cyrilzakka/clinical-trials huggingface dataset:
To Evaluate the Feasibility of Collecting Duodenal Fluid With SIMBA Capsules

In this study, the feasibility to use SIMBA (Small Intestinal MicroBiome Aspiration) capsules to collect small intestinal microbiome and metabolome information will be evaluated in patients with liver cirrhosis. Furthermore, the comparability oral, fecal and small intestinal microbiome and metabolome composition based on similarities and differences in 16s sequencing data and NMR metabolomics data will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Written informed consent
* Liver cirrhosis diagnosis by clinical/radiological/histological features
* Able to swallow a size-00 capsule (23mm length and 8mm width)

Exclusion Criteria:

* Inability to give informed consent
* Prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, cancer diagnosis or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.
* History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction.
* Known history abdominal radiation treatment.
* Use of any medications in the week prior to the screening study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, GLP-1 analogues); laxative use is allowed if it is kept unchanged in the week prior to the study visit. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 h before swallowing SIMBA capsules and PPI treatment is resumed only 4 hours thereafter.
* Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.
* Any significant heart, liver, lung, kidney, blood, endocrine or nervous system disease, which in the opinion of the investigator, would adversely affect study safety or outcome.
* History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration.
* Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed.
* Consumption of probiotic or prebiotic supplements within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed.
* Any prior Fecal Microbiota Transplantation.
* Colon cleanses/bowel prep for 2 weeks
* Pregnant or breastfeeding.
* Planning to become pregnant.
* Are scheduled for an MRI at any time during the study. Potential participants may be eligible to participate once their MRI procedure is completed.
* History of less than three (3) bowel movements per week.
Mental Health Consequences of COVID19 Infection in the French RMD Cohort

this observational, cross-sectional, national, comparative study, including RMD patients followed in hospital centres of the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners caring for patients suffering from inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases. The objective of the study is to compare RMD patients with COVID 19 infection (cases) to RMD patients who have not had COVID 19 infection (controls) on their mental health.


Eligibility Criteria:
Inclusion Criteria:

Patient case:

* Patient with inflammatory rheumatism, systemic autoimmune or autoimmune disease
* With confirmed COVID-19 infection (at least one month prior to study inclusion)
* Study information given to the patient
* Patient affiliated to social security

Patient control:

* Patient with inflammatory rheumatism, systemic autoimmune disease or autoimmune disease.
* Not having had a confirmed COVID-19 infection
* Study information given to the patient
* Patient affiliated to social security

Exclusion Criteria:

* Opposition to participation in the study by the patient and/or his legal representative
* Adult patient not able to understand the implications and rules of the study
* Protected adults under guardianship or curatorship
Transcranial Direct Current Stimulation in Conjunction with Individualized Physical Therapy for Individuals with Chronic Knee Pain

Background: There is a high prevalence of chronic pain in the US, with nearly half of adults experiencing chronic pain. Chronic pain is associated with impaired mobility, specifically ambulation. Treatment for chronic knee pain is complex given that pain is not only due to peripheral sources, but also due to alterations of the central nervous system (CNS). Majority of physical therapy (PT) interventions involve a bottom-up approach targeting the peripheral pain sources and many patients (\~66%) do not respond to this treatment approach. Noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) is a novel and promising option for a top-down intervention that can have neuromodulatory effects on the CNS and may better target central factors associated with chronic pain. Purpose: To determine if tDCS delivered to the primary motor cortex in conjunction with individualized PT will result in greater improvements in pain and function compared to sham tDCS with individualized PT in individuals with chronic knee pain. Methods: This study will be performed at outpatient PT clinics at the University of Illinois Hospital. Eligible participants will include patients with chronic knee pain (duration \> 3 months) who have not undergone surgery to this area and are scheduled to receive formal PT intervention. Subjects will be randomized to the active tDCS + PT group or sham tDCS + PT group and will receive the intervention for 8 sessions. Outcomes include pain ratings, pressure pain thresholds, patient specific functional scale, lower extremity functional scale, quadriceps strength, knee range of motion, 2-minute walk test, 5 time sit to stand, patient health questionnaire-2, and Central Sensitization Inventory. Impact: The use of adjuvant therapies such as tDCS have the potential to optimize rehabilitation treatment for individuals with chronic pain by offering a more comprehensive treatment that targets peripheral and central sources of pain.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years old
* Knee pain
* Knee pain duration \>/= 3 months

Exclusion Criteria:

General exclusion criteria

* History of surgery on affected knee
* Pregnant

tDCS exclusion criteria

* Skin hypersensitivity
* History of contact dermatitis
* Any other skin or scalp condition that could be aggravated by tDCS
* Previous adverse reactions to tDCS
A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Subjects from 16 to 75 years, both inclusive
* Well-characterized focal epilepsy or epileptic syndrome
* Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period
* Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50 % of the minimum recommended maintenance dose

Exclusion Criteria:

* Seizure type IA non-motor as only seizure type
* History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline
* Other serious uncontrolled disease
Intra Oral Kinetics of Fluoride Containing Dentifrices

The aim of this study is to assess the impact of formulation differences on fluoride retention clearance with US levels of fluoride (1150 ppm of fluoride) by evaluating and comparing between treatments the concentrations of fluoride and calcium ions in saliva over 60 minutes after a single brushing with US marketed fluoridated dentifrices and following a dietary acid challenge post 60 minutes of brushing with study treatment.


Eligibility Criteria:
Inclusion Criteria:

* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
* Aged 18-65 years
* Understands and is willing, able and likely to comply with all study procedures and restrictions
* Good general and mental health with, in the opinion of the investigator or medically qualified designee:

  1. No clinically significant and relevant abnormalities of medical history or oral examination
  2. Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures and requirements
* A minimum of 20 permanent natural teeth
* A gum-base stimulated whole saliva flow rate ≥ 0.8 mL/min and an unstimulated whole saliva flow rate ≥ 0.5 mL/min.

Exclusion Criteria:

* Pregnant or breast feeding women
* Presence of chronic debilitating disease.
* Any condition that causes xerostomia as determined by the Investigator.
* Evidence of untreated caries.
* Gross periodontal disease.
* Tongue or lip piercing or presence of dental implants. Professional tooth cleaning or dental treatment during study. Oral surgery or extraction within 6 weeks of the screening visit.
* Self reported oral symptoms including lesions, sores or inflammation
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
* Currently taking antibiotics or have taken antibiotics within 2 weeks of the screening visit
* Any medication that could affect salivary flow or cause xerostomia as determined by the Investigator
* Use of multivitamins, calcium supplements and or fluoride supplements within 7 days of treatment phase
* Participant unwilling to abstain from smoking for at least 4 hours on the day of each test visit
* Recent history (within the last year) of alcohol or other substance abuse.
Dry Needling Versus Strain-counterstrain on the Upper Trapezius

This study investigates the effect of two different techniques (dry needling and Strain-counterstrain manual technique) on the upper trapezius myofascial trigger point (MTP). Subjects with active or latent MTP in this location of the muscle will be identified and will be randomly assigned to one out of three groups: dry needling, strain-counterstrain or placebo manual technique. Pain pressure threshold, provoked pain, pain at rest, neck disability and electromyography (EMG) activity of the upper trapezius will be registered before and after six sessions of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Active myofascial trigger point at the upper trapezius

Exclusion Criteria:

* Diagnosed fibromyalgia
* Cervical radiculopathy
* Facial neuralgia
* Coagulation alteration
* Cancer
* Allergy (included needles)
* History of cervical or shoulder surgery
* History of deep venous thrombosis
* History of myopathy
* History of infiltration at upper trapezius trigger point
* Anticoagulant medication
* Aspirin intake during the last 3 days
* Drug intake (AINES, narcotics, antiepileptics, or any other analgesic medication)
* Pregnancy
Affective Responses in Neurological Rehabilitation

Using a single blind within-subject design, 16 patients with neurological disorders were randomly exposed to two different treatments: physical therapy and robotic assisted gait training. Both before and after the treatments, a self-report Mood Survey Scale (MSS) was used to assess the effects on the treatment on distinct affective states. The subscales of the MSS were tested for pre-post changes and different effects between treatments with non-parametric tests.


Eligibility Criteria:
Inclusion Criteria:

* voluntary participation
* neurological incident

Exclusion Criteria:

* lack of communication ability
* interference of consciousness
* inability to speak German language
Comparison of Brimonidine Purite, Dorzolamide, and Brinzolamide as Adjunctive Therapy to Prostaglandin Analogs

The purpose of this study is to compare the efficacy of brimonidine Purite, dorzolamide, and brinzolamide in reducing intraocular pressure when added to prostaglandin analog therapy (bimatoprost, latanoprost, or travoprost) in patients with glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma or ocular hypertension.
* Must be over 40 years of age.
* Intraocular pressure must be 18 mm Hg or higher after 6 weeks of treatment (run-in) with a prostaglandin analog (bimatoprost, latanoprost, or travoprost).

Exclusion Criteria:

* History of angle closure or narrow angle.
* Previous intraocular surgery.
* Laser trabeculoplasty within 3 months prior to screening.
* History of uveitis or intraocular inflammation.
* Use of medications other than the study medications that are known to affect IOP (e.g., beta-blockers, steroids, or angiotensin II blockers) within 3 months of study entry or during the study.
* Intolerance of or hypersensitivity to prostaglandin analogs, sulfonamides, alpha-agonists, or the preservative benzalkonium chloride.
* Women of childbearing age who are pregnant or not using contraception.
Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone

Objectives: The purpose of this study was to assess the impact of the Empowering Community Pharmacists program on pharmacists' knowledge, perceived barriers, attitudes, confidence, and intentions regarding naloxone services implementation, as well as change in number of naloxone prescriptions dispensed.

Methods: A 3-month pragmatic randomized controlled trial was conducted in 2018-2019. Alabama community pharmacists were recruited by email, phone, fax, and mailed postcards and randomized to intervention (monthly resources/reminders + educational webinar) or control (monthly resources/reminders + delayed educational webinar). Outcome measures were assessed via online surveys at baseline (T1), immediately post-intervention (T2), and 3-months post-intervention (T3), including: naloxone knowledge (percent correct); perceived barriers, attitudes, and confidence regarding naloxone services implementation (7-point Likert-type scale, 1=strongly disagree to 7=strongly agree); and number of naloxone prescriptions dispensed. Mean differences between control and intervention groups from T1-T3 were assessed using two-way mixed ANOVA and adjusted analyses were conducted using generalized estimating equations (GEE) with negative binomial distribution (alpha=0.05).


Eligibility Criteria:
Inclusion Criteria:

* Registered pharmacists.
* Employed at least 30 hours per week at a community pharmacy.
* Employed at a community pharmacy located in one of 20 Alabama priority counties with the highest opioid overdose mortality rates.

Exclusion Criteria:

* Multiple pharmacists from the same pharmacy site.
* Members of the stakeholder panel (from the formative phase of the study).
Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder

The purpose of this study aims to investigate the utility of Pivotal Response Treatment (PRT), a behaviorally derived intervention, to improve the quality and frequency of communication and social engagement of toddlers with siblings who have an autism spectrum disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social interaction between 12 and 15 months of age.


Eligibility Criteria:
Inclusion Criteria:

* toddlers, age 12 - 15 months, who have an older sibling with ASD
* delays of at least 1.5 standard deviations in communication (receptive/expressive language) based on developmental testing
* scores that exceed the ASD cutoff on standardized measures of social-communicative behavior

Exclusion Criteria:

* physical or neurological disorder (e.g., seizures, cerebral palsy)
Comparison Between Two Different Healing Abutments in Single Posterior Implants

The aim of this randomized clinical trial is to evaluate the volumetric analysis of peri-implant soft tissues after 3 months of the use of a prefabricated healing abutment with scan peg in comparison to customized healing abutment.

Volumetric analysis of peri-implant soft tissues after 3 months of the use of a prefabricated healing abutment with scan peg with convex emergence profile in comparison to customized healing abutment with concave emergence profile.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who are classified as ASA I or II physical status and require mandibular single implants (single missing mandibular posterior teeth) with:

  1. Proper bone height and width.
  2. Adequate zone of keratinized tissue (at least 2 mm)

Exclusion Criteria:

* Any systematic disease as uncontrolled diabetes mellitus or metabolic bone diseases
* Pregnancy and Lactation
* A history of head and neck radiation treatment.
* Chronic periodontal diseases.
* Poor oral hygiene (Silness-Löe plaque index score 2 and 3)
* Parafunctional habits.
Prioritising and Optimising Multi-medication in Multimorbidity

Objective: To investigate whether the complex intervention will improve the appropriateness of prescriptions in elderly multi-morbid patients with multi-medication in general practices.

Study hypothesis: The primary objective of the study is to determine whether the complex intervention will improve the appropriateness of prescriptions compared to usual care. The primary efficacy endpoint is the change in the Medication Appropriateness Index (MAI) score from baseline (T0) to 6 months after baseline (T1), i.e. the difference MAI T1-T0.

Key elements (1 to 4) of the complex intervention:

1. Basic assessment of medicines that were actually taken (brown bag review) by a general practice based health care assistant (HCA) and
2. Checklist-based (MediMoL - Medication-Monitoring-List) pre-consultation interview on problems relating to medicines (technical handling, potential adverse drug reactions) and patient's therapeutic aims by HCA provides structured information in the Medication-Monitoring-List (MediMoL) for the general practitioner (GP) and enables patients to discuss their problems with the GP.
3. GP uses a computerized decision support system (pharmaceutical information system, AiD+) to optimize medication (reducing number of inappropriate prescriptions, e.g. pharmaceutical interactions, renal dose adjustments, duplicate prescriptions) and
4. prioritizes medication in the physician-patient consultation taking into consideration patient's preferences.

Eligibility Criteria:
Inclusion Criteria:

* at least 60 years old of both sexes
* at least three chronic diseases affecting two or more organ systems, which require pharmaceutical treatment
* at least five long-term prescriptions with systemic effects
* health care provided by GP (at least one contact in most recent quarter)
* patient is legally competent to sign any documents
* ability to understand and participate in trial of own free will, to fill out questionnaires and participate in telephone interviews
* written informed consent to participate in trial

Exclusion Criteria:

* diseases cause life expectancy of less than 12 months
* abuse of alcohol or illegal drugs and visible clinical signs or symptoms thereof
* cognitive impairment that prevents trial participation (MMSE \< 26)
* emotional stress that prevents trial participation
* participation in a clinical trial within the last 30 days
Effect of the PLAN CUIDARTE on the Caregiving Competence of People With Heart Failure

According to the World Health Organization (WHO), by 2021 cardiovascular diseases (CVD) will be a public health problem, among them heart failure (HF), since this is a chronic disease, patients should be competent in their care. Despite the above, according to research conducted in Colombia, 59.7% of people with chronic noncommunicable diseases (NCDs) have a level of care competence considered not optimal; patients report not having sufficient knowledge of the disease or experience feelings of lack of tools for the management of symptoms and the challenges of post-hospitalization.

The objective of the research is to determine the effect of the PLAN CUIDARTE on the caregiving competence of people with HF

Methodology: Pre-posttest randomized clinical trial, with blinding of the participants, where the intervention "PLAN CUIDARTE" is applied and the initial and subsequent caregiving competence is evaluated in the comparison group and in the intervention group for pretest - posttest and between-group comparisons.

Eligibility Criteria:

Inclusion criteria

* Patients over 18 years of age with a diagnosis of HF.
* Patients with HF who are hemodynamically stable.
* Patients with SPMSQ - PFERFFER of 0 - 4 errors or 5 errors, patient who has not received primary education.
* Patient with a PULSES of 6 to 11

Exclusion criteria

* Patients with heart failure with heart transplantation scheduled in the next 6 months.
* Patients requiring transfer to an intensive or intermediate care unit.

Outcome Measures:

* Primary: Caring competence.
* Secondary: Satisfaction with care

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age who are hospitalized and admitted to the institution with a diagnosis of HF decompensation with a time of diagnosis greater than 6 months.
* Patients who are hemodynamically stable, without alteration of the state of consciousness.

Exclusion Criteria:

* HF patients who are hospitalized for cardiac transplantation,
* Who are under palliative management or who, at the time of discharge, have a formal
* Who have a designated formal caregiver or are discharged to an institution other than home.
Comparative Effects Of Spencer and Reverse Distraction Technique In Patients With Adhesive Capsulitis

To compare the effects of spencer and reverse distraction technique in patients with adhesive capsulitis

Adhesive capsulitis, also known as frozen shoulder, is an inflammatory condition characterized by shoulder stiffness, pain, and significant loss of passive range of motion. Adhesive capsulitis has a prevalence of approximately 2% to 5% in the general population, with a mean onset of age of 55.

A randomized clinical trial will be conducted at Ibne Sina Hospital, Multan . Non probability convenience sampling technique will be applied on 50 patients who will be allocated through computerized randomization into group A \& group B to collect data. Group A will be given spencer technique and group B will be given reverse distraction technique along with baselines. The study will be completed within the time duration of ten months. Primary Outcome measures of the research will be pain, range of motion, function, muscle strength, disability and quality of life will be measured pre and post intervention. The whole treatment protocols will be given for four weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age group 40-60 years
* Male and female
* Positive Capsular pattern (ER more limited than Abd which is more limited than IR)
* Limitation in shoulder ROM ; Flexion \<180 , Abduction \<180 , External Rotation \<50
* Patients of stage 2 and 3 of adhesive capsulitis

Exclusion Criteria:

* History of surgery of the affected shoulder
* Fractures in around the shoulder
* Neurological disorders leading to altered muscle activity
* Systemic arthritic conditions (RA, Osteoporosis)
* Disorders of the cervical spine