cyrilzakka/clinical-trials huggingface dataset:
Treatment of Acute Hepatitis C Virus Infection With Pegylated Interferon in Injection Drug Users

Injection drug use accounts for transmission of a high proportion of Hepatitis C Virus (HCV) infections. The purpose of this trial is to investigate the effectiveness of pegylated interferon in treating injection drug users (IDUs) with acute HCV.

IDUs are at high risk for developing HCV. Pegylated interferon is a man-made form of interferon, a chemical naturally produced by the body that works to fight viruses. Interferon helps to stop HCV from replicating, and helps the immune system to kill HCV. The purpose of this trial is to determine the effectiveness of pegylated interferon in IDUs with HCV.

This trial will last 24 weeks. Participants will be randomly assigned to one of two groups. Group 1 will receive pegylated interferon while group 2 will receive an active control. Injection with either pegylated interferon or control will occur weekly. During each injection visit, participants will be asked about adverse events, including common side effects to interferon such as injection site reactions, headache, myalgias, arthralgias, insomnia, and hair loss. At Weeks 2, 4, and then every 4 weeks thereafter, participants will complete depression self-reports. Laboratory assessments will occur at Week 2, and then on a monthly basis for the remainder of the study. Follow-up assessments will occur every 4 weeks after Week 24.

Eligibility Criteria:
Inclusion Criteria:

* Documented HCV antibody seroconversion within the 12 months prior to study entry
* Serum positive for HCV
* Meets hematologic, biochemical, and serologic criteria at entry visit
* Thyroid stimulating hormone within normal limits
* Hepatitis B surface antigen negative
* Reads at an eighth grade reading level
* Willing to use adequate contraception for the duration of the study
* Plans to remain in the study area for 12 months

Exclusion Criteria:

* Positive test for Hepatitis A antibodies, Hepatitis B antibodies, or HIV antibodies
* Suspected hypersensitivity to pegylated interferon
* Liver disease
* Hemoglobinopathies
* Immune mediated disease
* Significant cardiac or pulmonary disease
* Uncontrolled seizure disorder
* Renal insufficiency with serum creatinine levels greater than 11.5 mb/ml or less than 60 mb/ml
* History of thyroid disease
* Active gout
* Any medical condition requiring or likely to require steroids during the course of study
* Untreated severe psychiatric disorder, as determined by study psychiatrist
* Any condition, which in the opinion of the investigator, would preclude successful completion of the study
* Pregnant or breastfeeding
Exercise, Activity and Smoking in Young Adults

The purpose of this study is to evaluate how physical activity levels change in young adults when they start a specific exercise program.

The purpose of this study is to evaluate how physical activity levels change in young adults when they start a specific exercise program. Physical activity levels will be monitored daily via a FitBit Flex. Outcome measures include number of minutes of activity per day and distance traveled per day.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old,
* stable physical/mental health,
* current smoker
* currently minimally active,
* ambulatory,
* interested in increasing their physical activity,
* willingness to attend weekly exercise intervention sessions at a SNAP Fitness location within 10 miles of the University of Minnesota campus,
* the ability to comply with the study protocol and provide informed consent

Exclusion Criteria:

* Contraindications to increasing physical activity including, but not limited to,
* abnormal electrocardiogram or V02 test results,
* high blood pressure (defined as systolic blood pressure over 165 or diastolic blood pressure over 100),
* heart attack, acute (2 days) cardiac event or stroke in preceding six months,
* unstable angina,
* uncontrolled dysrhythmias causing hemodynamic compromise,
* symptomatic severe aortic stenosis,
* uncontrolled symptomatic heart failure,
* acute pulmonary embolism or pulmonary infarction,
* acute myocarditis or
* pericarditis,
* dissecting aneurism,
* acute systemic infection and
* unstable pulmonary or cardiovascular conditions.
Shared Decision Making in the Emergency Department: Chest Pain Choice Trial

Our long-term goal is to promote evidence-based patient-centered evaluation in the acute setting to more closely tailor testing to disease risk. To compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration, we propose the following:

1. Test if Chest Pain Choice safely improves validated patient-centered outcome measures in a pragmatic parallel patient randomized trial.

   Hypothesis: The intervention will significantly increase patient knowledge, engagement, and satisfaction with no increase in adverse events.
2. Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment.

Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate of cardiac testing, and total healthcare utilization.


Eligibility Criteria:
Inclusion Criteria:

1. 18+ years of age (at least 18).
2. Admitted to emergency department for chest pain.
3. Being considered by the treating clinician for admission for cardiac testing.

Exclusion Criteria:

1. Ischemic changes on the electrocardiogram not known to be old as determined by the treating clinician in real time.
2. Elevated cardiac troponin (cTn) above the 99th percentile reference limit.
3. Known coronary artery disease as defined by consensus guidelines on risk stratification studies for emergency department patients with potential acute coronary syndrome (≥ 50% stenosis on cardiac catheterization; prior electrocardiographic changes indicative of ischemia, e.g., ST-segment depression, T-wave inversion, or left bundle branch block; perfusion defects or wall motion abnormalities on previous exercise, pharmacological, or rest imaging studies; previous documentation of acute myocardial infarction; or, if no records are available, patient self-report of coronary artery disease).
4. Cocaine use within the previous 72 hours by clinician history.
5. Pregnancy.
6. Referral to the emergency department by a personal physician for admission.
7. Patients who indicate that a hospital different than the site hospital is his or her "hospital of choice" in the event of a return emergency department visit.
8. Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order.
9. Homelessness, out-of-town residence or other condition known to preclude follow-up.
10. Patients in police custody or currently incarcerated individuals.
11. Patients who have, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent (or use the decision aid).
Comparison of Two NN1250 Formulations in Healthy Volunteers

This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.


Eligibility Criteria:
Inclusion Criteria:

* Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG (electrocardiogram), as judged by the Investigator
* Body mass index 18.0-27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
European Registry of Anti-Epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS)

This is a registry study, where sites will enter patients with LGS who require a modification in anti-epileptic therapy (either the addition of another anti-epileptic drug, or the change of one drug to another). This will include patients who are started on rufinamide. Patients will be reviewed according to local practice, but it is envisaged that review will occur at approximately one month, three months and six months, and then every six months. Upon entry to the registry baseline details concerning disease severity, diagnosis, prior therapy, and developmental assessment will be recorded. On each subsequent visit the patient (usually through their caregiver) will be asked about current medication, general seizure profile, any seizures deemed to be of medical significance, tolerability, AEs (including suicidal-related events), and healthcare resource utilisation.


Eligibility Criteria:
INCLUSION CRITERIA

* Patients will be four years and older
* Patients will have an established diagnosis of Lennox-Gastaut syndrome, and:
* Documented history or current presence of multiple seizure types associated with LGS (including tonic or atonic seizures (drop attacks) and atypical absences)
* Documented history or current presence of typical EEG abnormalities (e.g., bursts of slow spike and wave activity)
* Presence of intellectual / learning disability (a variable degree is permitted)
* Patients entered on the registry will be those requiring a modification in their current anti-epileptic medication. This includes but is not limited to patients who are commenced on rufinamide as adjuvant therapy

EXCLUSION CRITERIA

* Female patients who are pregnant, lactating, or whom are planning to become pregnant
* Female patients, of child bearing potential, who are not willing to use appropriate contraception (This is at the discretion of the investigator)
* Those starting rufinamide and for whom the investigator considers it necessary to administer in contradiction to the indications, and warnings within the current Summary of Product Characteristics (SPC).
Monitor Patients With Acute Heart Failure

This is a prospective, multi-center, non-randomized study to evaluate performance of an external monitor for heart failure patients

External monitoring of heart failure patients with the AVIVO System.

Eligibility Criteria:
Inclusion Criteria:

* Is female or male, 18 years of age or older
* Has an ejection fraction of 40% reported within 12 months of enrollment
* Having acute decompensated heart failure and receiving treatment for fluid overload

Exclusion Criteria:

* Is participating in another clinical study that may confound the results of this study
Investigation of the Serotoninergic System in Multiple System Atrophy: a Positron Emission Tomography (PET) Study

Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder of the adult associated to a poor prognosis. MSA is clinically characterized by the association of extra-pyramidal, dysautonomic, cerebellar and pyramidal symptoms. Histological and biological studies have raised the hypothesis that, beside the well known dopamine deficiency, some of the symptoms could be related to a dysfunction in serotoninergic neurotransmission. Serotonin is involved in the modulation of several functions impaired in MSA, such as mood, motricity or sleep. The recent description of an association between loss of brainstem serotonin neurons and sudden death in patients with MSA reinforced the hypothesis of a critical role played by this neurotransmitter in the pathophysiology of this disease. Autoreceptors called 5-HT1a are strongly involved in the regulation of serotonin neurotransmission. During the last years several radio-ligands allowing in vivo PET quantification of 5-HT1a receptors, such as 18F-MPPF (4-(2'-methoxyphenyl)-1-\[2'-(N-2''-piridinyl)-p-fluorobenzamide\]methylpiperazine), were developed. Moreover, the investigators recently demonstrated the ability of this brain functional imaging method to investigate, in healthy volunteers, the functional properties of 5-HT1a autoreceptors through an evaluation of their desensitization after a single oral dose of fluoxetine.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Multiple system atrophy (MSA)

  * MSA possible or probable
  * Male and female
  * Age : 30 to 80
  * No cognitive impairment
  * Unmodified treatment for 2 months
  * Able to give informed consent
  * Affiliated to social insurance
* Patients with idiopathic Parkinson's disease (IPD):

  * Positive clinical criteria for IPD
  * Male and female
  * Age : 30 to 80
  * No cognitive impairment
  * Unmodified treatment for 2 months
  * Able to give informed consent
  * Affiliated to social insurance
* Healthy controls:

  * Absence of neuropsychiatric disorder
  * Male and female
  * Age : 30 to 80
  * Able to give informed consent
  * Affiliated to social insurance

Exclusion Criteria:

* Patients with Multiple system atrophy (MSA)

  * Other Parkinsonian syndrome
  * Dementia
  * Recent intake (\< 4 weeks or 8 weeks for fluoxetine) of medication acting on 5-HT1a receptors
  * History of major depression
  * Contraindication to brain MRI
  * Contraindication to PET
* Patients with idiopathic Parkinson's disease

  * Other Parkinsonian syndrome
  * Dementia
  * Recent intake (\< 4 weeks or 8 weeks for fluoxetine) of medication acting on 5-HT1a receptors
  * History of major depression
  * Contraindication to brain MRI
  * Contraindication to PET
* Healthy controls:

  * Patient having a neuropsychiatric disease
  * Recent intake (\< 4 weeks or 8 weeks for fluoxetine) of medication acting on 5-HT1a receptors
  * History of major depression
  * Contraindication to brain MRI
  * Contraindication to PET
Subcostal Transversus Abdominis Block Versus Erector Spinae Block in Open Cholecystectomy

Open cholecystectomy is a surgical procedure involving the removal of the gallbladder through a traditional, open abdominal incision the surgeon makes an incision in the upper abdomen, exposes the gallbladder, and carefully disconnects and removes it. Postoperative pain management is a critical aspect of patient care following cholecytectomy surgery. Inadequate pain control can lead to a cascade of complications, including atelectasis, pneumonia, and delayed mobilization. These complications can prolong hospital stays, increase healthcare costs, and lead to patient dissatisfaction. Regional anesthesia techniques, such as subcostal transversus abdominis plane (TAP) block abd erector spinae block are commonly used to provide effective analgesia after cholecystectomy surgery. These techniques target the nerves that supply the surgical site, providing pain relief without the need for opioids. Opioids are associated with a number of side effects, including nausea, vomiting, constipation, and respiratory depression. Subcostal TAP block is a relatively new technique that has been shown to be effective in providing postoperative analgesia after upper abdominal surgery. This technique involves injecting local anesthetic into the TAP, a fascial plane that lies between the internal oblique and transversus abdominis muscles. The TAP block provides anesthesia to the nerves that supply the abdominal wall, including the subcostal nerves. Erector Spinae Plane Block is a newer technique targeting the dorsal rami of the T7-T12 spinal nerves, potentially offering broader analgesia encompassing the abdominal wall, thorax, and diaphragm. Early studies suggest improved pain control and respiratory function compared to traditional methods.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Both sex.
* American Society of Anesthesiologists (ASA) I-II Undergoing elective open cholecystectomy surgery.
* Patients who need at least 24hrs hospital admission.

Exclusion Criteria:

* Known allergy to local anesthetics
* Coagulopathy or bleeding disorders
* Severe respiratory disease
* Neurological disorders
* Pregnancy
The Effect Methylphenidate Hydrochloride on Pain and Auditory Sensitivity in Healthy Subjects

1. To examine whether Ritalin has analgesic properties in healthy subjects.
2. To examine if Ritalin analgesic effect is a pain specific phenomenon or a part of a broader, non-specific effect on high mental functions.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects between the ages of 20 to 40
* Healthy subjects without known disease and without any chronic pain
* Subjects without known cognitive problems, which can understand the research and its goals
* Subjects who are not taking any medications
* Subjects without hearing problems
* Subjects without attention deficit disorder (ADHD) problems

Exclusion Criteria:

* Subjects who are known to suffer from any disease or any chronic pain
* Subjects taking psychotropic drugs (except Ritalin) or any analgesics
* Subjects who have any contradictions for ritalin administration
* subjects with suspected cognitive disability
Condensed Percutaneous Tibial Nerve Stimulation (PTNS) Protocol

The purpose of this study is to understand how the frequency of PTNS sessions impacts their efficacy in the treatment of over active bladder syndrome.

This study aims to evaluate the impact of the periodicity of the PTNS treatments on the efficacy of treating patients with OAB. We will compare the efficacy of a condensed (twice weekly) protocol to the standard (once per week) protocol of PTNS therapy.

Objective #1 (6-wk CP vs. 12-wk SP) is to show that 6 weeks of the condensed protocol (CP) will yield a higher efficacy compared to the standard 12-week protocol (SP). If this 6-week CP is proven effective, candidates for PTNS treatment could potentially experience symptom relief in half the time as the current standard of care, improving their quality of life quicker. Objective #2 (12-wk CP vs. 12-wk SP) is to show that 12 weeks of the CP will have a higher efficacy compared to the 12-week SP. If the superiority of this 12-week CP is proven, it could be beneficial in treating patients with refractory OAB.

Eligibility Criteria:
Inclusion Criteria:

* Women and men (18 years of age and older) with overactive bladder syndrome, who are interested in receiving PTNS treatment.

Exclusion Criteria:

* Patients with anatomical limitations preventing successful placement of the electrode, medical disorders precluding stimulation (bleeding disorders, cardiac pacemakers, peripheral vascular disease or ulcers, or lower leg cellulitis).
* Pregnant women or women who are planning to become pregnant during the course of the study.
Exercise Genes: Genomic Association With Exercise Reinforcement

This study tests whether different physical activity patterns are linked an individual's genes.

The investigators propose that an individual's genetics are one factor that may be associated with the motivating aspect or attractiveness of exercise and therefore the choice to exercise rather than be sedentary. They propose to study the association of the genomic signatures with the reinforcing (motivating) value of different types of exercise. This has never been investigated and may uncover underlying mechanisms that would help to understand individual differences in exercise motivation. The ultimate impact of this work is a greater number of Americans being physically active, meeting the United States Department of Agriculture (USDA) dietary guidelines for physical activity, and maintaining a healthy body weight. This study will be funded and undertaken at the Grand Forks Human Nutrition Research Center (GFHNRC). The purpose will be to assess genetic underpinnings of the motivating value of resistance and aerobic exercise, and to determine whether the motivating value of aerobic and resistance exercise are associated with usual participation in these modes of exercise.

Eligibility Criteria:
Inclusion Criteria:

* BMI within 18.5-35.0 kg/m2
* Healthy enough to exercise
* Active or inactive (not exercising at this time)

Exclusion Criteria:

* Taking any drugs that affect energy expenditure (e.g., thyroid, glucose-lowering drugs)
* Have gained or lost more than 5% of body weight over the past 6 months
* Use tobacco
* Pregnant or lactating or plan to become pregnant in the next 6 months
* Have any health conditions that prevent the individual from safely exercising (e.g., cardiovascular, liver, endocrine, or pulmonary diseases)
Changes of Functional Connectivity After rTMS in Depression

In order to explore the effect of repetitive TMS, which has shown to be effective in intractable depression, we will examine resting-state, default-mode network functional connectivity in patients with major depression. We will use a double-blind, sham-controlled design. Our target sample size is 60(30 patients will be treated by active rTMS, the other 30 will be treated by sham rTMS). We will apply 10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.

Up to now, 24 patients with major depression and 6 normal controls are enrolled. Twenty-three patients and 4 normal participants have taken 10 days rTMS. One patients and one control withdrew their consent without any reason and one control withdrew the consent because of headache.

We scanned fMRIs(to examine functional connectivity)twice for each participant, which were taken 3 days before the first and 3 days after the last rTMS.

All of participants have not reported side effects except mild headahe. There's been no seizure event up to now.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV major depressive episode
* Failure of at least 3 different kind of antidepressant

Exclusion Criteria:

* Organic brain disorder
* Other diagnosis of DMS-IV except nicotine dependence
* History of seizure disorder
A Study to Evaluate the Long-term Efficacy and Safety of AK102 in Patients With Hyperlipidemia

This is a randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the long-term efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.

This is a Phase 3 clinical study to evaluate the long-term efficacy and safety of AK102, a monoclonal antibody, against proprotein convertase subtilisin/kexin type 9 (PCSK9), in subjects with primary hypercholesterolemia and mixed hyperlipidemia.

Eligibility Criteria:
Inclusion Criteria:

1. Subject understand and voluntarily sign the written Inform Consent Form (ICF), which must be signed before performing the study procedures.
2. Male or female patients aged between 18 and 80 years (including upper and lower limits).
3. The fasting serum LDL-C level of subjects did not meet the treatment goal after at least 4 weeks of stable lipid-lowering background treatment.
4. Triglyceride ≤ 4.5 mmol/L (400 mg/dl).

Exclusion Criteria:

1. Homozygous Familial Hypercholesterolemia (HoFH).
2. Received PCSK9 inhibitors within 6 months before randomization.
3. Known sensitivity to PCSK9 inhibitors and any substances to be administered.
4. Severe liver and renal dysfunction.
5. Previously received organ transplantation.
6. Uncontrolled hypothyroidism or hyperthyroidism.
7. Uncontrolled hypertension.
8. Known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc.
9. History of malignancy of any organ system within the past 5 years.
10. Pregnant or lactating women.