cyrilzakka/clinical-trials huggingface dataset:
Phase I: Safety and Efficacy of an Injectable Follistatin Plasmid Gene Therapy in Humans

This study examines the safety and effects of an injectable plasmid gene therapy. Plasmids are circular pieces of DNA which have been widely studied as a non-permanent \& non-heritable method for transferring genes and inducing gene expression. In this study the plasmid is a gene vector which contains the human FST344 gene intended to express and secrete bioidentical human follistatin into serum circulation. Follistatin is a myostatin and activin inhibitor that has demonstrated improved functional outcomes in mouse models of neuromuscular disease.

Participants will undergo dual energy x-ray absorptiometry scans before and after the treatment's administration to compare change from baseline and rates of change in fat vs muscle tissue and bone density. Participants will also undergo metabolic and epigenetic blood panels to observe any changes. Participants will be monitored at the clinic site for a short time period after receiving the therapy and participants will be able to report any adverse events through an online form. Lastly, participants will have blood drawn just prior to, and three months after, the gene therapy's administration in order to assess circulating levels of follistatin. This study is administered at the Global Alliance for Regenerative Medicine clinical research site on the island of Roatan and is sponsored by Minicircle. The main contact for this study is Mac Davis.


Eligibility Criteria:
Inclusion Criteria:

* Openness to morphological change
* Will practice contraception for the duration of trial (if female)

Exclusion Criteria:

* Women who are pregnant, nursing or of childbearing potential who are unwilling or unable to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illness
* Pre-existing joint, ligament, or heart issues
* Systolic blood pressure (supine) ≤90 mmHg;
* Resting heart rate \> 100 bpm
* Unwilling or unable to give written informed consent.
Autoantibodies and Direct-acting Antivirals

The investigators assessed non-organ-specific antibodies before and 24 weeks after the end of therapy with direct-acting antivirals, in order to better clarify the clinical relevance of these antibodies in terms of treatment response and prognostic value.

To achieve this goal patients with hepatitis C virus related advanced liver disease, with detectable circulating autoantibodies on at least two determinations before treatment, were enrolled.

About 40-70% of hepatitis C virus patients develop at least an autoimmune extra-hepatic disorder presumably due to the interaction between hepatitis C virus E2 envelope protein and B lymphocyte Cluster of Differentiation-81 receptor. In addition, the same interaction is responsible for the production of different serum non-organ-specific antibodies. The clinical significance of the latter phenomenon has not been fully understood except for the presence of liver kidney microsome-1 antibody, which is linked to a molecular mimicry between the cytochrome enzyme CYP2D6, primarily expressed in the liver, and hepatitis C virus proteins in genetically predisposed subjects.

Actually, no data are available about the prevalence and clinical significance of serum non-organ-specific antibodies in hepatitis C virus patients treated with second generation direct-acting antivirals.

Eligibility Criteria:
Inclusion Criteria:

HCV positive patients Presence of advanced liver fibrosis Eligibility to the treatment with direct-acting antiviral therapy.

Exclusion Criteria:

History of autoimmune hepatitis and/or cholangitis Evidence of active hepatocellular carcinoma Human immunodeficiency virus coinfection Hepatitis B virus coinfection.
Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis

This is a study of the safety and efficacy of topical Econazole Nitrate Foam 1% and the foam vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 12 years of age and of either sex.
* Have a clinical diagnosis of interdigital tinea pedis involving at least2 web spaces in total which extends no more than approximately 1 inch proximal to the web spaces or metatarsophalangeal joints with at least i) moderate scaling and ii) mild erythema defined as a Grade 2 and Grade 1, respectively on the Grading of Signs and Symptoms at baseline.
* Be willing and able to give informed consent/assent or have their parent/guardian do so, if applicable.
* Be willing and able to use the assigned study medication as directed and to commit to all follow-up visits for the duration of the study.
* Have microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte in the skin scrapings taken at the Baseline Visit. Subjects with a positive KOH may be entered into the study pending the results of the fungal culture.
* Be in good health and free of any disease or physical condition which might, in the Investigator's opinion, expose the subject to an unacceptable risk by study participation.
* Females must be non-pregnant (confirmed by a negative urine pregnancy test at baseline), non-lactating and not intending to become pregnant during the course of the study.

Exclusion Criteria:

* Is pregnant, nursing or planning a pregnancy during the study.
* Has used topical antifungals or topical corticosteroids on the feet within 30 days prior to the start of the study.
* Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
* Has used systemic antibacterials or systemic corticosteroids within 30 days prior to the start of the study. Systemic corticosteroids do not include intranasal, inhaled, and ophthalmic corticosteroids used for the management of allergies, pulmonary disorders or other conditions.
* Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
* Has concurrent tinea infection e.g. tinea versicolor, tinea cruris, moccasin-type tinea pedis, etc. (in the opinion of the Investigator).
* Onychomycosis, involving ≥ 20% of the area of either great toenail or involvement of more than five toenails in total.
* Has any other skin disease which might interfere with the evaluation of tinea pedis.
* Is currently enrolled in an investigational drug or device study.
* Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study.
* Is unreliable, including subjects with a history of drug or alcohol abuse.
* Has known hypersensitivity to any of the components of the study medications.
Passive Music Intervention for the Reduction of Anxiety in Patients Undergoing Bone Marrow Aspiration and/or Biopsy

This phase III trial compares the effect of adding passive music when undergoing bone marrow biopsy/aspirate versus bone marrow biopsy/aspirate alone in reducing anxiety. Music therapy helps relieve pain or stress and promote well-being. Listening to music during a bone marrow biopsy/aspirate procedure may reduce anxiety during the procedure.

PRIMARY OBJECTIVE:

I. To determine whether music listening alleviates psychological distress such as anxiety in patients undergoing bone marrow aspiration and/or biopsy that do not require general anesthesia.

SECONDARY OBJECTIVE:

I. To determine if patients with lower to no anxiety during bone marrow aspiration and/or biopsy will also experience less pain.

EXPLORATORY OBJECTIVE:

I. To design and implement an evidence-based music intervention protocol that could be used during bone marrow aspiration and/or biopsy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo standard of care bone marrow biopsy and/or aspiration.

GROUP II: Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration.

Eligibility Criteria:
Inclusion Criteria:

* Documented informed consent of the participant and/or legally authorized representative
* Willingness to participate in the study
* Ability to read English, or willingness to have one of the staff members help with the questionnaire
* Age: ≥ 18 years
* Hematological conditions requiring a bone marrow biopsy and/or aspiration procedure, regardless of their disease state, and experience with such procedures

Exclusion Criteria:

* Hearing impairments, and non-verbal communication
* Scheduled to undergo a sedated bone marrow biopsy
* Scheduled to be premedicated with any anxiolytic or pain medication 30 minutes prior to the procedure
* Unwillingness to listen to music
* Altered mental health status that would prohibit informed consent and following protocol required instructions
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)

This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk mitigation strategies developed in partnership with the FDA to manage known and potential risks associated with the treatment of tocilizumab. Patients will be randomized to receive tocilizumab either 4 mg/kg intravenous (iv) or 8 mg/kg iv with concomitant non-biologic DMARDs, or 8 mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is 500-1000 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* moderate to severe active rheumatoid arthritis for \>6 months;
* inadequate clinical response or unable to tolerate current or prior biologic or non-biologic Disease-modifying antirheumatic drug (DMARD) therapy;
* Swollen joint count (SJC) \>/=4 and Tender joint count (TJC) \>/=4
* body weight \</=150kg
* current permitted non-biologic DMARDs must be on stable dose for \>/= 7 weeks prior to baseline;

Exclusion Criteria:

* history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
* functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in rheumatoid arthritis;
* treatment with rituximab within 6 months before screening;
* intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
* known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
The Effect of Q10 and Selen Supplement on Muscular Adverse Events in Statin Therapy

The purpose of this study is to determine whether supplements of Q10 and Selen are effective in reducing muscular adverse events (AE) in statin therapy.

Statins inhibit the synthesis of cholesterol by inhibiting the enzyme HMG-CoA reductase. The reduction of intracellular cholesterol leads to an increase in the number of LDL-receptors, and subsequent increased uptake and metabolism of LDL in the liver. Several large clinical trials have shown that the use of statins decreases morbidity and mortality in patients with risk factors for atherosclerotic disease. Unfortunately, 5% of statin users experience adverse events (mainly gastrointestinal \[GI\] and muscular).

Statins inhibit not only cholesterol synthesis, but also synthesis of other substances in the mevalonate pathway. Among these other substances are Q10 and selenoproteins.

It is well known that serum Q10 levels decrease during statin therapy, and that Q10 supplement inhibits this decrease. One study has shown reduction of Q10 in blood-platelets during statin therapy. Q10 is an important element in the mitochondrial respiratory chain. Depletion of Q10 leads to a reduction of high energy phosphates, anaerobe metabolism and mitochondrial dysfunction. This is suggested to be the cause of muscular adverse events in statin therapy. There are several reports of individuals relieved from muscular adverse effects after Q10 supplement, but no randomized, placebo controlled studies have been conducted.

Symptoms of selenoprotein deficiency are very similar to adverse events seen in statin therapy, but no clinical trials have been conducted to evaluate the effect of selen supplement on adverse effects of statin therapy.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 - 75 years old
* Indication for statin
* Previous history of muscular AE on statin therapy.

Exclusion Criteria:

* If female, be of non-childbearing potential, i.e., post-menopausal (defined as \>12 months since last menstrual period) or surgically sterilised, or using adequate barrier contraception if of childbearing potential.
* Previously serious muscular AE
* Patients taking drugs interacting with statins, and where these drugs cannot be stopped.
* Allergy against selen
* Liver or kidney failure
Understanding Needs

The "Understanding Needs" Project is designed to gain an understanding of the needs of informal caregivers. Researchers have designed a survey to highlight activities of daily living involved in the caregiving role, pain related to caregiver, and potential services desired. The initial phase of the study will consist of a focus group of informal caregivers to discuss current needs. The survey will then be refined based on knowledge gained from the focus group, and feedback from expert researchers. The refined survey will then be disseminated to caregivers throughout the country.

Please click on the following anonymous link to participate: https://chhscolostate.co1.qualtrics.com/jfe/form/SV_54j83BQSItMuoUB

The "Understanding Needs" Project highlights the needs of informal caregivers. An informal caregiver is defined as a person who regularly provides unpaid care to another adult. The survey will ask about pain intensity, pain interference, and relation of pain to the caregiving role. The survey will also address which activities the caregiver assists with, and activities now lacking since becoming a caregiver. One focus group will be completed to refine the contents of the survey prior to dissemination. The results will be analyzed by an occupational therapist, with a focus on how pain may connect to assistance with daily living activities provided to the care recipient. The needs of caregivers within the community will be compiled to inform future involvement in remediation of needs.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Informal caregivers (unpaid)
* have been a caregiver for \> 6 months
* provide at least 8 hours of care/week
* able to read english

Exclusion Criteria:

* Less than 18 years old
* paid caregivers
* not able to read english
* Caregiver or care recipient has a terminal diagnosis with a life expectancy of less than one year
Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery

Orthognathic surgery aims to standardize position of the maxilla and the mandible and therefore chewing, breathing, phonation and swallowing functions. In postoperative, several physical and functional consequences are observed in patients: transient edema of the face, maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain and sensory disturbances (labial or/and chin paresthesias).

Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease of postoperative edema, improved postoperative comfort and mental well-being.

The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic drainage to reduce postoperative edema.

Orthognathic surgery aims to standardize position of the maxilla and the mandible and therefore chewing, breathing, phonation and swallowing functions. In postoperative, several physical and functional consequences are observed in patients: transient edema of the face, maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain and sensory disturbances (labial or/and chin paresthesias).

Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease of postoperative edema, improved postoperative comfort and mental well-being.

The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic drainage to reduce postoperative edema. Secondary objectives of the study are to assess impact of sessions of manual lymphatic drainage on patient comfort (pain, aesthetic discomfort, difficulty in breathing and discomfort in swallowing) and on ental well-being.

Patients allocated to the intervention group will have 13 sessions of manual lymphatic drainage and those allocated in control group will not.

Edema of patients will be measured at day 1, day 8, day 15 and day 22 after surgery by a different physiotherapist than physiotherapist achieving drainage sessions, blind to the randomization group of the patient. At the same time, comfort criteria will be assessed by a visual analogue scale and mental well-being with the General Health Questionnaire (GHQ28).

Eligibility Criteria:
Inclusion Criteria:

* Orthognathic surgery (mandibular osteotomy, maxillary osteotomy or both)
* Providing informed consent.

Exclusion Criteria:

* Postoperative flexible restraint on the chin region.
* Inability to understand and/or follow all scheduled visits.
The Safety and Efficacy of an Oral Superfruits Supplement

This study is conducted to evaluate the safety and effectiveness of an oral superfruits supplement for skin brightening and wrinkle reduction. Superfruits are reported to have high bioactive compounds with beneficial effects on human health. The study duration is 12 weeks and the skin assessment will be carried out at baseline, week 2, week 6 and week 12. The participants will consume the supplement for 6 weeks and at week 12, final skin assessment will be conducted. The main questions this study aims to answer are:

1. The skin brightening effect of the oral superfruits supplement.
2. The effect of the oral superfruits supplement on wrinkle reduction.
3. To observe any adverse effect occurrence with the consumption of the oral superfruits supplement.


Eligibility Criteria:
Inclusion Criteria:

* Malaysian citizen
* Male and female (age 20-60 years old)

Exclusion Criteria:

* Participant who taking any dietary supplements for the past 4 weeks which can affect the study results
* Participant who are on contraceptive pills for the past 3 months
* Participant who undergo cosmetics treatments such as botox, filler and laser and light treatment within the last 3 months
* Pregnant or plans to get pregnant and breastfeeding women
Burst Spinal Cord Stimulation for Neuropathic Pain

Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory induction of paresthesias. This permits for the first time to scientifically prove that spinal cord stimulation is better than placebo stimulation. A study was therefore initiated to find out whether spinal cord stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled way.

Patients receive three type of stimulation (burst, tonic and sham). We want to compare these different stimulation protocol to verify which one is the one the patient prefer the most and have the least side-effects (paresthesia)

Eligibility Criteria:
All patients were selected after multidisciplinary discussion with a specialized pain physician, a psychological and psychiatric evaluation was performed to rule out psychogenic pain as well as other psychiatric morbidity contraindicating an implant. After authorization by the psychologist and psychiatrist an implant was offered.

Inclusion Criteria

* Patients enrolled in this study must meet the following inclusion criteria:
* Patients able to provide informed consent to participate in the study;
* Patient is between the age of 18 and 75;
* Patient has Failed Back Surgery Syndrome;
* Patient has a simulator implanted at the dorsal column spinal cord powered by an EON/EON Mini® internal pulse generator.
* Patient medication has remained stable for at least 4 weeks prior to baseline data collection;
* Patient agrees not to add or increase medication throughout the randomization trial period of the study;
* Patient is willing to cooperate with the study requirements including compliance with the treatment regimen and completion of all office visits.

Exclusion Criteria

A patient will be excluded from participation in this study if they meet any one of the following criteria:

* Patient has current evidence of any psychiatric disorder, as documented by the DSM-IV-TR criteria with psychotic characteristics;
* Patient has a history of life-threatening severe illness or is suffering from severe chronic disease other than the indication for the study;
* Patient has history of substance abuse or substance dependency in the past 6 months prior to baseline data collection;
* Patient currently participating in another clinical study;
* Patient with demand-type cardiac pacemakers, an infusion pump or any other implantable neurostimulator device except for the spinal cord stimulator under study;
* Patient is not willing to maintain current medication regimen;
* Female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child.