cyrilzakka/clinical-trials huggingface dataset:
Arteriovenous Fistula Pain and Cold Application

TThis study was designed as a single-group comparative prospective intervention study. The aim of the study was to assess the effectiveness of different pain management interventions during AVF cannulation. The effects of pain management methods such as cooling spray, aloe vera gel, and the standard procedure on pain levels, and which intervention was more effective in reducing pain compared to the standard procedure, were investigated.

The study included patients over 18 and under 65 years old, undergoing hemodialysis, having an AVF, literate, without an aloe vera allergy, and without communication barriers or psychiatric disorders.

The main research questions were defined as follows: Did different pain management methods (cooling spray, aloe vera gel, and standard procedure) affect pain levels during AVF cannulation? Which intervention was more effective in reducing pain levels? The primary hypotheses were defined as The application of cooling spray and aloe vera gel would reduce pain levels more than the standard procedure.

The researchers compared pain levels after each intervention to determine which one was more effective. Three different interventions (cooling spray, aloe vera gel, and standard procedure) were applied to participants in sequence, and pain levels were assessed after each intervention using the Visual Analog Scale (VAS). Additionally, feedback from participants regarding each intervention was collected.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 and under 65 years old
* Literate
* Have an arteriovenous fistula (AVF)
* Undergoing hemodialysis (HD) treatment at least twice a week
* No allergy to aloe vera
* No communication barriers and/or psychiatric disorders

Exclusion Criteria:

* Diagnosed with malignancy
* Having any sensory problems that prevent the assessment of perception and pain
* Using any analgesic preparations
* Having a vascular access other than AVF
* Patients in whom AVF cannulation is not successful in a single attempt
Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial

The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.

APRON is a multicenter, randomized, double-masked, placebo controlled trial of 4 weeks of treatment with aprepitant or placebo for patients with symptoms of gastroparesis and related disorders. Screening for eligibility and collection of baseline data will span up to 4 weeks after obtaining informed consent and registration. Eligible patients will consist of patients with symptoms of gastroparesis and will be randomized to either aprepitant (125 mg per day) or placebo for 4 weeks.

The symptoms will be measured with the Gastroparesis Cardinal Symptom Index Daily Diary (GCSIDD) for one week at baseline and for four weeks after randomization. In addition, the nausea symptom will be measured daily on a 0 to 100 mm visual analog scale (VAS) for one week at baseline and daily for four weeks after randomization. There will be a 2 week washout period at the end of the treatment to ensure patient safety following the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older at registration
* Gastric emptying scintigraphy within 2 years of registration
* Normal upper endoscopy or upper GI series within 2 years of registration
* Symptoms of chronic nausea or vomiting compatible with gastroparesis or other functional gastric disorder for at least 6 months (does not have to be contiguous) prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of greater than or equal to 21
* Significant nausea defined with a visual analog scale (VAS) score of greater than or equal to 25 mm on a 0 to 100 mm scale

Exclusion Criteria:

* Another active disorder which could explain symptoms in the opinion of the investigator
* Use of narcotics more than 3 days per week
* Significant hepatic injury as defined by significant alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations of greater than 2x the upper limit of normal (ULN) or a Child-Pugh score of 10 or greater
* Contraindications to aprepitant such as hypersensitivity or allergy
* Concurrent use of warfarin, pimozide, terfenadine, astemizole, or cisapride
* Pregnancy or nursing
* Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
* Failure to give informed consent
Bioequivalence Study of 300 mg Gabapentin

The objective of this study was to confirm if two formulations of gabapentin (capsules) are bioequivalent.

Test product was Darbetin® 300 mg (Laboratorios Dermatológicos Darier) and reference product Nerotin® 300 mg (Pfizer). One capsule was the single dosage.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 26 healthy volunteers, both genders, adults between 18-55 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility Criteria:
Inclusion Criteria:

Males 18-55 years. Healthy based on comprehensive medical history, lab tests, Chest x-ray, Electrocardiogram, negative tests for Hepatitis B and C, and HIV. Negative urine doping test. BMI 19-26.5 kg/m2. Lab test in normal range +/- 10%. Blood pressure 139-90/89-50, heart rate 100-55, respiratory rate 24-17, temperature 37.5-35 °C. Non-smoking at least for 10 hrs before study. Written informed consent. Women must be not pregnant, nor breast-feeding.

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Exclusion Criteria:

Hypersensitivity to study medication or other related drug. History of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition.

Requiring any drug interfering with minocycline pharmacokinetics. Exposed to inducers or inhibitors of hepatic enzymes. Intake of possible toxic drugs 30 days before study. Intake of any drug 14 days or 7 half-lives before study. Hospitalization or severe disease 60 days before study. Receiving investigational drug out of study center 30 days before study. Blood loss or blood donation =\>450 ml 60 days before study. Recent history of drug abuse including alcohol. Intake of xanthine containing products 10 hrs before study. Intake of grapefruit juice or hot-spice 10 hrs before study.

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Influence of In-line Microfilters on Systemic Inflammation in Adult Critically Ill Patients

Studies showed that infusion or injection of drugs and fluids results in introduction of microparticles into the bloodstream. These microparticles may cause organ damage and stimulate the immune system thus aggravating the underlying disease. Given that critically ill patients are characteristically suffering from a high disease severity and receive large amounts of fluids and drugs, they may be at particular risk of harm by these microparticles. In-line microfilters have been shown to clear microparticles from intravenous drugs and solutions. The investigators hypothesize that use of in-line microfilters reduce the days with the systemic inflammatory response syndrome in adult critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* critical illness
* expected length of stay in the intensive care unit \> 24 hours
* central venous catheter in place or placed within the first 24 hours

Exclusion Criteria:

* age \< 18 years
* pregnancy
* neutropenia or known immunesuppresion
* limited intensive care
* inclusion into another clinical trial
* refusal of written informed consent
Atypia of Undetermined Significance (AUS) / Follicular Lesion of Undetermined Significance (FLUS)

According to the guidelines for reporting thyroid fine needle aspirations known as The Bethesda System, the category of atypical cells known as AUS/ FLUS category has an estimated rate of 5 to 15% for malignancy. This study aims to determine the rate of malignancy of this category in our institution and to evaluate the clinical outcome of the participants.

This is a retrospective study that will help us to find out the rate of AUS/ FLUS in our population of Mississippi and the percentage of malignancies in these cases.The specimens will be searched through the University of Mississippi Medical Center's Pathology Laboratory Information system (Copath), from April 2010 to December 2016. The retrospective cases will be retrieved using natural language search. The total number of thyroid FNA will be retrieved and the percentage of cases with AUS/ FLUS will be calculated. Followup of these cases will be done looking for additional fine needle aspirations of the thyroid or thyroidectomy specimens. Cases with diagnosis of AUS/ FLUS will have correlation with the diagnosis on the thyroidectomy specimens if available in our system.

Eligibility Criteria:
Inclusion Criteria:

* Thyroid fine needle aspirations interpreted as AUS/ FLUS at University of Mississippi Medical Center from April 2010 to December 2016.

Exclusion Criteria:

* Fine needle aspirations of thyroid with diagnosis of unsatisfactory, benign, suspicious for follicular neoplasm/ Follicular neoplasm, suspicious for malignancy and malignant.
Effects of Plyometric and Circuit Training in Volleyball Players

Circuit training is a formed type of training in which the trainees goes through a series of selected exercises of activities that are performed in a sequence or in a circuit. Plyometric training is an intense, advanced form of exercise in which the muscles are first stretched, then contracted (the pre-stretching makes the muscle contract with greater force). Plyometric training is one of the most popular training approaches adopted by coaches and strength and conditioning professionals in both, team and individual sports.

Circuit training is a formed type of training in which the trainees goes through a series of selected exercises of activities that are performed in a sequence or in a circuit. Plyometric training is an intense, advanced form of exercise in which the muscles are first stretched, then contracted (the pre-stretching makes the muscle contract with greater force). Plyometric training is one of the most popular training approaches adopted by coaches and strength and conditioning professionals in both, team and individual sports. This study will be a randomized clinical trial and will be conducted in Pakistan sports complex. Non-probability convenience sampling technique will be used to collect the data. The sample size of total 28 athletes will be taken in this study. The participants will be divided into two groups: group I will follow plyometric training and group II will receive circuit training. The plyometric training program progressed from level one (weeks one and two; 1-2 sets of 10 repetitions) to level two (weeks three and four; 1-2 sets of 8 repetitions) and finally level three (weeks five and six; 1-2 sets of 6 repetitions). Plyometric training programs included both leg jumps, single-leg jumps, hurdle jumps, drop jumps, box jumps or lunge jumps.

The circuit training consists of 6 exercises, divided in 2 blocks (1st block contains

½ squats, bench press and pushups and 2nd block contains burpees, squat thrust and lunges) of 3 minutes. Cooper's test, Sprint test, Vertical jump test and Agility shuttle run test will be used to evaluate the results after 6 weeks

Eligibility Criteria:
Inclusion Criteria:

* Only Males
* Age between 16-25 years
* volleyball players
* Players have spent at least one year in sports EXCLUSION CRITERIA
* Players undergone surgery or had an accident.
* Any malignant or chronic diseases
* Patients with infections or any inflammatory disease
* Patients with contraindications to exercise therapy (uncontrolled hypertension, respiratory diseases.
* Patients with spinal deformities or fractures.
A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

This is a study to investigate the effectiveness and safety of \[S,S\]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of any race, at least 18 years of age
* Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)

Exclusion Criteria:

* Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia
* Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder
* A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression
* History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features
Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder

Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal of suffering. Many patients benefit from established treatments, the mainstay of which are cognitive behavioral therapy and a group of antidepressant medications known as serotonin reuptake inhibitors. However, 20-30% of patients get minimal benefit from these established therapeutic strategies. New avenues of treatment are urgently needed.

Existing medications for obsessive-compulsive disorder affect the neurotransmitters serotonin or dopamine; but increasing evidence suggests that functional disruptions of a different neurotransmitter, glutamate, may contribute to some cases of OCD. The investigators are therefore interested in using medications that target glutamate as novel treatment options for those OCD patients who do not benefit from established treatments.

One such medication is the drug riluzole, which is FDA approved for amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease, but may be of benefit to patients with psychiatric disorders due to its ability to moderate excessive glutamate. In preliminary studies, in which the investigators treated patients with riluzole (in addition to their established pharmacological regimen) in an open-label fashion (that is, without a placebo-treated control group), the investigators have found about 40-50% of patients to substantially improve over 2-3 months.

While immensely promising, these preliminary studies do not prove riluzole is truly a new beneficial medication for the treatment of OCD; a more rigorous placebo-controlled trial is needed for that purpose. The investigators are therefore now recruiting patients to participate in a double-blind, placebo-controlled trial of riluzole, added to whatever other OCD medications they are taking.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) diagnosis of OCD, confirmed by Structured Clinical Interview for DSM-IV (SCID-IV); symptoms of at least 1 year duration
* moderate to severe OCD symptoms as measured by a score on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) of 16 or greater
* documented failure of an adequate trial of a selective serotonin reuptake inhibitor (SSRI)
* agreement to engage in a reliable form of birth control (women only)

Exclusion Criteria:

* primary diagnosis of a psychotic disorder
* active substance abuse or dependence
* unstable medical condition
* prior exposure to riluzole
* prior psychosurgery
* pregnancy, breastfeeding, or intent to become pregnant during study
* liver function tests (LFTs) elevated to more than 2x the upper limit of normal
* evidence of active liver disease
* seizure disorder
* active suicidal ideation
The Impact of Video Information on Preoperative Anxiety in Interventional Cardiology Patients.

This study evaluates the impact of educative videos on anxiety for patients entering hospital for cardiology intervention


Eligibility Criteria:
Inclusion Criteria:

* patient entering hospitalisation in cardiology department for a cardiology intervention.

Exclusion Criteria:

* protected person.
Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony

Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony

The primary objective of this study are:

* to investigate and compare the clinical performance of standard (default) FlexPoint settings to minimum FlexPoint settings and to the maximum value for permitted peritoneal residual volume of FlexPoint settings of the PD cycler sleep•safe harmony in the treatment of PD patients.
* to assess whether usage of the settings of the therapy option FlexPoint (flexible volume and dwell time management) of the PD cycler sleep•safe harmony that deviate from the system default and from former sleep•safe settings, influences the efficacy of APD treatments as well as the hydration status (by using BCM) of PD patients.

The secondary objectives of this study are:

* Patients´ Quality of Life (QoL)
* Number of alarms
* To investigate the effects on solute removal
* To investigate the tolerability of the FlexPoint therapy options
* Adverse events / SAE

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated by study patient and investigator/ authorised physician
* Minimum age of 18 years
* CKD patients with indication for renal replacement therapy
* Patients being treated with APD for at least 3 months
* Patients using the sleep•safe harmony PD cycler (version 3.1)
* Fluid status regularly monitored with Body Composition Monitor (BCM)
* Proper functioning catheter
* Intraperitoneal Pressure (IPP) ≤ 18 cm H2O
* Ability to understand the nature and requirements of the study

Exclusion Criteria:

* Any conditions which could interference with the patient's ability to comply with the study
* Previous participation in the same study
* Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
* Patients receiving polyglucose containing PD solution
* Respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (FV) manipulation
* Patients who suffer from peritonitis/exit site infection during the last 4 weeks
* Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period
* Life expectancy \<3 months
* Participation in an interventional clinical study during the preceding 90 days
Healthy Mood Internet Recruitment Study

This study is pilot testing a self-help automated Website (similar to a self-help book) designed to help individuals to learn methods to manage their mood. The methods are cognitive-behavioral skills found effective in the treatment of depression when provided by live therapists. The purpose of the study is to determine the number of individuals who will visit the site, use the site, and respond to online surveys reporting their mood levels while using the site, and at 1, 3, and 6 months after starting to use the site. The investigators want to eventually examine whether learning these methods online would help prevent depression.

Self-help automated website in Spanish and English consisting of an 8-lesson course on mood management based on cognitive behavioral methods.

Accessible via the web.

Follow-up assessments conducted at 1, 3, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* valid email address
* fluent in English

Exclusion Criteria:

* less than 18 years of age
* no valid email address
* not fluent in English
Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)

The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-IO system in patients with Primary Open Angle Glaucoma (POAG)

This study is a prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients.

From the ARGOS-01 to the ARGOS-02 study, some modifications were made to the form of the ARGOS-IO implant in consequence of the outcomes of the ARGOS-01 study.

Maximal 5 patients of the ARGOS-01 study and maximal 21 patients of the ARGOS-02 study will take part in this study.

The sensor was always implanted in one eye only which will be the study eye.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor.

Exclusion Criteria:

* N/A
Effectiveness Evaluation of Panax Ginseng, Vitamins and Minerals in Improvement of Stress and Fatigue

We hope that with the drug, patients obtain reduced levels of stress and fatigue, according to the scales that we use in the study. Hopefully the results of the treated group are significantly higher than the control group (placebo).


Eligibility Criteria:
Inclusion Criteria:

* Agree with all study procedures, signing the IC in two ways;
* Patients older than 18 years, male or female, regardless of ethnicity or social class;
* Presence of mild to moderate stress, confirmed with the Stress Symptom Inventory (ISS);
* Presence of staff fatigue with a score greater than 36 according to the Fatigue Severity Scale (FSS).

Exclusion Criteria:

Constitute exclusion criteria of the study:

* Participation in clinical trials in the 12 months preceding the survey;
* Current treatment with drugs that are stimulants or central nervous system depressants such as hypnotics, anxiolytics, antipsychotics, antidepressants, statins and muscle relaxants;
* Alternative therapies that scientifically, or have no influence in the tables of stress or fatigue as color therapy, acupuncture or relaxing massages;
* Treatment psychotherapeutic medication or not;
* Current treatment or prediction of treatment with oral anticoagulants (due to interaction with the tocopherol);
* Women who are pregnant or lactating;
* Patients with lactose intolerance;
* Patients allergic to soy or peanuts;
* chronic renal failure;
* Patients using other multivitamins or individual vitamins such as vitamin D and / or A.
* Chronic alcoholism;
* Patients with clinical diagnosis of diseases causing severe chronic pain or adversely affect the clinical interpretation as fibromyalgia, multiple sclerosis, neuropathies and myopathies;
* Patients with hypothyroidism or hyperthyreosis diagnosed clinically;
* Patient history and physical examination suggestive of severe hepatorenal failure;
* Patients with decompensated diabetes mellitus (fasting glucose above 180 mg / dL);
* Patients undergoing treatment for cancer;
* Amendment of the routine of life during the study as early vacation or suspected change in working hours;
* Patients with complaints of excessive sleepiness caused by organic disease such as sleep apnea and morbid obesity (BMI above 35);
* History of hypersensitivity to any component of the product under investigation;
* Any finding of clinical observation (clinical history or physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study.