cyrilzakka/clinical-trials huggingface dataset:
Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates

The researchers are trying to compare the effectiveness of Vertebral Fracture Assessment (VFA) in addition to the current standard of care spine x-ray in evaluation pre-liver transplant patients.


Eligibility Criteria:
Inclusion criteria

* First time liver transplant candidates deemed too early for liver transplant
* 24 hour urine Creatinine clearance of \> 40 mg/dl. However bone turnover markers (beta CTx and P1NP) will be measured only in those with creatinine clearance \>60mg/dl

Exclusion criteria

* Patients with prior solid organ transplantation
* Liver/kidney combination will be excluded
* Patients with 24 hr. urine creatinine clearance \< 40mL/minute
* Patients who have been on osteoporosis medications - Bisphosphonates \[Fosamax (Alendronate), Actonel (Risedronate), Boniva (Ibandronate), or Reclast (Zoledronic acid)\] Teriparatide (Forteo), Abaloparatide (Tymlos), Denosumab (Prolia), within the past 5 years
* Use of other systemic medications that can effect bone remodeling including sex hormone replacement therapy (estrogen or testosterone), calcitonin, androgen deprivation therapy, aromatase inhibitors, or SERMS in the past 6 months
* Underlying disease that significantly impacts bone metabolism such as primary hyperparathyroidism, hyperthyroidism, Paget's disease of bone, fibrous dysplasia, or malignancies with skeletal metastases
Musical Intervention in Non-invasive Ventilation

Non-invasive ventilation (NIV) might be associated with anxiety, thus leading to NIV failure, and intubation. Music therapy has been used in various clinical context, including in ICU patients under mechanical ventilation. We aim to evaluate the effect of a musical intervention on respiratory comfort during NIV for acute respiratory failure.

We plan a randomized controlled trial with 3 different arms, in ICU patients requiring NIV for acute respiratory failure : "usual care", "sensory isolation" and "sensory isolation and musical intervention".At the onset of respiratory failure, each patient will be randomized in one of the 3 arms. "Usual care" assigned patients will receive NIV according to each unit protocol; "sensory isolation" assigned patients will receive NIV associated with a mask obscuring the eyes and a noise-reducing headset."musical intervention patients" will receive a 30 minutes musical intervention during each NIV session. Respiratory discomfort will be blindly assessed before, immediately after NIV is correctly set (5 minutes), at 30 minutes, and at hours 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 according to NIV session length, and at the end of NIV session during each NIV session.

Eligibility Criteria:
Inclusion Criteria:

* respiratory distress requiring NIV
* Glasgow coma score above 12

Exclusion Criteria:

* NIV contraindication : Hemodynamic failure, neurologic failure, head trauma, vomiting
* Severe hypoacusis people without hearing device
* Decision to limit active treatment with an estimated life expectancy of less than 48 hours
A Trial of Taurine Supplementation in Parenteral Nutrition 1

The purpose of this study is to investigate whether the inclusion of 1g of intravenous taurine as part of the nitrogen source of parenteral nutrition reduces parenteral nutrition associated cholestatic liver disease, a common side effect of parenteral nutrition.

Parenteral nutrition associated cholestasis (PNAC) is one of the main causes of death during long-term home parenteral nutrition (HPN). In one study 65% of patients on NPN developed PNAC after a median of 6 months and 41.5% developed HPN associated liver disease after a median of 17 months. It is thought that this condition develops due to changes in bile acid conjugation. Bile acids are conjugated with either taurine or glycine before their secretion in bile. Man obtains taurine mostly from the diet and hepatic taurine conjugation of bile acids accounts for 30-40% of the total bile acid pool. Taurine-conjugated bile acids are more water soluble and less toxic than glycine-conjugated bile acids. The ratio of glycine to taurine conjugated bile acids appears to be important and studies in rats have found that the bile acid sulfolithocholate, which is conjugated with glycine, was cholestatic while the taurine conjugated was not. Further studies in guinea pigs have shown that dietary taurine supplements prevent the cholestasis induced by sulfolithocholate by increasing the percentage of taurine conjugated bile acids. Patients on intravenous nutrition with intestinal failure may not re-absorb bile acids normally and may have increased losses of taurine conjugated of bile acids. They have also been found to have low levels of taurine. It is thought that chronic taurine deficiency, by altering the pattern of conjugation of bile acids, may predispose to cholestasis and ultimately severe hepatic dysfunction. In a study of hepatobiliary surgical patients given dietary taurine post operatively, there was enhanced conjugation and secretion of bile acids. Bilirubin levels fell during taurine supplementation compared to patients not receiving taurine although this was not significant. We are going to investigate if parenteral taurine supplementation is beneficial in our patients experiencing this condition.

Eligibility Criteria:
Inclusion Criteria:

* Chronic intestinal failure (CIF) patients on long term home parenteral nutrition, under the care of the Nutrition and Intestinal Failure Clinic at St Mark's, who have PNAC.
* Must be over 18
* On HPN for 6 months and stable
* Life expectancy of over 12 months
* HPN should provide \> 75-80% of estimated nutritional requirements
* Should be on HPN for 5 or more days per week

Exclusion Criteria:

* No consent.
* Pregnancy/lactation.
* Planned surgery.
* Renal failure.
* Hepatitic failure, ultrasound proven fibrosis or cirrhosis, poorly controlled diabetes, hepatitis B or C, autoimmune liver disease, receiving \> 40 kcal/kg/day from HPN, current sepsis, co-existing surgical complications such as intestinal obstruction, hepatotoxic drugs, primary liver cancer or metastases or any other cause for pre and post hepatic jaundice.

Inability to adhere to the protocol.
Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects

This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of food effects of CKD-510.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject
* Non-smoker subject or light smoker
* Body mass index (BMI) between 18 and 30 kg/m2 inclusive at screening
* Laboratory parameters within the normal range of the laboratory.
* Male volunteers must be either vasectomized or agree to use a condom during the course of the study and until 3 months (90 days) after the participant's last visit
* Signing a written informed consent prior to selection

Exclusion Criteria:

* Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease
* Blood donation within 2 months before administration
* General anesthesia within 3 months before administration
* Presence or history of drug hypersensitivity, or allergic disease
* Any drug intake (except paracetamol or contraception) during the 28 days prior to the first administration
* History or presence of alcohol or drug abuse
* Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
* Use of an investigational drug within 3 months (or 90 days) prior to Day1
Rosiglitazone Versus Placebo in Chronic Stable Angina

We wish to see if the drug rosiglitazone, currently used in the treatment of type 2 diabetes, could be used as a new treatment for angina when compared with placebo in overweight subjects who do not have overt diabetes. The drug will be given for 3 months and the subjects will be have their angina tested, by way of exercise testing, angina quality of life questionnaire and 24-hour ECG monitoring before and after using the drug.

Chronic stable angina is a common manifestation of ischaemic heart disease. Current mechanical therapies (percutaneous coronary intervention and coronary artery bypass grafting) and pharmacological therapies (nitrates, calcium channel blockers, betablockers and potassium channel activators) main actions are to treat the end product of ischaemic heart disease on chronic stable angina, i.e. the flow limiting stenosis. We postulate that by treating insulin resistance, an upstream factor in the pathogenesis of ischaemic heart disease, we will improve angina by in turn improving endothelial function. We will attempt to demonstrate this by way of full bruce protocol exercise tolerance test, Seattle Angina Questionnaire and 24 hour ST segment analysis before and after treatment with the insulin sensitiser rosiglitazone for three months.

Eligibility Criteria:
Inclusion Criteria:

* Chronic stable angina - to see if this improves
* Previous positive exercise tolerance test - to ensure that repeating it yields a result
* Disease not suitable for coronary intervention (Coronary artery bypass grafting or angioplasty) - so that best routine care is not withheld
* Do not have overt diabetes - work on this is being undertaken elsewhere
* Body mass index (BMI) greater than 25

Exclusion Criteria:

* Diabetes mellitus - see above
* Liver failure (ALT\>70U/l, AST\>80U/l)
* Renal failure (creatinine \> 130mmol/l)
* Cardiac failure - rosiglitazone is contraindicated in those with NYHA 3 and 4 cardiac failure
* Physical disability - if it precludes treadmill testing
* Women of child bearing capacity
* Breast feeding mothers
Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation.

Adrenal radiofrequency (RF) ablation has been increasingly used for the treatment of unresectable adrenal tumors. But one of the major complication is a increase in blood pressure. Hormonal release during RF ablation is considered the cause of hypertension. But there has been no evidence that adrenal hormones affects changes in blood pressure. In this prospective study, we evaluate the changes in adrenal hormones during RF ablation and clarify the cause of hypertensive crisis.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable adrenal tumor which will be treated by radiofrequency (RF)ablation
* Blood pressure is 140mmHg or less before RF ablation
* Age of 20-years or more
* Performance status of 0 or 1
* Agreement from the patient

Exclusion Criteria:

* Platelet count of 50,000/mm\^3 or International normalized ratio (INR)\>1.5
Assessment of The Clinical Course of Dyspnea in Acute Heart Failure Patients

Acute heart failure (AHF) is defined as a gradual or rapid change in heart failure (HF) signs and symptoms, such as shortness of breath (also called dyspnea or breathlessness), leg swelling, fatigue, breathlessness with exertion, trouble sleeping flat at night, and weight gain resulting in a need for urgent therapy. AHF results in over 1 million hospitalizations every year, resulting in an enormous public health burden. Approximately 1/3rd of patients will either be re-hospitalized or die within three months, and the resultant financial costs are large. As such, improving outcomes for AHF patients is critically important. Shortness of breath is the most common reason why patients with AHF present to the ER. As such, understanding how severe this symptom is, how much it improves with current treatments is very important to both patients and physicians. The purpose of this study is to determine the degree to which your shortness of breath improves during the first few days of hospitalization and its association with how fast you are breathing.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* AHFS is the primary working diagnosis for ER management and treatment with planned admission
* Have received IV diuretic therapy
* Enrolled within 3 hours of initial diuretic dose

Exclusion Criteria:

* BNP level is ≤ 300 pg/mL (may be initially enrolled and then will be excluded for second assessment)
* Transplant recipients of any kind
* Fever \> 101.5
* Severe lung disease (required home O2 or daily oral steroids)
* Any ACS event within last 30 days
* Life expectancy less than 12 months for any reason
* Current treatment for any malignancy of any kind
* Cardiogenic shock and/or requiring IV inotropic therapy
* Pregnant or recently pregnant within last 90 days
* Inability to give appropriate written consent
Effect of Acupuncture on Postoperative Ileus After Gastric Surgery (EAPIG)

Postoperative ileus (POI) is a common problem after major abdominal surgery. Acupuncture is being accepted in the West as a treatment option for managing POI and various functional gastrointestinal disorders. Therefore, we conducted a prospective randomized pilot study to evaluate the effect of electro-acupuncture on POI and other surgical outcomes in patients who underwent gastric surgery for a later large-scale study.

Before surgery, patients were randomized (using simple randomization) to either acupuncture (A) group or non-acupuncture (NA) group. In both groups, sitz markers were inserted in duodenum or jejunum during surgery for detection of postoperative remnant sitz markers by Xray. In the A group, acupuncture treatment was given once daily for up to 5 consecutive days starting on postoperative day 1. The acupuncture points which were used were based on traditional Korean medicine. No acupuncture treatment was performed in the NA group.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective surgery for gastric cancers
* Patients with American Society of Anesthesiologists grades I-III
* Patients who provided written informed consent

Exclusion Criteria:

* Patients who developed intraoperative problems or complications
* Patients with contraindications to had electrical stimulation devices (pacemaker or implantable defibrillator)
* Patients who were allergic to acupuncture needle
Coordinated Assessment of Notifications of Trials Containing Overt Published Errors

Clinical research, like all science, is self-correcting, with errors detected by the scientific community and communicated to the publishing journals, which then relay the information (and its resolution) to its readers. If this relaying process fails, science grinds to a halt. In this study we are testing its integrity.

This prospective study documents the outcome of notification to journal editorial boards (or equivalent authorities) of factually incorrect or inconsistent claims, in reports they have published.

Eligibility Criteria:
Inclusion Criteria:

* Report of a clinical trial in humans of treatment of heart disease with bone marrow derived stem cells
* Report containing discrepancy by reference to same report or another report

Exclusion Criteria:

* Discrepancy has already been corrected by an erratum
Israeli 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation

The purpose of this study is to evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.

Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.

Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Bronchoscopic Lung Volume Reduction (BLVR) Hydrogel System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. The current study will evaluate the safety and efficacy of this procedure in patients with advanced emphysema.

Eligibility Criteria:
Inclusion Criteria include:

* Clinical diagnosis of advanced heterogeneous emphysema
* Age \> 18 years at the time of initial presentation
* Clinically significant dyspnea (MRC Dyspnea \>/= 2)
* Failure of standard medical therapy to provide relief of symptoms
* BUN, creatinine, ALT, AST, alkaline phosphatase, WBC, hematocrit, platelet count, PT and PTT within normal limits
* Pulmonary function tests

Exclusion Criteria:

* Alpha-1 protease inhibitor deficiency verified by a serum level of \< 80 mg% or knowledge of PI\*ZZ genotype
* Body mass index \< 15 kg/m2 or \> 35 kg/m2
* Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis
* Tobacco use within 16 weeks of the initial clinic visit
* Allergy to fish or pork products or sensitivity to tetracycline
* FEV1 \<20% with DLCO \<20% or homogeneous disease
Research on Effectiveness and Safety of the Treatment, Hyperthermic Intraperitoneal Chemotherapy Combined With Tislelizumab and Targeted Therapy, That is Used for High-risk Hepatocellular Carcinoma After R0 Resection

There are limited treatment options for HCC with high recurrence risk, and there is no consistent plan for adjuvant therapy after surgery. Hence an unmet clinical need. Based on previous studies on unresectable HCC patients combined with targeted and immunotherapy, it has been found that the effect is significant, but the effect of combined with HIPEC is not clear, and no similar studies have been reported. Therefore, this project intends to carry out a single-arm clinical study on the efficacy and safety of HIPEC + tislelizumab combined with targeted therapy for high recurrence risk HCC. And observe the clinical benefits, to provide new ideas and evidence-based basis for the treatment of HCC with high recurrence risk.


Eligibility Criteria:
Inclusion Criteria:

* (1) In line with the diagnostic criteria of Western medicine, the pathological section was diagnosed as HCC; imaging and intraoperative exploration of HCC patients with high risk of recurrence: multiple tumors or satellite lesions, tumor diameter\>5cm, HCC rupture and bleeding, combined with vascular invasion, and serum AFP\>32ng/ml.

(2)18-70 years (3) Liver function: Child-Pugh A、B (4) Patients voluntarily receive treatment with this program.

Exclusion Criteria:

* (1) Patients did not meet the inclusion criteria. (2) Use of other antineoplastic drugs during the follow-up period (3) Severe heart and kidney damage. (4) Failure to follow the prescription for medication, and unable to judge the efficacy or incomplete information (5) Not suitable for targeted therapy and anti-PD1 immunotherapy.
RN624 For Pain Of Post-Herpetic Neuralgia

This study will test the efficacy and safety of two doses levels of RN624 versus placebo for the relief of pain caused by post-herpetic neuralgia (PHN).


Eligibility Criteria:
Inclusion Criteria:

* Male or female of any race, at least 18 years of age.
* Patients must have pain present for more than 3 months after healing of the herpes zoster skin rash.
* Has a pain score at screening that qualifies.
* Completes at least 3 average daily pain diaries during the 3 days prior to randomization and has an average pain level that qualifies.
* Body Mass Index less than or equal to 39 kg/m2.
* If female, is post-menopausal, surgically sterile, or uses adequate contraception consisting of 2 forms of birth control, one of which must be barrier method, is not lactating, and is not breastfeeding.
* Male patients must agree that female spouses/partners will use contraception as defined above or be of nonchildbearing potential (post-menopausal or surgically sterile).
* Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Patients must consent in writing to participate in the study.

Exclusion Criteria:

* Patients who cannot discontinue the use of other pain medications during the screening period and during the study.
* Disqualifying scores on questionnaires.
* Other moderate to severe pain from other conditions.
* History of allergic or anaphylactic reaction to antibodies.
* Use of biologics, including any live vaccines within 3 months of the week prior to the baseline visit.
* Unable to use acetaminophen.
* Disqualify laboratory values, Hepatitis B or C or HIV.
* Patients that have had a stroke or TIAs, dementia, epilepsy or seizures, or peripheral neuropathy from other conditions.
* Significant cardiac disease within 3 months of the study such as angina, heart attack, congestive heart failure, and other cardiac problems.
* Cancer other than basal cell or squamous cell carcinoma.
* Fails a urine test for illegal drugs including prescription drugs without a prescription.
* Plans for surgery during the study.
* History of alcoholism or drug abuse in the past two years.
* Surgery for post-herpetic neuralgia.
* Any condition that the investigator feels would put the safety of the patient at risk.
A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BKM120 Plus GSK1120212 in Selected Advanced Solid Tumor Patients

This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and /or recommended phase II dose (RP2D) and schedule for the PI3K (Phosphatidylinositol 3-Kinase) inhibitor BKM120 given in combination with the MEK inhibitor GSK1120212 in patients with selected, advanced solid tumors. The focus will be on tumors with RAS/RAF mutations and on triple negative breast cancer.

Both study drugs will be administered once daily orally on a continuous schedule, a treatment cycle is defined as 28 days.

Cohorts of at least 3 and up to a maximum of 6 patients eligible for the dose-determining set will be enrolled per dose combination below the MTD. The MTD is defined as the highest drug dosage not causing in the first cycle of treatment medically unacceptable, dose-limiting toxicity (DLT) in more than 33% of the treated patients.. At least 12 patients will be required at MTD and 6 patients at RP2D level to allow the evaluation of the combination's safety and pharmacokinetics or pharmacodynamics.

Upon declaration of MTD and/or RP2D, patients will be enrolled to an expansion part of the study, to further assess safety, as well as to learn more about the efficacy of the study drug combination.

* Expansion Arm 1 will consist of approximately 15 patients with RAS or BRAF mutant advanced NSCLC
* Expansion Arm 2 will consist of approximately 15 patients with RAS or BRAF-mutant ovarian cancer
* Expansion Arm 3 will consist of approximately 15 patients with RAS or BRAF-mutant pancreatic cancer


Eligibility Criteria:
Inclusion Criteria:

* histologically/ cytologically confirmed, advanced non resectable solid tumors
* Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0

Exclusion Criteria:

* Patients with primary Central Nervous System (CNS) tumor or CNS tumor involvement.
* Clinically manifested diabetes mellitus - Unacceptable ocular/retinal conditions

Other protocol-defined inclusion/exclusion criteria may apply.