cyrilzakka/clinical-trials huggingface dataset:
Chewy Satiety - the Interplay Between Food Structure, Oral Processing and Satiety

This study examines if there are differences in satiety responses between structurally different wholegrain rye products.

The study consists of a satiety trial and mastication trial. The satiety trial consists of five study visits. Five cereal products with berry soup are presented in random order for each subject serving one of them in each study visit (crossover study design). Each meal consists of rye product or wheat bread providing 190 kcal of energy and of 3 dl berry soup (3 dl) providing 140 kcal of energy. The participants are instructed to evaluate their satiety and related sensations before eating the test food, right after eating and then every 30 min until 210 min after breakfast consumption. The evaluated sensations are hunger, fullness, satiety, desire to eat and prospective food consumption ("How much would you be able to eat right now?"), "thirstiness", "mood", "vigourosness" and "pleasantness"."Pleasantness" will be evaluated only right after eating the test food.

Cereal food samples with 3-digit number codes will be offered to each participant in a random order in mastication trial. The study products are rye products with varying structures. First the participant is asked to evaluate the expected satiety of the product (How filling would you expect this portion to be on a scale from 0 (=not full at all) to 10 (=extremely full)). Secondly the same food will be served to the participant in three portions and the participant will be asked to masticate each portion until she considers it to be ready for swallowing. Instead of swallowing the bolus will be expectorated to a plastic container which is kept on ice. The mastication process is characterized by measuring electrical activity of facial muscles by electromyography (EMG). The mastication process will be video-recorded to support data handling.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-25 kg/m2
* Habit of eating breakfast

Exclusion Criteria:

* Significant changes in body weight (+ or - 4 kg) during the previous year
* Smoking
* Pregnant or lactating
* Missing teeth (except 3rd molars)
* Acute temporomandibular disorders (TMD)
* Dietary restrictions possibly affecting the study (celiac disease, allergies or aversions to cereal foods/high carbohydrate foods)
* Abnormal eating behaviour (according to EDDS (Eating Disorder Diagnostic Scale))
Effect of Vitamin B12 and n-3 Polyunsaturated Fatty Acids on Plasma Homocysteine

Vitamin B12and n-3 polyunsaturated fatty acids (PUFA) decrease blood homocysteine (Hcy) concentration. However, the combined effect of these nutrients on Hcy and ferritin, and C-reactive protein is limited and inconclusive. The objective was to examine the synergistic effect of vitamin B12 in combination of n-3 PUFA on plasma Hcy, ferritin, and other biochemical markers. In a randomized controlled trial, thirty eligible subjects were randomly divided into three groups, and assigned to receive 1000 μg of vitamin B12, 2g fish oil, or 1000 μg vitamin B12 and 2g fish oil respectively for 8 weeks. Plasma phospholipid (PL) fatty acids and biochemical markers were determined. we hypothesize that combination of vitamin B12 and fish oil have synergistic effect on lowering plasma concentrations of Hcy and ferritin.


Eligibility Criteria:
Inclusion Criteria:

* reliability, regular eating habits, normal weight, nondrinking, and nonsmoking status

Exclusion Criteria:

* None of the selected subjects used any vitamins or dietary supplements and was taking no medication for at least 8 weeks before the start of and during the entire experimental period
NFL Dynamics as a Predictor Factor in Patients With Out of Hospital Cardiac Arrest

To investigate the pharmacodynamics of light chain of NFL in patients with out-of hospital cardiac arrest after successful resuscitation and determine the difference in the serum levels of NFL in patients with favorable neurological outcome compared to those with non-favorable neurological outcome.

To investigate the serum levels of the light chain of NFL at different time points after ICU admission (12, 24, 30, 36, 42, 48 hours after ICU admission) patients with out-of hospital cardiac arrest after successful resuscitation and determine the difference in the serum levels of NFL in patients with favorable neurological outcome compared to those with non-favorable neurological outcome.

Eligibility Criteria:
Inclusion Criteria:

* out-of-hospital cardiac arrest successfully resuscitated and admitted to the ICU

Exclusion Criteria:

* trauma, drowning, electrocution, less than 18 years of age,
Atropine vs Isoprenaline in the Invasive Diagnosis of Arrhythmias

During electrophysiological study (EPS) multiple drugs are used to reveal arrhythmias and/or conductive system disorders. Two most often used agents are atropine and isoprenaline. Due to their distinct pharmacological properties, they are affecting myocardium in different manner. Those dissimilarities can affect the EPS course and long-term prognosis. The aim of presented study is to evaluate the optimal protocol of pharmacotherapy during EPS.

Electrophysiological study (EPS) is essential tool for heart rhythm disorders diagnostic. Inducibility of arrhythmia before ablation to confirm the diagnosis and inability to do so after the procedure is crucial for long-term success. Multiple drugs are used to reveal arrhythmias and/or conductive system disorders. Two most often used are atropine and isoprenaline. Atropine is a natural, selective antagonist of cholinergic receptors M1 and M2. It reverses the inhibitory effect of vagal nerve on myocardium. This improves sinus node automatism and conduction in atrioventricular node. Isoprenaline is a preferential agonist of beta-1-adrenergic receptors. It has bathmotropic and chronotropic effect. During daily clinical practice those two drugs are often used interchangeably. However, differences in pharmacokinetics and pharmacodynamics may affect the results. There are lack of data directly comparing those two agents. There are isolated evidences that arrhythmia inducibility rate after the ablation differs between those two drugs. This may lead to the misconception of ablation as successful. The aim of presented study is to evaluate the optimal protocol of pharmacotherapy during EPS.

Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for electrophysiological study according to present guidelines of European Society of Cardiology

Exclusion Criteria:

* Not willing or incapable to give written informed consent.
* Previous diagnosed ventricle tachycardia or fibrillation
* Previous diagnosed atrial fibrillation or flutter
* Glaucoma (contraindication for atropine)
A Controlled Trial of Erenumab in Migraine Prevention

The purpose of this study was to assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM).

Migraine prevention is an area of a large unmet medical need, with existing therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) receptor antagonism is a novel approach to migraine preventive therapy. Erenumab is a human monoclonal antibody against canonical CGRP receptor. The present study is a phase 3 trial intended to assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM).

The study consists of a screening period (up to 7 weeks, including a 4-week baseline period), a 24-week double-blind treatment period (DBTP), a 28-week open-label treatment period (OLTP), and an 8-week safety follow-up period (12 weeks after the last dose of investigational product).

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
* Japanese subjects greater than or equal to 20 to less than or equal to 65 years of age upon entry into screening.
* History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report
* Migraine frequency: Chronic Migraine (CM) or Episodic Migraine (EM) over the 3 months before screening based on the following criteria:

  1. CM is defined as greater than or equal to 15 headache days per month of which greater than or equal to 8 headache days on average across the 3 months meet criteria as migraine days
  2. EM is defined as less than 15 headache days per month of which at least 4 or more headache days on average across the 3 months meet criteria as migraine days

Exclusion Criteria:

* Subjects greater than 50 years of age at migraine onset.
* History of cluster headache or hemiplegic migraine headache.
* Unable to differentiate migraine from other headaches.
* Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period.
* Malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.

Other exclusion criteria may apply
Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD

Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing ventilation (PLBV) ventilation in advanced COPD

Intervention:

Non-invasive ventilation with dynamic positive pressure during expiration (pursed-lip breathing ventilation, PLBV) Control Conventional bi-level non-invasive ventilation (NIV) with static positive pressures Duration of intervention per patient 3 months as randomized (1:1) followed by 9 months as chosen by patient

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Age \>40 years
3. COPD diagnosis known for at least 12 months
4. NIV therapy for at least 3 months

4. Regular use of NIV with extrapolated usage time of at least 700 hours / year 5. Current inspiratory NIV pressure ≥20 mbar 6. Patient understands the requirements of the study 7. Patient is able to follow the study protocol

Exclusion Criteria:

1. Current COPD exacerbation (is allowed 4 weeks after end of treatment)
2. Radiologically proven pneumonia within the past month
3. Other leading pulmonary illness
4. Tracheostomy
5. Pneumothorax
6. Pregnancy or lactation
7. BMI \>35 kg/m²
8. Steroid therapy with \>15 mg prednisolon daily for \>1 month
9. Condition causing hypercapnia other than COPD
10. 6MWT distance of \>300 meters within the last 7 days
11. Previous therapy with the Vigaro NIV device
12. Weight loss of more than 5 kg / 12 months
13. Further criteria to exclude confounding factors
Vascular Closure With Novel External Compression Device: The LockeT Study

Single center, retrospective review study comparing Figure of Eight suture to LockeT, enrolling approximately 70 patients.

The volume of catheter ablation procedures for the treatment of atrial fibrillation and other arrhythmias are on the rise in the United States and worldwide. Despite refinement in ablation tools and techniques which has led to a significant decline in complication rates, achieving vascular hemostasis following femoral access with large bore sheaths remains a challenge. Manual compression (MC) the current standard of care, requires bedrest, often up to 8 hours. This prolonged bedrest is associated with longer length of stay and at times complications from indwelling catheters.

Other methods of vascular closure include figure-of-eight (F-8) a, subcutaneous suture or Z-stitch or fellow's stitch has been evaluated as a means to achieve homeostasis following major cardiovascular procedures. One pooled meta-analysis of six studies including 982 patients demonstrated that F-8 is safe and effective means of achieving hemostasis. In comparison to MC time to hemostasis was significantly lower and overall access site complications like hematoma, bleeding was also noted to be lower in F-8 group.

In recent years, invasive, vascular closure devices have become popular. However, results continue to suggest that the risk versus benefit has not been definitively demonstrated. LockeT is a new suture retention device designed to closely mimic manual compression without the need for a healthcare professional to stand bedside.

Eligibility Criteria:
Inclusion Criteria:

All participants must meet the following criteria to be included in this study.

* Subjects must be at least 18 years of age.
* Subjects underwent Atrial Fibrillation radiofrequency ablation procedure.
* Subjects must have undergone F-8 or LockeT for venous closure.

Exclusion Criteria:

If a subject meet any of the following criteria will be excluded from study participation.

* Subjects under the age of 18.
* Subject's electrophysiology procedure is not planned to access the left atrium or ventricle.
* Subjects in which F-8 or a LockeT was not used.
* If the EP physician detected a formed hematoma prior to venous closure, that patient will be excluded from the study.
Validation of Sodergren Score for Haemorrhoids in Malaysia

To validate the ability of the Sodergren score in guiding the management of symptomatic haemorrhoids in a Malaysian population.

All participating, consented subjects will be scored with the Sodergren score prior to receiving a standardized ambulatory treatment regime. The questionnaire will be self-administered by the subjects. Subjects whom are not able to self-administer the questionnaire will be assisted by the investigator or research assistant. The nature and severity of the subject's haemorrhoidal symptoms are considered as the pre-treatment baseline. A follow up period of 12 months will be carried out post treatment for failure or success of treatment. The data collected will be compared to pre-treatment scores and analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Male and female genders
* Previous ambulatory treatment
* Internal Haemorrhoids

Exclusion Criteria:

* Presence of external haemorrhoids
* Prior haemorrhoidal surgery
* Anti-coagulant therapy
* Anal fissure
* Inflammatory bowel disease
* Underlying colon-rectal malignancy
Preoperative High Protein vs Immunodiet in Surgical Cancer Patients

Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.

Between March 1, 2019, and December 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: A-high protein oral supplements (ONS) and B- immunomodulating ONS. The study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* resectable GI cancer
* written consent

Exclusion Criteria:

* inoperable GI cancer
* known allergy to the drug
Direct Thawing of Vitrified Human Blastocyst

There are more than million frozen embryo transfers around the world each year; a faster, safer, and cheaper method can save a significant amount of money for patients undergoing IVF treatment worldwide.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are willing to use direct-thawed blastocysts

Exclusion Criteria:

* Patients who are not willing to use direct-thawed blastocysts
Impact of Low Protein Diet Supplemented With Ketoanalogues Supplementation on Uremic Toxins Production

Chronic kidney disease (CKD) is associated with accumulation of uremic toxins like p-cresyl sulfate and indoxyl sulfate that are associated of cardiovascular complication and perturbation of glucose metabolism. These toxins are produced by fermentation of protein by intestinal microbiota but the role of low protein diet and ketoanalogue supplementation on uremic toxins production and microbiota composition are unknown. Low protein diet supplemented with ketoanalogues is recommended inCKD patients to prevent progression of renal disease. The aim of this study is to determine the impact of uremic toxins concentration, microbiota composition and gut hormone involved in carbohydrate metabolism ( GLP-1, FGF19, bile acids) with low protein diet supplemented with ketoanalogues.


Eligibility Criteria:
Inclusion Criteria:

* CKD stage 4-5 with estimated glomerular filtration rate \< 30 ml/min/1,73m2
* No dialysis
* No history of kidney transplantation
* Non-diabetic (fasting glucose \<1.26 g / L, or no insulin or oral antidiabetic therapy)
* BMI between 18 and 30 kg / m2
* Patient followed in the nephrology department of Professor FOUQUE at the Lyon Sud hospital
* For women of childbearing age, at least one method of contraception recognized as effective
* Patient who gave consent to open participation and signed the consent to participate in the study

Exclusion Criteria:

* Patient with progressive inflammatory, infectious, cardiovascular or neoplastic disease
* Patient refusing a dietary follow-up
* Patient having a planned transplant or dialysis project in the next 6 months.
* Patient having a colectomy, resection of the small intestine or cholecystectomy
* Patient who has received antibiotics, prebiotics, probiotics in the last 3 months.
* Patient treated with more than 2 g of calcium per day
* Patient using laxatives (more than 2 per day)
* Patient having:
* Uncontrolled metabolic acidosis (bicarbonatemia \<18 mM)
* Hyperparathyroidism (PTH greater than 5 times the upper limit of normal)
* Hypercalcemia (Calcium\> 2.55 mmol / L) or hypophosphoremia \<0.70 mmol / L
* Anemia (hemoglobinemia \<80g / L)
* Undernutrition criteria: albumin \<38 g / L or prealbumin \<0.3 g / L
* Known hypersensitivity to any of the substances or excipients of Ketosteril
* Subject in exclusion period of a previous study
* Patient not affiliated to social security
* Patient under guardianship or in the interests of justice
* Patient who is pregnant, breastfeeding or likely to become pregnant during the study
Rebeccamycin Analog as Second-Line Therapy in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer That Relapsed After Previous First-Line Chemotherapy

Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well rebeccamycin analog works as second-line therapy in treating patients with limited-stage or extensive-stage small cell lung cancer that has relapsed after previous first-line chemotherapy.

OBJECTIVES:

I. Determine the objective response rate in patients with limited or extensive stage small cell lung cancer that relapsed after prior first-line chemotherapy when treated with rebeccamycin analogue as second-line therapy.

II. Determine the duration of remission and survival of patients treated with this drug.

III. Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed annually.

PROJECTED ACCRUAL: A total of 20-39 patients will be accrued for this study within 15 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of small cell lung cancer (SCLC)

  * Limited or extensive stage
* At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* Sensitive\* relapsed disease after only 1 prior chemotherapy regimen
* Brain metastasis allowed provided the following criteria are met:

  * Stable brain disease
  * Not receiving irradiation
  * No steroid requirement to control symptoms
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* At least 12 weeks
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* AST and ALT \< 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement is present)
* Bilirubin ≤ 1.5 mg/dL
* Creatinine \< 2.0 mg/dL
* Creatinine clearance ≥ 60 mL/min
* No New York Heart Association class III or IV heart disease
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active or ongoing infection
* No other concurrent uncontrolled illness
* No psychiatric illness or social situation that would preclude study compliance
* See Disease Characteristics
* See Disease Characteristics
* See Disease Characteristics
* Prior radiotherapy allowed
* No other concurrent investigational agents
* No other concurrent therapies for SCLC
* No concurrent combination antiretroviral therapy for HIV-positive patients
Tofacitinib for Reduction of Spinal Inflammation in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement

To evaluate the efficacy of Tofacitinib in reducing inflammation in the sacroiliac joints and spine on magnetic resonance imaging (MRI) in patients with active Psoriatic Arthritis (PsA) with axial Involvement (BASDAI \[Bath Ankylosing Spondylitis Disease Activity Index\] ≥ 4 and total backpain ≥ 4 despite treatment with NSAIDs plus evidence of active inflammation in the sacroiliac joints or spine on MRI).

This study is a prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy of Tofacitinib in reducing inflammation in the sacroiliac joints and in the spine on MRI in patients with active axial PsA.

Eligible patients (n=80) will be randomized 1:1 to receive either Tofacitinib 5mg orally twice daily or placebo for a 12-week period. After week 12, all patients will receive Tofacitinib 5mg orally twice daily for another 12 weeks. The study duration will include a 6-week screening period, a 24-week treatment period and a safety follow-up period of 4 weeks. Patients will be closely monitored throughout the study on a total of 11 visits. Safety data will be collected in the form of adverse events, vital parameters, physical examinations, and laboratory parameters throughout the study.

The baseline MRI of the whole spine and sacroiliac (SI) joints will be performed within the 6-week screening period to confirm the presence of active inflammation (bone marrow edema) compatible with Spondyloarthritis (will be assessed by a central reader), at week 12 to evaluate the primary study endpoint, and at week 24 to evaluate the secondary endpoint.

The primary study endpoint will be an improvement of the total Berlin MRI score for sacroiliac joints and spine at week 12 as compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

* Psoriatic Arthritis fulfilling ClASsification for Psoriatic ARthritis (CASPAR) criteria
* chronic back pain \> 3 months
* BASDAI value ≥ 4 and backpain ≥ 4 / 10 VAS
* presence of active inflammation in Screening MRI of sacroiliac joints and / or spine (central reading)
* history of inadequate response to ≥ 2 NSAIDs or intolerance / contraindications

Exclusion Criteria:

* active current infection, severe infections in the last 3 months
* history of recurrent Herpes zoster or disseminated Herpes simplex
* immunodeficiency
* chronic Hepatitis B, C or HIV infection
* women: pregnant or lactating (have to practice reliable method of contraception)
* other severe diseases conflicting with a clinical study, contraindications for MRI