weekly exercise regimen given to them by the study physical therapist.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of possible, probable or definite amyotrophic lateral sclerosis (ALS) based on the revised El-Escorial criteria
* Presence in ipsilateral leg of either weakness in any muscle group or of active denervation by needle electromyography (EMG) which is a surrogate marker of early denervation
* Ipsilateral quadriceps femoris strength: \>=4
* Ambulatory with or without assistance
* Revised ALS Functional Rating Scale (ALSFRS-R) Score \> 30
* Forced expiratory vital capacity (FVC) \>50% of predicted

Exclusion Criteria:

* ALSFRS-R ≤ 30
* Quadriceps femoris strength \<4
* Unable to walk or uses wheelchair as primary means of mobility
* More than mild atrophy of quadriceps
* Bleeding disorder or uptake of anticoagulants
* Unwilling to comply with exercise and needle muscle biopsy
* Not a good research candidate according to the medical opinion of investigator
Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy

The purpose of this study is to gather information on patients who have heart failure and are eligible for one of the following two procedures: 1) mechanical support, i.e. ventricular assist device (VAD) or 2) heart transplant. the study seeks to determine which patient populations benefit from heart transplant or ventricular assist device. This will allow to offer the state-of-the-art care to the patients in heart failure.

Cardiogenic shock (CS) develops in the end stage of various etiologies of heart failure and continues to hold high mortality; ranging from 50 to 80%. Expert consensus recommends use of more powerful mechanical circulatory support device (MCSD) in this patient population; however, scientific evidence has been anecdotal relying on mostly single-center small case series and, more fundamentally, because there is no unified definition to grade the severity of the highly heterogeneous condition CS. Well-designed studies are warranted to precisely characterize the various "phenotypes" of CS as well as the role of MCSD in this condition with still excessive mortality.

This multicenter registry will be the first multicenter large-scale registry focused on mechanical circulatory support (MCS) therapy for CS. The fundamental goal of RESCUE is to advance the understanding and application of MCSD in order to improve the persistently dismal survival of patients with CS with the following intents:

1. Elucidate current indication and outcomes of MCSD use in CS.
2. Redefine CS with better description of this disease entity, which will allow better prediction of outcomes, selection of treatment strategy, and comparison and design of studies.
3. Facilitate the refinement of patient selection to maximize outcomes with current and new device options.
4. Improve and expedite new device clinical trials by providing historical control data.
5. Develop consensus "best practice" guidelines to improve clinical management by reducing short and long-term complications of MCSD therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who receive any MCSD including Veno-Arterial Extracorporeal Membrane Oxygenation (VA ECMO), surgical VAD, and percutaneous VAD, used to treat CS on or after 9/30/10. Intraaortic balloon pumping (IABP) is not considered an MCSD in this Registry.
* Adult patients who have signed informed consent. For patients who are too ill to give informed consent the health care proxy of the patient or next of kin will be approached for the informed consent.

Exclusion Criteria:

* patients younger than 18 years of age.
The Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis

The objectives of this clinical trial were to determine the radioprotective effects and underlying biological mechanisms of Phellinus igniarius and its active components during radiotherapy in patients with thoracic malignant tumors.

The study group was given the formulation of Compound Phellinus igniarius decoction daily during radiotherapy, 150ml bid until the end of radiotherapy; The control group only received standard dose radiotherapy without the formulation of Compound Phellinus igniarius decoction intervention.

The baseline differences between the two groups were compared, including gender, smoking history, body mass index (BMI), pathological classification, median age of onset, inflammatory factors, tumor markers, TNM stage, KPS score, fatigue score, incidence and grade of radiation pneumonitis, incidence of other radiotherapy-related adverse reactions, and average radiation dose.

Investigators measured the levels of inflammatory factors and tumor markers in blood samples of patients in the two income groups, and administered questionnaires on the degree of fatigue and general status of patients. Metabolite changes and gut microbiota homeostasis in patient fecal samples were then detected by untargeted metabolomics and metagenomics.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years, ECOG score≤2, possess adequate communication and comprehension abilities, and have an anticipated survival time exceeding 6 months
* Confirmed diagnosis of lung malignancy through imaging and pathological examination
* Indications for thoracic radiotherapy, DT:50-60Gy/20-30F
* Normal function of vital organs, including the heart, liver, kidneys, and gastrointestinal system

Exclusion Criteria:

* Patients with pre-existing pulmonary conditions, including idiopathic pulmonary fibrosis
* Individuals with systemic immune disorders
* Those with concurrent major infections
* Patients diagnosed with hematological disorders. All participants provided written informed consent
Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients

The aim of this study is to find out whether inflammation markers including cardiac markers have predictive value in evaluation of pathogenesis of sepsis in neutropenic haematological patients.

Adult AML and ASCT patients with neutropenic fever. Observation of possible progress to severe sepsis or septic shock. Blood sample collection on days 0-3 (from the beginning of neutropenic fever).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis: acute myeloid leukaemia
* age under 70 years
* neutropenic fever

Exclusion Criteria:

* age above 70 years
* no neutropenic fever