cyrilzakka/clinical-trials huggingface dataset:
Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.

PURPOSE: To provide expanded access and study the side effects of yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.

OBJECTIVES:

Primary

* Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with primary cancer to the liver and who are not surgical resection candidates.
* Evaluate patient experience and toxicities associated with TheraSphere® treatment.
* Enter treatment experience into a liver database.

Secondary

* Determine the tumor response rates in patients receiving this treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic arterial infusion. Patients may be retreated between 30-90 days after the initial infusion.

After completion of study therapy, patients are followed for 30 days and then annually thereafter for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of hepatocellular carcinoma
* Surgical evaluation by a member of the Liver Tumor Program must conclude the patient is not a candidate for resection or ablation
* Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2
* Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

* Absolute granulocyte count =\<1,500/ul
* Platelet count =\<75,000/ul
* Serum creatinine \>= 2.0 mg/dl
* Serum bilirubin

  * \>= 2.0 mg/dl for bilateral treatment or lobar treatment
  * \>= 3.0 mg/dl for single lesion which could be treated by segmental fusion
* History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
* Bleeding, diathesis not correctable by usual forms of therapy
* Severe peripheral vascular disease that would preclude catheterization
* Portal hypertension with portal venous shunt away from the liver
* Evidence of potential delivery greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:

  1. first TheraSphere administration; or
  2. cumulative delivery of radiation to the lungs \> 30 Gy over multiple treatments
* Evidence of any detectable Tc-99m MMA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
* Significant extrahepatic disease representing an imminent life-threatening outcome
* Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy)
* Active uncontrolled infection
* Significant underlying medical or psychiatric illness
* Pregnant women may not participate
* Children may not participate
Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women

SARS-CoV-2 impact on pregnant women is not well known yet. Some authors demonstrated that lung ultrasound can give similar results if compared to chest computed tomography and better results if compared to chest x-rays without radiations and limited risks for mother and fetus.

The Lung Ultrasound Score (LUS) can be used to asses the entity and monitor the evolution of lung impairment.

Some authors described an artifact, the "light beam", as a typical ultrasound sign in COVID-19 positive patients.

With our study we hypothesize to understand the prevalence of this sign and other ultrasound signs in pregnant COVID-19 positive patients.


Eligibility Criteria:
Inclusion Criteria:

* All pregnant COVID 19 positive patients admitted at our institution who had lung ultrasound performed

Exclusion Criteria:

* are \< 18 years old
* history of rheumatic disease
* history of spontaneous pneumothorax
* fibrothorax
* history of thoracic surgery
* no consent given
Unusual Toxicity Induced by Radiotherapy

In order to evaluate the physiopathological knowledge of the different pathological manifestations associated with individual radiosensitivity, it seems essential to carry out this pilot study. It has agglomerated homogeneous tissue samples to identify new biomarkers for patient diagnosis and follow-up, and may predict the therapeutic response. These knowledge will help to treatment customization.


Eligibility Criteria:
Inclusion Criteria:

* Child or teenager aged 2 to \<18
* Man, Woman\> 18 years old
* Patient with one of these situations:

  * Unusual toxicity in progress or after radiotherapy
  * Indication of radiotherapy and suspicion of abnormal pathways of response to ionizing radiation - constitutional (genetic disease) or acquired (systemic disease) - which may generate unusual radioinduced toxicity
* Patient information and informed consent signed by the patient. For children and teenager : information to parents and obtaining informed consent
* Affiliation to a social security scheme.

Exclusion Criteria:

* Contraindication for skin and / or tumoral biopsy
* Contraindication for blood sample of 2.5 ml
* Persons deprived of liberty or under supervision
Evaluation of the Effect of Wismemo on Alzheimer's Dementia Patients

The present studies demonstrated that pro-inﬂammation, systemic oxidative stress and dysfunction in the brain-gut microbiota axis were involved in Alzheimer's disease (AD) pathogenesis. These results implied the decreased regulation of inflammation-associated risk and microbiota in AD patients could provide the novel strategies for combating the disease. This study was designed to assess the addition of Wismemo in treatment of cholinesterase inhibitors (such as donepezil, rivastigmine, galantamine) in the AD patients.

Previously studies have shown some probiotics could improve stress-related diseases such as anxiety, autism, depression and schizophrenia might be through regulating brain-gut microbiota axis, pro-inﬂammation and oxidative stress. Although recent clinical study indicated that mix-probiotics (containing Lactobacillus acidophilus, Lactobacillus casei, Bifidobacteria bifidum and Lactobacillus fermentum) consumption could improve the cognitive function of dementia patients.

In this clinical study, whether Genmont specific strain probiotics could improve the clinical syndromes and delay worsens in Alzheimer's dementia patients with regular treatment were clarified. A Randomized, double-blind, placebo-controlled clinical trial would be carried out. AD's patients with regular treatment are additive consumption multi-strain probiotic supplement (Wismemo). Half of participants will receive Wismeno and regular treatment in combination, while the other half will receive placebo and regular treatment in combination. To evaluate of the effect of probiotic supplementation on cognitive, emotional and related status on Alzheimer's dementia patients.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with Alzheimer's Dementia. (According to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association diagnostic criteria (NINCDS-ADRDA) and new criteria and guidelines to diagnose Alzheimer's disease were published in 2011 by the National Institute on Aging and Alzheimer's Association)
2. Subjects with administrating cholinesterase inhibitors, such as donepezil, rivastigmine, galantamine.
3. Subjects in age of 55-95 years old.

Exclusion Criteria:

1. Subjects are mixed dementia and vascular dementia.
2. Administration of probiotic dietary supplement 2 weeks before inclusion expect for yakult or yogurt.
3. Participation in other clinical trials.
4. Subjects with thyroid dysfunction.
5. Subjects are receiving cancer drugs.
6. Subjects are receiving immunosuppressant drugs.
Beta Glucosylceramide for Treatment of NASH

Oral administration of betaglucosylceramide was shown effective in reducing inflammation in animal models and was found safe in humans.

Patients with NASH to receive the treatment versus placebo for 40 weeks followed by a liver biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven NASH

Exclusion Criteria:

* Other therapies
Opioid Receptors Influence Ischemia-Reperfusion Injury

The most powerful protective mechanism against ischemia-reperfusion injury other than rapid reperfusion is ischemic preconditioning. Ischemic preconditioning is defined as the development of tolerance to ischemia-reperfusion injury by a previous short bout of ischemia resulting in a marked reduction in infarct size. This mechanism can be mimicked by several pharmacological substances such as adenosine and morphine.

We, the researchers at Radboud University Nijmegen Medical Centre, have recently developed a method in which we can detect ischemia-reperfusion injury in the human forearm by using Annexin A5 scintigraphy (Rongen et al). With this method we will determine whether opioid receptors are involved in ischemic preconditioning. We expect to find that morphine can mimic ischemic preconditioning and that acute ischemic preconditioning can be blocked with the opioid receptor antagonist naloxon. This study will increase our knowledge about the mechanism of ischemic preconditioning and may also provide leads to exploit this endogenous protective mechanism in a clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Exposition to radiation due to imaging techniques in the previous five years
Repair or Not Repair Pronator Quadratus in the Volar Plating of Distal Radial Fracture Are Functional Outcomes Differ ?

The theoretical benefits of the repair of the pronator quadratus include flexor tendon protection, remain of the normal pronation-supination range of motion (ROM) and strength, and keeping the stable DRUJ.

Repair or not repair pronator quadratus in the volar plating of distal radial fracture-Are functional outcomes differ?

In the operation of distal radial fractures, the volar plating techniques become popular. During the surgical approach, the pronator quadratus (PQ) muscle needs split or full-thickness strip to exposure the fracture site and facilitate the instrumentation of the plate. Generally, the PQ would be repaired. Sometimes, the PQ is damaged by the fracture fragment so severely that it is difficult to repair the PQ. However, there is few reviews paper to discuss the consequence of the unrepaired or repaired PQ and the AAOS guideline1 of the treatment of distal radial fracture in 2009 did not even list the management of the PQ. The function of the PQ includes pronation and stability of the distal radial-ulnar joint (DRUJ). According to the study, the elimination of PQ function will cause a significant decrease in pronation torque, which is supposed to affect the function of the wrist in the daily life. The theoretical benefits of the repair of the pronator quadratus include flexor tendon protection3,4, remain of the normal pronation-supination range of motion (ROM) and strength, and keeping the stable DRUJ.

Eligibility Criteria:
Inclusion Criteria:

* ≧ 20 or ≦ 80-years-old adult patients
* Cooperative to evaluation
* Distal radial fracture, fresh, single fracture
* Volar plating

Exclusion Criteria:

* \< 20 or \> 80-years-old patients
* Uncooperative adult, such as dementia
* Old fracture, more than 1 Week
* Multiple fractures
* Pathological fracture
* Surgery other then volar plating
Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis

In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. Clinical data from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. In this retrospective study, the incidence of re-compensation and its clinical characteristics were mainly explored.

In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. WBC, RBC, HGB, PLT, CRP, PT, PTA, INR, ALT, AST, TB, DB, ALB, GLO, ALP, GGT, CHE, BUN, Cr, Na, GLU, CHOL, TG, HDL-C, LDL-C, AFP, HBsAg, HBV-DNA, LSM, BUS, MRI/CT and gastroscope from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. This retrospective study aimed to explore the incidence of re-compensation and its clinical characteristics.

Eligibility Criteria:
Inclusion Criteria:

1. Ascites and/or variceal hemorrhage (VH) as the first decompensated events;
2. Initiating antiviral therapy within 3 months of the first decompensated events;
3. Clinical parameters were available at the first decompensated events, including PLT, ALT, ALB, TB, PT/INR, Cr, HBV DNA, BUS,
4. Clinical outcomes were classified:

   1. Without further decompensation: medical records at year-1, year 2 to 4, and year-5 were available.
   2. With ≥ 2 episodes of decompensation: medical records for decompensation were available.

Exclusion Criteria:

1. Hepatocellular carcinoma prior to /within 6 months of first decompensated events;
2. Liver transplantation /death within 6 months of first decompensated events;
3. complicated with other chronic liver diseases, including HCV, DILI, AIH, NAFLD, ALD.
4. Any complication of severe heart, lung, kidney, brain, blood diseases or other severe systematic diseases;
5. Pregnant women.
Effect of Simultaneous Application of HD-tDCS and Robot-assisted Gait Training on Gait Function in Stroke Patients

The purpose of this study was to investigate the effects of simultaneous application of transcranial direct current stimulation (tDCS) with robotic gait training in stroke patients with gait impairment.


Eligibility Criteria:
Inclusion Criteria:

* Age: 19 - 79 years
* More than 3 months post stroke
* Functional ambulation classification (FAC) (1\~4)

Exclusion Criteria:

* History of serious neurological disease other than stroke
* Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
* History of psychiatric disease
* Contraindicated to tDCS
The Effect of Deep Tissue Massage on Respiratory Parameters in People with Asthma

Bronchial asthma, as a chronic inflammatory disease of the respiratory tract, significantly reduces the quality of life of patients. Standard treatment includes pharmacotherapy, but a holistic approach, including manual therapies, can support pharmacological therapy, reducing the need for drugs.

The aim of the research is to verify whether deep tissue massage (DTM) techniques applied to the chest significantly affect respiratory parameters in people with asthma. The study is the next stage of the study conducted on healthy people. After obtaining positive results in the study involving people not suffering from respiratory diseases, the next step is to examine people with, in this case, bronchial asthma. It is important to determine whether the use of this form of manual therapy can bring benefits in the context of improving respiratory functions, reducing respiratory muscle tension and relieving subjective symptoms associated with asthma, such as shortness of breath or limitations in everyday functioning.

The hypothesis assumes that DTM techniques can have a bigger effect on the respiratory system than classic massage (CM).

The study is a randomized controlled trial, where participants will be randomly assigned to one of two groups: the study group (subjected to DTM) or the control group (subjected to CM). Before and after the massage intervention, participants will undergo spirometry to assess the changes in respiratory parameters. The obtained data will then be analyzed for effects on respiratory parameters and differences between both groups.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with bronchial asthma
* stable health condition, allowing participation in the study
* informed consent to participate in the study

Exclusion Criteria:

* acute or chronic comorbidities that may affect the results (e.g. COPD, heart failure, cancer)
* any chest surgery performed within the last 6 months
* contraindications to massage (e.g. skin infections, wounds)
* pregnancy
* participation in other clinical trials in the last 3 months
Prehospital Triage of Patients With Suspected Non-ST-segment Elevation Acute Coronary Syndrome: the TRIAGE-ACS Study

With the Emergency Medical Services (EMS), no prehospital risk stratification and triage is performed for patients suspected of having an Non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS). While the latest ESC Guidelines recommend an early invasive strategy within 24 hours for all high risk NSTE-ACS patients and same-day transfer to a PCI (Percutaneous Coronary Intervention) center. With the potential emerging logistical problem surrounding this, prehospital risk stratification and triage can have great benefits in this population as well, especially in patients with a high risk of having an NSTE-ACS. The recently validated PreHEART score makes it possible to stratify patients in a low-risk and high-risk group for having a NSTE-ACS and gives the EMS the opportunity to make triage decisions in the prehospital setting. Patients with a high risk for having an NSTE-ACS are transferred directly to an PCI-center for further diagnostic work-up. Patients with a low risk for having NSTE-ACS and transferred to the ED of the nearest hospital without PCI facilities (non-PCI center) for further diagnostic work-up, resulting in an optimization of the regional care utilization.

This is the first study to focus on patients who are at a high risk of having an NSTE-ACS and to assess if whether prehospital triage using the PreHEART score is able to significantly reduce time to final invasive diagnostics and revascularization in patients in need of coronary revascularization.


Eligibility Criteria:
Inclusion Criteria:

* Chest pain suspected for NSTE-ACS
* Age ≥ 18 years
* Intention to transfer patient to Emergency Department

Exclusion Criteria:

* ST-segment elevation Acute Coronary Syndrome
* Post resuscitation patients
* Hemodynamic instability defined as Killip Class IV
* Suspected other life treating pathology
* Pregnancy
* No informed consent for data usage
Pilot Stair Climbing Study

This pilot study seeks to demonstrate feasibility to conduct data collection and illustrate potential for effect of fractionalized bouts of stair climbing on glucose control in adults at risk for type 2 diabetes.

Objective: Compare the short-term effects of two different fractionalized stair climbing bout protocols on glucose control among adults at risk for type 2 diabetes.

Rationale: Fractionalized physical activity is associated with reduced BMI, glycated hemoglobin, lower 2-hr plasma glucose and insulin sensitivity in cross-sectional studies. Yet, few studies have examined the effects of fractionalized or intermittent physical activity in a prospective manner. Furthermore, the research is limited to patients with diagnosed type 2 diabetes, or using exercise of a moderate intensity.

The hypothesis is that stair climbing, a vigorous-intensity activity, may have a greater health effect. However, this has not been tested in short bouts of activity that are spread out during a day.

Implications: Fractionalized physical activity may be more feasible for adults at risk for, or with diagnosed type 2 diabetes who are not currently active. These short bouts can increase energy expenditure throughout the day, rather than in one long continuous bout as currently recommended.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 40 years but less than 65 years (working age adult with reduce physiologic capacity to regulate glucose)
* BMI of overweight or obese (25.0 to 35.0)
* Answered "No" to all questions on the Physical Activity Readiness Questionnaire, or has physician approval to participate
* Hemoglobin A1C% value in the at-risk range of 5.7 to 6.4

Exclusion Criteria:

* Unable to physically perform stair climbing
* Currently exercising for 60 or more minutes weekly.
* Weight over 275 lbs (because stair climbing machine has a weight limit)
Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV

The Phase 3 LIMT-2 study will evaluate the safety and efficacy of Peginterferon Lambda treatment for 48 weeks with 24 weeks follow-up compared to no treatment for 12 weeks in patients chronically infected with HDV. The primary analysis will compare the proportion of patients with HDV RNA \< LLOQ at the 24-week post-treatment visit in the Peginterferon Lambda treatment group vs the proportion of patients with HDV RNA \< LLOQ at the Week 12 visit in the no-treatment comparator group.

This is a randomized, open-label, parallel arm study that will allocate patients (2:1) with chronic HDV infection to one of two treatment groups: Peginterferon Lambda 180 mcg QW for 48 weeks with 24 weeks follow-up (Arm 1, n=100), or no treatment for 12 weeks followed by Peginterferon Lambda treatment for 48 weeks with 24 weeks of follow-up (Arm 2, n=50). All patients will receive concomitant therapy with a potent 2nd generation anti-HBV nucleos(t)ide analogue (NUC) throughout the study duration.

Data collected during Peginterferon Lambda treatment in Arm 2 will not be included in the primary analysis. The primary purpose of Arm 2 is to provide benchmark data in a parallel reference group for the expected rate of HDV RNA suppression among patients with chronic HDV infection who receive 12 weeks of anti-HBV NUC therapy alone.

Prior to randomization, all patients will enter a run-in phase with 12 weeks of anti-HBV NUC therapy, which will ensure virologic control of HBV (\< 100 IU/mL) prior to randomization and start of Peginterferon Lambda therapy.

Eligibility Criteria:
Inclusion Criteria:

* Chronic HDV infection documented by a positive HDV antibody test or a positive HDV RNA by RT PCR test for at least 6 months at Screening Visit 2
* Quantifiable HDV RNA by RT-PCR test at Screening Visit 2
* Documented confirmed suppression of HBV DNA (\< 100 IU/mL) following at least 12 weeks of anti-HBV NUC treatment with ETV or a TNF-based NUC (TDF or TAF) at Screening Visit 2
* Serum ALT \> upper limit of normal (ULN) and \< 10 × ULN.
* Patients categorized with Child-Turcotte-Pugh score of ≤ 5 with well compensated liver disease.

Exclusion Criteria:

* History or current evidence of decompensated liver disease (episodes of bleeding esophageal or gastric varices, ascites and/or encephalopathy)
* Treatment with interferons (IFNs) or immunomodulators within 6 months before Screening Visit 2 or refractory to prior IFN treatment.
Effect of Intraperitoneal Nebulisation of Magnesium Sulphate for Analgesia Following Laparoscopic Cholecystectomy

intraperitoneal nebulisation with magnesuim sulphate will reduce post operative pain and analgesic consumption in postoperative period following laparoscopic cholecystectomy.

Sixty patients undergoing laparoscopic cholecystectomy belonging to American Society of Anaesthesiologist (I-II) of age 18-65 yrs will be enrolled.Group one (n=30) will receive 1.5 gm magnesium sulphate diluted in 3ml of normal saline and group 2 (n=30) will receive 5 ml of NS.

Eligibility Criteria:
Inclusion Criteria: ASA I-II

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Exclusion Criteria: history of

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