cyrilzakka/clinical-trials huggingface dataset:
Cardiometabolic Risk in Cardiac Rehab

1. Primary Objectives:

   * To characterize cardiometabolic risk factor profiles of patients entering cardiac rehab using traditional approaches (eg LDL-C) as well as a more comprehensive panel of cardiovascular and metabolic biomarkers. It is hypothesized that the comprehensive panel will identify further increased risk that would not have been detected using only traditional approaches. Specifically, it is hypothesized that a greater percentage of the cohort will be identified with "high risk" levels of LDL-P (\>1100 nmol/L) and/or apoB (\>80 mg/dL) than of LDL-C (\>100 mg/dL). It is further hypothesized that the prevalence of elevated Lp(a) and elevated levels of inflammatory and insulin resistance markers will be higher in this cohort when compared to population norms (HDL, inc reference data).
   * To assess improvements in laboratory and lifestyle risk factors and rate of goal attainment at completion of rehab (eg 3 months). This objective is primarily descriptive, and improvements in traditional risk factors (eg LDL-C) will be compared to existing published data. Improvements in non-traditional risk factors (eg LDL-P, insulin resistance markers) in a cardiac rehab population have not been extensively investigated.
   * To determine which attributes at baseline best predicted recurrent events and re-hospitalizations assessed one year later.
2. Secondary/Developmental Objective:

   * To inform and guide development of a subsequent study protocol designed to compare outcomes associated with biomarker-guided personalized treatment plans vs. standard of care in the cardiac rehab setting.

This pilot study will characterize risk factors of patients as they enter cardiac rehab, track how comprehensive biomarker profiles change during the normal course of rehab, and associate biomarkers at baseline with MACE outcomes assessed one year later. Blood draws, vitals, and patient medical histories will be collected as subjects enter rehab and at the end of the rehab program. Major adverse cardiac events will be assessed via phone interview at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Known CAD/ IHD
* Eligibility for cardiac rehab following an acute coronary event; either:

  * ST elevation myocardial infarction
  * Non ST elevation myocardial infarction
  * Angina
  * CABG

Exclusion Criteria:

* Younger than 18 years old
A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) Amyloidosis

The treatment with oral melphalan and prednisone has been recommended as standard treatment of AL amyloidosis but the results are rather disappointing. Another therapeutic option is pulsed high-dose dexamethasone + melphalan (Mel-Dex) with more encouraging results regarding the achievement of a faster disease response and higher rates of haematological remission. In the last 5 - 10 years, promising treatment outcomes after therapy with high-dose melphalan and autologous stem cell support have been reported by several groups but only highly selected patients are eligible for this treatment. Lenalidomide has been shown to be effective in phase II and III trials in MM patients. Because of the relationship to MM, Lenalidomide is a promising therapeutic option also for patients with AL amyloidosis. The addition of Lenalidomide to Mel-Dex could improve rate of complete response (CR) and organ response in patients not eligible for or refused high-dose chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven systemic untreated AL amyloidosis requiring systemic chemotherapy
* Not eligible for or refused HDM
* Measurable plasma cell disease
* Life expectancy \> 3 months
* WHO performance status \< 3
* NYHA \< stage IV
* Understand and voluntarily sign an informed consent form
* Laboratory test results within these ranges Absolute neutrophil count \> 1.5 x 109/L Platelet count \> 100 x 109/L Creatinine Clearance / MDRD \> 40 ml/min Total bilirubin \> 2,5 mg/dL
* Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.

Exclusion Criteria:

* Multiple Myeloma stage II and III (Durie and Salmon)
* Previous organ transplantation
* Not able to visit the Amyloid Clinic in Heidelberg once per month
* Refusal of aspiration of 100 ml bone marrow at study inclusion
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Use of any other experimental drug or therapy within 28 days of baseline.
* Known hypersensitivity to thalidomide.
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Any prior use of lenalidomide.
* Concurrent use of other anti-cancer agents or treatments.
* Known positive for HIV or infectious hepatitis, B or C.
* Patients who are in a depending position of the Sponsor or the Principal Investigator
Correlation Between PET and Advanced MRI in Multiple Sclerosis

Traditional Magnetic Resonance Imaging (MRI) in Multiple Sclerosis (MS) has enabled clinicians to measure disease activity but there are inherent limitations. Clinical/radiographic dissociation can be seen in some patients and the abnormalities are not specific.

This pilot study is an opportunity to determine the relationship between quantitative advanced MRI measures and OCT with PET measurements of microglial activation and myelin health.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Multiple Sclerosis according to the 2011 McDonald criteria.
* Aged 18 to 60
* High or mixed affinity binder to rs6971 TSPO polymorphism

Exclusion Criteria:

* Pregnant or breastfeeding
* Suffering from an unstable medical condition
* Have a neurological or ocular disorder other than MS
* Any contra-indications to MRI
Glutenfree, Gut Microbiota and Metabolic Regulation

High intake of dietary fiber provides health benefits and reduces the risk of developing cardio-metabolic diseases, such as type 2 diabetes (T2D) and cardiovascular disease (CVD). The intake of fiber is below the recommendations worldwide. In Norway, bread and cereals represent a major source of fiber. A low fiber intake is evident for people with celiac disease due to the removal of wheat, rye and barley from the diet. We therefore need to increase our knowledge in relation to fiber-rich food that will be tolerated also by people with celiac disease. The aim of the study is to investigate the effect of fiber rich gluten free products on blood glucose levels compared to benchmark gluten free products.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals with celiac disease
* BMI 18.5-27
* 18-65 years

Exclusion Criteria:

* chronic metabolic diseases, such as diabetes (type 1 and 2), cardiovascular diseases, cancer the last six months
* gut diseases, including chron's disease, ulcerative colite
* food allergies or intolerance, except for coliac disease
* pregnant and/or lactating
* smokers
* BMI \<18.5 and \>27
* planned weight reduction and/or 5% weight change the last three months
* blood donor the last two months and during the study period
* not willing to stop using dietary supplements, including probiotic products, cod liver oil etc, four weeks before and throughout the study
* use of antibiotics \< three months before study start and throughout the study period
* alcohol consume \> 40 g/day
* hormone treatment (except for contraceptives)
Vitamin D and Preeclampsia

Hypothesis : Vitamin D serum concentration is decreased in the first trimester in pregnant women who will develop preeclampsia in the second or third trimester compare to a control group Primary purpose : To determine the vitamin D status in the first trimester in a large population of french pregnant women in order to evaluate the importance of the vitamin D deficiency in France and correlate this deficiency with preeclampsia

Primary purpose : To compare the vitamin D (25OHD) status, in the first trimester, in a group of patients with preeclampsia and a group of pregnant women without preeclampsia.

Secondary purpose : (i)To compare the vitamin D status in the third trimester in a group of patients with preeclampsia and a group of pregnant women without preeclampsia. (ii) To evaluate the deficit un vitamin D in a population of pregnant women in the parisian area. (iii) To evaluate the calcemia of the newborns after maternal systematic oral intake of vitamin D 100000U at 28 weeks Methodology : Multicenter (6 centers), Cohort, Nested case-control study Protocol : 4500 patients will be recruited. A blood sample will be performed : in the first trimester (11-14 weeks), in the third trimester (28-40 weeks), and cord blood. For each patient with preeclampsia, 4 controls will be taken from the cohort and matched by parity, race/ethnicity, maternal age, season, BMI. The serum concentration of 25OHD will be measured in all samples.A dosage of 25OHD will be performed in 1000 women from the initial cohort in order to calculate the prevalence of vitamin D deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman
* First trimester
* Singleton
* Affiliated to Social security policy
* Woman who gave informed consent

Exclusion Criteria:

* Hypercalcemia (\>2.65 mmol/l) or any other phosphocalcic disease
* Hypertension (\>140/90) from the first trimester
* Renal insufficiency (creatinine \> 120µmol/l)
* Bone disease (osteogenesis imperfecta...)
* Lithium therapy
* Bowel malabsorption
* Kidney stones
A Study of the PK, Safety and Antiviral Activity of A-831 in HCV Carriers

The purposes of this study are:

* to determine the safety and tolerability of multiple doses of A-831 at various doses
* to determine how multiple doses of A-831 are distributed through the bloodstream
* to determine if A-831 reduces the amount of Hepatitis C virus in the blood


Eligibility Criteria:
Inclusion Criteria:

* Volunteers will be males of any race aged 18-60 years with a BMI between 18 and 32 kg/m2 at the time of the screening medical
* Volunteers who have given their written informed consent to participate in the study
* Volunteers who are willing and able to comply with the protocol and study procedures
* Volunteers who have a diagnosis of chronic hepatitis C infection and are in good health (other than history of Hepatitis C infection)

Exclusion Criteria:

* Voulnteers with concurrent medical conditions or taking concurrent medications
A Prospective Randomized Study Comparing Different Dilation Durations for Endoscopic Papillary Balloon Dilatation

Endoscopic papillary balloon dilation is as effective as sphincterotomy in treating bile duct stone. However, a need to switch to sphincterotomy is noted in about 20% of cases receiving dilation for lithotripsy. It is hypothesized that a longer dilation duration (5 min. vs. 1 min.) can decrease the need of switching to sphincterotomy.

Endoscopic papillary balloon dilatation (EPBD) has been proposed as an alternative to endoscopic sphincterotomy (EST) for endoscopic treatment of common bile duct (CBD) stones. EPBD is as effective as EST in stone clearance with a lower risk of hemorrhage, and may preserve the function of sphincter of Oddi. However, it has been reported that about 20% of patients undergoing EPBD need EST as a rescue procedure for lithotripsy. A longer dilation duraton of 5 mintues as opposed to 1 minute has been proposed to decrease oozing after dilation and facilitate lithotripsy, and it is hypothesized that it will reduce the need of switching to EST.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing endoscopic retrograde cholangiopancreatography for choledocholithiasis

Exclusion Criteria:

* Consent not obtained.
* No apparent stone.
* Intradiverticular papilla.
* Prior EST.
* Bile duct stricture.
* Pancreatic or biliary malignant disorders.
* Intrahepatic stones.
* Active acute pancreatitis.
* Sphincter of Oddi dysfunction.
* Pregnancy.
* Primary sclerosing cholangitis or choledochocyst.
* Previous biliary surgery other than cholecystectomy.
* Stone impaction at ampulla.
* Precut for cannulation.
A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence


Eligibility Criteria:
Inclusion Criteria:

* Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
* Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
* Child-Pugh Score 5 or 6
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Any evidence of tumor metastasis or co-existing malignant disease
* Participants previously receiving any prior therapy for HCC, including loco-regional therapies
* Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation
* Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella \[MMR\]).

Other protocol defined inclusion/exclusion criteria apply
Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME)

Almost 90% of systemic sclerosis (SSc) patients experience hand function limitation, which leads to impaired daily functioning and work participation. An important cause of impaired hand function are contractures of the hand, which are reported in up to a half of patients. With this longitudinal cohort study in patients with SSc and VEDOSS (very early diagnosis of systemic sclerosis) the investigators aim to gain more insight into processes involved in hand function impairment.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years

Exclusion Criteria:

* Patients with diabetic cheiroarthropathy and Dupuytren's disease, based on expert opinion
Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.

The objective of the study is to compare the results of a coordinated and interactive program for the treatment, monitoring and control of patients with a moderate-severe diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the currently established situation.

Methodology: Equivalence randomized comparative study . It will include patients with diagnosis of moderate-severe OSA (apnea-hypopnea Index \>=15) that should start treatment with (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis has been made and it was indicated that treatment with CPAP. Patients Will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6 months. Primary outcomes: number of hours of use per day (according to the accountant of the CPAP), so that use \>= 4h/day is defined as good adherence to the treatment. Secondary outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment. It will be collected demographic ,clinics and anthropometric variables. At the end of follow-up primary and secondary outcomes will be compared between two groups.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years old.
* Patients with OSA diagnosis performed in the sleep units
* Written informed consent signed.

Exclusion Criteria:

* Previous CPAP treatment for OSA diagnosis
* Psycho-physical inability to complete questionnaires.
* Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and restless leg syndrome
* Patients with respiratory diseases (overlap syndrome, hypoventilation, restrictive diseases)
* A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.
* Any medical factor, social or geographical, that may jeopardize patient compliance.(e.g., alcohol consumption (more 80 gr/day in men and more than 60 gr / day in women), no fixed address, disorientation, or a history of non-compliance).
ESBA1008 Microvolume Study

The purpose of this study is to demonstrate a treatment effect of ESBA1008 applied as a microvolume injection or infusion on retinal function and morphology in subjects with exudative age-related macular degeneration (AMD).

This 4-cohort study was conducted in 2 stages. Stage 1 consisted out of 2 Cohorts. In each cohort subjects were randomized 10:3 to either receive ESBA1008 (Cohort 1 : 2 injections, Cohort 2 : 1 infusion and 1 injection) or 2 Lucentis injections. Stage 2 was conducted similarly with a different dosing level for ESBA1008 (Cohort 3 and 4). Subjects had follow-up visits at Day 7 and Day 14. All cohorts receiving ESBA1008 on Day 0 also received ESBA1008 6mg/50 μL via injection on Day 28. After the Day 28 visit (all cohorts), subjects returned for follow up visits at Day 42 and Day 56.

Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent document;
* Able to make the required study visits and follow instructions;
* Age-related macular degeneration in the study eye;
* Visual acuity within protocol-specified range;
* 340 μm minimal central subfield thickness (CSFT; Spectralis Equivalent)
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Both eyes: Any active infection or inflammation;
* Study eye: Any treatment for exudative age-related macular degeneration (AMD) other than vitamin supplements;
* Study eye: Any current or history of macular or retinal disease;
* Study eye: Any concurrent intraocular condition such as cataract or diabetic retinopathy that, in the opinion of the Investigator, could either require medical or surgical intervention during the course of the study to prevent or treat visual loss;
* Study eye: Other ocular conditions or diseases that, in the opinion of the Investigator, could compromise visual acuity;
* Study Eye: Uncontrolled glaucoma;
* History of a medical condition that, in the opinion of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product;
* Women of childbearing potential who are lactating, pregnant, planning to become pregnant, or not using adequate birth control methods for the duration of the study;
* Intraocular surgery within 3 months of baseline;
* Study eye: Any history or current evidence of retinal angiomatous proliferation (RAP) lesions based on clinical exam;
* Other protocol-defined exclusion criteria may apply.
Open Label Crossover Study Pharmacokinetics (PK) Study in Healthy Volunteers Receiving Various Forms of Fentanyl

A partially randomized, open-label, 3-way crossover, single-center, systemic and CSF PK and bioavailability study in healthy volunteers.

An Open-Label Single-Dose Crossover Study Comparing the Plasma and Cerebrospinal Fluid Pharmacokinetics and Bioavailability of Fentanyl Delivered Intranasally Versus Sublingually Versus Intravenously in Healthy Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy male or female between the ages of 18 to 65 years. Never smokers or Non-smokers (cessation of smoking ≥ 6 months ago). Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 32.0 kg/m2.

No clinically meaningful findings in the physical examination, oral and nasal examination and 12-lead electrocardiogram.

Negative for drugs of abuse, alcohol, and nicotine. Negative for hepatitis A, B, and C and Human Immunodeficiency Virus (HIV). No clinical laboratory values outside of the acceptable range, unless, in the opinion of the Principal Investigator, they are deemed not clinically significant.

Exclusion Criteria:

* Subject has a known history of allergic reaction, hypersensitivity, or clinically significant intolerance to opioids, fentanyl or components of the study drugs.

  2. Subjects with a high potential for opioid addiction (personal or family history).

  3. Subject is lactating or considered at risk of pregnancy. 4. Subject has impaired liver function (e.g., alanine aminotransferase \[ALT\] ≥ 3 times the upper limit of normal \[ULN\] or bilirubin ≥ 3 times ULN), known active hepatic disease (e.g., hepatitis), or evidence of clinically significant liver disease or other condition affecting the liver that may suggest the potential for an increased susceptibility to hepatic toxicity with oral diclofenac exposure.

  5. Subject has any history of renal disease that, in the opinion of the investigator, would contraindicate study participation; or subject has significantly impaired renal function as evidenced by an estimated GFR of ≤60 ml/min/1.73m2.

  6. Subject has a history or evidence of significant nasal pathology, including polyps or nasal obstructions.
Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents

The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescents between and including 11-17 years of age, who provide written informed consent

Exclusion Criteria:

* Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease
A Study to Evaluate LY3154207 on the Brain of Healthy Participants

The purpose of this study is to learn more about how LY3154207 affects the brain of healthy participants by using magnetic resonance imaging. The study will last up to about nine weeks for each participant and may include up to four visits to the study center.


Eligibility Criteria:
Inclusion Criteria:

-Overtly healthy males and non-childbearing females, as determined through medical history and physical examination

Exclusion Criteria:

* Have known or ongoing psychiatric disorders
* Have contraindications to magnetic resonance imaging (MRI)