rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Multi-omics Analysis of Oral-gut Microbial Profiles
Status: Not yet recruiting

Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that periodontal treatment may influence the multi-omics profile on the oral-gut-systemic axis. 70 patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary, subgingival plaque, plasma and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  periodontitis Stage III or IV BMI between 20 and 29 kg/m2 free diet presence of at least 20 teeth  Exclusion Criteria:  systemic diseases (including diabetes, thyroid, liver, or kidney diseases) dietary allergies use of antibiotics or probiotics during the previous 90 days pregnancy or breast feeding - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals With Fragile-X Syndrome
Status: Not yet recruiting

This study focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Most individuals with FXS have moderate to severe intellectual disability (ID), and caregivers are mainly concerned about aggressive behavior and anxiety problems. Since FXS individuals have a normal lifespan, the overall lifetime cost for the Canadian society of a single case is estimated at $1.2 to $4.7 millions reaching $18 billions for all FXS cases. There is no cure for FXS, as all clinical trials so far have been unsuccessful.FXS is caused by transcriptional silencing of the Fragile X mental retardation protein (FMR1) gene, making FXS a simple model to study ASD and ID pathophysiological mechanisms. Of those, neuronal hyperexcitability is largely recognized as a core deficit in FXS, and a critical therapeutic target for the disorder. Using transcranial magnetic stimulation (TMS) in FXS patients, our team provided the first direct evidence of Gamma-aminobutyric acid (GABA) receptor a (GABAa) dysfunctions in humans with this disorder and showed that this inhibitory deficit is linked with cortical hyperexcitability (PMID: 31748507). Concurrent lines of evidence suggest that stimulation of the endocannabinoid (eCB) system with the administration of Cannabidiol (CBD) could upregulate GABAergic function and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. CBD has been shown to increase GABA concentration levels in the brains of healthy individuals, an effect that could help correct the hyperexcitability typically found in FXS. Thus, this trial aims to define the therapeutic potential of the eCB system for FXS, by measuring the impacts of oral CBD administration on the principal inhibitory neurotransmitter system of FXS patients, and the severity of the clinical phenotype.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Molecular diagnosis of FXS Age 7 to 40 inclusively Overall ABC-C score > 20 Taking up to 3 psychoactive drugs No therapeutic change for the last 3 months  Exclusion Criteria:  Taking valproic acid Taking clobazam History of liver problems aspartate aminotransferase (AST) or alanine transaminase (ALT), > 3 times the reference values Bilirubin > 2 times the reference values Absolute contraindication to the use of TMS and MRI (e.g. presence of metal in the body), will also be considered as an exclusion criterion. - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 40 Years - StdAgeList: Child, Adult
Cannabis (THC vs. CBD) in Multiple Sclerosis
Status: Not yet recruiting

The goal of this clinical trial is to examine the effect of Cannabis components, THC and CBD, on cognition and bladder symptoms in people with Multiple Sclerosis (MS).

Participants will complete questionnaires and cognitive tests. They will be randomly assigned to receive either CBD or THC oil and will take the study drug for 15 weeks.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 18 and 59 years inclusive. Confirmed diagnosis of Multiple Sclerosis as per McDonald criteria (any type) [12] Symptoms of neurogenic lower urinary tract dysfunction (NLUTD) as measured by neurogenic bladder symptom score (NBSS), with a minimum score of 7. If already on a medication for NLUTD, must be stable on this medication for at least 4 weeks. Sexually active men and women of child-bearing potential must agree to use adequate contraception. Written informed consent.  Exclusion Criteria:  Major psychiatric disorder such as schizophrenia or bipolar disorder Major neurological disorder which could affect cognition such as dementia, traumatic brain injury. Seizure disorder Use of antipsychotic medication Use of benzodiazepines other than exclusively at night/bedtime Experienced a MS relapse in the last ninety (90) days. Current use of cannabis or CBM greater than 3x/week. Currently using cannabis/CBM less than 3x/week and being unwilling to abstain for the duration of the study. Visual acuity (binocular) worse than 20/70 (in order to complete the cognitive outcomes) Significant upper extremity disability that would interfere with the cognitive tests battery. Indwelling catheter use/urinary diversion Pregnant or Breastfeeding - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 59 Years - StdAgeList: Adult
Safety of Ashwagandha (Withania Somnifera) Root Extract
Status: Recruiting

The primary objective is to evaluate the laboratory safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy based on Complete Blood Count, Renal Function Test, Liver Function Test, Lipid Profile and Thyroid Function Test, Fasting blood sugar and HbA1c Test. The secondary objectives are to evaluate the clinical safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy and to evaluate the effect of the Ashwagandha standardized root extract 500 mg on Quality of Life (QoL) using the SF-36 tool.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Both adults (male and female) aged between 18 and 65 years. Participant should be healthy and free from any chronic illness, such as diabetic, cardiovascular or any other condition that could affect the safety of the study. No plan to commence any other alternative treatment modality for their conditions. Willingness to sign an informed consent document and to comply with all study related procedures.  Exclusion Criteria:  History of Alcohol or smoking abuse. History of hypersensitivity to Ashwagandha. Taking nutritional or energy supplements, medication, or steroids. Any history of drug abuse. Having any clinical abnormalities. Simultaneously participating in any other clinical trial or participated in the past three months. Participants who use medication for blood pressure, use betablockers, inhaled any beta-agonists, use any hormonal contraceptives, having a history of corticosteroid use within three months, participants under psychotropic medication within last 8 weeks, and Participants diagnosed with any heart disease, diabetes, stroke, neurological disorders or depression. Have clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study. Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder, alcohol dependency; schizophrenia and mania. Patients with post traumatic disorder. Have an established practice of meditation for three or more months. Pregnant and lactating women. Participation in other clinical trials during previous 3 months. Any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families
Status: Not yet recruiting

The proposed study draws on prior research to evaluate the feasibility, acceptability and explore preliminary effectiveness of Coffee and Family Education and Support, Version (CAFES2) using a pilot randomized type 1 hybrid effectiveness-implementation design. CAFES2 is a peer-led family and social strengthening multiple family group intervention that is designed to respond to multi-level needs of refugee families. Results of the trial will contribute to the emerging evidence base on family-based mental health interventions for refugee and newcomer communities. The trial will also generate new insights regarding implementation strategies needed to promote successful delivery of services by peer providers and the unique role of human-centered design practices for adaptation of mental health and psychosocial interventions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria for Families:  being a resettled refugee family having one or more school-aged children aged 12 years and older living with them one family member (caregiver or youth) screens for moderate emotional distress  Inclusion Criteria for Adult Caregivers/Parents:  between ages of 18-45 years old arrived to the U.S as a refugee have at least one child currently living with them  Inclusion Criteria for Youth:  between ages of 12 and 17 years old) arrived as a refugee currently living with at least one caregiver.  Exclusion Criteria:  not meeting the above inclusion criteria families or individual in the midst of a crisis (e.g. family crisis or mental health crisis) - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 45 Years - StdAgeList: Child, Adult
Effect of CBD on the Brain
Status: Not yet recruiting

This proposal focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Although most individuals with FXS have moderate to severe intellectual disability (ID), caregivers are mainly concerned about aggressive behavior and anxiety problems, hallmark features of the condition. Concurrent lines of evidence suggest that targeting the endocannabinoid (eCB) system by administration of cannabidiol (CBD) could upregulate GABAergic functions and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. However, the eCB system and its effect on the brain remains unexplored in FXS patients. This clinical trial aims to define the therapeutic relevance of the eCB system for FXS using a multimodal neuroimaging approach to finely characterize the acute effects of oral CBD on the principal inhibitory neurotransmitter system (GABA) in a large cohort of FXS patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Eligibility criteria for FXS participants will include:  age between 7 and 55 years, molecular diagnosis of FXS, intelligence quotient (IQ) <70, aberrant behavior questionnaire score (ABC-C) > 20, <3 psychoactive drugs, drug stable for > 3 months.  Eligibility criteria for the control group:  18 and 55 years old, be in good general health, with no history of neurological or psychiatric disorders.  Eligibility Criteria for all Participants:  A minimum weight of 60 kg; no history of liver problems (A complete blood profile to measure liver enzyme levels (bilirubin, aspartate aminotransferase (AST), argininosuccinate lyase (ASL), alanine transaminase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)) will be obtained before randomization for all participants).  Exclusion Criteria:  The presence of an absolute contraindication to the use of TMS and MRI / MRS (ie presence of metal in the head). Individuals with ALT / ASL levels greater than 3 times the upper normal baseline, or if bilirubin exceeds 2 times the upper baseline, - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 7 Years - MaximumAge: 55 Years - StdAgeList: Child, Adult
Effect of Ration Formulations on Warfighter Energy Balance and Physical Performance During a Field Training Exercise
Status: Not yet recruiting

The goal of this randomized clinical trial is to determine the effects of consuming the Close Combat Assault Ration (CCAR) compared to the First Strike Ration (FSR) during a 7-day strenuous military training on energy intake and energy balance in healthy, Active Duty Warfighters.

The main questions it aims to answer are:

Will consuming the CCAR result in lower energy intake or energy balance compared to consumption of the FSR?
Will consuming the CCAR result in lower lower body strength or anaerobic power compared to consuming the FSR?
Will those consuming the CCAR report lower ration acceptability or greater gastrointestinal side effects compared to those consuming the FSR?

Participants will be asked to consume either the CCAR or FSR as the sole nutrition source during a 7-day field training exercise (FTX). The vertical jump test, running-based anaerobic sprint test, and lower-body strength pull will be conducted pre and post the 7-day FTX to assess physical performance. Energy expenditure and intake will be measured by the doubly-labelled water method and dietary logs, respectively. Surveys will be completed to assess ration acceptability and gastrointestinal symptoms.

Researchers will compare the CCAR and FSR groups to see if their consumption impacted energy intake, energy balance, physical performance, ration acceptance, or gastrointestinal side effects.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Active-duty male or female military personnel who are actively participating in the 7-day strenuous military training exercise. Willing to consume only foods/beverages provided by study staff during the training exercise, except for coffee and water.  Exclusion Criteria:  Any injury or health condition limiting full participation in the 7-day Field Training Exercise. Any food allergy, lactose intolerance, or vegetarian practices. Not willing to participate in all study procedures. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult
Effects of a Supervised Rehabilitation Program on Disease Severity in Spastic Ataxias
Status: Not yet recruiting

Spastic ataxias are a group of diseases causing symptoms such as walking difficulties and balance impairments that lead to a high risk of falls. No pharmacological treatments exist to treat these diseases. Unfortunately, little effort is made to develop non-pharmacological treatments specific to spastic ataxias despite the detrimental impact of the disease on several aspects of an individual's life and the high cost of falls for society each year. The three objectives of this project are: 1) to determine the effect of a 12-week rehabilitation program on disease severity as compared with usual care for individuals with spastic ataxias; 2) to identify which factors can help (or not) the implementation of the program in the clinical settings ("reel world"); and 3) to explore the cost-benefits of IMPACT [rehabIlitation prograM for sPAstiC aTaxias]. The team has developed the program to specifically target symptoms present in these patients and was previously pilot-tested. Based on the results obtained in this pilot project, positive effects are expected concerning the disease severity of participants. The investigators want, with this project, provide to health care professionals an option to offer better-suited services to people living with spastic ataxia worldwide.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  have a confirmed genetic diagnosis of ARSACS or SPG7 be able to maintain standing position and to transfert be authorized by their treating neurologist speak French or English be able to give informed consent.  Exclusion Criteria:  have active participation in a rehabilitation program (self-reported information) have another condition causing physical limitations be uncomfortable in a swimming pool be pregnant. - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult
Better Birth Outcomes Through Technology, Education, and Reporting
Status: Recruiting

This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it helps to reduce maternal anemia and other adverse pregnancy outcomes. The BETTER intervention includes one motivational interviewing session and bi-weekly text messages to encourage patients to connect with resources that address their social needs, including housing, food, and transportation. Quantitative data will be used to study participant outcomes, including surveys, and electronic health record data.

Eligibility:
- EligibilityCriteria: Inclusion Criteria  Less than 20 weeks and 6 days pregnant upon enrollment At least 18 years of age Receiving obstetric care at OSU McCampbell Hall or OSU Outpatient Care East Singleton pregnancy and fetus with a heartbeat English speaking Able to receive text messages  Exclusion Criteria  Has a significant medical condition (eg sickle cell disease) that is a cause of anemia Has a plan for transfusion during pregnancy - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: This study is restricted to pregnant individuals. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial
Status: Recruiting

This study aims to develop a typology-based intervention delivered by smoking cessation (SC) counselors to prevent smoking relapse in ex-smokers who recently quit. The two main research questions include (1) Can a typology-based smoking relapse prevention intervention be feasible and accepted by the smokers and SC counselors who deliver the new intervention? (2) What is the preliminary evidence on the efficacy of the typology-based smoking relapse prevention to increase tobacco abstinence in ex-smokers who have recently quit? If the intervention shows at least a small effect size (i.e. risk ratio>1.3), or the intervention is feasible while modifications can potentially increase the efficacy, a future definitive RCT is warranted.

Eligibility:
- EligibilityCriteria: Inclusion Criteria (for Ex-smoker) :  Have ever habitually used conventional cigarettes in the past year Not using cigarettes for past 7 days Aged 18 years or above No barriers in speaking and listening Chinese  Exclusion Criteria (for Ex-smoker) :  Have unstable physical or psychological conditions as advised by doctors or counsellors Users of illicit drugs (e.g., heroin, marijuana, ketamine, etc.) Have become pregnant in the past two months  Inclusion Criteria (for SC counsellors) :  SC counsellors from local SC clinics under Tung Wah Group of Hospitals, Pok Oi Hospital, Hospital Authority (HA), and Youth Quitline of the University of Hong Kong. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
Status: Not yet recruiting

The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in growth factors (PRGF) for reducing postoperative endothelial cell loss. Subjects scheduled for endothelial keratoplasty will be enrolled and randomized to have the graft incubated in PRGF or not prior to graft implantation. The main outcome is the percentage central corneal endothelial cell loss 6 months after surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  undergoing endothelial keratoplasty (DSEK or DMEK) at the Bascom Palmer Eye Institute or Price Vision Group, using corneal graft tissue within 14 days of preservation  Exclusion Criteria:  History of corneal transplantation in the study eye, BCVA worse than 20/40 in the contralateral eye, systemic immunosuppression, previous intraocular surgical procedures (other than cataract surgery) such as glaucoma tubes or silicone oil.  The following special populations will be excluded.  Adults unable to consent Pregnant women Prisoners - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Mesotherapy Treatment of Irritable Bowel Syndrome
Status: Not yet recruiting

Irritable bowel syndrome (IBS) is a gastrointestinal transit disorder characterized by chronic abdominal pain and impaired transit in the absence of demonstrated organic disease. Considered a non-fatal disease, its effects relate more to quality of life, work production and health care systems.

Given the complexity of this disease, no treatment has been recognized as standard treatment. The treatment is rather focused on treating the symptoms caused (chronic pain or intestinal transit disorder). In general, therapy is considered individualized and includes lifestyle/diet modifications and pharmaceutical therapy.

Several published case studies evaluating the effect of mesotherapy on improving the severity of the disease have demonstrated an improvement in the symptoms of this syndrome. Due to the limited number of case studies and the insufficient level of evidence to conclude, our study will therefore be a before-and-after intervention study, to evaluate the effect of four mesotherapy sessions on the treatment of IBS symptoms.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient suffering from Irritable Bowel Syndrome according to the Rome IV criteria, whose diagnosis was made by a specialist in Hepato-Gastro-Enterology, Francis score >75/500, i.e. minimal, moderate or severe severity, Patient who has failed conventional treatment (treatment followed for at least 1 year and not showing an improvement in symptoms) Absence of risk of ongoing pregnancy in women of childbearing age, validated by a urine test during the first consultation and before treatment and each month during treatment and until 1 month after the end of treatment  Exclusion Criteria:  Patient with the following medical history or current pathologies: organic gastrointestinal pathology, disabling neurological pathology, disabling psychiatric pathology Recent Post Traumatic Stress Syndrome (<1 year), Fibromyalgia syndrome, Known allergy to medications used in mesotherapy treatment, Pregnant or breastfeeding woman - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult