cyrilzakka/clinical-trials huggingface dataset:
Effects of Yogurt With Spirulina on Cardiometabolic Risk Markers

The effects of yogurt with spirulina consumption compared to conventional yogurt (without spirulina) on several cardiometabolic and anthropometric parameters in individuals at risk of cardiovascular disease

This randomized, double-blind, controlled clinical trial aims to evaluate the effects of the consumption of yogurt with spirulina compared to conventional yogurt in high cardiometabolic risk volunteers. Volunteers must be overweight/obese either with prediabetes, and/or hypertension, and/or hyperlipidemia and following a Westernized-type diet. The participants will be divided and randomly assigned into 2 groups. Each participant will be instructed to consume two 200 g servings of their designated low-fat sheep yogurt daily before consuming the main meal. The intervention group will receive two spirulina-enriched yogurt desserts daily, which will provide a total of 4 g spirulina per day, while the control group will receive unfortified yogurt along with their usual Westernized-type diet. Participants in both groups will be instructed to consume the two yogurts (enriched or plain), either all at once or separately, before their main meals, along with their usual Westernized diet. No other dietary advice will be provided to participants.

Participants will be asked to maintain their usual physical activity during the intervention period. At the beginning of the study, at 8 weeks, and 12 weeks after the beginning of the intervention (follow-up), blood samples will be collected after 12 hours of fasting. Two-hour oral glucose tolerance test (OGTT) will be performed using a continuous glucose monitoring system at the beginning and at 8 weeks. Blood lipids (total cholesterol, HDL-cholesterol, triglycerides, and LDL-cholesterol), CRP, IL-6, vitamin D, iron, ferritin, and total blood count will be measured at the beginning, 8 weeks, and 12 weeks. Anthropometric measurements (body weight and body composition analysis) will be performed at the beginning and every two weeks for 12 weeks. Basal metabolic rate (BMR) and central aortic blood pressure will be measured at the beginning, 4 weeks, 8 weeks, and 12 weeks of the intervention. Fecal samples will be collected and analyzed to study the gut microbiome composition at the intervention's beginning and at 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \>= 25 kg/m2
* Prediabetes \[Fasting blood glucose \> 100 mg/dL\], or/and
* Hypertension \[Systolic blood pressure (SBP) \> 130 mmHg or Diastolic blood pressure (DBP) \> 80 mmHg\], or/and
* Hyperlipidemia \[Total cholesterol \> 200 mg/dL, and/or LDL-C \> 100 mg/dL, and/or triglycerides \> 150 mg/dL\]

Exclusion Criteria:

* Severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver diseases, endocrine conditions)
* Medication that affects glycemia such as metformin, glucocorticoids, thiazide diuretics
* Gastrointestinal disorders
* Pregnancy
* Lactation
* Alcohol abuse
* Drug dependency
* Body weight lowering medications and/or history of bariatric surgery
* Depression and other psychiatric diseases
* Cancer
* Current spirulina intake
Manitoba Inflammatory Bowel Disease Cohort Study

The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study participants were drawn from a population-based research registry.

The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys and annually with interviews. Diagnosis and disease type were verified by chart review.

The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study, initiated in 2002, is study of adults with IBD who have been tracked prospectively through annual clinical interviews and semiannual surveys. The participants were drawn from a validated population-based research registry, which identified and recruited individuals using an administrative definition of IBD from the comprehensive health data base of Manitoba Health, the single insurer that provides health care to all residents in the province.

The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys and annually with interviews. Diagnosis and disease type were verified by chart review. It has been demonstrated that the Cohort is representative of the provincial IBD population as a whole, with comparable age distribution, sex distribution, disease duration, and rural/urban residence.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed within the previous 7 years with Inflammatory Bowel Disease

Exclusion Criteria:

-
Fluid Restriction in Patients With Heart Failure

There is a concept increasingly consolidated by clinical evidence that at each hospitalization due to HF decompensation there is a substantial loss of quality of life, which is associated with an initial period of great clinical vulnerability, with high rates of rehospitalization and an increased risk of death. The non-pharmacological measures that are widely practiced and recommended for HF patients, such as fluid restriction, specially at the first 30 days after hospital discharge, still lack clearer evidence of their therapeutic efficacy.

The need for hospitalization is an important marker of poor prognosis in patients with heart failure. It is estimated that 25% of patients presenting with acute heart failure are readmitted within 30 days. The maintenance of signs and symptoms of congestion at hospital discharge are common causes of hospital readmission. Thus, the reduction of these signs is a goal to be reached during hospitalization so that the chances of readmission are reduced. However, there is evidence that approximately ¼ of the patients are released despite persisting signs of congestive symptoms. It seems plausible to speculate that patients with HF at higher risk of rehospitalization would be those with the greatest chance of benefiting from therapeutic strategies that seek to reduce the congestive state, such as fluid restriction. In this scenario of initial vulnerability after hospitalization for acutely decompensated HF, recent studies have demonstrated a correlation in the number of B lines in the pulmonary ultrasound of patients at the time of hospital discharge and the prediction of frequent clinical outcomes. It was observed that the presence of pattern B, defined as the presence of more than 3 B lines in at least 2 pulmonary fields bilaterally, was associated with a worse prognosis (mortality from all causes and hospitalization due to decompensation). The present study, therefore, will evaluate the effect of outpatient fluid restriction on levels of NT-proBNP in patients who remain with signs of congestion based on pulmonary ultrasound at the bedside during hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Hospital admission for primary diagnosis of acutely decompensated heart failure, regardless of etiology, according to the criteria of the American College of Cardiology;
* Diagnosis on echocardiography of heart failure with reduced ejection fraction (\<40%);
* Presence of pulmonary congestion defined as at least 2 pulmonary fields with more than 3 B lines in each field on pulmonary ultrasound at the time of hospital discharge.

Exclusion Criteria:

* Pulmonary fibrosis or other severe disease that changes the image acquisition (significant pleural effusion, severe pulmonary emphysema, previous pneumectomy or lobectomy, primary or metastatic lung cancer, breast implants);
* Pregnancy;
* Dialysis renal failure patient;
* Factors that could hinder follow-up (not returning to the outpatient clinic of Hospital de Clínicas);
* Disability or refusing to understand and adhere to the protocol;
* Refusal to sign consent form.
Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)

Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended.

In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination was shown (U07-3503-02). But the sponsor has no data that verifies this difference in Japanese patients.

Thus, this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients with essential hypertension. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.


Eligibility Criteria:
Inclusion criteria:

1. Essential hypertensive patients

   * If already taking antihypertensive drugs, mean seated diastolic blood pressure (DBP) must be \>=90 and \>=114 mmHg
   * If not taking any antihypertensive drugs, mean seated DBP must be \>=95 and \>=114 mmHg
2. Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.

Exclusion criteria:

1. Patients taking 3 or more antihypertensive drugs at signing the informed consent form
2. Patients with known or suspected secondary hypertension
3. Patients with clinically relevant cardiac arrhythmia
4. Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
5. Patients with recent cardiovascular events
6. Patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form
7. Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors; or patients with post-renal transplant or post-nephrectomy
8. Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with ARBs or ACE inhibitors
9. Patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs
10. Patients with hepatic and/or renal dysfunction
11. Pre-menopausal women who are nursing or pregnant
A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in \<50% of tumor cells.


Eligibility Criteria:
Key Inclusion Criteria:

1. Patients with histologically or cytologically documented squamous or non-squamous NSCLC who either have stage IIIb or stage IIIc disease who are not candidates for treatment with definitive concurrent chemo-radiation or have stage IV disease. Patients must have PD after receiving one prior line of chemotherapy treatment for advanced NSCLC.
2. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue biopsy sample
3. Biopsy evaluable for expression of PD-L1 as determined by a PD-L1 Immunohistochemistry (IHC) pharma diagnostic test (pharmDx) assay performed by a central laboratory
4. At least 1 radiographically measureable lesion by computed tomography (CT) per RECIST 1.1 criteria
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Key Exclusion Criteria:

1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
2. Active or untreated brain metastases or spinal cord compression
3. Patients with tumors tested positive for epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase (ROS1) fusions
4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years
6. Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest a risk of immunerelated treatment-emergent adverse events (irTEAEs)
7. Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of randomization

Note: Other protocol defined Inclusion/Exclusion criteria apply.
Effects of Neuromodulation on Brain Electric Activity of Parkinson's Disease Patients

Parkinson's disease (PD) is a neurodegenerative and progressive movement disorder, whose population incidence is increasing. It is characterized by motor symptoms such as tremor, stiffness and bradykinesia, and non-motor symptoms, highlighting the executive dysfunction that can be present from the early stages of the disease. These deficits increase the risk of falls and reduce functional independence. Transcranial Direct Current Stimulation (ETCC) can be an attractive rehabilitation option in PD because it is a non-invasive and safe method that can modulate cortical excitability and improve motor and non-motor symptoms. One of the techniques to detect neurophysiological biomarkers associated with changes in the functional health of the brain and the effectiveness of this type of treatment is the analysis of microstates from the electroencephalogram (EEG). So, the objective of the present study is to investigate the effects of different assemblies of multifocal ETCC on the electrical brain activity represented by the EEG microstates and clinical characteristics in patients with PD.

For this, a randomized, triple-blind clinical trial will be conducted with 60 people with PD, between 40 and 75 years old, regardless of sex, recruited from the reference centers in neurology and physiotherapy in João Pessoa-PB. Participants will be randomized into three groups: Group 1 - ETCC over M1 + CPFDL; Group 2 - ETCC on M1 + APF; Group 3 - ETCC on M1. In each condition an initial baseline assessment (T0) will be performed after 16 treatment sessions (T1) and 30 days after the end of the protocol (Follow-up Assessment - T2). The evaluated outcomes will be: analysis of microstates and spectral analysis of frequencies by EEG; dual task capability with Timed Up and Go (TUG); executive function (Stroop test and verbal fluency test); motor aspects of daily life (MDS UPDRS II). For all analyzes, the statistical software SPSS (SPSS Inc, Chicago IL, USA) for Windows, Version 20.0, will be used and statistical significance considered at 5% (p ≤ 0.05).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD, issued by a neurologist specializing in movement disorders;
* Disease staging between I and III, according to the modified Hoehn and Yahr scale;
* Regular antiparkinsonian pharmacological treatment;
* Score higher than 24 or 18 (for participants with low education) in the Mini -Mental State Examination

Healthy Subjects inclusion criteria:

* Ages: 40 - 75 years
* Sex: All
* Subjects who do not have self-report of neurodegenerative disorders

Exclusion Criteria:

* Diagnosis of atypical parkinsonism;
* Neurological comorbidities;
* History of epilepsy, neurosurgery (including metal clip implantation) and pacemaker implantation;
* DBS implantation - deep brain stimulation;
* Patients missing two consecutive protocol sessions.

Healthy Subjects exclusion criteria:

* History of epilepsy;
* Metallic implants in the head;
* Clinical evidence of brain injury.
Efficacy and Safety of Atacicept in IgA Nephropathy

This main purpose of this study was to evaluate the safety, tolerability, dose response and efficacy of Atacicept in participants with IgA nephropathy and persistent proteinuria. The study hypothesis was that treatment with Atacicept would reduce proteinuria compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to (\>=)18 years of age
* Biopsy-proven Immunoglobulin (IgA) nephropathy
* Urine Protein to Creatinine Ratio (UPCR) \>= 0.75 and \<= 6 milligram per milligram (mg/mg) during screening
* Stable and optimal dose of Angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blockers (ARB) at least 8 weeks prior to screening

Exclusion Criteria:

* Concomitant significant renal disease other than IgA nephropathy
* IgA nephropathy with significant glomerulosclerosis or cortical scarring
* Diagnosis of Henoch-Schonlein purpura
* Failure to meet estimated glomerular filtration rate (eGFR) and biopsy requirement criteria
* Serum IgG below 6 grams per liter (g/L)
* Use of cyclophosphamide ever or use of other immunosuppressants or systemic corticosteroids within 4 months
* Active infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks
* History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB infection
* History of or positive HIV and/or positive for hepatitis B or Hepatitis C at screening
* History of malignancy
* Nursing or pregnancy
* Any condition, including any uncontrolled disease state other than IgA nephropathy
Observational Study to Observe the Safety of Levemir® Treatment in Children and Adolescents With Type 1 Diabetes

This observational study is conducted in Europe. The trial aims to observe the incidence of serious adverse drug reactions in children and adolescents with type 1 diabetes during Levemir® treatment.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained prior to any trial-related activities
* Any patient with diabetes type 1 is eligible for the study, including newly
* The selection of the patients will be at the discretion of the individual physician

Exclusion Criteria:

* Type 2 diabetes
* Currently treated with Levemir®
The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis

The goal of this clinical trial is to know if rituximab can improve cognitive and hand functions in secondary progressive multiple sclerosis (SPMS) patients with high disability (EDSS 6.5 or more). The main questions it aims to answer are:

Can rituximab improve cognitive and hand functions in SPMS patients? Can rituximab improve the quality of life and the Expanded Disability Status Scale (EDSS) in SPMS patients?

Researchers will compare patients who receive rituximab to patient who receive placebo to see the effects of rituximab on cognition, hand functions, quality of life and EDSS.

Demographic and clinical data as age, gender, disease duration and EDSS will be obtained from each participant. Participants will perform The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), The Nine-Hole Peg Test (9-HPT) and The MS-QLQ27 questionnaire at baseline and after one year of receiving either rituximab or placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of secondary progressive multiple sclerosis by Lorscheider et al's criteria (disability progression by 1 EDSS step in patients with EDSS ≤ 5.5 or 0.5 EDSS step in patients with EDSS ≥ 6 in the absence of a relapse, a minimum EDSS score of 4 and pyramidal functional system (FS) score of 2 and confirmed progression over ≥3 months, including confirmation within the leading FS).
2. Baseline EDSS ≥ 6.5.

Exclusion Criteria:

1. Patients received disease modifying therapy for SPMS other than rituximab.
2. Clinical relapse in the last 3 months before recruitment.
3. Patients with documented hypersensitivity or contraindication to rituximab.
4. Patients with concomitant neurologic conditions that may affect cognitive or hand functions.
Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.


Eligibility Criteria:
Inclusion Criteria:

* Severe haemophilia A (FVIII level less than or equal to 1%)
* Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
* HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial

Exclusion Criteria:

* Presence of any bleeding disorder in addition to haemophilia A
* Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
* Abnormal renal function tests
* Known hypersensitivity to Advate®