cyrilzakka/clinical-trials huggingface dataset:
Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy Participants

This is a single center, randomized, open label, 4-treatment, 4-period, 4-sequence, 4-way crossover study to compare the pharmacokinetics of mycophenolate mofetil (MMF) metabolites from 4 tablet formulations in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

A body mass index (BMI) between 18 and 32 kilogram per meter square (kg/m\^2)

Exclusion Criteria:

* Any evidence of clinically significant allergic, renal, cardiac, bronchopulmonary, vascular, gastro-intestinal, neurological, metabolic or immunodeficiency disorders, cancer, hepatitis or cirrhosis
* Any evidence of gall bladder surgery, surgery of the gastro-intestinal tract or any other medical condition considered likely to affect drug absorption
* Any major illness within 2 months prior to first dosing or febrile illness within 14 days prior to first dosing
* Any known history of clinically significant allergic reactions or drug hypersensitivity, especially hypersensitivity to MMF or mycophenolic acid (MPA)
* Any other ongoing concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participants
* Any prescribed or over-the-counter (OTC) medication, herbal medicine or dietary aid taken within 2 weeks before the first study drug dosing or within six times the elimination half-life of the medication before the first study drug dosing
Efficacy of the Electronic Acupuncture Shoes: A Clinical Trial for Chronic Low Back Pain

This randomized , double-blind, parallel-arm clinical trial was designed to study the efficacy and safety of the "Electronic Acupuncture Shoes" treatment on chronic low back pain patients.

Chronic low back pain patients, aged 20-60, of both gender were recruited. As the primary outcome measure to assess the efficacy, "0-10 numerical rating scale" was used. Secondary outcome measure included the speed of pain-relief.

The number of samples in the experimental group and the control group ratio of 1 : 1 , is expected to total effective sample number is 60 . Experimental group will receive a six-week "Electronic Acupuncture Shoes" treatment and a week back to the clinic three times , subject to a total of 18 treatments , each course of about one hour . Subjects will take NSAID placebo in the first week of the course of treatment . After the second week of NSAID placebo on disabled.

Control subjects will also accept the six- week treatment , control subjects will be equally back to the clinic three times a week , each group will be given to the subject of one hour each shoe pseudo electrotherapy treatment group and control group run by entering from the test day in the first week of the course , each taking ibuprofen 400mg, taken three times a day , the second week after the NSAID drugs on disabled.


Eligibility Criteria:
Inclusion Criteria:

A. Diagnosed with chronic low back pain (pain that persists for more than 12 weeks ).

B. Subjects who agreed to be involved and signed the agreement, after being explained to by the investigators.

Exclusion Criteria:

A. Diagnosed with cancer . B. Early menopause ( before age 50 ) . C. Ovariectomized D. Under steroid therapy E. Rheumatoid arthritis F. With fractures or have undergone back surgery. G. Compression syndrome: e.g. HIVD ( Herniated Intervertebral Disc) , spinal disorder .

H. Renal calculus. I. Pacemaker users . J. Pregnant women or women who expect to be pregnant. K. Visual impairment . L. Diabetes. M. Visceral infections, e.g. pancreatitis, nephritis . N. Under other clinical trials (under medication or given other treatment) within 30 days before . O. Contraindications of ibuprofen. P. Poor function of heart, liver, GI tract or kidney. Q. Be suspected by the doctors of potential illness, disease or any other reason, which may endanger the subjects .
The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia

This study applied a randomized parallel case-controlled design. The study purpose was to evaluate the effects of progressive muscle relaxation on anxiety, psychiatric symptoms and quality of life among patients with chronic schizophrenia compared with an active control.

Background: Anti-psychotic drugs are limited in their ability to improve psychiatric symptoms, quality of life, and anxiety status in patients with chronic schizophrenia. Progressive Muscle Relaxation (PMR) can potentially reduce anxiety status and improve subjective welling in acute patients. It is an ideal rehabilitation intervention for patients with chronic schizophrenia. However, no study has investigated the effects of PMR on outcomes among patients with chronic schizophrenia.

Design: This study applied a randomized parallel case-controlled design.

Methods: Hospital-based randomized control trial in Taiwan. Eighty subjects with chronic schizophrenia were recruited from a psychotic ward and randomized into PMR, or control groups. Patients in the intervention group participated in progressive muscle relaxation for 12 weeks; while patients in the control group members received supportive treatment-as-usual (TAU). All participants completed anxiety, psychotic syndromes and quality of life measures at baseline, 3-month, and 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Schizophrenia
* Without the risk of self-injury and violence
* Patients aged from 20-65 years old
* Had no alcohol and drug abuse
* Can use Mandarin or Taiwanese to communicate

Exclusion Criteria:

* Patients with another psychiatric comorbidity
* Patients with musculoskeletal problems
* patients who cannot sit last for 50 minutes
* Had received progressive muscle relaxation training within the last year
* Diagnosis of confirmed cardiovascular disease
The Effects of DHA on Periodontitis

The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in the treatment of periodontitis in adults.

1. The primary aim of this study is to investigate the effect of docosahexaenoic acid (DHA; 2 gm/day) plus low dose aspirin (ASA 81 mg/day)compared to ASA alone on periodontitis over three months. Our hypothesis is that DHA plus ASA will improve periodontitis as measured by objective periodontal exam, including decreased pocket depth (mm), gingival index (0-3), plaque index (0-3) and bleeding on probing (yes/no) compared to ASA alone.
2. Assess the effect of DHA and ASA exposure on markers of local inflammation, including gingival crevicular fluid (GCF) CRP, IL-1 beta and IL-6 three months after exposure to DHA plus ASA compared to ASA alone.
3. Evaluate potential mechanisms through changes in the periodontal microbial flora which may occur as a result of exposure to DHA and ASA compared to ASA alone. Our hypothesis is that there will be a substantial post therapy change in the microbial flora of dental plaques, favoring bacteria associated with a lower systemic inflammatory state.
4. Assess the effect of DHA and ASA exposure on markers of systemic inflammation, including serum C-Reactive Protein (CRP), interleukin-6 (IL-6) and vascular adhesion molecule (VCAM) compared to ASA. Our hypothesis is that there will be a decrease in serum CRP, IL-6 and VCAM three months after exposure to DHA plus ASA compared to ASA alone.
5. Assess the effect of DHA and ASA exposure on markers of systemic bone turnover, including urine N-terminal telopeptide (NTx) compared to ASA. Our hypothesis is that there will be a decrease in urine NTx three months after exposure to DHA plus ASA compared to ASA alone.

Eligibility Criteria:
Inclusion Criteria:

* age \>40 years
* \>20 natural teeth (excluding third molars)
* no orthodontic appliances
* periodontitis defined as \>4 teeth with pocket probing depths \>5 mm

Exclusion Criteria:

* pregnancy
* diabetes
* severe chronic diseases
* gastrointestinal bleeding
* uncontrolled chronic diseases
* autoimmune disorders
* conditions requiring antibiotic prophylaxis
* warfarin
* clopidogrel
* antimicrobial therapy within 30 days
* chronic use of non-steroidal anti-inflammatory drugs (other than aspirin)
* omega-3 fatty acid use within 6 months
* loose teeth
* painful teeth
* periodontal abscess
* pocket depths \>10 mm in \>1 tooth
* periodontal therapy within the past two years
* allergy to aspirin
* allergy to fish oil
* allergy to corn oil
* allergy to soybean oil
Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment

Primary Objective:

The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement.

Secondary Objectives:

* Evolution of fasting plasma glucose
* Evolution of insulin dose and body weight
* Hypoglycemia incidence
* Safety
* Patients satisfaction when they change their insulin for HOE901-U300

The total study duration per patient is approximately 28 weeks.

Eligibility Criteria:
Inclusion criteria :

* Type 2 diabetic adult patients treated with basal insulin, with or without oral anti-diabetic agents, with or without glucagon-like peptide-1 (GLP-1) receptor agonist
* HbA1c \> 7.5%

Exclusion criteria:

* Patients with high dose of insulin (\>1.2 U/kg)
* Use of prandial insulin
* Change of dose of antidiabetic drugs within the last 8 weeks
* Use of systemic glucocorticoids during at least 2 weeks in the last 12 weeks

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior

This study aims to evaluate the acceptability, safety, and efficacy of a smartphone-delivered intervention called Therapeutic Evaluative Conditioning for Suicide (TEC-S) in reducing suicidal thoughts and behaviors (STB) among adults with recent and frequent suicide ideation.

The present study is a two-arm randomized controlled trial (RCT) designed to evaluate the safety, acceptability, and efficacy of Therapeutic Evaluative Conditioning for Suicide (TEC-S), a smartphone-delivered intervention aimed at reducing suicidal thoughts and behaviors (STB). Participants in this study will be 60 adult participants (ages 18+) who report recent and frequent STB, residing within the greater-Boston, Ma area.

Participants will be randomized to receive either the control condition, which consists of 3x/daily ecological momentary assessment (EMA) of emotions and STBs and optional inactive TEC (n = 30), or the experimental condition, consisting of 3x/daily EMA and optional active TEC-S (n = 30). Evaluative conditioning uses classical conditioning to alter attitudes. The aim of TEC-S is to alter attitudes toward suicide and, in turn, reduce STB. EMAs will monitor STB, safety, and acceptability, and efficacy. Weekly behavioral and self-report assays will assess hypothesized treatment mechanisms. The study's aim is to determine if the active TEC-S condition reduces STB and to explore if altered attitudes toward suicide mediates this effect.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18+
* Relatively frequent and recent (≥5 days within the past-month) active suicidal thoughts as assessed via SITBI-R.
* Willing and able to provide at least one emergency contact (name, phone number, relation).
* Owns an Android or iOS smartphone.
* Possesses at least occasional access to Wi-Fi-enabled internet for data down/uploads.
* Fluent in English and willing to provide informed consent.
* Living in the Boston metropolitan area (i.e., \~50 mile radius around Boston, MA)

Exclusion Criteria:

* Recent (past 3-month) hypo/manic symptoms or homicidal ideation or lifetime psychosis spectrum diagnosis as assessed via MINI 7.0.2.
* Recent acute suicide risk operationalized as affirmative responses to BOTH below items during structured clinical interview AND evaluation by the PI in consultation with Mentors/Advisor Drs. Wilhelm, Kleiman, and/or Bentley:
* At any time in past week: ≥ 8/10 current intent to act on suicidal thoughts (0 \["not at all"\] to 10 \["extremely strong"\]); AND
* At any time in past week: thought of a specific suicide plan (i.e, known method/means and/or location) with access to lethal means
* Impaired vision (e.g., legal blindness), technological illiteracy, or intellectual disability that might impair ability to provide valid data and/or informed consent.
Trans People Living With HIV Throughout Europe

The project will study a European cohort of individuals identifying themselves as transgender or non-binary and living with HIV.

The study will collect both qualitative data on this cohort and clinical data over an 18 month period. The study will investigate the success of HIV treatment for this cohort through the primary outcome measure of HIV viral load recorded in routine blood tests.

The results from this study will assist in informing future HIV treatment guidelines on the monitoring of HIV infection in transgender and non-binary individuals and assisting in the design of future interventional studies within this population.

The TIME Study is a multi-centre cohort study, combined with a cross-sectional survey.The study will comprise recording clinical data from up to three visits over an 18-month period. The study visits will happen at the same time of routine clinical care, and all clinical data will be collected in the study database. At the screening/baseline study visit (following written consent), a survey will be administered to all study participants. The overall recruitment target is 200 participants.

The primary aim is to assess the rate of virological response to antiretroviral therapy in transgender and non-binary (gender diverse) people living with HIV (TPLWH) in Europe. It's secondary outcomes are:

* To explore demographics, risk behaviours and community needs
* To explore the barriers and facilitators to adherence to cART
* To report TPLWH experiences with regard to:

  * Stigma
  * Quality of life
  * Prevalence of opportunistic infections
* To record data on:

  * Retention into care
  * Clinical characteristics (e.g. drug toxicity, BMD results, hormone intake, drug interactions between hormones and antiretrovirals, cardiovascular risk, etc.)
* Implement and analyse a trans-inclusive method of gender identity data collection, in order to provide comprehensive demographic information that is acceptable at the community-level and includes a diverse spectrum of trans/non-binary genders across all study sites. People living with HIV (PLWH) who refer to themselves as transgender and non-binary (and all gender diverse people).

Eligibility Criteria:
Inclusion Criteria:

* Participant self-identifies as transgender and/or has a current gender identity which differs from gender assigned at birth (includes all gender diverse people)
* Age \> 18 years
* HIV infection diagnosis at any time before study consent
* Having been prescribed antiretroviral therapy at any time (including people for who antiretroviral therapy initiation is planned after study enrolment)
* Willing to sign an informed consent and take part in the study

Exclusion Criteria:

* Age \< 18 years
* Unable to take part in the study according to the Investigator opinion (example: unable to understand the study information leaflet, unable to provide written consent, etc.)
Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia

In this study, investigators will evaluate the efficacy and related mechanism of probiotics and prebiotics as an add-on treatment in improving the antipsychotic induced psychotic syndrome, the cognitive impairment, gastrointestinal function, and metabolic disorders in schizophrenia patients, through genotype identification, psychopathology, neuropsychology, biochemical evaluation and other methods.

The study will recruit 210 schizophrenia patients who meet the criteria of DSM-4, and then randomized to 3 groups: control group, probiotics group and prebiotics group for a 14-weeks clinical trail and 12-weeks follow-up period. In addition to probiotics, prebiotic or maltodextrin interventions, in the meantime, all participants will also use one of the prescribed antipsychotics medications. Clinical efficacy and safety assessment will be done at baseline, clinical trail and follow-up period. The specific aims are to evaluate these tips: 1) psychotic syndrome; 2) cognition; 3) Gastrointestinal function; 4) inflammatory and metabolic related markers. Psychotic syndrome will be measured by the Positive and Negative Syndrome Scale. Cognitive function will be assessed by the MATRICS Consensus Cognitive Battery. Gastrointestinal function will be assessed by gastrointestinal symptom assessment scale (GSRS). Biological samples also will be collected, and stored to research Intestinal inflammation, intestinal permeability, intestinal flora and other indicators.

Eligibility Criteria:
Inclusion Criteria:

* Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia
* Duration of illness 5 years, Subjects are currently receiving first-line recommended antipsychotic medication
* The total PANSS score ≥60, containing at least three positive or negative items with scores of 3 or more at screening
* Junior high school or above
* Capacity for written informed consent.

Exclusion Criteria:

* Pregnant or lactating women
* Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, abnormal liver function, renal failure, immunodeficiency diseases, cancer, or gastrointestinal diseases ( inflammatory bowel disease or celiac disease, except functional constipation)
* Subjects had acute or chronic infections or are taking anti-inflammatory drugs and cortisol hormones. Receipt of antibiotic medication within the previous 1 month.
* Other neuropsychiatric disorders (organic diseases of the central nervous system, a mental disorder caused by a physical disease or psychoactive substance, mental retardation).
* Having history of substance dependence or abuse，including alcohol
* BMI is not within the normal range (18.5 to 23.9)
Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion

This study is a multicenter, retrospective data collection of routine clinical use with the Spectra Optia® apheresis system for white blood cell depletion.

The goal of this study is to gather a broader knowledge and information from routine clinical use on the performance and safety of white blood cell depletion procedures with the Spectra Optia® apheresis system.

In order to do so, retrospective data on white blood cell depletion procedures with the Spectra Optia® apheresis system done in routine use in 3 different centers will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients having received a minimum of 1 white blood cell depletion procedure via the Spectra Optia Apheresis System

Exclusion Criteria:

* none
Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Mycophenolate Mofetil in Healthy Volunteers

This study characterizes the pharmacokinetic effect of ASP015K on mycophenolate mofetil in healthy volunteers.

The subjects will be confined to the unit for 13 days and have a brief follow-up visit to obtain hematology blood samples. Numerous blood and urine samples will be taken to determine the pharmacokinetics of the drugs.

Eligibility Criteria:
Inclusion Criteria:

* If female, the subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
* If male, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
* Subject is medically healthy, with no clinically significant medical history or abnormalities
* Subjects must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2

Exclusion Criteria:

* Subject has a history of chronic diarrhea
* Subject has been vaccinated within the last 60 days prior to study drug administration
* The subject has a previous history of any clinically significant neurological, gastro-intestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, and hematological disorder or disease
* Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
* Subject has a history of the human immunodeficiency virus (HIV) antibody
* The subject has an absolute neutrophil count (ANC) \< 2500 cells/mm3
* Subject has had clinically significant illness within 1 month prior to study drug administration
* Subject has a recent history (within the last 6 months) of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse/illegal drugs
Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes (The CGM TIME Trial)

The investigators hypothesize that REAL-Time Continuous Glucose Monitoring (RT-CGM) will be more effective if introduced in children and adolescents with established diabetes at the same time as they are starting pump therapy. This randomized controlled trial will compare the effectiveness of simultaneous vs delayed introduction of RT-CGM in children and adolescents with type 1 diabetes who are starting insulin pump therapy.

REAL-Time Continuous Glucose Monitoring (RT-CGM) improves diabetes control in adults with type 1 diabetes. However, studies of RT-CGM in children and adolescents have been mostly negative. The lack of effectiveness in the pediatric population appears directly related to adherence to RT-CGM, i.e., the willingness of children and teens to wear and use this technology. Most previous RT-CGM studies have focused on experienced pump users or children with new-onset diabetes. At the time of pump initiation, children and adolescents who have been living with diabetes (and their parents) are highly motivated to make changes in their diabetes management and to take on additional responsibilities to improve their diabetes control and lifestyle, the two primary reasons for initiating pump therapy in the pediatric population. The investigators hypothesize that readiness for making changes in diabetes management will be greater at the time of pump initiation than at six months after the pump start. Further, the investigators hypothesize that readiness for change at the time of RT-CGM initiation will predict future adherence to RT-CGM and its effectiveness.

Eligibility Criteria:
Inclusion criteria:

* Males and females age 5-18 years old.
* Established T1D diagnosis for a minimum of one year.
* Naïve to CSII therapy and ready to start CSII with the Veo pump (Medtronic) .
* Willing to use RT-CGM and to be randomly assigned to either simultaneous or delayed RT-CGM initiation.
* Regular diabetes follow up at one of the 5 participating sites.
* Internet access at home (to upload RT-CGM data).
* Parent(s) or legally acceptable representative able to speak and read English or French.
* Ability of the subject and parent(s) or legally acceptable representative to participate in all aspects of this clinical trial.
* Written informed consent must be obtained and documented, with assent of the child if \<14 years of age.

Exclusion Criteria

* Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study.
* Has received oral and/or intravenous steroid therapy (for any indication, at any dose and/or for any duration) on more than 2 separate occasions in the past 12 months. Use of inhaled and/or topical steroid therapy in the last 12 months does not exclude the subject.
* Prior use of RT-CGM for more than 50% of the time over the past 6 months.
* Prior enrollment in the current study.
* Current enrollment in another intervention trial.