cyrilzakka/clinical-trials huggingface dataset:
Research on Traditional Chinese Medicine (TCM) Clinical Treatment of the Acute Episode of Bronchial Asthma.

Bronchial asthma is a common disease and frequently encountered disease of respiratory apparatus. It has very complex mechanism and multiple inducing factors. This study will focus on a new Chinese therapy on Bronchial asthma, analyzing the treatment mechanism of internal and external use, based on Traditional Chinese Medicine (TCM) theory and clinical practice. The study will also investigate the efficacy of the Chinese drugs and treatments on Bronchial asthma, and provide an effective therapy for this disease.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 65 years old;
* Patients with mild-to-moderate bronchial asthma on attacking stage;
* Without cardiopulmonary or other complications;
* To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome differentiation;
* Informed consent form is required to be signed.

Exclusion Criteria:

* Older than 65 years or younger than 18 years old;
* Pregnant woman or suckling period woman;
* Patients combine serious primary disease in liver, renal, cardiovascular and cerebrovascular, hemopoietic system diseases,or psychosis.
* Severe levels of disease is between severe and critical extent. Combine Pulmonary Heart Disease or respiratory failure;
* Irritable the physique, or allergic to the given composition of drugs in this research;
* Patients who are in the process of other clinical research.
Hepatic Manifestations and Effect of Long COVID-19 on Patients With Chronic Liver Disease

To measure the frequency of persistent liver dysfunction (raised liver enzymes, serum albumin, prothrombin time, etc) in recovered COVID -19 patients.

To compare the hepatic manifestations in post COVID -19 patients with and without liver disease

The digestive tract, particularly the liver, has recently been reported to be affected by SARS-CoV-2. Although abnormal liver enzymes were regularly described as an extra-pulmonary clinical feature, and almost one half of patients experienced grades of hepatic injury. liver damage in patients with SARS infections was primarily manifested in the mild and moderate elevation of alanine and/or aspartate aminotransferases (ALT and AST) with some degree of hypoalbuminemia and hyperbilirubinemia during the early stage of the illness.

Eligibility Criteria:
Inclusion Criteria:

* Patients previously diagnosed by COVID 19 eg : PCR and / or HRCT chest, lab of more than 1 month duration.

Exclusion Criteria:

* Patients less than 18 y.
* Patients with acute COVID 19.
Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.

Randomized open-label multicenter active-controlled study of anemic patients with Chronic Renal Failure who are not yet receiving dialysis. The duration of the study was five months. After screening procedures including multiple hemoglobin values, patients were randomly assigned to either IV Iron Sucrose (200mg X 5) or oral iron sulfate (325mg TID)for 29 days. Safety assessments included the recording of all adverse events, physical examinations, vital signs, electrocardiograms and clinical laboratory tests. Efficacy parameters included hematologic parameters.

Eligibility Criteria:
Inclusion Criteria:

* Creatine Clearance \<40 mL/min
* Average Baseline Hemoglobin \< 10.5g/dL
* TSAT \< 25% and Ferritin \<300ng/mL

Exclusion Criteria:

* Blood Transfusion within 30days
* Uncontrolled Hypertension
* Suffering form concommitant disease of the liver
* Serious bacterial infection
* Pregnancy / lactation
* Symptomatic HIV
* Expected to under dialysis or renal transplant during study
Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial

Aim The aim is to test whether a short psychotherapeutic intervention targeting Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the outcomes of the Standard Multidisciplinary Program (SMP) against chronic back pain development.

Focus Patients with back pain often demonstrate symptoms of PTSD measured via the Harvard Trauma Questionnaire Scale (HTQ). It has been found that PTSD and pain may maintain each other.

Methods Thousand consecutive patients with Low Back Pain (LBP) referred to the Spine Center are screened for PTSD. It is expected that 100 patients will meet the inclusion criteria and be randomized to SMP or to SMP plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'.

Conclusion The project started in 2013, so there have not yet been any results. Currently total reached 65 back pain patients; 34 patients in the SMP + sessions intervention arm.

Effect parameters are: Pain, daily function, EuroQOL and (HTQ), anxiety and depression, fear avoidance (Tampa Scale for Kinesiophobia) on entry, and at 6/12 months.

This "Nested Randomized Trial in a Cohort Design" is one of the very first studies targeting both PTSD and chronic pain-related symptomatology.

Eligibility Criteria:
Inclusion Criteria:

* Back pain: from 1/2 Y duration or longer
* Trauma according to HTQ

Exclusion Criteria:

-
Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures

Explore the benefit of the game-based virtual reality system in improving lower extremity kinematics and balance in patients suffering from disease/disorders including Diabetes, Cancer, Multiple Sclerosis, Arthritis, Parkinson's disease, Cognitive Disorders, Brain Injury, Stroke or Frailty. A four to six weeks of training with 2 training session/week will be provided.

Individuals suffering from certain disorders/diseases including diabetes, arthritis, cancer, osteoarthritis, stroke, Parkinson's disease, cognitive impairment or brain Injury are more likely to experience a fall or a fall-related injury than healthy individuals during to impaired postural stability or diminished joint perception. Under certain circumstance they may also experience pain, depression, anxiety, and a decreased quality of life. The investigators' research has been designed to provide exercise training using non-invasive body-worn sensors (similar to those used in an iPhone®) to provide real-time visual information about joint motion in a virtual environment. These sensors will be worn using a vest, t-shirt or elastic band. The investigators will, 1) assess changes in participant's perception of lower extremity position while they perform these exercises; 2) motivate and guide simple exercise performance in the clinic/home, using an interactive game-like scheme; and 3) assess changes in participant's postural stability and gait as a result of provided exercise training. The information gathered will provide new understanding about more helpful rehabilitation strategies that improve postural stability in patient population.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of:

* diabetes
* cancer
* multiple sclerosis
* arthritis
* Parkinson's disease
* cognitive disorders
* brain injury
* frailty
* stroke

Exclusion Criteria:

* conditions not related to specific disorders affecting balance and gait
Effect of Blueberry Consumption on Metabolic Syndrome & DNA Damage

Obesity usually brings with it disturbances in the body that increase the chances of developing serious diseases like diabetes and cancer. These disturbances include one or more symptoms of a condition called "metabolic syndrome" that often leads to diabetes. High levels of damage to the DNA that makes up our chromosomes have also been observed in obese people. It is possible that these two disturbances are connected. The goal of this project is to test this whether consumption of blueberries will improve these abnormalities.

Unbalanced diets rich in refined carbohydrate calories, saturated fats, and trans fats, but low in vitamins, minerals, fiber, polyphenolics and ω-3 fatty acids are common in the United States, particularly among the obese. Insulin resistance and high levels of DNA damage commonly accompany obesity. There also appears to be a relationship between oxidative DNA-damage and biomarkers that characterize metabolic syndrome. The bioactivity of blueberries is usually attributed to their high content of polyphenolics which can reduce oxidative DNA damage. Since oxidative damage to mitochondrial DNA is a suggested causal factor leading to increased insulin resistance, we will test if blueberry consumption can be an ameliorative dietary factor for insulin resistance as well. If blueberry consumption both shifts metabolism away from insulin resistance and reduces DNA damage, it may be a useful tool to assist in understanding relationships between these two obesity-associated conditions.

Eligibility Criteria:
Inclusion criteria:

1. Age 30-60 years;
2. BMI \> 30;
3. Blood pressure \<140/90 mmHg without antihypertensive medicines or with a stable dose of antihypertensive medicines (no change in last 3 months).;
4. Insulin resistance (HOMA/IR) \> 2.0;
5. Willing to restrict intake of high polyphenol-containing foods during the trial period;
6. Willing to forego intake of nutritional supplements other than a multivitamin;
7. Willing to maintain their current daily level of exercise throughout the study.

Exclusion criteria:

1. Known diabetes mellitus according to the 2013 ADA criteria;
2. Medications known to affect glucose metabolism;
3. Weight loss pharmacotherapy;
4. Lipid-lowering medication;
5. Untreated thyroid or chronic liver, renal, or cardiovascular disease;
6. Smoking;
7. Pregnancy- a negative urine pregnancy test will be documented for any women participants of childbearing age prior to enrollment.
8. History of allergic reactions to blueberries.
9. Any pathological condition known to alter white blood cell count over the previous 6 months;
10. Exposure to drugs known to cause mutations or radiation within the previous 6 months;
11. Alcohol consumption greater than 2 drinks/d for males and 1 drink/d for females.
Long-term Outcomes After Hypothermic Oxygenated Machine Perfusion of Donor Livers Using Real-world Data

End-ischemic hypothermic oxygenated machine perfusion (HOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), with several published randomized controlled trials on short-to-medium term outcomes, scientific evidence for HOPE has currently reached stage 3. Assessment of long-term outcomes after HOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking. Therefore, we aim to conduct an international, multi-center, retrospective, observational cohort study to assess long-term outcomes after transplantation of donor livers preserved by hypothermic oxygenated machine perfusion (HOPE).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic HOPE (including donation after normothermic regional perfusion) between 01.01.2012 and 31.12.2021.

Exclusion Criteria:

* Simultaneous multiorgan transplantations, sequential normothermic machine perfusion (e.g., DHOPE-COR-NMP, but not NRP), living partial liver donation.
The Effect of Human Recombinant Erythropoietin in Acute Renal Failure

The purpose of this study is to determine if the use of erythropoietin when used in high dose during acute kidney injury can decrease the number of days of kidney injury.

Acute kidney injury is associated with increased morbidity. The most common injury to the kidney occurs during hospitalization with either ischemic or nephrotoxic insult to the kidney. This can prolong hospitalization and depending on the severity of the insult result in permanent decreased kidney function. Recent studies in animals have suggested benefits of using erythropoietin in high doses at time of kidney injury with eividence for less injury in the kidney tissue of those animals who received treatment compared to those animals that received only saline. Limited human data also suggests that use of high dose erythropoietin at the time of stroke can decrease the extent of brain injury. In addition cardiac cell culture studies also have shown decrease in cell injury with use of erythropoietin. These studies have prompted us to evaluate if admininstering erythropoietin to those with onset of acute kidney injury during their hospitalization may benefit from this intervention. This pilot study then evaluates that use of high dose erythropoietin administed daily over 3 days in patients with acute kidney injury on whether the days spent in renal failure are less than those who will receive no study medication. Those patients with kidney failure from either ischemic or nephrotoxic insult and no other contraindication to erythropoietin use will be considered for the study. Informed consent is obtained from the patient or next of kin

Eligibility Criteria:
Inclusion Criteria:

* age equal or greater than 21 yo
* acute neprhotoxic or ischemic kidney injury, acute tubular necrosis

Exclusion Criteria:

* no active or current malignancies
* not actively receiveing epo
* GFR less than 60 ml/min
* unable to provide informed consent
* contraindication to erythropoietin use
Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation

Catheter ablation has emerged as an effective therapy for atrial fibrillation (AF). However, achievement of complete\& durable isolation of the pulmonary veins (PVs) is challenging, primary limited both by operator experience and also the limits of currently available ablation technology. Direct contact force sensing (CFS) is a novel technology that may help to ensure adequate lesion delivery. CFS may also help to improve the safety profile of catheter ablation. The purpose of this study is to compare two strategies of wide antral PV isolation plus linear ablation for persistent AF:

1. guided by contact force sensing (CFS) OR
2. blinded to contact force sensing (CFS) - i.e. standard approach


Eligibility Criteria:
Inclusion Criteria

* Age \> 18 years.
* Patients undergoing first-time catheter ablation for AF.
* Persistent AF defined as episodes greater than 7 days duration.
* Symptomatic AF defined as patients who have been aware of their AF anytime within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
* At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 24 months of enrolment.
* Willing and able to provide informed consent.

Exclusion Criteria

* Paroxysmal AF.
* AF secondary to a reversible cause.
* Patients with contraindications to systemic anticoagulation with heparin, coumadin, or a direct thrombin inhibitor.
* Patients who have previously undergone AF ablation.
* Patients with left atrial size \>55 mm (echocardiography, parasternal long axis view).
* Patients who are or may potentially be pregnant.
Validation of SMS Protocol for HCC Screening in High-risk Patients

The investigators will assess implementation of the proposed SMS protocol as a surveillance tool in patients at high risk of developing HCC in a prospective multicenter study.

Over the past 20 years, the prevalence of HCC has been growing extensively. HCC makes up for 75-85% of primary liver cancers and has a poor prognosis with a 5-year survival rate lower than 20%. The incidence of HCC is higher in patients diagnosed with hepatitis and/or cirrhosis. The current guidelines recommend a bi-annual US screening of this patient group. However, recent meta-analysis showed that the sensitivity of such US surveillance for detecting early stage HCC is merely 47%. In addition, early detection of small HCC lesions (with a diameter less than 2 cm) will provide a higher survival chance. It is therefore of major importance to develop a better surveillance tool.

The use of MRI should be considered as a surveillance tool for this patient group. In comparison to US, MRI come with high cost, long duration of the scan, limited availability and a potential risk related to the use of contrast agents. The investigators have developed and validated a short MRI surveillance (SMS) protocol for HCC screening in high-risk patients. This protocol has been evaluated among a database of 215 patients. In this prospective, multicenter study, the investigators will evaluate the value of the SMS protocol in a high-risk patient group and they will assess the cost-effectiveness of the SMS protocol as a surveillance tool with respect to a bi-annual US screening.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients above 18 years of age
* High-risk patients with cirrhosis and/or hepatitis

Exclusion Criteria:

* Patients below the age of 18 years
* Patients who will not sign the informed consent form
* Patients with general contra-indications for undergoing MRI examination
Feasibility of a Goal-based Agenda Setting Intervention

This study aims to assess the feasibility of a new, brief intervention, the 'coopeRATE Prompt', for informing conversations between patients and physicians in routine tele-health and in-person adult Cystic Fibrosis (CF) care. The coopeRATE Prompt is two questions designed to elicit patients' concerns and goals to facilitate collaborative goal setting within the health care visit. This is a prospective single arm study that will be conducted at four CF care centers in the United States.

Participating patients will be asked to complete two online surveys. The first survey, which includes the coopeRATE Prompt intervention questions, is completed 1-4 days before their upcoming healthcare visit. After completing this survey and before their visit, patients' intervention responses are shared with their physician and, if requested, other members of their care team. The second patient survey is completed within 24 hours after their healthcare visit. Participating clinicians are asked to complete a single online survey within one month after completion of patient data collection.

Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of CF
* are 18 years of age or older
* can read and write English
* have a scheduled in-person or tele-health routine CF care visit
* have access to internet and email

Exclusion Criteria:

* does not have a diagnosis of CF
* is less than 18 years of age
* cannot read and write English
* does not have a scheduled in-person or tele-health routine CF care visit
* does have access to internet and email
Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial

This study will compare the tolerability and efficacy of conventional formula Exclusive Enteral Nutrition (EEN) and whole-food blended smoothie EEN by enrolling a total of 60 participants with newly diagnosed pediatric Crohn's disease (CD).

Participants will be provided either commercial formula or guided on the preparation of the home-blended smoothie. These participants will be given a specific recipe, blender, and be provided the food components to the smoothie. The study will total 8 weeks and will assess tolerance, clinical outcomes, stool microbiome, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age 8 -21 years old.
* Diagnosis of Crohn's disease within 24 months
* Elevation in objective inflammatory markers at enrollment: C-reactive protein (CRP), ESR, or fecal calprotectin
* Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10.
* Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent.

Exclusion Criteria:

* History of surgery for Crohn's disease.
* Perianal disease as part of Crohn's disease phenotype.
* Recent use of:
* corticosteroids (within 4 weeks),
* dose adjustment of immunomodulator (within 8 week)
* azathioprine 4 weeks prior to study final visit (week 8)
* start or adjust methotrexate 3 weeks prior to final study visit.
* Prior use of biological medication
* Prior treatment with EEN or other dietary therapy for Crohn's disease.
* Prior treatment with antibiotics for Crohn's disease.
* Known allergies to any of the food components in the smoothie.
* Admission to hospital due to severity of Crohn's disease and associated symptoms.
* Unwillingness to provide informed consent.
A Phase II Study of HMPL-504 in Lung Sarcomatoid Carcinoma and Other Non-small Cell Lung Cancer

This is a Phase II, open-label, multicenter study of Savolitinib administered orally once per day(QD) to locally advanced/metastatic PSC patients and other NSCLC patients with MET Exon 14 mutation. The targeted population is the patients with MET Exon 14 mutation who have failed prior systemic therapy (ies), or are unwilling or can not tolerate to receive chemotherapy. Pathological diagnosis will be confirmed retrospectively by the central pathological laboratory.

Savolitinib will be administrated 600mg or 400mg once per day (QD). The treatment will be discontinued for the patients who experience disease progression, death or experience unacceptable toxicity, whichever occurs first. A cycle of study treatment will be defined as 21 days of continuous dosing.

Eligibility Criteria:
Inclusion Criteria:

* 1.Fully understood the study and voluntarily signed Informed Consent Form
* 2.Age \> 18 years
* 3.Histologically or cytologically documented locally advanced or Metastatic pulmonary sarcomatoid carcinoma (PSC) patients and other Non-small cell lung cancer（NSCLC） with MET Exon 14 mutation who have failed piror systemic therapy(ies), or are unwilling or unable to receive chemotherapy
* 4.Patient should have measurable disease per RECIST1.1
* 5.ECOG performance status of 0, or 1
* 6.Expected survival \> 12 weeks

Exclusion Criteria:

* 1.Co-existing malignancy or malignancies diagnosed within the last 3 years other than lung cancer with the exception of adequately treated skin basal cell carcinoma or cervical cancer in situ.
* 2.Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 3weeks prior to initiation of study treatment, or received TKI (for ex. EGFR-TKI) treatment within 2 week prior to initiation of study treatment
* 3.Palliative radiation to bone metastases within 2 weeks prior to the initiation of study treatment
* 4.Herbal therapy within 1 week prior to the initiation of study treatment
* 5. has EGFR, ALK or ROS 1 positive mutation