cyrilzakka/clinical-trials huggingface dataset:
The Effects of Terminalia Chebula Fruit Extract on the Gut Microbiome and Skin Biophysical Properties

The purpose of this study is to assess the use of oral Terminalia chebula fruit extract on the gut microbiome and skin biophysical properties. The fruit is commonly used for skin treatments in India. It is thought to have antioxidant properties, reduce inflammation and affect the microorganisms in the gut.

The information the investigators will learn from this study may indicate how and if oral dosing can affect the skin and gut microbiome. This may lead to an improved understanding of the skin and determine whether these oral products are effective for improving the skin's appearance.


Eligibility Criteria:
Inclusion Criteria:

1. Females aged 25 to 55 years of age
2. Subject must be able to read and comprehend study procedures and consent forms.
3. BMI 25-35

Exclusion Criteria:

1. Subjects must have no history of malignancy, kidney disease, or chronic steroid use.
2. No history of smoking or chewing tobacco or vaping nicotine based products within the past year or if the pack-year history of smoking tobacco is greater than 5 pack-years.
3. No history of anorexia
4. Those that are currently taking serotonin or SSRIs.
5. No intake of pomegranate containing drinks, walnuts, and strawberries two weeks prior to enrollment and throughout the study
6. Those who are unable to discontinue topical medications for two weeks.
7. Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure
8. Individuals who are currently using or during the past 30 days have used hydroquinone, or a retinoid such as Retin A, or other Rx/OTC Retinoid, or steroids.
9. Those who are unable to discontinue systemic antibiotics or oral probiotics for one month prior starting the study.
10. Those who are unable to discontinue their Triphala or Terminalia chebula regimen for one month prior to starting study.
11. Subjects who are postmenopausal or perimenopausal as determined by the investigator based on history or documented menopause
12. Males will be excluded to reduce the contribution from gender-based differences in testosterone which can affect sebum production on the face.
13. Those who are pregnant or breastfeeding
14. Those that are prisoners or cognitively impaired
15. Those who have a known allergy to Triphala or Terminalia chebula
Efficacy and Safety of Early COVID-19 Convalescent Plasma in Patients Admitted for COVID-19 Infection

Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavirus infection. This study is an open-label randomized trial in which patients with high risk of COVID19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. COVID-19 convalescent plasma will be collected from individuals according to the institutional protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years
* CALL score ≥ 9 (progression risk score)
* PCR-confirmed COVID-19 infection with equal or less than 7 days of symptoms (or imaging consistent with COVID-19 pneumonia and confirmed COVID-19 contact)
* Any symptoms of COVID-19 infection
* Admission due to COVID-19 infection
* Signed informed consent
* ECOG before COVID-19 infection 0-2

Exclusion Criteria:

* PaFi \<200 or mechanical ventilation indication
* Clinically relevant co-infection at admission
* Pregnancy or lactation
* IgA deficiency or IgA nephropathy
* Immunoglobulin or plasma administration in the last 60 days
* Contraindication to transfusion or previous allergy to blood-derived products
* Do-not-resuscitate status
* Patients receiving other investigational drug for COVID-19 in a clinical trial
* Any condition, that in opinion of the investigator may increase the risk associated with study participation or interfere with the interpretation of study results.
A Study of Metyrapone and Oxazepam Combination Product (EMB-001) and Cocaine

EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®; now marketed as oxazepam (generic) only).

This Phase 1b cocaine interaction study is being conducted in order to assess the safety and PK of EMB-001 and cocaine in combination.

This is a single center, randomized, double-blinded, multiple-dose, PLB controlled, 2-period, 4-sequence, crossover study design.

After establishing eligibility approximately 16 subjects with cocaine use disorder will be randomized to one of four sequences.

Treatment periods will be separated by a 7-day in-patient washout period. EMB-001/PLB will be orally administered for 7 consecutive days, BID for 6 days (starting on Day 1 and Day 15) followed on the last day (Day 7 and Day 21) by one EMB-001/PLB oral dose in the morning. Infusion of 40 mg IV cocaine and IV saline-to-match cocaine infusion will be administered in a randomized order, 2 hours apart, starting 3 hours after the last morning EMB-001/PLB oral administration.

The subjects will be discharged from the research clinic 2 days after the last dose of cocaine, and will have a follow-up visit 7 days after last dose.

Eligibility Criteria:
Inclusion Criteria:

* non-treatment-seeking cocaine users with a positive urine toxicology screen for cocaine at least once during screening
* have a medical history and physical examination that demonstrate no clinically significant contraindication for participating in the study
* males must use contraception; females must be of non-childbearing potential

Exclusion Criteria:

* drug allergies or reactions to metyrapone or benzodiazepines, or severe hypersensitivity reactions (like angioedema) to any drugs
* history of clinically significant adverse reaction to cocaine
* a low out-of-range serum cortisol value at screening or subjects who have a heightened likelihood of having adrenal insufficiency, or have signs or a history of adrenal insufficiency or confounders of the levels of cortisol and/or cortisol binding globulin
* treatment with glucocorticoids
* history of seizures, benzodiazepine use disorder, respiratory disease, neurologic or neuromuscular disease, liver disease or cardiovascular disease
* other psychiatric or substance use disorders of clinical significance, or suicidality
* clinically significant finding on medical history, physical examination, clinical laboratory tests, vital signs or ECGs
* use of any other drugs
* abnormal BP or HR
* positive urine drug screen at for alcohol or any drug other than marijuana (THC) or cocaine
* positive serology test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg) or Hepatitis C Antibody (HCVAb)
tDCS and Aphasia Treatment

This project will investigate the use of noninvasive brain stimulation in the form of tDCS (transcranial direct current stimulation) in conjunction with speech-language therapy, for the improvement of language production in stroke survivors with aphasia. The hypothesis is that anodal tDCS and speech-language therapy will facilitate improved outcomes compared to speech therapy alone.

Aphasia, commonly defined as impairment or loss of language functions, is a frequent and often chronic consequence of stroke, with detrimental effects on patient autonomy and health-related quality of life (HRQOL). Although beneficial in some cases, the effectiveness of behavioral therapy is often limited, and therefore new complementary treatments must be developed in order to improve rehabilitation of post-stroke aphasia.

In most individuals, language areas in the brain are localized in the left hemisphere. After stroke, there is evidence that the brain reorganizes such that either areas close to damaged language areas in the Left Hemisphere, or anatomically similar areas in the Right Hemisphere, are recruited to perform language tasks.

Recently, studies have begun to examine the effects of non-invasive brain stimulation on aphasia rehabilitation. One such technique is transcranial direct current stimulation (tDCS), which involves administering weak electrical currents through surface electrodes on the scalp. The effects can either stimulate an area, or inhibit an area of the brain. The main hypothesis is that stimulating language areas in the Left Hemisphere in conjunction with speech language therapy will facilitate reorganization of language-relevant areas of the brain, and improve expression.

The proposed study will compare the effects of transcranial direct current stimulation (tDCS) activating language centers in the Left Hemisphere and sham tDCS, in right-handed individuals with chronic post-stroke aphasia. This study will provide information on the effects of tDCS, in conjunction with speech-language therapy, on aphasia rehabilitation.

Eligibility Criteria:
Inclusion Criteria: single left hemisphere stroke, more than three months post stroke, right handed, no other medical problems, ages 18-100 -

Exclusion Criteria: more than one stroke, less than three months post stroke, other medical problems, pacemaker or other electronic implant (e.g. hip replacement), pregnancy

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Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)

Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, has shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.


Eligibility Criteria:
Inclusion Criteria:

* Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
* No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
* Caregiver required.

Exclusion Criteria:

* Have an uncontrolled, unstable clinically significant medical condition.
* Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions

The aim of this study is to compare the effects of electroacupuncture of different frequency in patients with chronic urinary retention caused by lower motor neuron lesions


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with urinary retention caused by lower motor neuron lesions (e.g., sacral plexus, cauda equina, or sacral cord lesions).
* 18 years or older.
* Baseline post void residuals (PVR) ≥150 mL.
* The course of urinary retention ≥1 month.
* Having normal bladder sensation.
* Using clean intermittent catheterization (CIC), indwelling catheterization (IC), manual assisted voiding including putting pressure on abdomen, or cystostomy catheterization.
* Signed informed consent and voluntary participation in the study.

Exclusion Criteria:

* Having a lower urinary tract obstruction, such as bladder neck contracture, urethral stricture, prostatic hyperplasia, or large urinary stones that can cause obstruction.
* Having any type of malignant tumors not removed.
* Having severe systemic disorders not controlled.
* Having implanted electrodes of cardiac pacemaker, pudendal nerve stimulation, bladder stimulation, or SNM.
* Pregnancy or lactation.
* Eletroacupuncture treatment duration \< 2 weeks.
Dermal Cryotherapy in Patients Undergoing Abdominoplasty

A prospective, interventional, single-arm study to evaluate histologic changes in skin following cryotherapy with the study device.

This study is to include healthy adults who intend to undergo an abdominoplasty surgery, and agree to have small areas of their middle and lower abdomen exposed to cooling with the Dermal Cooling System within 180 days before the planned surgery. Exposure of multiple test sites will be completed in areas of skin that will be excised as part of the abdominoplasty procedure. Clinical assessments of the treatment sites at 1-week post-treatment and at 1-month post-treatment intervals throughout the time period prior to surgical excision, and histologic evaluation of the treated skin will be conducted to assess skin changes.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects \> 18 years of age.
2. Subjects eligible, consented, and scheduled for abdominoplasty.
3. Subject is willing to use photoprotection (e.g., sun avoidance) of the treated areas during the duration of the follow-up period.
4. Subject has read and signed a written informed consent form. -

Exclusion Criteria:

1. Subject has medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., liposuction, mesotherapy, hydroquinone, corticosteroids, laser surgery).
2. Subject has a known history of subcutaneous injections into the abdomen within the past six months (e.g., insulin, Enbrel).
3. Subject has a known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).
4. Subject is taking methylxanthines (phosphodiesterase-inhibitors like amino- or theophylline)
5. Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period.
6. Subject is unable or unwilling to comply with the study requirements.
7. Subject has any dermatological conditions or scars (other than stretch marks) within the area of planned abdominoplasty excision that may interfere with the ability to obtain test sites for treatment or evaluation.
8. Subject has a history of abnormal wound healing or abnormal scarring.
9. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
10. Patient is pregnant or intending to become pregnant within the next 6 months.
11. Patient is lactating or has been lactating in the past 9 months.
12. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the patient.
To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV.

This is a Phase 1, randomized, double-blind, placebo-controlled, multicenter study in adults aged 18 to 55 years in overall good health and without HIV. Participants will be enrolled concurrently into 1 of 3 dose levels of VIR-1388 or placebo. The overall study design includes 2 study parts, Part A and Part B. Part A will be a lead-in phase enrolling a limited number of HCMV seropositive persons of non-childbearing potential (PONCBP) with a frequent safety monitoring schedule. Part B will expand enrollment into a broader population of HCMV-seropositive participants, including persons of childbearing potential required to use 2 forms of contraception and maintains a similar overall safety monitoring schedule as Part A . There is an optional long-term follow-up study that would lengthen study participation for up to 3 years post-first dose.

Eligibility Criteria:
Inclusion Criteria:

* In overall good health as determined by medical history, physical exam, and laboratory values
* HIV uninfected
* CMV seropositive
* Willing to use condoms during intercourse for the duration of the study
* Assessed by clinic staff as being low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last protocol visit
* Childbearing status

  * Part A: Only participants of non-childbearing potential
  * Part B: Participants of childbearing potential must be on 2 forms of contraception and not planning on becoming pregnant for the duration of the study

Exclusion Criteria:

* Participant is immunocompromised
* Participant has an autoimmune disorder
* Participants having intimate contact with immunocompromised individuals
* Participants having intimate contact with a pregnant partner or partner planning to become pregnant
* Participants who are breastfeeding
Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging

The human brain presents outstanding challenges to science and medicine. Brain function and structure span broad spatial scales (from single neurons to brain-wide networks) as well as temporal scales (from milliseconds to years). Currently, none of the tools available for studying the brain can fully capture its structure and function across these diverse scales - "the neuroimaging puzzle". This poses crucial limitations to understanding how the brain works, and how it is affected by numerous diseases.

The central goal of this project is to expand currently available tools for non-invasive human brain imaging, to bridge critical gaps in the neuroimaging puzzle. New methodologies will be developed, focused on ultra-high field magnetic resonance imaging (UHF MRI) and its combination with electroencephalography (EEG). New contrast mechanisms and technological advances enabled by UHF MRI and EEG will be explored to allow unprecedented views into the microstructure of brain regions like the thalamus, and to capture the activity of large-scale neuronal networks in the brain with high sensitivity, temporal and spatial specificity. These advances will be directly applied to address open questions in the diagnosis and treatment of essential tremor, and psychosis.

In general, improved brain imaging techniques are critical for a deeper understanding of how the brain works, and to detect and characterize diseases more effectively, thereby improving clinical management and leading to a healthier population. The non-invasive characterization and treatment of neurodegenerative diseases like tremor is particularly relevant to aging modern societies.


Eligibility Criteria:
Inclusion Criteria:

* Common to all participant groups: be 18 years old or older; be able to understand instructions; be able to provide informed consent.
* Specific to healthy participants: have no history of neurological or mental disorders; normal vision or corrected-to-normal using contact lenses.
* Specific to the patient groups: not be hospitalized; having been diagnosed with tremor, epilepsy or psychosis and invited to participate by our team's clinicians; for some groups: normal vision or corrected-to-normal using contact lenses.

Exclusion Criteria:

* Contra-indications for MRI (e.g. an implant that is not MRI-compatible), also including having claustrophobia or being pregnant.
* Inability to follow the necessary tasks of the study (e.g. unable to lie on the scanner bed).
* Having undergone brain surgeries in the past.
Electrical Stimulation of the Optic Nerve in Patients With Glaucoma.

The goal of this observational study is to evaluate electrical stimulation of the optic nerve with the Eyetronic Nextwave System device as a possible treatment for glaucoma.

The main question it aims to answer is:

Could this therapy be an option to counteract the loss of visual field seen in glaucoma and thus delay the progression of the disease?

Participants will have approximately 14-18 study visits during 12 months including 10 visits for the electrical stimulation treatment. The treatment involves electrically stimulating the optic nerve by an external approach via the facial skin.

1. During the study visits participants will have: general eye examination (visual acuity check, examination of the front and back of the eye, eye pressure measurement, pupil dilation), Visual field (VF) testing, Imaging the optic nerve with Optical Coherence Tomography (OCT), Optic nerve photos.
2. The treatment will include ten sessions during 2 weeks on an outpatient basis in a quiet and dimly lit room with the patient comfortably seated or lying down in a reclining chair. Each treatment session will last approximately 60 minutes including the time to determine the treatment settings.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years or older who have glaucoma
* Humphrey visual field mean deviation (MD) values between - 6 dB and -20 dB

Exclusion Criteria:

* Age \< 18 years
* Implanted electronic devices
* Metallic artifacts in the head (except dentures)
* Migraine
* Epilepsy
* Brain tumor
* Pregnancy
* Breastfeeding patients
* Uncontrolled intraocular pressure (IOP)
* IOP lowering medication started less than six months before enrollment
* Any intraocular surgery less than 6 months before enrollment
* Arterial hypertension without appropriate treatment
* Acute retinal hemorrhage
Nurse-Led Quality of Life Study-Phase I

The purpose of this study is to pilot test a brief, population-specific nurse-led, quality of life (QOL) intervention with early phase cancer clinical trial (EP-CT) participants.

The name of the intervention used in this research study is:

-Nurse-Led Quality of Life Intervention (comprised of nurse-patient relationship, assessment and monitoring of participant QOL, and interdisciplinary team meetings led by the CRN (clinical research nurse).

This is a single-site study evaluating the feasibility and acceptability as well as patient-reported and clinical outcomes of a nurse-led, quality of life intervention with EP-CT participants.

The research study procedures include obtaining consent to participate, meeting with research nurses monthly for three months, completing questionnaires, and an interview with the study staff at the end of the study.

Participation in this research study is expected to be for a total of six months.

It is expected that about 35 people, 25 caregivers, and 10 clinicians will take part in this research study.

The Oncology Nursing Foundation is supporting this research study by providing funding.

Eligibility Criteria:
Patient Inclusion Criteria:

-\> 18 years of age.

* Adults with cancer enrolled on an EP-CT in the Termeer Center at Massachusetts General Hospital.
* Able to read and respond to questions in English.

Caregiver Inclusion Criteria:

* A relative or friend of the eligible patient whom the patient identifies as being involved in their medical care.

  -\> 18 years of age.
* Verbally fluent in English.

Clinician Inclusion Criteria:

* Clinician must be an oncology nurse.
* CRN for a minimum of 18 months.
* fulltime employee in the Termeer Center.