cyrilzakka/clinical-trials huggingface dataset:
Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC

A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma).

This is a Phase III, randomised, open label, 3 arm, multi-centre, international study assessing the efficacy and safety of savolitinib plus durvalumab compared with sunitinib in participants with MET-driven (without co-occurring FH mutations), unresectable and locally advanced or metastatic PRCC, who have not received any prior systemic anti-cancer therapy in the metastatic setting. The study will also investigate the contribution of durvalumab to the savolitinib plus durvalumab combination.

Approximately 200 participants will be randomised in a 2:1:1 ratio to one of the following intervention groups: savolitinib (600mg, oral, once daily) plus durvalumab (1500mg IV Q4W), sunitinib (50mg, oral, once daily for 4 consecutive weeks, followed by a sunitinib-free interval of 2-weeks, Q6W), or durvalumab monotherapy (1500mg IV Q4W).

Participants will continue to receive study intervention until objective radiological PD per RECIST 1.1 is assessed by the investigator, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met.

Depending on the preferred subsequent therapy, participants randomised to the durvalumab monotherapy arm will be eligible to switch to receive savolitinib in combination with durvalumab at the time of objective radiological PD assessed by BICR per RECIST 1.1, without any intervening systemic anti-cancer therapy following discontinuation of durvalumab monotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed unresectable and locally advanced or metastatic PRCC
* PRCC must be centrally confirmed as MET-driven using a sponsor-designated central laboratory validated NGS assay
* No prior systemic anti-cancer treatment in the metastatic setting; no prior exposure to MET inhibitors, Durvalumab or Sunitinib in any setting
* Karnofsky Score \>70
* At least one lesion, not previously irradiated, that can be accurately measured at baseline
* Adequate organ and bone marrow function
* Life expectancy ≥12weeks at Day 1

Exclusion Criteria:

* History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement, with or without normal LFTs
* Spinal cord compression or brain metastases, unless asymptomatic and stable on treatment for at least 14 days prior to study intervention
* Active or prior cardiac disease (within past 6 months) or clinically significant ECG abnormalities and/or factors/medications that may affect QT and/or QTc intervals
* Active infection including HIV, TB, HBV and HCV
* Active or prior documented autoimmune or inflammatory disorders
* Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention
Fiber Longer Term Study on Energy Intake

Dietary fibre seems to have a relevant role in body weight management. In an acute study the investigators found that high viscous-high gelling pectin increased feelings of satiety. The objective of this study is to study the effects of 2 weeks of supplementation of high gelling-high viscous fibre or a high gelling-high viscous non-fibre control on energy intake.

The investigators do this by measuring the difference in ad libitum energy intake after 15 days of pectin or 15 days of control supplements. The investigators will further measure differences in 24h feelings of satiety, fasting blood glucose and insulin, fermentation and composition of microbiota.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-30 year
* BMI: 18.5-25 kg/m2
* Healthy: as judged by the participant
* H2 producer

Exclusion Criteria:

* Weight loss or weight gain of more than 5 kg during the last 2 months
* Using an energy restricted diet during the last 2 months
* Lack of appetite for any reason
* Restrained eater
* Smoking
* Heavy alcohol use: \>5 drinks/day
* Reported stomach or bowel diseases or disorders (e.g. irritable bowel syndrome)
* Reported diabetes
* Reported thyroid disease or any other endocrine disorder
* Using medication other than birth control, paracetamol, aspirin, hey fever and asthma
* Antibiotic use \<2 months before the study
* Reported intolerance, allergy, or not liking of the research foods
* Vegetarian
* Current dietary fibre supplementation
* Fasting glucose levels \>5.8 mmol/l
* Experienced any problems with drawing blood in the past
* Thesis students or employees of the division of Human Nutrition
* Volunteers who participated in the ProVe study
Platelet Activation and Reactivity in Acute Exacerbations of COPD

Chronic obstructive pulmonary disease (COPD) is known for development of severe cardiovascular co-morbidities. Systemic inflammation during acute exacerbations of COPD (AE-COPD) is thought to play a role in development of cardiovascular disease. Platelets contribute to acute cardiovascular events and atherosclerosis. When platelets are activated, they form complexes with monocytes. These platelet-monocyte complexes (PMCs) are an early process in atherothrombosis and promote inflammation. In COPD, platelet function in AE-COPD is scarcely studied. This study aims to address this gap by investigating platelet function and coagulation in patients with AE-COPD and after convalescence.


Eligibility Criteria:
Inclusion Criteria:

* \>40 years
* Spirometry confirmed diagnosis of COPD (i.e. post-bronchodilator FEV1/FVC \< 70% and less than 12% on reversibility testing\< Lower limit of normal (LLN))
* ≥10 pack years of smoking

Exclusion Criteria:

* Use of anti-coagulation or other platelet function inhibitors
* Asthma
* Chronic inflammatory diseases, for example rheumatoid arthritis, psoriasis, inflammatory bowel diseases , systemic lupus erythematous (SLE)
* Malignancies
Impact of n-3 Polyunsaturated Fatty Acids in a Protein-enriched Diet With Low GI in Type 2 Diabetes Patients

Type 2 diabetes is tightly associated with overweight and obesity. Inflammatory processes are crucial triggers for insulin resistance that paves the way to type 2 diabetes. In a previous study the investigators have shown that n-3 polyunsaturated fatty acids diminish adipose tissue inflammation in morbidly obese non-diabetic subjects. in this observational study the investigators will apply n-3 polyunsaturated fatty acids as addition to a protein-enriched diet with low glycemic index to overweight and obese patients with insulin resistance, prediabetes and manifest type 2 diabetes over up to 6 months. Primary efficacy parameters are changes from baseline in HbA1c and body weight for for type 2 diabetes and all other patients, respectively.


Eligibility Criteria:
Inclusion Criteria:

* overweight or obesity AND
* insulin resistant OR pre-diabetes OR type 2 diabetes

Exclusion Criteria:

* changes in anti-diabetic medication in the lat two months
* acute illness during the last two weeks
* HIV infection
* hepatitis of other clinically significant hepatic disease other than non-alcoholic hepatic steatosis
* severe or insufficiently treated cardiovascular, renal (GFR-MDRD \< 60 ml/min) or pulmonary disease
* Macroproteinuria (\> 300 mg/g creatinine)
* clinically significant or insufficiently treated thyroid disease
* anemia
* active malignant disease
* inborn or acquired coagulopathy
Renal Sympathetic Denervation Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: a Pilot Study

The autonomic nervous system plays an important role in the precipitation of AF in structurally-abnormal hearts. Restoration of autonomic imbalance may therefore prevent new-onset AF.

Renal artery denervation (RDN) is a novel percutaneous procedure that uses radio-frequency energy to destroy the sympathetic renal nerves. Symplicity 1 and -2 studies have shown that RDN effectively reduces blood pressure in up to 80% of treated patients. LVH regression and improvement of diastolic dysfunction follow as a consequence of afterload reduction and renin-angiotensin-aldosterone system modulation. RDN may thus also reduce intra-atrial pressure resulting in less stretch of the pulmonary venous ostia where most ectopic AF-foci originate.

Hypothesis: RDN restores autonomic imbalance in HTHD and lowers intra-atrial pressure by reducing afterload. These synergistic mechanisms may prevent new-onset AF.

One hundred consenting patients meeting all inclusion criteria will undergo an exercise stress test, 2D and M-Mode echocardiograms and 24-hour ambulatory blood pressure holter monitoring prior to being randomised to receive either renal denervation (RDN) with a Symplicity renal denervation catheter plus medical therapy or medical therapy alone. Coronary angiography with/without coronary revascularisation will be performed as per the treating cardiologist's clinical judgement and a Reveal® holter will be implanted in all patients at the end of the procedure.

Time zero will be defined as starting at three months after the procedure. Follow up visits will be scheduled to scan the holter for the primary end point, i.e. high atrial rates (AF-surrogate defined as: "episodes of atrial rate \>190 beats per minute for more than 6 minutes") or new-onset AF. Patients will be followed six monthly for three years.

Eligibility Criteria:
Inclusion Criteria:

* Must have an indication for coronary angiography e.g.
* Acute coronary syndrome
* Positive stress ECG: - Defined as ≥1mm ST segment shift (depression or elevation) in ≥2 contiguous leads with/without chest discomfort)
* Age ≥55 years
* Office blood pressure ≥160/90mmHg in non-diabetics or ≥150/90mmHg in diabetics
* Subjects must be on at least 3 anti-hypertensive drugs, including a diuretic agent
* Sinus rhythm
* Left ventricular hypertrophy defined on echo as:
* Estimated LV mass \> 255 g or LVMI \>131 g/m2 for men
* Estimated LV mass \>193 g or LVMI \>113 g/m2for women
* Left atrial diameter ≥45mm on any echocardiographic window

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) \< 45ml/min/1.73m2
* Renal artery anatomy unsuitable for RDN
* Substantial stenotic valvular heart disease
* Pregnancy or planned pregnancy
* Thyrotoxicosis
* Patients needing to undergo coronary artery bypass surgery
Efficacy of Fractional Microneedle Radiofrequency and Fractional Erbium-Doped Glass 1,565-nm for Baggy Lower Eyelids

The purpose of this study was to compare the efficacy and safety of FMR and NAFL in the treatment of baggy lower eyelids(BLEs)

Fifteen baggy lower eyelids(BLEs) volunteers were recruited prospectively. Everyone was divided into two groups with FMR and NAFL according to the random number table. One side of the face was treated with FMR device and the other side was treated with NAFL device. Subjective and objective adverse reactions were recorded during the operation. Subjective adverse reactions were recorded after each treatment. The VAS score of patient satisfaction and the blind method score of standard photo observer were used for subjective evaluation, and the objective evaluation was carried out by using VISIA，Antera-3D and CineScan.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Bags lower eyelids ( BLEs )；
2. Two senior attending surgeons diagnosed the BLEs;
3. The clinical diagnosis standard was mild swelling or puffiness under the eyes;
4. Between 18 to 60 years old.

Exclusion Criteria:

1. History of retinoic acid;
2. History of hormone use;
3. History of keloids;
4. History of injection of botulinum toxin or filler at the site of treatment;
5. Skin inflammation or facial infection;
6. Pregnancy or lactation.
Triheptanoin for Children with Primary-Specific Pyruvate Dehydrogenase Complex (PDC) Deficiency

This is a medical research study to test a medication in patients with a disease called Pyruvate Dehydrogenase Complex (PDC) Deficiency. The medication is triheptanoin, which is currently FDA approved for the treatment of Long-Chain Fatty Acid Oxidation Disorders. Previous research suggests that triheptanoin may also be effective in the treatment PDC Deficiency. This study will investigate the safety and efficacy (how well it works) of triheptanoin in patients with PDC Deficiency.

Participation in the study will require the patient to participate in up to 10 visits over a two-year period. Five of those visits must be done at the UPMC Children's Hospital of Pittsburgh (CHP). Other visits can take place at CHP or remotely. All of these visits will include blood draws.

Triheptanoin will be added to the patients' diet and administered at least 4 times per day. The target dose will be 1.2-3.9 g of triheptanoin per kg body weight with a max goal dose of about 4 g/kg per day.

The triheptanoin will be provided to the patients at no cost. All other costs will be billed to the patients' insurance.

Eligibility Criteria:
Inclusion Criteria:

1. Age 1 year to \<18 years of age
2. Subjects with PDCD would need to have a metabolic physician following their clinical care needs prior to their enrollment in the study
3. Diagnosis of PDCD by molecular genetic confirmation of PDHA1, PDHB, DLAT, PDHX, or PDP1 mutation
4. Not pregnant or lactating
5. Parental permission and assent of minor and willingness to comply with study procedures
6. Not participating in any interventional treatment clinical trials
7. Not a recipient of gene therapy, organ transplant, or bone-marrow transplantation
8. If currently on any investigational drugs or therapies, must complete a 30-day washout period prior to Intake \& Dosing (Day 1).
9. Negative pregnancy test for all female patients of childbearing age. Individuals of childbearing potential must agree to use a highly effective method of contraception, and males must agree not to father a child or donate sperm. True abstinence for the duration of the study will also be accepted.
10. Subjects are following some form or type of ketogenic diet at the time of the screening visit.

Exclusion Criteria:

1. Diagnosis of medium-chain acyl-CoA dehydrogenase (MCAD)
2. Use of alcohol or drugs of abuse
3. Evidence of liver disease as defined by elevations of AST or ALT \>2x ULN in the past 6 months
4. Pregnant, breastfeeding, or lactating females
5. On any investigational product research study (and not completed the required 30-day washout period prior to Intake \& Dosing) or recipient of gene therapy or organ or bone-marrow transplantation
Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants

To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.


Eligibility Criteria:
Inclusion Criteria:

* Neonates and infants, expected to require parenteral nutrition (PN) for 28 days
* Postmenstrual age ≥ 24 weeks
* Birth weight ≥ 750g
* Gastroschisis, duodenal, jejunal or ileal atresia, volvulus, spontaneous intestinal perforation or necrotizing enterocolitis (Bell's stage 2B or higher)
* At least 80% of nutritional needs at baseline received by PN
* Signed and dated informed consent obtained from at least one parent or legal guardian

Exclusion Criteria:

* Conjugated bilirubin \> 0.6 mg/dL
* Any known pre-, intra- or posthepatic complication increasing conjugated bilirubin levels \> 0.6, mg/dL during study participation
* Suspected liver disease or liver damage based on either aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) exceeding 2.5x upper limit of normal range
* Active bloodstream infection demonstrated by positive blood culture at screening
* Cystic fibrosis
* Meconium ileus
* Serum triglyceride levels \> 250 mg/dL
* Cyanotic congenital heart defect
* Severe renal failure with serum creatinine \> 2.0 mg/dL
* History of shock requiring vasopressors
* Anasarca
* Extracorporeal Membrane Oxygenation (ECMO)
* Known inborn errors of metabolism
* Known congenital viral infection
* Unlikely to survive longer than 28 days
* Known hypersensitivity to fish-, egg-, soya- or peanut protein or to any of the active substances or excipients
The Combination of Tacrolimus and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Randomized, open-label, multicenter study to compare the efficacy and safety of combination of tacrolimus and danazol versus danazol for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).

The investigators are undertaking a randomized controlled trial of 120 adults with steroid-resistant/relapse ITP in China. Patients were randomized to tacrolimus plus danazol and danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Primary immune thrombocytopenia (ITP);
* 18 years older;
* Platelet count of less than 30×10\^9/L at enrollment;
* Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
* Patients who were receiving other maintenance regimens, primarily corticosteroids, ciclosporin, or mycophenolate mofetil, were also eligible if the dose of treatment had been stable in the past month and the dose was expected to be stable after enrolment and remained unchanged at least for the first 4 weeks of study until initial response was assessed, unless severe adverse events were suspected.

Exclusion Criteria:

* Secondary ITP (e.g., patients with HIV, HBV, HCV, Helicobacter pylori infection or SLE);
* Congestive heart failure, severe arrhythmia;
* Nursing or pregnant women;
* ALT or AST levels ≥ 3× the upper limit of the normal threshold;
* Creatinine or serum bilirubin levels ≥ 1.5× the upper limit;
* Active or previous malignancy ;
* Patients who had received danazol treatment or did not respond to danazol;
* Patients unable to have routine blood tests because of reasons such as insufficient time.
Phase II Study of HMPL-004 in Subjects With Crohn's Disease

A double blind, randomized, multi-center, placebo-controlled study to evaluate the efficacy and safety of HMPL-004 in patients with active moderate Crohn's Disease.

This was a double-blind, randomized, multicenter, placebo-controlled study evaluating the efficacy and safety of oral HMPL-004 in subjects with active moderate Crohn's disease (CD) - Crohn's Disease Activity Index (CDAI) 220 to 400 - on stable doses of CD medications who had not received anti-tumor necrosis factor alpha (anti-TNF-α) for at least 3 months prior to start of treatment. HMPL-004 (or placebo) was added to the subject's existing CD medications. Subjects were observed for an 8-week treatment period and a subsequent 4-week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Have active confirmed Crohn's Disease (confirmed radiographically, endoscopic, or histologically), with a CDAI of 220-400 at baseline screen

Exclusion Criteria:

* They have received anti-TNF-α antibody within 3 months of starting study medication, or cyclosporine, tacrolimus, thalidomide or mycophenolate mofetil within 2 months of starting study medication
COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI Trial

Remote ischemic conditioning (RIC) and intravenous exenatide administered immediately before primary angioplasty have been found to limit infarct size in patients with STEMI (ST segment elevation myocardial infarction), but the reduction is limited. This study investigates whether a combination therapy including both therapies is more effective.

COMBAT-MI is an investigator-driven, randomized, double-blind and placebo-controlled clinical trial aimed at evaluating the effect of Remote Ischemic Conditioning and exenatide, alone and in combination, on Myocardial Infarct size in 428 STEMI patients (107 per group) (ST segment elevation myocardial infarction). Patients with TIMI (Thrombolysis in Myocardial Infarction) flow grade \> 1 will be excluded. The study has a 2 x 2 factorial design (Remote Ischemic Conditioning , Exenatide, both or neither). The primary end-point will be Myocardial Infarct size measured by Cardiac Magnetic Resonance Imaging (CMRI) performed 3 - 7 days after primary Percutaneous Coronary Intervention (pPCI) (expressed as % of left ventricular (LV) mass). Sample size has been calculated in 274 patients with TIMI 0-1 available for analysis of the primary end-point, and inclusion will end when this number is reached, which will require, according to the current rate of TIMI 0-1 in our STEMI population, to randomize 428 patients. Secondary end-points will include myocardial salvage index, based on angiographic and CMRI derived estimations of the area at risk, and frequency of Major Adverse Cardiovascular Events (MACE) and of major adverse events during admission.

Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥18 years of age
* STEMI characterized by 2 mm ST segment elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV(millivolt) ST segment elevation in the limb leads (II, III and aVF leads, I, aVL leads) and V4-V6.
* Patients presenting within 6 hours of chest pain.

Exclusion Criteria:

* Known hypersensitivity to exenatide or any of the excipients
* Known contraindication to CMR imaging such as significant claustrophobia, severe allergy to gadolinium chelate contrast, severe renal insufficiency (defined as estimated glomerular filtration rate \[eGFR\] (epidermal growth factor receptor) \<30 mL/min/1.73 m2), presence of CMRI contraindicated implanted devices (e.g., pacemaker, implanted cardiac defibrillator, cardiac resynchronization therapy device, cochlear implant), embedded metal objects (e.g., shrapnel), or any other contraindication for CMRI.
* Assumed life expectancy \< 1 year e.g. due to non-cardiac disease.
* TIMI flow grade \> 1 at the time of diagnostic coronary angiography. These patients will be excluded from the analysis of infarct size but will be included in the safety analysis.
* Pregnant women
* Patients with loss of consciousness or confused, not able to read the information and to sign the writting consent
* Patients with oro-tracheal intubation
* Patients with cardiogenic shock persisting 48h after reperfusion