cyrilzakka/clinical-trials huggingface dataset:
Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease

The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass index and waist circumference)in diabetic subjects with non-alcoholic fatty liver disease.

Helicobacter pylori (HP) antigens have been found in the liver of individuals with benign and malignant liver diseases. The role of HP in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.

This randomized double blind clinical trial was performed in diabetic dyspeptic patients with positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two weeks. HP eradication was documented by UBT. Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein, HOMA-IR, and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six weeks post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic dyspeptic patients with positive antibody to H.pylori and persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic

Exclusion Criteria:

* Alcohol use (more than 20 gram per day in men and 10 gram per day in women per day), heart disease (ischemic or congestive), hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion), renal disease (serum creatinine concentration of \> 1.5 mg/dl), any severe systemic co-morbidities, neoplasm, using any hepatotoxic medication during the past 3 months, previous history of peptic ulcer, previous history of H.pylori eradication, existence of alarm signs (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal cancers), and pregnant or lactating women.
Impacts of Subsidized Ridesharing on Drunk Driving, Alcohol Consumption, and Mobility

The purpose of this research study is to understand people's alcohol use in public places and their risks for harm. The overall goal of this study is to test the effects of subsidized ridesharing as an intervention to reduce self-reported alcohol-impaired driving, along with alcohol consumption and changes to mobility.

Motor vehicle crashes are the leading cause of death for people aged 13-25 years in the US, and approximately 31% of all fatal crashes involved some alcohol use. Several peer-reviewed studies have found that ridesharing was associated with fewer alcohol-involved crashes and DUI arrests. Theories of behavioral economics provide a clear theoretical mechanism by which ridesharing will reduce alcohol-involved motor vehicle crashes compared to other private transportation. However, while ridesharing may be an effective intervention to reduce alcohol-involved crashes, it may simultaneously increase alcohol consumption. This study will assess the impacts of subsidized ridesharing on impaired driving, alcohol consumption, and mobility. Participants will be randomized to either receive a rideshare voucher or an online shopping voucher, and effects on alcohol impaired driving and alcohol consumption will be measured. A GPS sub-group will use a custom smartphone application for GPS tracking to measure mobility.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 21 years old
* Reside in a study city
* Have a driver's license
* Have access to a motor vehicle
* Have consumed alcohol in a bar in the last 30 days
* Own a smartphone
* Read English

Exclusion Criteria:

* Non-English speaking participants
Active-Controlled Study to Assess the Efficacy and Safety of DFD-05 in Subjects With Common Warts

DFD05 vs. Active01 in the treatment of common warts


Eligibility Criteria:
Inclusion Criteria:

1. Subjects, any gender or race, must be in good general health as determined by the Investigator with a clinical diagnosis of common warts.
2. Subjects must have at least 1 visible, discrete, common wart with at least a 3 mm longitudinal diameter on the hands, feet (excluding soles) and palms (in that order of priority).
3. The warts must have been present for at least the past 12 weeks, but not more than 3 years
4. Subjects must agree to only use the study products and to not use any other wart-removing product (prescription, OTC or occlusion) during the course of the study.
5. Subjects must be free of any systemic or dermatologic disorder, which in the opinion of the Investigator, will interfere with the study results.
6. Female subjects of childbearing potential must agree to use contraception during the study. All women of childbearing potential must have a negative urine pregnancy test at Screening and Baseline and at 4, 8 \& 12 weeks visits.
7. Subjects are physically able to apply study product to all affected areas or can obtain help.

Exclusion Criteria:

1. Women who are pregnant or nursing or planning to become pregnant during the study.
2. Subjects who have been treated for warts within the 30 days prior to the Baseline Visit (e.g. salicylic acid, azelaic acid, cryotherapy).
3. Subjects who have participated in a trial involving any investigational product in the 30 days prior to the Baseline Visit.
4. Subjects with chronic or active liver disease, renal impairment, cutaneous or systemic lupus erythematosus, an autoimmune disorder, immunosuppression, or any other disease or medical condition that would interfere with the study or place the subject at unacceptable risk, as determined by the investigator.
5. Subjects on immunosuppressive agents that would impact their immune response e.g. cyclosporine, mycophenolate mofetil, azathioprine, etc.
6. Subjects who use or have used local/systemic steroids or any other immunosuppressive medication within the 30 days prior to the Baseline Visit.
7. Subjects who use or have used systemic or topical retinoids within the 30 days prior to the Baseline Visit.
8. Subjects who are unable to comply with study requirements.
9. Subjects with other skin diseases like molluscum contagiosum that may confound the evaluation of common warts.
10. Subjects who have received treatment for any type of cancer within 5 years of the Baseline Visit, except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.
11. Subjects unable to comply with study requirements
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation

This is a pilot, open label, single center study in 30 women undergoing breast augmentation. The study will assess and collect information on pharmacokinetics and safety of EXPAREL administered as a pectoral plane block.

A total of 15 subjects will be enrolled in each of the 2 cohorts.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18 or older, undergoing breast augmentation and are American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
2. Able to provide informed consent, adhere to the study schedule, and complete all study assessments
3. Body Mass Index ≥18 and ≤30 kg/m2

Exclusion Criteria:

1. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
2. Documented history of long-term diabetes (≥10 years) or severe peripheral vascular disease
3. Renal (serum creatinine level \>2mg/dL \[176.8 μmol/L\]) or hepatic dysfunction (serum alanine or aspartame transferase \> 3 times the upper limit of normal)
4. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion may confound the post dosing assessments
5. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
6. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
7. Previous participation in an EXPAREL study
8. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
9. Currently pregnant, nursing, or planning to become pregnant during the study
10. Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study
11. Currently on neuroleptic agent \[e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.\]
12. Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)
Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders

This study investigates whether caloric vestibular stimulation can modulate a measure of insight in obsessive-compulsive spectrum disorders.

Obsessive-compulsive and related disorders (OCRD), including obsessive compulsive disorder and body dysmorphic disorder, are chronic and disabling conditions characterized by recurrent intrusive thoughts and associated compulsive behaviors that affect millions of individuals in the US each year. Individuals affected by OCRD differ in insight, or the degree to which they understand their intrusive thoughts to reflect illness. Impairments in insight limit individuals' motivation to engage in care and predict worse outcome in those who access treatment.

This study seeks to explore whether unilateral stimulation of the vestibular system, which activates cortical areas hypothesized to underlie clinical insight, may beneficially modulate insight in individuals with OCRD.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Primary diagnosis of Obsessive-Compulsive Disorder, Body Dysmorphic Disorder, Illness Anxiety Disorder or Somatic Symptom Disorder (excluding "with predominant pain")
* Strongly held OCRD-related concerns meeting BABS score criterion.
* No recent change in psychopharmacological treatment, if any
* Capacity to provide informed consent

Exclusion Criteria:

* Psychiatric or medical conditions (eg, vertigo, history of otological surgery) that might make participation unsafe
* Pregnant or nursing women
* Active or recent substance use
A Multicenter Randomized Study of Vitamin D Combined With HD-DXM Versus HD-DXM for the Treatment of ITP

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of vitamin D combining with high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

The investigators anticipate to undertaking a prospective, multicenter, randomised controlled trial of 60 ITP adult patients. One part of the participants are randomly selected to receive vitamin D (given Rocaltrol orally at a dose of 0.25 μg per day for 1 month), combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, two-cycles with an interval of 10 days); the others are selected to receive high-dose of dexamethasone treatment plus placebo. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Serum calcium and creatinine are monitored. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of vitamin D combining with high-dose dexamethasone therapy for the treatment of adults with ITP.

Eligibility Criteria:
Inclusion Criteria:

1. Corresponding to the diagnostic criteria for immune thrombocytopenia
2. Newly diagnosed ITP patients
3. To show a platelet count \<30 \* 10\^9/L, and with bleeding manifestations
4. Willing and able to sign written informed consent

Exclusion Criteria:

1. Suffered from diseases associated with hypercalcemia.
2. Vitamin D intoxication
3. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit;
4. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit; 3.Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study;
5. Current HIV infection;
6. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period;
8. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
9. Patients who are deemed unsuitable for the study by the investigator.
Stress Urinary Incontinence in Elite Athletes

A protocol of pelvic floor muscles training (PFMT) in elite athletes was applied. They will do it for 4 months. Then re-evaluated.

The athletes of the Portuguese national female's volleyball team were evaluated through perineometry, pad-test and Kings health questionnaire. They were taught a plan of pelvic floor muscles training (PFMT) to perform for 4 months. After this time they will be re-evaluated with the same measuring instruments.

Eligibility Criteria:
Inclusion Criteria:

* Elite female athletes
* Nulliparous
* Volleyball team.

Exclusion Criteria:

* Inability to contract the PFM, elderly
* Prolapse of the pelvic organs.
Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578)

The purpose of the study is to determine whether ezetimibe plus simvastatin will be more effective than simvastatin alone in preventing progression of atherosclerosis of the inner layer of the carotid artery.


Eligibility Criteria:
Inclusion Criteria:

* Genotype-confirmed heterozygous familial hypercholesterolemia with written documentation of the genetic diagnosis at the time of screening and LDL-C \>=210 mg/dL (5.43 mmol/L), or clinical diagnosis of heterozygous familial hypercholesterolemia, defined as LDL-C \>=210 mg/dL (5.43 mmol/L) and at least one of the following:

  * tendinous xanthoma
  * child \<18 years of age with hypercholesterolemia (LDL-C \>159 mg/dL (4.11 mmol/L)
  * has a sibling with hypercholesterolemia (LDL-C \>190 mg/dL \[4.91 mmol/L\]) and tendinous xanthoma
  * family history with an LDL-C value distribution pattern compatible with dominant autosomal transmission and at least one relative presenting fasting total cholesterol values \>348 mg/dL (9.0 mmol/L) after exclusion of secondary causes of dyslipidemia
* LDL-C \>=210 mg/dL (5.43 mmol/L) 1 week before randomization
* plasma triglyceride level \<=400 mg/dL (4.52 mmol/L)

Exclusion Criteria:

* pregnancy or any other situation, condition, or illness that, in the opinion of the investigator, may interfere with optimal participation in the study
* presence of an apolipoprotein B gene mutation with confirmed absence of an LDL receptor mutation in either allele
* undergoing LDL-apheresis or plasma apheresis
* unsuitable plaque or artery morphology
* use of certain drugs, foods, or other agents known to alter cholesterol levels or to cause pharmacokinetic interactions with either ezetimibe or simvastatin
The Relationship Between Pain Perception, Severity of Temporomandibular Joint Dysfunction, and Spinal Health in Geriatric Individuals

It is aimed to examine the relationship between pain perception, temporomandibular joint disorder severity and spine health in elderly individuals.

The research sample will consist of elderly individuals who reside in Tokat and Kırıkkale, are over 65 years old, have good cognitive status, and volunteer to participate in the study. According to the G\*Power analysis, if the sample size is α= 0.05, β= 0.80, acceptable correlation coefficient r= 0.70, and negligible correlation coefficient r= 0.20, 16 individuals are sufficient to measure the relationship between two parameters. Since the relationship between four parameters will be evaluated, 64 individuals are required.

Data for the study will be collected face to face by researchers using The Centrality of Pain Scale, Discomfort Intolerance Scale, Spine Functional Index, and Fonseca Anamnestic Index, which can be filled in by individuals themselves.

Statistical Package for Social Sciences (SPSS), version 22.0 computer package program for Windows, will be used for statistical analysis. Statistical data will be expressed as mean ± standard deviation (X±SD), median, or percentage (%). One Sample Kolmogorov Smirnov test will be performed to show the parametric or nonparametric distribution of the data. When parametric test assumptions are met, the relationship between parameters is determined by Spearman correlation test; When parametric test assumptions are not met, the relationship between the parameters will be examined with the Pearson correlation test. Statistical significance value will be accepted as p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* To be volunteer

Exclusion Criteria:

* Having any neurological, psychiatric or cognitive disorder
The Effect of Two Non-pharmacological Methods on Pain and Anxiety Experienced During Intrauterine Device Application.

The purpose of this study is to determine the effect of emotional freedom technique and music, which are effective in relieving pain and anxiety, on the pain and anxiety that occur during intrauterine device application.

Intrauterine devices, which are considered one of the most effective contraceptive methods, can be effective up to 99% when used correctly. While 17% of women of reproductive age around the world use intrauterine devices, 13.7% of women in our country prefer intrauterine devices as a contraceptive method. Intrauterine devices have many benefits such as being easy to use, returning fertility when removed, being able to be used for a long time, and being low in cost. Intrauterine devices are recommended to women as the first choice by medical institutions due to their high effectiveness rates. However, anxiety and pain experienced during the intrauterine device placement procedure may prevent women from choosing intrauterine devices as a birth control method. Music and emotional liberation techniques can be used as alternative methods to relieve pain and anxiety. In this research, the effects of emotional freedom technique and music, which are effective on pain and anxiety, on pain and anxiety during intrauterine device application will be investigated. Additionally, it will be tested whether the emotional liberation technique and music are superior to each other in relieving the pain and anxiety that occur during intrauterine device application. Additionally, no research has been found in the literature examining the effects of emotional liberation technique and music recital on the pain and anxiety experienced during intrauterine device application. With this research, the gap in the field will be eliminated and new research and applications will be structured.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily agreeing to participate in the research
* Being between the ages of 18-49

Exclusion Criteria:

* Having a verbal communication problem
* Being medically diagnosed with a psychiatric disorder
* Presence of wounds, scars and infections in the areas touched in the emotional freedom technique
* Having a hearing problem
* Having had an intrauterine device (IUD) inserted before
* Being exposed to domestic violence
* Being diagnosed with any medical condition (hypertension, diabetes, etc.)
* Having used analgesics seven hours before the procedure
* Having a gynecological examination just before IUD application
A Study to Access the Efficacy and Safety of Meloxicam in Patients With Osteoarthritis of the Knee

To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56 days


Eligibility Criteria:
Inclusion Criteria:

- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)

Exclusion Criteria:

none
Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section

The project aims to introduce into clinical practice for Caesarean section conducted under general anesthesia with the rapid induction myorelaxation with rocuronium and the reversal of neuromuscular blockade by using sugammadex. The aim is to demonstrate at least the same efficiency and confirm the safety of the procedure for both mother and newborn compared with older procedure.

Project "Modern myorelaxation procedure and reversal of neuromuscular blockade during general anesthesia for caesarean section" aims to introduce in other indications for rapid induction of general anesthesia common and safe, alternative method of combining short-acting intravenous anesthetics propofol and fast-onset non-depolarizing muscle relaxant rocuronium into the clinical practice and demonstrate the efficacy and safety in this indication. At the same time to demonstrate the benefits of using modern reversal of neuromuscular blockade by sugammadex in termination the caesarean section under general anesthesia. Both procedures will be monitored by clinical observation, monitoring instrumentation and laboratory examination of mother and fetus (newborn) in various stages of peripartal period. The main benefit of this procedure will be in particular risk groups of mothers which are indicated by Caesarean Section while neuraxial blockade is contraindicated.

Eligibility Criteria:
Inclusion Criteria:

* caesarian section under general anesthesia in informed patient (after interview with anesthesiologist and obtain the signature for informed consent)

Exclusion Criteria:

* patient disagreement
* indicated and performed neuraxial blockade
* the anesthesiologist or obstetrician opposition to their inclusion in the study
* allergy or intolerance to one or more of study drug or known allergies or reactions to iodine