cyrilzakka/clinical-trials huggingface dataset:
A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.

Determine the optimal dose of IV N-acetylcysteine (NAC) to produce opioid reduction following spine surgery and estimate the difference in opioid consumption between placebo and the selected optimal dose.

First 20 subjects: 5 participants will be randomized to each dose group (placebo, 50, 100, and 150 mg/kg) to estimate the dose response curve and to identify the optimal dose.

If the dose response curve is adequate and the optimal dose identified, 15 additional participants will be randomized to placebo and 15 to the optimal dose to estimate the difference in opioid consumption between participants on placebo vs. the optimal dose. (Total of 50 subjects with 20 from dose response curve and 30 to estimate the difference in opioid consumption.)

If the dose response curve is not adequate after the initial 20 subjects 5 per each dose group, then an additional 5 participants will be randomized and to each dose group (placebo, 50, 100, and 150 mg/kg) to estimate the dose response curve and to identify the optimal dose. Once the optimal dose is identified with these initial 40 patients, 10 additional participants will be randomized to placebo and 10 to the optimal dose to estimate the difference in opioid consumption between participants on placebo vs. the optimal dose. (60 patients total with 40 to create the dose response curve and 20 more to estimate the difference in opioid consumption.)

A sample size of 20 subjects per group (placebo and optimal dose) allows us to estimate a 95% confidence interval for the mean difference in opioid consumption with a width of + 0.64 standard deviations from the mean. 70 subjects may be enrolled to account for withdrawal but the study will be completed once 50 or 60 subjects (based on the number of subjects required to create the dose response curve) have completed the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective spine surgery involving 4 levels or less of the thoracic, lumbar, or sacral spine.
* 18 years of age and older.

Exclusion Criteria:

* Less than 40kg in weight.
* Unable to provide written, informed consent.
* History of an adverse or anaphylactoid reaction to acetylcysteine.
* Active asthma, wheezing, or using inhaled bronchodilators.
* Pregnant Women
* Known blood clotting deficiency
Stereotactic Body Radiation Therapy in Treating Patients With Low- and Intermediate-Risk Prostate Cancer

This clinical trial studies stereotactic body radiation therapy in treating patients with low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PRIMARY OBJECTIVES:

I. To evaluate, in terms of late toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.

SECONDARY OBJECTIVES:

I. To evaluate, in terms of acute toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.

II. To determine stereotactic treatment efficacy through biochemical failure (Phoenix criteria).

III. To determine the protocol completion rate. IV. To describe patient-reported outcomes using International Index of Erectile Function (IIEF) and EPIC Urinary and Bowel Assessment questionnaires.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo standard daily fractions of stereotactic body radiation therapy (SBRT) over 7-8.5 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have low or intermediate risk adenocarcinoma of the prostate as defined by:

  * Low-risk disease - Histopathology score (Gleason sum): =\<6, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA: \<10
  * Intermediate-risk disease as either:

    * Histopathology score (Gleason sum) =\< 6, T-stage (per current American Joint Committee on Cancer \[AJCC\] staging criteria): T1c-T2a, and prostate-specific antigen (PSA) \> 10 but =\< 20; or
    * Histopathology score (Gleason sum) 7 with =\< 50% of any cores positive, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA \< 10
* Charlson index of comorbidity score =\< 4
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
* Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment
* Patients with a history of pelvic irradiation for any reason
* Life expectancy \< 10 years - Prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two
* Prior radiation therapy, brachytherapy, or cryotherapy
* Prior surgical procedure involving peri-rectal and peri-prostatic area
Effects of Transcranial Direct Current Stimulation on Postural Control

Parkinson's disease is a progressive, degenerative neurological disease associated with profound changes in the quality of life of its survivors. Recent evidence has demonstrated the potential use of transcranial direct current stimulation (tDCS) to modulate cerebral excitability and movement control in neurological chronic conditions. However, few studies have investigated the effects of tDCS on postural control in patients with Parkinson's disease. This study aims to investigate the effect of bihemispheric tDCS on postural control in people with Parkinson's disease. Participants will be randomized to receive a single session of anodal and sham bihemispheric tDCS (7 days between each type of stimulation).

Primary clinical outcome (balance) will be collected before and immediately after tDCS. The data will be collected by a blind examiner to the treatment allocation.


Eligibility Criteria:
Inclusion Criteria:

Medical diagnosis of idiopathic Parkinson's disease present for at least 12 months

In clinical follow-up and pharmacological treatment by a responsible physician

Parkinson's classification of 1.5-3 according to the Hoehn and Yahr scale

Signing of the free and informed consent form-

Exclusion Criteria:

Use any associated orthopedic device to aid gait or balance control

Signs of severe dementia (evaluated by the Mini-Mental State Examination - MMSE)

Diagnosis of other neurological disorders (including those of central and peripheral nature)

Previous treatment with tDCS

Medical diagnosis of psychiatric illnesses with the use of centrally acting medications (depressants)

The use of pacemakers or other implanted devices.-
One Needle Hand Acupuncture for MSK Disorders

The purpose of this research study is to study the method of acupuncture called one needle hand acupuncture, where a needle is placed just in your hand, in order to treat pain in various locations. Benefits of acupuncture will be studied over time to determine short and long term effects of acupuncture, and see how acupuncture may alter or modify a patient's disease process.

Patients with neck, shoulder, low back, or hip pain that is exacerbated by movement will be randomized 1:1:1 to receive either verum hand acupuncture at the correct location (with or without movement) or control acupuncture at a nearby incorrect location. After needling and as part of the intervention, the movement groups will perform gentle active range of motion (ROM) exercises, while the without movement group will lay on the examination table, all for 10 minutes. Immediately pre- and post- intervention, numeric pain rating scores (NPRS) and goniometer- or inclinometer-obtained ROM measurements will be recorded for the most provocative movement plane.

In the physical therapy literature, within-session improvements in pain and ROM have been shown to correlate with between-session improvements.All patients will complete PROMIS Pain Interference, Physical Function, Anxiety, and Depression measures prior to the acupuncture intervention and then 1,2, 4, and 8 weeks later.

Four potential treatment response modifiers will be assessed. In Traditional Chinese Medicine (TCM), a strong needling sensation felt by the patient during an acupuncture treatment is called a "deqi" response and is thought to be a positive prognostic sign. In Western medicine, a local twitch response (LTR) observed during needling of muscle trigger points is thought to represent a polysynaptic reflex and has been linked to local pain improvements.Other potential modifiers include patients' underlying musculoskeletal structural diagnosis and the provider's experience performing acupuncture.

Eligibility Criteria:
Inclusion Criteria:

* Primary pain localized to neck, shoulder, low back, hip.
* Pain \>=4 on Numeric Pain Rating Scale with one of predetermined motions.
* Willing to participate in study and fill out questionnaires.

Exclusion Criteria:

* Fracture, malignancy
* Condition that requires urgent treatment (e.g. cervical myelopathy)
* Contraindications to needling (e.g. pregnancy, active infection)
Trajectories and Experiences of People With Multimorbidity in Spain (LOXO-MULTIPAP) Project: a Mixed Methods Study

The overall objective of the study is to analyze the evolution of multimorbidity, its most relevant patterns and trajectories in the Spanish National Health System population, from 2012 to 2022, and to analyze the factors that determine it, as well as the experience of professionals and patients in navigating the health system and in shared decision making.

Multimorbidity trajectories can help identify homogeneous groups of individuals with similar needs and prognoses, and help practitioners and health systems to personalize clinical interventions and preventive strategies. Capturing this dynamism is the only way to better understand the natural history of multimorbidity and shed light on hitherto unexplained findings.

* Design: Mixed-method study.

  * Quantitative study: retrospective and prospective observational study. It integrates demographic and clinical information from electronic medical records and clinical-administrative databases. It involves the harmonisation of the cohorts of users of the public health system of the 7 participating regions.
  * Qualitative study with a phenomenological and ethnographic approach using focus group techniques, semi-structured interviews and Photovoice to find out the perspective of patients and professionals in shared decision-making.
  * Systematic literature review on the effectiveness of interventions on training, multimorbidity and polypharmacy in health professionals.
* Analysis:

  * Quantitative study: Cluster, network and trajectory analysis
  * Qualitative study: Thematic content analysis that will be triangulated among the members of the research team. Meanings will be interpreted and an explanatory framework will be created with the contributions of each type of informant.

Eligibility Criteria:
Inclusion criteria:

* 60 years or older
* 2 or more chronic diseases

Exclusion criteria:

- Not having used the national health system in the last year
Effect of Mouthrinsing on Inflammation of the Gums.

The purpose of this study is to determine whether rinsing with an amine fluoride/stannous flouride mouthrinse in addition to daily tooth brushing is more effective than tooth brushing alone.

Gingivitis prevalence is 100% among the population. This is mostly due to an inadequate mechanical cleaning of the teeth. However, remaining dental biofilm can be approached by antibacterial mouthrinses. As a consequence of regular use of these mouthrinses, gingivitis can be reduced. Amine fluoride/stannous flouride mouthrinse (ASF)has proved its efficacy in several studies. In the previous years, a new formulation that does not contain ethanol anymore was introduced in the market. Therefore, it is the aim of the study to proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone. In addition, effects on dental plaque, discoloration of teeth and bacterial colonization should be studied.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults aged ≥18 years.
* Participants who have gingivitis/mild chronic periodontitis (approximal probing depth ≤ 3.5 mm at ≥ 80 % of the sites and at ≤ 20 % of the sites \> 3.5 mm and \< 5 mm).
* Participants must have read, understood and signed the informed consent form.
* Participants who have a GI ≥ 1.3 at baseline.
* Participants who have at least 20 own teeth excluding the wisdom teeth (incl. 16 natural crowns).
* Participants who have an acceptable compliance according to the investigators' assessment.

Exclusion Criteria:

* Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e. g. phenytoin, nifedipine, cyclosporine, antibiotics, steroids, antiphlogistics).
* Participants who require antibiotic treatments for dental appointments (endocarditis prophylaxis).
* Participants who were treated with antibiotics 8 weeks before recruitment and during the course of the study.
* Participants who were treated with any antibacterial mouthrinse 6 weeks before recruitment.
* Participants who use other than the recommended mouthrinse or toothpaste during the study period.
* Participants who have moderate and severe chronic or aggressive periodontitis.
* Participants who have irregularities of the gingival tissues, e. g. hyperplastic gingiva, mucosal diseases.
* Participants who have rampant caries.
* Participants under guardianship or without freedom by administrative or legal award.
* Known hypersensitivity or allergy to the study product and standard toothpaste ingredients used in the present study.
* Known pregnancy or breast feeding during the course of the study.
* Participation in another clinical trial or receipt of an investigational compound/treatment at the same time and 4 weeks prior to inclusion.
A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients With CD4 Counts Greater Than 300 Cells/mm3

The purpose of this study is to examine how rIL-2 affects HIV-positive patients with CD4 counts over 300 cells/mm3 who are on anti-HIV drug therapy. The drug rIL-2 has been shown to increase CD4 cell counts, which help the body fight off HIV.

There is strong evidence that rIL-2 increases CD4 cell counts (cells of the immune system that fight infection). This study examines the effect of 2 different amounts of rIL-2 on CD4 cell count and the amount of HIV in the blood (viral burden).

There is substantial evidence that rIL-2 increases CD4+ cell count. Whether or not rIL-2 delays progression to AIDS and extends survival is currently unknown, such clinical benefits of rIL-2 can only be established in a large, long-term, randomized trial. This study examines the effect of two different rIL-2 doses on HIV viral burden and CD4+ cell count and provides additional information on optimal dosing, safety, and antiviral activity of rIL-2.

Patients are randomized to receive one of two subcutaneous (sc) doses of recombinant rIL-2 or no rIL-2. Those patients who take rIL-2 initially receive three courses of treatment. For this study, a course is defined as eight calendar weeks, including the five-day period of sc rIL-2 administration. Additional courses are given (no more frequently than every 6 weeks) in order to maintain a CD4+ count of at least twice its baseline level or at least 1,000 cells/mm3. Follow-up will continue for all patients until a common closing date of 12 months following enrollment of the last patient.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Agree to practice abstinence or use effective birth control methods during the study.
* Are on anti-HIV therapy and have a CD4 count of at least 300 cells/mm3.
* Are at least 18 years old.

Exclusion Criteria

You will not be eligible for this study if you:

* Have a history of progressive diseases.
* Have a history of severe autoimmune/inflammatory disease.
* Have Crohn's disease.
* Are taking antiseizure medications or certain other medications.
* Are receiving chemotherapy.
* Are pregnant or breast-feeding.
* Have ever received rIL-2.
Effects of Low Fat Milk Consumption on Metabolic Syndrome

This study aimed to investigate the effects of low-fat milk consumption on metabolic parameters and biomarkers related to inflammation, oxidative stress, and endothelial function in Korean adults with metabolic syndrome.

A randomized, controlled, parallel, dietary intervention study was designed. Subjects with metabolic syndrome and body mass index ≥23 kg/m2 were randomized to the low-fat milk group, which were instructed to consume 2 packs of low-fat milk per day (200 mL twice daily) for 6 weeks, and the control group was instructed to maintain their habitual diet. Metabolic markers were evaluated at baseline and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects were enrolled if their body mass index (BMI) was ≥23 kg/m2 and they met the criteria for metabolic syndrome.

Exclusion Criteria:

* Those who were allergic to milk; those who had a history of digestive disorder; those with a medical history of cardiovascular diseases, including coronary artery diseases, valvular heart diseases, heart failure, or stroke; those who had cancer in the past 5 years; those who were taking hypoglycemic agents for diabetes mellitus; those who had chronic disease such as renal failure or liver cirrhosis; and those with a hemoglobin A1c (HbA1c) level ≥ 7% were excluded from the research. People who had a weight change \> 5% of the total weight within the past 3 months, those who had started taking or had changed their dose of anti-hypertensive agents or medications for dyslipidemia within the previous 1 month, those who had a newly diagnosed dyslipidemia requiring drug treatment, those who had taken steroids either orally or by injection within the previous 3 months, those who were pregnant or were expecting to become pregnant; and those who regularly consumed milk in quantities ≥ 200 mL per day at least 3 times a week on average were also excluded.
Will Cleaning the Bowel With an Enema Before Vaginal Prolapse Surgery Prevent Complications?

Traditionally, many gynecologic surgeons have asked patients to perform a cleansing enema the night before a vaginal surgery done to repair pelvic organ prolapse (dropped bladder, dropped uterus). The belief is that there is then less or no stool present at the vaginal incision and less chance of infection of the wound by bowel bacteria. However, not all surgeons follow this practice. There is no evidence in the medical literature if one way is better than the other. In this study, patients scheduled for vaginal surgery to correct prolapse will be randomly assigned to perform an enema or not to perform an enema.

The factors to be measured will be wound infection rates, and need to cleanse an incision of escaped stool.

Eligibility Criteria:
Inclusion Criteria:

* female, AND
* undergoing vaginal surgery for prolapse.

Exclusion Criteria:

* pregnant women,
* age younger than eighteen,
* male sex, OR
* concurrent abdominal surgery.
The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study

The goal of this project is to evaluate the nicotine induced acute cardiovascular changes in E-Cigarette users and also study the mechanism involved particularly with vascular impairment.

We will recruit 30 experienced E-cigarette users (those using E-Cigarette for at least 1 month and ≤ 1 tobacco cigarette / day), between ages 21-40 years; in 4 day study visit and 10 non-smokers (those who used less than 100 tobacco cigarettes in their lifetime and not active nicotine/tobacco or related product user) for a one study visit.The participants will be asked to abstain from all tobacco/nicotine and related product use for 12 hours before each visit.

Measurements will be taken at each study visit before and after E-cigarette use, each day with different nicotine dose, to look at both the individuals' exposure to nicotine and also the effects on the cardiovascular system. These measurements will include blood and urine samples as well as non-invasive cardiovascular measurements.

Eligibility Criteria:
Inclusion Criteria:

1. Participant will be currently healthy individuals, between 18 and 40 years of age.
2. E-Cigarette users using E-Cigarette for at least 1 month and smoke ≤ 1 tobacco cigarette / day; non-smokers who used less than 100 tobacco cigarettes in their lifetime and are not active nicotine/tobacco or related product users
3. Participants willing to abstain from vaping, smoking and tobacco for 12 hours prior to study.
4. Do not meet any of the Exclusion criteria.

Exclusion Criteria:

1. Unwilling or unable to provide informed consent.
2. Participant that have: Diabetes, Hypertension HIV, hepatitis, liver disease (including fatty liver), anemia, unhealed wounds, active infection, febrile, anemia, organ transplant, renal replacement therapy, kidney disease or insufficiency, dialysis, active cancer of any type, and untreated thyroid disease, major injury or trauma.
3. Body weight less than 100 pounds or BMI \>40.
4. Participants that are taking the following medications: estrogen, testosterone, anti TNF agents, cyclophosphamide, ketoconazole, methoxsalen, pilocarpine, Isoniazid, rifampicin certain biologics, or Procrit
5. Participants that are currently using nicotine patches, nicotine gum or any form of nicotine-containing cessation device
6. Pregnant or lactating women.
7. Prisoners and other vulnerable populations.
8. Anyone that PI thinks is unsafe to participate in the study.
SSS and the Impact of Portion Size on Daily Energy Intake

Reducing food portion size is a potential strategy to reduce energy intake. However, it remains unclear who is most susceptible to the portion size effect (PSE). There are just two studies which have examined the PSE in the context of socioeconomic position (SEP), with mixed findings. In an online trial the PSE on intended consumption of unhealthy snacks was 18-24% larger for participants of lower SEP compared to participants of higher SEP. However, in a recent laboratory study which examined the PSE on total daily energy intake, participants of lower SEP were no more susceptible to the influence of portion size on eating behaviour than participants of higher SEP. Further research is required to elucidate these divergent findings.

There is also an absence of evidence examining the moderating role of subjective social status (SSS) - an individual's perceived standing in society - on the PSE. Given evidence that the subjective experience of social class may be associated with health outcomes, the present study examines whether reductions to the portion size reduces daily energy intake, and whether and how SSS (higher vs lower) moderates the PSE.

In a crossover experiment, participants will be served all meals in the lab on two separate days, with the portion size of main components at breakfast, lunch and dinner manipulated (i.e. smaller on one day vs larger on the other day). All other foods offered are identical. Food intake from the portion-manipulated breakfast, lunch and dinner, as well as all other meal components (non-portion-manipulated sides, dessert, seconds, snacks, etc.) will be measured, to assess total daily energy intake (kcal).

See Study Protocol attached.

Eligibility Criteria:
Inclusion Criteria:

* Female
* UK (United Kingdom) residents, able to visit laboratory in Liverpool
* Aged 18 or over
* Fluent in English
* willing to consume the test foods
* Self report willingness to eat test foods
* BMI between 18.5 - 32.5kg2

Exclusion Criteria:

* participation in our previous study
* food allergies, intolerances or specific dietary requirements (except vegetarian)
* taking medication which affects appetite
* currently pregnant
* history of eating disorders
* currently on a diet to lose weight