cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Actiponin on Antiobesity in Obese Korean Subjects.

Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year. In vitro and animal studies elucidated Actiponin as a novel anti-obesity agent. However, the efficacy and safety of Actiponin supplementation on body weight regulation in humans are lacking.

The primary aim of the study was to investigate the effect of Actiponin in Korean subjects on body weight and fat loss along with changes in metabolic markers based on 12 week, randomized, double-blind, placebo-controlled clinical trial.

Eighty obesity subjects with BMI \> 25kg/m2 and waist-hip ratio (WHR) ≥ 0.90 for men and ≥ 0.85 for women were randomly divided into either Actiponin (n=40, 450mg/day) or placebo group (n=40, 450mg/day) for 12weeks.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 25kg/m2 and WHR ≥ 0.90(men), WHR ≥ 0.85(women)

Exclusion Criteria:

* Significant variation in weight(more 10%) in the past 3 months
* Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker
* History of disease that could interfere with the test products or impede theire absorption, such as gastrointestinal disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* Abdominal hepatic liver function
* Renal disease, e.g. acute/chronic renal failure, nephritic syndrome
* Used antipsychosis drugs therapy within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnancy or breast feeding
* History of alcohol or substance abuse
* Allergic or hypersensitive to any of the ingredients in the test products
Vagal Nerve Stimulation in mTBI

Mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) are important conditions for the Veterans Administration (VA) that frequently occur together in combat Veterans from the conflicts in Afghanistan and Iraq. In many Veterans these become chronic, raising the risk the burden of neurotrauma can worsen over time. This study will examine a new intervention called non-invasive Vagal Nerve Stimulation (nVNS) and its effects on memory and symptoms of PTSD and mTBI as well as brain and physiology in Veterans with mTBI and PTSD.

This projects will assess the effects of non-invasive Vagal Nerve Stimulation (nVNS) on neurobiology and cognition in combat Veterans with mild Traumatic Brain Injury (mTBI) and co-morbid posttraumatic stress disorder (PTSD) during the performance of stressful tasks (traumatic scripts, mental arithmetic) and verbal declarative memory tasks using measurement of memory performance, peripheral inflammatory markers in blood (IL6) and cardiovascular responses using wearable gated sensing devices and electro- and seismocardiography, as well as brain response (anterior cingulate, hippocampus) measured with High Resolution Positron Emission Tomography (HR-PET) and radiolabelled water (15O\[H2O\]). The investigators hypothesize that nVNS but not sham control will result in enhanced memory, and hippocampal activation with memory encoding, and reduced cardiovascular, sympathetic, and inflammatory responses to stress. The investigators will also assess the effects of nVNS and sham on memory retention when applied to the encoding phase of a declarative memory learning task repeated daily over a four day period and on ratings of PTSD and pain in Veterans with mTBI and co-morbid PTSD and repeat assessments after three months of twice daily treatments.

Eligibility Criteria:
Inclusion Criteria:

* Veterans with mTBI and PTSD

Exclusion Criteria:

* amnesia for the inciting event lasted longer than 24 hours
* Glasgow Coma Scale Score after 30 minutes was less than 13
* loss of consciousness more than 30 minutes
* positive pregnancy test
* meningitis or other neurological disorder other than mTBI
* alcohol or substance abuse use disorder based on the SCID within the past 12 months
* current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, anorexia nervosa or bulimia, based on the SCID
* active suicidal ideation based on criteria outlined below
* a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
* active neuroleptic, opiate, or benzodiazepine treatment
* structural abnormality on brain MRI or CT
Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.

This study is to investigate if there has been a shift in treatment with tofacitinib, assessing real world patient data and entered in the Corrona registry between 2016 and 2020.


Eligibility Criteria:
Inclusion Criteria:

* RA patients in Corrona initiating tofacitinib or a TNF biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) after 06 November 2012 (market approval of Tofacitinib) during follow-up in Corrona with no prior use of tofacitinib. Only the patient's first initiation after 06 November 2012 will be included in the analysis
* Have a 6 and / or 12-month follow-up visit (with +/- 2 month window)
* Have Clinical Disease Activity Index (CDAI) measures at baseline and at the follow-up visit

Exclusion Criteria:

* Patients who have not failed methotrexate (MTX) or another csDMARD (ie 1st line initiators)
Anabolic Effects of Whey and Casein After Strength Training in Young and Elderly

The aim of this study is to investigate the acute anabolic effects of native whey, whey protein concentrate 80 (WPC-80) and milk after a bout of strength training in young and elderly. The investigators hypothesize that native whey will give a greater stimulation of muscle protein synthesis and intracellular anabolic signaling than WPC-80, and that WPC-80 will give a stronger stimulus than milk.

Increasing or maintaining muscle mass is of great importance for populations ranging from athletes to patients and elderly. Resistance exercise and protein ingestion are two of the most potent stimulators of muscle protein synthesis. Both the physical characteristic of proteins (e.g. different digestion rates of whey and casein) and the amino acid composition, affects the potential of a certain protein to stimulate muscle protein synthesis. Given its superior ability to rapidly increase blood leucine concentrations to high levels, whey is often considered the most potent protein source to stimulate muscle protein synthesis. Native whey protein is produced by filtration of unprocessed milk. Consequently, native whey has different characteristics than WPC-80, which is exposed to heating and acidification. Because of the direct filtration of unprocessed milk, native whey is a more intact protein compared with WPC-80. Of special interest is the higher amounts of the highly anabolic amino acid leucine in native whey.

The higher levels of leucine can be of great interest for elderly individuals as some studies in elderly has shown an anabolic resistance to the effects of protein feeding and strength training. By increasing levels of leucine one might overcome this anabolic resistance in the elderly.

The aim of this double-blinded, randomized, partial cross-over study is to compare the acute fractional protein synthesis and intracellular signaling response to a bout of strength training and intake of 20 grams of protein from either native whey, whey protein concentrate 80 or milk, in young and old individuals. Furthermore, the investigators wil investigate fractional protein breakdown, markers of protein breakdown, amino acid concentrations in blood.

The investigators hypothesize that native whey will induce a greater anabolic response than whey protein concentrate 80, and that whey protein concentrate 80 will give a stronger anabolic response than milk.

Eligibility Criteria:
Inclusion Criteria:

* Healthy in the sense that they can conduct training and testing
* Able to understand Norwegian language written and oral
* Between 18 and 45, or above 70 years of age

Exclusion Criteria:

* Diseases or injuries contraindicating participation
* Use of dietary supplements (e.g. proteins, vitamins and creatine)
* Lactose intolerance
* Allergy to milk
* Allergy towards local anesthetics (xylocain)
Transcriptome Sequencing Analysis of Whole Blood From Patients With Trigeminal Neuralgia

Trigeminal neuralgia is a type of neuropathic pain that brings great physical and psychological pressure to patients. Chronic pain can cause changes in the composition of central and peripheral body fluids, and these changes may be useful for the prediction and treatment of pain. In this study, the whole blood of patients with trigeminal neuralgia and non-chronic pain was collected, and transcriptome sequencing (RNA-seq) was performed to determine the peripheral transcriptome changes of trigeminal neuralgia (TN) patients. And compare the expression of neuropeptide Y (NPY) in plasma and cerebrospinal fluid of TN and non-chronic pain patients.

Trigeminal neuralgia is a kind of paroxysmal, knife-cutting, stubborn and severe pain in the facial distribution area of the trigeminal nerve caused by slight stimulation, which brings a great physical and psychological burden to the patient. Chronic pain can cause changes in the composition of central and peripheral body fluids, and these changes are very useful for the prediction and treatment of pain. In this study, the whole blood of patients with trigeminal neuralgia and non-chronic pain was collected for transcriptome sequencing (RNA-seq) sequencing. The results of transcriptome sequencing can derive the differentially expressed genes in the whole blood of TN patients and the pathways enriched by differentially expressed genes. At the same time, NPY (Neuropeptide y) plays an important role in head and face pain. We will also verify the difference in NPY expression in the cerebrospinal fluid and plasma of TN and non-chronic pain patients, and the correlation between NPY expression and pain.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary trigeminal neuralgia receive trigeminal nerve microvascular decompression, and healthy people without a history of chronic pain or patients with facial nerve palsy without chronic pain receive facial nerve decompression as a control;
2. Age from 30 to 60 years old
3. Complete white blood cell count: 4.8\~11.0x109/L

Exclusion Criteria:

1. Patients with co-infection and tumor
2. Patients with craniocerebral disease
Efficacy of PTX+IFN Alpha+ RBV on Hepatitis C Virus Coinfected HIV Patients

Current Hepatitis C virus (HCV) treatment consists of the combination of interferon alpha 2a (IFN-alpha 2a) plus ribavirin (RBV) and it provides sustained virologic responses (SVR) on 54 to 56% on HCV monoinfected patients and this response is even lower on HIV-HCV coinfected patients. A previous study on HCV monoinfected patients showed that the addition of pentoxyfylline (PTX) to a treatment scheme based on interferon-alfa and ribavirin increased SVR on 25%, although it is not known if the same effect is to be obtained in HCV-HIV coinfected patients.

On the other hand, other factors such as host genetics, have proved to influence treatment response on HCV infected patients. The best described genetic factor so far is the interleukin 28B (IL28B) polymorphism rs12979860, where a cytosine-cytosine (CC) genotype provides an almost twice increase on SVR than the rest of the genotypes.

Therefore, this is a randomized, double blind study to assess the efficacy of pentoxyfylline addition to a treatment scheme based on interferon-alfa and ribavirin in chronic HCV genotype 1, co-infected HIV-1 positive subjects, considering the IL28B polymorphism rs12979860.

HIV-HCV coinfected subjects currently receiving Highly active antiretroviral therapy (HAART), with at least 8 months on undetectable HIV viral load and T helper cells count of 200 or higher will be included. Patients will be randomized on one of two groups:

* Group A: IFN alpha 2a + RBV + PTX
* Group B: IFN alpha 2a + RBV + placebo

Patients will be followed for primary outcome during 72 (for rapid responders) or 96 weeks (for non rapid responses). Outcome measures will be the following:

* SVR rate 24 weeks after the end of treatment
* Grade of Hepatic fibrosis from baseline to the end of treatment, measured by transient elastography and the AST to platelet ratio index (APRI index)
* IL28B rs12979860 genotype

The study hypothesis is that the addition of PTX to a treatment scheme based on IFN-alfa2a and RBV in chronic HCV genotype 1, co-infected HIV-1 positive subjects will improve SVR rate and fibrosis progression irrespectively of IL28B rs12979860 genotype.


Eligibility Criteria:
Inclusion Criteria:

* HIV/HCV coinfected patients
* 18 to 65 years old
* currently receiving HAART
* non-pregnant women
* HIV infection controlled as: undetectable viral load (\<40 copies/mL) for at least 8 months and T helper cells count of 200 cells/μL or above
* no contraindications to IFN alpha2a, RBV or PTX treatment
* sign informed consent form
* laboratory parameters within acceptable ranges

Exclusion Criteria:

* Women that present a positive pregnancy test during the study
* Patients that for any reason no longer wish to receive IFN alpha2a, RBV or PTX treatment
* Serious adverse events that prevent to continue IFN alpha2a, RBV or PTX treatment; such as severe neutropenia, severe thrombocytopenia or severe anemia
* Presence of an opportunistic infection or malignancy that requires treatment with drugs interacting with IFN alpha2a, RBV or PTX
* Patients that fail to adhere to treatment
Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment

In patients who show signs of bleeding and bleeding after polypectomy such as EMR and ESD for polyps with a diameter of 2 cm or more in the lower gastrointestinal tract, the effectiveness and safety of Nexpowder as an endoscopic hemostatic treatment are confirmed.

Total number of target subjects 66 Test group 33 / Control group: 33 If endoscopic polypectomy is performed on polyps of 2cm or more, the probability of bleeding as a complication is 6.5%. This clinical study is an observational study to confirm the safety and effectiveness of Nexpowder, an endoscopic hemostatic powder after colonoscopy polypectomy, and an exploratory evaluation of 60 patients is conducted.

Eligibility Criteria:
Inclusion Criteria:

1. Adult volunteers aged 19 or older during screening
2. A person who is scheduled to perform polypectomy for polyps with a diameter of 2 cm or more, such as Endoscopic Mucosal Resection (EMR) or Endoscopic Submucosal Dissection (ESD)
3. If the researcher agrees to voluntarily participate in the clinical study and determines that the subject cannot voluntarily consent due to the elderly aged 80 or older or other emergency situations, a written consent of the subject's legal representative is required

Exclusion Criteria:

1. Upper gastrointestinal bleeding
2. If ulcerative bleeding is not caused by the procedure
3. If you are suffering from a blood clotting disorder
4. Aspirin and anticoagulant medications cannot be discontinued
5. Pregnant or lactating
6. Where colonoscopy is prohibited due to comorbid diseases, etc
7. If the bleeding area cannot be identified or the bleeding area cannot be reached with an endoscope
8. If you have participated in a relevant clinical trial that may affect the results of this study within the last one month
9. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption
10. A person who is hypersensitive to food additive Blue No. 1 or has a history of allergies
11. In the case where the researcher determines that it is inappropriate to participate in clinical trials due to other reasons other than the above selection exclusion criteria
Patient-centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research

PROSPER (Patient-centered Research into Outcomes Stroke patients Prefer and Effectiveness Research) is a three year research project to create a national, sustainable model to improve decision-making and patient-centered stroke outcomes through comparative effectiveness research.

We propose to address existing evidence gaps and develop the requested data on the range of clinical outcomes that may be experienced by stroke survivors. To achieve these goals, we will link the nation's largest stroke registry, the American Heart Association (AHA) Get With The Guidelines-Stroke program and nationwide Medicare claims data, coupled with telephone interviews for longitudinal treatment and downstream patient-reported outcomes.

Design \& Procedures:

Retrospective: Using GWTG-Stroke database and its associated 1900 hospitals, we will conduct several comparative research protocols prioritized by stroke survivor focus groups and surveys. GWTG-Stroke registry clinical data linked with Medicare claims will be used for analysis of effectiveness and safety of post-stroke therapies on long-term clinical outcomes (n= 450,000). Outcomes of interest include:

"Home-time" (days alive and at home) Death Stroke/TIA readmission All-cause readmission Cardiovascular readmission Bleeding readmission

Prospective:

We will use the existing AVAIL registry combined with an additional 2000 stroke survivors for a combined cohort of over 5000 patients to obtain detailed information on patient-reported outcomes. The AVAIL Registry (IRB # Pro00012243) collected data from 3000 stroke survivors between 2006 and 2008. We plan to use these data to supplement our prospective PROSPER study. The PROSPER study will enroll a minimum of 2,000 subjects to augment the data collected from the AVAIL study. Consented patients from at least 75 sites will complete interviews at 3 and 6 months after discharge. We anticipate that the PROSPER questionnaire will include the following tools: Fatigue Severity Scale (FSS), Patient Health Questionnaire (PHQ8), modified Rankin scale (mRS), Barthel Index, EuroQOL (EQ-5D), Stroke-specific quality of life (SSQOL-12) and Lawton Instrumental Activities of Daily Living (IADL). Sites will consent interested patients and have them complete a patient contact information form which includes, name, address, phone numbers, email address, etc. Outcomes of interest include: : Post-stroke fatigue, Depression, Chronic pain, Medication intolerance, Modified Rankin scale (mRS), EuroQOL and Stroke-specific quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Consistent with GWTG inclusion criteria, patients must be older than 18 and have a primary diagnosis of acute ischemic stroke.
* Ability to give informed consent or the availability of a surrogate who can consent on the patient's behalf.

Exclusion Criteria:

* Patients with subarachnoid or intracerebral hemorrhage
* Patients with transient ischemic attack (TIA)
* Patients with expected survival less than 6 months/discharged to hospice
Intake of Beta-glucan and Postprandial Regulation of Blood Glucose Metabolism in Healthy Subjects

The overall aim is to investigate the intake of beta-glucan in relation to glucose metabolism and satiety in a postprandial study with healthy subjects. The potential effects will be related to changes in the gut microbiota, the circulating levels of short chain fatty acids, inflammation and gene expression in peripheral mononuclear blood cells

The intervention study will have a fixed order, cross-over design with three test meals containing low (0.5 g / 100 g of product), medium (3.5 g / 100 g of product) and high (8 g / 100 g product) amount of beta -glucans, respectively. The test meals are in the form of cereals. All participants will eat the three test meals three constitutive days with 2 weeks apart. At day four, the participants will perform a postprandial glucose test (OGTT, 75 g glucose in 150 ml water) at Oslo and Akershus University College. Blood samples will be taken before and at different time points after glucose test.

At the screening visit the participants will be asked to limit the intake of dietary fiber from grains two weeks prior to the baseline visit (0) and during the study. Otherwise, participants will be asked not to change their diet and exercise habits during the study period.

At the baseline visit (visit 0) an OGTT will be performed. OGTT will also be performed at visit 1, 3 and 5 after intake of low, medium and high beta-glucan, respectively.

The participants will receive the test meals at visit 1, 2 and 4.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18,5 and 27 kg/m2
* Fasting plasma glucose ≤ 6.1 mmol/l

Exclusion Criteria:

* Chronic metabolic diseases such as diabetes type 1 and 2, coronary heart disease and cancer the last 6 months.
* Intestinal diseases such as chrons disease, ulcerative colitis and irritable bowel syndrome.
* Food allergy and intolerances towards grain and dairy products.
* Pregnant and lactating
* Smokers
* Fasting blood glucose ≥ 6.1 mmol/L
* CRP \> 10 mg/L, measured at baseline (visit 0)
* BMI \<18,5 and \>27 kg/m2
* Planned weight reduction and or ± 5% weight change over the past three months.
* Use of antibiotics last 3 months before study entry and during the study period
* Use of probiotics the last month before study entry and during the study period
* Blood donor last 2 months before study entry and or during the study period
* Not willing to end the use of dietary supplements four weeks prior to study entry and throughout the study period
* Alcohol consumption \> 40g / day
* Hormone treatments (except contraceptives)
A Risk Prediction Model for Hypothermia After Laparoscopic Gastrointestinal Tumor Surgery

The incidence of postoperative hypothermia in patients with laparoscopic gastrointestinal tumors is high. Hypothermia increases the risk of postoperative complications and medical costs. Early warning can effectively reduce the incidence of postoperative hypothermia in patients. Multivariate prediction models help identify high-risk patients and reversible factors. At present, there are few reports on the risk factors and prediction models of postoperative hypothermia in patients with laparoscopic gastrointestinal tumors. Therefore, this study aims to clarify the risk factors of postoperative hypothermia in patients with laparoscopic gastrointestinal tumors. Four machine learning algorithms, traditional Logistic regression analysis, decision tree, random forest and naive Bayes, were used to establish risk prediction models. According to the TRIPOD statement, C-index, Hosmer-Lemeshow ( H-L ) test and decision curve analysis ( DCA ) were used to evaluate the prediction and fitting effects of the models in all aspects, and the optimal model was selected and verified. Provide reference for subsequent research.


Eligibility Criteria:
Inclusion Criteria:

* The types of surgery included laparoscopic radical gastrectomy for gastric cancer, duodenal cancer, colon cancer, rectal cancer and small bowel cancer. Age ≥ 18 years ; the anesthesia method was general anesthesia ; elective surgery.

Exclusion Criteria:

* Patients with abnormal body temperature such as fever and hypothermia before operation ; patients who need low temperature to protect organs during operation ; patients who were converted to laparotomy during the operation ; a clear diagnosis of sweat gland dysfunction ; patients with external auditory canal active disease ; reject participants.