cyrilzakka/clinical-trials huggingface dataset:
Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment

The primary aim of this study is to assess whether daily dosing with medium chain triglycerides in subjects with mild cognitive impairment (MCI) will improve cognitive performance.

Twenty eligible subjects will be enrolled in the study that will consist of a baseline visit followed by six post-baseline visits. The control and placebo groups will each be comprised of ten subjects randomly assigned to the groups. The assessments at baseline will include concomitant medications, vital signs, height, and weight. In addition, subjects will complete a medical history questionnaire, and receive group instruction on incorporation of the study products into the diet from a registered dietitian. Study products will be dispensed at each visit in excess of requirements, and re-issued at every visit after measurement of the remaining product that subjects will be instructed to bring to every visit. The post-baseline study visits will include body weight and vital sign measurements, concomitant medications, dispensation of study products, group instruction by a registered dietitian, and an assessment for adverse events.

Between study visits the subjects will receive a telephone call from the study coordinator to encourage compliance with the diet, and to ask about any adverse events. The study visits will conclude at week 24. The psychological tests conducted by clinicians at screening will be repeated during the cognitive testing visit.

Eligibility Criteria:
Inclusion Criteria:

1. Are male or female with a diagnosis of Mild Cognitive Impairment
2. Are 50 years of age or older

Exclusion Criteria:

1. Been on medication for Mild Cognitive Impairment less than 90 days
2. Major depression
3. Uncontrolled hypothyroidism
4. Known B12 deficiency
5. Hepatic (liver) disease or insufficiency
Prospective Global Registry for the Study of Chronic Total Occlusion Intervention

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly being performed in patients with advanced coronary artery disease, but there is limited information on the techniques utilized and the procedural outcomes. The goal of this multicenter, investigator initiated registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing CTO PCI among various participating centers. The information collected will be used to determine the frequency of CTO PCI performed at the participating sites and examine the procedural strategies utilized, and the procedural (both immediate and during follow-up) outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing CTO PCI at each of the participating centers.

Exclusion Criteria:

* None
A Study to Evaluate Impact of Ibrutinib on the Quality of Life (QOL) in Patients With Chronic Lymphocytic Leukemia

The aim of this study is to evaluate the impact of Ibrutinib monotherapy in the QoL of subjects with Chronic Lymphocytic Leukemia (CLL) based in European Quality of Life 5 Dimensions (EQ-5D) and FACIT- fatigue questionnaires assessment from baseline to 1 year of treatment in Argentinian routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained prior to any screening procedure
* Patients 18 years or older, to be treated with Ibrutinib, able to answer the complete QoL questionnaires.
* Diagnosis of CLL, according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria, with pathology confirmation (World Health Organization 2008).
* Patients with CLL in first-line or with prior therapies or treatment-naïve patients that harbours deletion 17p according to fluorescence in situ hybridization (FISH) standards with an indication of treatment with ibrutinib.

Exclusion Criteria:

* Pregnant and breast-feeding patients
* Impairment of ingestion and/or absorption of ibrutinib
* Mental or physical limitation to complete the QoL questionnaires.
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).

TG1101-RMS303 is an open-label, single-arm extension study designed to evaluate long-term safety and efficacy of ublituximab in participants with RMS. Participants who complete the 96-week, double-blind treatment period of TG1101-RMS301 (RMS301 \[NCT03277261\]) or TG1101-RMS302 (RMS302 \[NCT03277248\]) are eligible for participation in this Open Label Extension (OLE) study. Participants may also be eligible for TG1101-RMS303 if they have completed Week 208 of TG1101-RMS201E (RMS201E \[NCT03381170\]) (United States of America \[USA\] participants only).

Eligibility Criteria:
Inclusion Criteria:

Participants must meet the following criteria:

1. Complete the 96-week double-blind TG1101-RMS301 (NCT03277261) or TG1101-RMS302 (NCT03277248) study or complete the final Week 208 visit of the TG1101-RMS201E (NCT03381170) study
2. Investigator believes may benefit from treatment with ublituximab
3. Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol
4. Female participants of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 20 weeks after the last dose of ublituximab

Exclusion Criteria:

Participants who meet any of the following exclusion criteria are not to be enrolled to this study:

1. Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as:

   1. Absolute neutrophil count \< 1.5 x 10e3/µL
   2. Hematocrit \< 24%
   3. Platelet count \< 150,000 cell/mm\^3
   4. Hypogammaglobulinemia immunoglobulin G (IgG) \< 4.0g/L
2. Active infection
3. Ongoing pregnancy (female participants)
4. Participants who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period or prior to completing the final Week 208 visit of the TG1101-RMS201E study
5. Participants who have started any disease modifying therapy (DMT), stem cell transplantation, or participation in any other interventional clinical trial after completion of the 96-week visit in the TG1101-RMS301, TG1101-RMS302, or after completing the final Week 208 visit of the TG1101-RMS201E study
6. Participants who have had a confirmed multiple sclerosis (MS) relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, participants must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE
7. Participants with unstable disease activity
8. Presence of malignancy, except for surgically excised basal or squamous cell skin lesions
9. Vaccination with live virus within 2 months of randomization
Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation

The purpose of this study is to compare whether a same total dose given up front as a single dose is more effective and as safe as the same dose given as a fractioned dose.

Evaluate the Utility of the the Dry Tube Test Evaluating its Correlation with Coagulation Test Results (fibrinogen, platelets, INR, PT and PTT).

Explore the Evolution of some Serum Markers (CK, DHL, metalloproteinase), Amount of Venom and Antivenom Levels and the Progression of Local Lesions.

Snake bite Envenomation is a Public Health Problem especially for tropical and subtropical countries. The WHO estimates 40 000 annual deaths in the world for this cause. In México the Ministry of Health estimated 3 882 cases on 2005, being the age of 15-44 the most affected. There are not official numbers of mortality, although the thought is that there are few cases of death, most of them related with a delay on treatment.

There are a broad variety of clinical presentations depending on many factors such as species, snake bite variability or patient conditions. Proteolytic action of venom produces amines and vasoactive peptides such as bradykinin, histamine and serotonin which cause capillary lesions with anticoagulant effects. Coagulopathy is one of the most important systemic consequences. The Dry Tube Test has been proposed as an indirect test to evaluate coagulopathy related to this pathology.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 6 to 65 years of age
* Presenting for emergency treatment of snake bite
* Requiring treatment with antivenom
* Informed consent document read and signed by patient (or parent/legal guardian)
* Participation within the last month on any clinical trial
* Arrival to Hospital within 24 hours after the snake bite

Exclusion Criteria:

* Allergy to horse serum
* Underlying medical conditions that significantly alter coagulation (oral anticoagulants, vitamin K deficiency, hepatic disease)
* Use of AINE 48 hours previously
* Use of any antivenom 2 weeks previously
* Pregnancy or breast-feeding women
Neonatal Brain Oxygenation Study

Implementing target ranges for regional cerebral saturations in extremely preterm infants in the first week of life may improve neurodevelopmental outcomes at 22-26 months corrected age compared to those without targeted cerebral saturations (Csat) using near-infrared spectroscopy (NIRS). Infants will be randomized to a targeted cerebral saturation monitoring group with visible reading of Csat or to a control group with cerebral saturation monitoring, but with blinded Csat measures. Those in the targeted Csat group will follow a treatment guideline to maintain cerebral oxygenation in the target range. The primary outcome is neurodevelopmental outcome as determined by Bayley III cognitive scale score.


Eligibility Criteria:
Inclusion Criteria:

* Very preterm infants with gestational age at least 23 weeks but less than 29 completed weeks
* Less than 6 hours of age

Exclusion Criteria:

* Skin integrity insufficient to allow placement of NIRS sensors
* Decision not to provide full intensive care support
* Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment
Clinical Outcomes in Patients Referred to Pulmonary Rehabilitation

Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production, which often misunderstood as aging or catching a cold. These symptoms may be progressive over time. To provide better disease management and early detecting, pulmonary rehabilitation is now considered a fundamental component of the integrated disease management of this population. However, few studies have evaluated the beneficial outcomes in patients referred to pulmonary rehabilitation. Therefore, the purpose of this study is to investigate the clinical outcomes in patients referred to pulmonary rehabilitation in National Taiwan University Hospital.


Eligibility Criteria:
Inclusion criteria:

1. age \> 20 years old
2. patients with chronic respiratory disease diagnosed by physician that referred to pulmonary rehabilitation in National Taiwan University Hospital including, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, bronchiectasis
3. can cooperate with pulmonary rehabilitation clinic

Exclusion criteria:

1. angina, acute myocardial infarction in the previous one month
2. pregnancy
Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients.

The objective of this study was to evaluate the effect of Whey Protein (WP) and Soy Protein (SP) nutritional supplements on nutritional status and disease activity in Crohn's disease patients.

The patients were split into two groups: one group was supplemented with whey protein and the other, with soy protein. Participants were assessed at three moments: before starting the intervention and after 8 and 16 weeks. The nutritional status and body composition were measured using bioimpedance analysis, anthropometry and albumin and pre-albumin dosages. Dietary intake was determined by 24-h dietary recalls. The disease activity was evaluated by Crohn's Disease Activity Index, serum cytokines and C-reactive protein dosages.

Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease patients treated with azathioprine or anti-tumor necrosis factor-alpha (anti-TNF-alpha) or azathioprine and anti-TNF-alpha

Exclusion Criteria:

* smokers
* who were using other medication or nutritional supplements.
Ultrasound Instrument to Prevent Dialysis Graft Failure

This research study aims to show that a newly developed investigational Doppler instrument can reliably measure blood flow in dialysis access grafts, to see if a decrease in the flow may be a sign of impending graft failure and also to see if there is evidence that by monitoring the flow in these grafts their lives may be extended.

The new investigational device is to be known as FloMon; this is an ultrasonic device that provides blood flow measurements from a small probe placed in a noninvasive manner above the graft or blood vessel. The instrument is being developed so that it may help give insight to on-coming graft failure which may be prevented.

The FloMon is an extension of a previously Food and Drug Administration (FDA) cleared instrument, Echoflow-A, which had been used in a similar study as this one. The Echoflow-A is similar to this device in all respects with the exception of design and calculation of measurement. The FloMon compared to the Echoflow-A is better ergonomically designed and reads flow readings in about 2 minutes versus twice the time necessary to take similar measurements using the Echoflow-A.

Vascular access failure is one of the largest causes of morbidity for chronic hemodialysis patients: 16-25% of hospital admissions among United States end-stage renal disease (ESRD) patients are related to vascular access complications, and the associated cost is estimated to be over one billion dollars per year.

The most frequent cause of AV access-graft failure is thrombosis that occurs as a result of stenosis at or near the venous anastomosis. Over 50% of existing vascular access-grafts in the US are 6 mm PTFE tubes and their thrombosis rate is much higher than that of native Arteriovenous Fistulas (AVF).

Several studies have shown that early detection and repair of stenosis can prevent access thrombosis, reducing the morbidity and costs that follow thrombosis. The cost of duplex ultrasound for access monitoring is prohibitive. Blood flow, measured by indicator-dilution methods, seems to be a reliable indicator of impending access failure, but recent randomized controlled studies intended to examine this were equivocal.

This study, funded by the NIH (2R44 DK067775), is to determine if a new instrument to monitor access blood-flow can reduce graft failure and associated costs. In a pilot study using the new Doppler ultrasound instrument for weekly monitoring, conducted by the Renal Research Institute and funded by the NIH, the method predicted impending graft failure with 80% sensitivity and a false-alarm rate of less than .5/year. It measures access blood flow in less than three minutes, and uses almost no consumables.

This study is designed to test if monitoring with the new instrument improves health and reduces cost for hemodialysis patients with access-grafts.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patients with an AV access graft

Exclusion Criteria:

* Anticipated change in renal replacement modality or geographic location
* Inability to give informed consent
* Anticipated life expectancy of less than one year
Comparaison Between MRI Alone or Combined With Positron Emission Tomography for Brain Metastasis Diagnosis

During gamma scalpel treatment of brain tumors and metastases, a follow-up magnetic resonance imaging (MRI) scan is performed. The radiologist who reviews the MRI assesses whether there is an increase in signal at the tumor site. This increase potentially indicates that the treatment was not effective. However, in 25% of cases (one in four people), this signal enhancement is not due to ineffective treatment, but to inflammation (swelling/damage) and tissue death around the tumor. This is why when an increase in signal is detected, additional follow-up is essential. The standard additional follow-up has an accuracy of about 83%.

This is an observational study on patients with brain metastatis comparing MRI alone or combined to PET-FET to improve accuracy of diagnosis of metastasis recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years of age;
* Having undergone gamma knife radiosurgery for brain metastasis;
* Presenting for a first MRI follow-up (Cohort C1);
* Presence of one or more brain metastases with increased enhancement on follow-up MRI (Cohort C2.1 and C2.2); A participant recruited for Cohort C1 could be recruited for follow-up in Cohort C2.1 or C2.2 if the MRI result is ambiguous.

Exclusion Criteria:

* Pregnancy or breastfeeding;
* Other condition that may influence the imaging result;
* Renal impairment (\<30 mL/min/1.73 m2). This threshold is consistent with recent RAC recommendations; Note: For participants with intermediate renal clearance (30-60 mL/min/1.73 m2), the total gadobutrol dose injected is set at the manufacturer's recommended clinical dose. For patients with renal clearance greater than 60 mL/min/1.73 m2, a dose of 1.5x the normal dose is used. These dose values have been approved by Dr. Chénard and are consistent with the RAC recommendations.
* Inability to maintain supine position for the required duration (variable, depending on the sequence);
* Patients who have previously received full brain irradiation;
* Patients who are claustrophobic and cannot tolerate insertion into the MRI scanner;
REASSURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents

Primary:

To assess the effects of rimonabant on HbA1c in patients with Type 2 diabetes who are overweight or obese (Body Mass Index (BMI) \> 27 kg/m² and BMI \< 40 kg/m²), have uncontrolled HbA1c (7.0% - 9.0% inclusive) and are currently on maximal tolerated doses of two Oral Anti Diabetic medications - Metformin (Met) and Sulfonylurea (SU).

Secondary:

To assess the effects of rimonabant on Anthropometric measures, Glucose measures, Lipid measures, Other measures and changes in quality of life


Eligibility Criteria:
List of Inclusion and Exclusion criteria:

Inclusion Criteria:

* History of Type 2 diabetes
* HbA1c between 7% to 9% (inclusive)
* BMI ≥ 27kg/m² and BMI ≤ 40kg/m²
* Currently taking Metformin and Sulfonylurea.

Exclusion Criteria:

* Uncontrolled serious psychiatric illness such as major depression
* Current use of antidepressants
* Severe renal impairment (creatinine clearance less than 30ml/min)
* Severe hepatic impairment known by investigator or Aspartate Aminotransferase and/or Alanine Aminotransferase \> 3 times Upper Limit Normal
* Patient treated for epilepsy
* Pregnant or breast-feeding women
* Women of childbearing potential not protected by effective contraception
* Hypersentivity/intolerance to rimonabant or any of the excipents
* Presence of any condition, current or anticipated that in the investigator's opinion would compromise the patient's safety
* Use of insulin for longer than 1 week within 4 weeks prior to screening
* Chronic use of systemic corticosteriods
* Use of glitazone therapy, glucagon-like peptide or dipeptidyl peptidase IV
* History of drug or alcohol abuse wihtin the last three years
* Heart failure class III-IV (New York Heart Association classification)
* Severe hypertension
* Adminstration of the following medications: phentermine, amphetamines, orlistat, sibutramine, herbal remedies
* Use of non-lipid agents known to affect lipid metabolism: retinoids, antiretrovirals, hormone replacement therapy containing estrogens, cyclosporin, thiazolidinediones (glitazones), fish oils, plant sterols
* Use of ketoconazole, itraconazole, ritonavir, clarithromycin, rifampicin, phenytoin, phenobarbitone, carbamazepine or St John's Wort
* Participation in a clinical study within the 4 weeks prior to randomisation
* Patients involved in an existing weight loss program
* Presence of chronic hepatitis
* Use, or misuse, of substances of abuse
* Marijuana or hashish users
* History of gastrointestinal surgery for weight loss purposes or who are scheduled for such surgery within the duration of their expected participation in this study
* History or presence of bulimia or laxative abuse
* Non-English speaking

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Impact of Patient-Prosthesis-Mismatch on Coronary Flow Reserve

Complete normalization of CFR following AVR for aortic stenosis was observed only for stentless valves. Besides the superior hemodynamic performance this might explain the excellent long term results of this valve design.


Eligibility Criteria:
Inclusion Criteria:

Aortic valve stenosis

Exclusion Criteria:

Coronary artery disease
Effect of Perioperative Hypothermia on Postoperative Pain

This study aims to observe the impact of perioperative body temperature on postoperative pain and pain sensitization for the patients with laparoscopic surgery. Based on this study the investigators aimed to explore the effect of perioperative hypothermia on postoperative pain.

This study aims to included surgery patients to observe the impact of perioperative body temperature on postoperative pain and pain sensitization for the patients with laparoscopic surgery. Body temperature and postoperative pain will be continuously assessed, and then association analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years old
* American society of anesthesiologists I-III
* Patients who plan to laparoscopic surgery under general anesthesia
* Volunteer to participate in this study and sign informed consent.

Exclusion Criteria:

* the patient with chronic pain
* Patients with fever
* The patient is infected
* Severe vision, hearing, language impairment or other reasons unable to communicate with visitors
* Patients with known mental illness or lack of communication or cognitive impairment before operation;
* Long-term use of sedatives, antidepressants or alcoholism
* Artificial cooling and low temperature protection were taken during the operation