cyrilzakka/clinical-trials huggingface dataset:
The Effect of Motor Imagery on Balance in Persons With Multiple Sclerosis

This study will investigate if the use of motor imagery to practice a balance task is as effective as physically practicing balance tasks as measured by the Berg Balance Scale (BBS) in persons with MS. A secondary purpose is to investigate if using a motor imagery balance intervention will limit fatigue typically experienced with physical movement in this population.

Motor Imagery, where persons practice mental performance of a task without the physical performance of the task has been found to improve many aspects of mobility in persons with MS. Its effect on balance is not known. Traditionally, balance training in persons with MS(pwms) has taken the form of physical performance of balance tasks. Although this is effective, this may increase the fatigue that commonly limits physical exercise in MS.

The purpose of this study is to compare the effects of Motor Imagery on physical performance on balance and fatigue in persons with MS.

Upon a participant's arrival to Dominican University NY, we will:

A) Provide participants with an informed consent, explain the process, and answer questions B) Collect intake data (demographics and subject characteristics - age, gender, ethnicity, EDSS/ Phenotypes, years since diagnosis, MS Impact Scale-29 (MSIS29), Fatigue Severity Scale (FSS), Activities-Specific Balance Confidence scale (ABC) C) Collect baseline observational measures: Berg Balance Scale (BBS)

The participants will then be randomized into the Standard of Care (physical practice) or the Motor Imagery group. Blocked randomization will be implemented to ensure even comparison between groups. Then each person will receive one on one training based on the item(s) on the BBS with which they had difficulty. For example, if the participant had difficulty with item 13 on the BBS, practicing that item would become part of their intervention. Participants in the Standard of Care group will be instructed on how to physically practice their items. Participants in the Motor Imagery group will be guided through mentally practicing their items.

The interventionist will select the 3 items on the BBS with which the participant struggled the most and provide in person and HEP instructions based on those items. We will instruct the participant to perform 10 minutes of total daily practice of these exercises at home in the mode indicated by their group. The 10 minutes will be divided among multiple exercises if applicable and can be done either all at once or broken up over the course of the day. Participants will receive a logbook with written and/or verbally recorded instructions on how to perform their exercises.

Participants will perform the interventions at home for 10 minutes a day for 2 weeks, and will then return to DUNY after the 2 weeks for post-test data collection.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Multiple Sclerosis
* A non-perfect score on the Berg Balance Scale

Exclusion Criteria:

* A perfect score on the Berg Balance Scale
* Current participation in a program focused on improving balance
Improving the Diabetic Health of Black Men: MANUP Feasibility Trial

Many Black Americans continue to be suffer from diabetes especially Black men. Although previous diabetes efforts have reduced overall disease burden, they have failed to eliminate racial and geographic disparities. The story of John Henry, the "steel-drivin' man" represents strength and self-determination among Black Men. But often these traits lead men to "manup" about their health and prevents them from taking care of their diabetes. This study examines how we can assist Black men in improving their diabetes. Based on the traits of John Henry, we will conduct a culturally-tailored study to 1) determine if our education program including coping strategies and motivation text messages lowers A1c; and, 2) how program operates in a rural setting while learning how we can best improve it for a larger study. We hope to have the information to conduct a larger study with Black men in rural areas to improve their diabetes outcomes.

As the United States' 7th leading cause of death, improving diabetic outcomes is a public health priority. Black American men disproportionately suffer from diabetes more than White counterparts. John Henryism endorses traditional masculine norms for Black Men, such as self-determination and strength, as assets. However, these norms can also act as barriers to diabetes self-management as they restrict access to support from family and friends at a time when it is most needed.

The purpose of this application is to pilot a targeted, culturally-tailored, diabetes self-management intervention for 50 rural Black men to improve diabetes-related outcomes. Aim 1: Implement a 6-month diabetes self-management intervention, grounded in John Henryism, with two arms consisting of the active intervention group and a delayed intervention group to test the intervention's effect on the primary outcome of A1c change. Aim 2: Determine the feasibility of conducting a 6-month culturally-tailored diabetes self-management intervention for Black men in a rural NC community.

The intervention includes a 10-week education program focusing on self-management, social support and coping strategies; and, daily motivational text messages. Aim 1 analysis includes repeated measures t-test (or the non-parametric equivalent Wilcoxon Matched Pairs test) to compare the mean scores of the both groups pre and post intervention. Aim 2 analysis focuses on key parameters required for conducting a future trial. This innovative study leverages the self-reliance and active coping mechanisms of John Henryism by fostering self-determination to properly self-manage diabetes while providing stress management and coping skills to buffer John Henryism's adverse effects.

Eligibility Criteria:
Inclusion Criteria:

1) reside in Halifax, County or Alamance County NC; 2) age 21 or older; (3) English language proficient; 4) able to walk unaided; 4) self-reported type 2 diabetes diagnosis.

Exclusion Criteria:

* Exclusion criteria includes being non-ambulatory or having a diagnosis that would preclude them from participating in an exercise program.
Hippocampal Memory Circuits in Delusions

This study will investigate dentate gyrus (DG) and hippocampal CA3 sub field function, using the pattern separation paradigm, as reflected by the difference in brain activation in response to same-as-previously- seen (OLD) vs. similar-to-previously-seen (SIM) objects in first episode psychosis (FEP) subjects before and after anti psychotic treatment and in matched healthy controls (HC). The current study uses three novel high-resolution task-based and post-encoding resting fMRI measures to probe hippocampal circuitry in delusions. It will also study CA1 function, using a sequential associative mismatch paradigm, as reflected by activation of CA1 in response to mismatching information compared to memory of that stimulus in FEP subjects before and after antipsychotic treatment and in matched HC. Finally, this study will evaluate plasticity of hippocampal intrinsic functional connectivity (IFC) in response to memory consolidation, using an encoding-plasticity paradigm, in FEP subjects before and after anti psychotic treatment and in matched HC. For each of the three imaging projects, a total of 50 FEP subjects and 50 matched healthy controls (HC) will be studied; hence, 300 subjects will be studied over 5 years. Within each paradigm, medication-naive FEP subjects will be studied at baseline and 8 weeks after starting anti psychotic medication. HC participants will be studied at baseline and 8 weeks later but will not receive any treatment.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 16 to 35 years of age, inclusive, at the time of informed consent
* Right-handed
* Must have experienced a first episode of non-affective psychosis over the past five years
* Must exhibit a persistence of delusions for at least 4 days per week for at least 4 weeks in the absence of psychotomimetic substance use or other potential organic etiologies, including epilepsy or significant head trauma.
* Must score at least a 2 (mild to moderate) on the "Amount of preoccupation with delusions" and "Conviction" items on the Psychotic Symptom Rating Scale (PSYRATS).

Exclusion Criteria:

* Diagnosis of major mood disorder or other Axis I disorder other than Schizophrenia, Schizoaffective Disorder or Schizophreniform Disorder.
* Significant medical or neurological illness by history or physical exam including seizure disorder, history of loss of consciousness related to head trauma or developmental disorder including mental retardation.
* Metal implants, pacemaker, or other metal in the body or medicinal patch.
* History of claustrophobia.
* Currently taking any anti psychotic medication (within 4 weeks).
Tissue Collection for Biomarkers Determining Resistance to Ibrutinib

Clinical validation of biomarkers determining resistance to BTK inhibition with Ibrutinib in Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia Stage 1.

With the recent FDA approval of Ibrutinib for the management of relapsed/refractory MCL and CLL, we are entering an exciting phase in the management of these conditions. A crucial next step is to validate biomarkers that predict clinical activity of Ibrutinib in order to tailor therapy and maximise benefit to patients. The recently opened named patient supply (NPS) of ibrutinib in the UK provides an excellent window of opportunity for these studies.

The investigators have set up a collaboration with Professor Simon Rule (Plymouth) and Dr George Follows (Cambridge), who are carrying out a prospective data collection study for patients entered on to the NPS. With the help of our collaborators the investigators will be able to identify centres in the NHS for collection of samples. Patients entered on to the NPS will be provided an information sheet and research specific consent form following which samples from consenting patients will be transferred to the Royal Marsden Hospital (RMH) for storage. Samples will be logged and tracked using a secure database. Samples for research will be collected at the same time as routine sampling and therefore no additional sampling will be required. For each patient, consent will be obtained for pretreatment, progression as well as any diagnostic samples taken or stored and patients will require to be on the study for at least 24 months from the start of their treatment. The collection will end 24 months after the last patient commences treatment on the NPS.

Once we have an idea of the number of patient samples we can collect, the second stage of this study will be initiated and will involve molecular screening of samples at RMH for biomarkers of resistance. The data from the molecular studies will then be correlated with the clinical response data from our collaborators for clinical validation.

Eligibility Criteria:
Inclusion Criteria:

* All patients entered into the Ibrutinib NPS for relapsed refractory MCL and CLL in the UK and who consent to have biological material stored for this research will be included in the study. Patients who have already commenced treatment with Ibrutinib will also be eligible whether or not they are responding.

Exclusion Criteria:

* All samples received will undergo histological (or morphological) review and immunophenotyping. The following samples will be excluded-

  1. Samples not satisfying the criteria for diagnosis of CLL or MCL.
  2. Samples with evidence of high grade transformation (e.g. Richter's transformation of CLL).
Trunk Position Sense, Postural Stability and Spinal Posture in Fibromyalgia

This study aims to investigate trunk position sense, postural stability and spine posture in fibromyalgia patients and healthy women.


Eligibility Criteria:
Inclusion Criteria:

* being women
* having FMS
* being volunteer

Exclusion Criteria:

* have neurologic, infectious, endocrine, and other severe psychological disorders
* malignancy,
* being pregnant
* any condition interfering with evaluation (advanced cardiac respiratory or orthopedic problems)
* spinal deformities such as scoliosis, spine surgery
* inflammatory rheumatic diseases
A Comparison of Gastric pH Control With High Dose Intravenous or Oral Esomeprazole

The investigators hypothesize that high dose esomeprazole 80mg given as a bolus, followed by 8mg/h would render gastric pH near neutral and that pH control with esomeprazole given in such a high dose either intravenous or orally is identical.

Bleeding peptic ulcer is a common and life threatening condition. Endoscopic therapy has become the mainstay of controlling bleeding. Recurrent bleeding after endoscopic control occurs in about 20% of patients with a high associated mortality. We previously demonstrated that the adjunct use of high dose proton pump inhibitor reduces risk of recurrent bleeding and thereby improves patients' outcome \[Lau JY N Engl J Med 2000\]. The newer PPI, esomeprazole, is an S-isomer of omeprazole. Esomeprazole is more effective in gastric acid control as measured by both basal and pentagastrin acid output when compared to omeprazole. Esomeprazole when given orally at a lower dose achieves a similar gastric control than intravenous esomeprazole. The gastric pH with a high dose esomeprazole when given either orally or intravenously has not been measured among Hong Kong Chinese. If a high dose oral esomeprazole achieves a similar pH control near gastric neutrality, the oral regime can be used in place of the intravenous formulation. This represents significant convenience in dosing and cost savings.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted with diagnosis of upper gastrointestinal bleeding aged between 18 and 80
* Endoscopic confirmation of a bleeding duodenal or gastric ulcer to which endoscopic control has been obtained
* Absence of H. pylori infection
* Informed written consent

Exclusion Criteria:

* Known incompatibility to the study drugs;
* Known incompatibility and hypersensitivity to proton pump inhibitor
* H. pylori infection
* Recent H2RA or PPI use (within last 4 weeks)
* Concomitant use of medications that may interfere gastric acid secretion or motility (e.g. anticholinergic, metoclopramide, domperidone)
* Pregnancy or lactation;
* Non-compliance e.g. mental subordination
* Nasopharyngeal or oropharyngeal pathology that would prevent passage of a nasal catheter
* Significant liver disease as PPI is metabolized by the cytochrome P-450 system
* Previous gastric surgery
* Chronic Aspirin user
* Presence of esophageal/ gastric varices
* Moribund patients, terminal malignancy \& patients with severe renal disease
* Patient unable to give written consent
Pulmonary Impacts of Anaesthetic Modalities Evaluated by Ultrasound

A prospective, observational, monocentric study aimed at identifying ultrasound changes in anaesthesia on the pulmonary parenchyma after knee arthroplastic surgery using the LUS score in the preoperative, immediate post-operative (D0) and late post-operative (D1) periods.

Post-operative pulmonary complications are responsible from morbidity and mortality close to cardiovascular complications.

Perioperative and post-operative respiratory changes are secondary to anaesthesia (general anaesthesia, elongated position, tidal volume) and to surgery in particular abdominal and cardiothoracic surgery.

Several risk factors related to patients were identified: age, ASA score\> 2, functional dependence, chronic obstructive pulmonary disease, congestive heart failure, obesity, smoking.

Pulmonary ultrasound is a simple and rapid means of monitoring, widely used in resuscitation and developing in anaesthesia.

The hypothesis of the study is that anaesthesia and / or ventilation is responsible for lung lesions observable by ultrasound from the recovery room, even after extra-thoracic surgeries.

To do this, it will perform 3 pleuro-pulmonary ultrasound scans, preoperatively on the day of surgery, post-operatively in the recovery room and the day after surgery. LUS score will be calculated. Preoperative data (morphology, comorbidities), preoperative (ventilation, filling, position, type of anaesthesia - general anaesthesia with intubation or laryngeal mask, spinal anaesthesia- , type of surgery) and postoperative data (constants, oxygen therapy, complications) will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing scheduled primary knee arthroplasty :
* Partial knee replacement surgery
* Total knee replacement surgery

  • Type of Anaesthesia
* General anaesthesia with orotracheal intubation
* General anaesthesia with laryngeal mask
* Spinal anaesthesia

  * Major Patient
  * Oral non opposition collected after oral information of the study

Exclusion Criteria:

* Refusal to participate
* Preoperative pleural pathology (pleural effusion, pleural symphysis)
* Pregnancy
* Patient under authorship or curators
* non-affiliation to a social security scheme
Drug-drug Interactions Between DWC202211 and DWC202212 in Healthy Subjects

An open-label phase 1 study to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability of DWC202211 and DWC202212 compared to coadministration in healthy


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged ≥ 19 and ≤ 50 years at screening
* Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening

  ※ BMI (kg/m2) = body weight (kg)/\[height (m)\]2
* Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
* Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.
Real World Study Of The Clinical Profile And Treatment Outcomes Of Advanced Therapies For Ulcerative Colitis In Portugal

This study aims to characterize the Portuguese population of patients with moderate-to-severe UC receiving advanced therapies, by describing clinical and sociodemographic characteristics, and remission outcomes . The clinical, biochemical, endoscopic, and histological outcomes will also be described, as well as frequency of selected EIM, comorbidities and the uptake of preventive care measures and hospitalizations .


Eligibility Criteria:
Inclusion Criteria:

* Aged at least 18 years old
* Diagnosed with Ulcerative Colitis, confirmed by a gastroenterologist
* Treated with anti-TNF or anti-integrin or JAK inhibitors drugs for at least 16 weeks
* Followed at one of the participating centers when initiating and during the current treatment
* Signed informed consent

Exclusion Criteria:

* Treated with anti-TNF or anti-integrin or JAK inhibitors drugs at induction phase
* Enrolled in randomized clinical trials or other experimental studies in the last 12 months prior to initiation of advanced therapy
The Clinical Course of Coronary Artery Disease in Coronary Multidetector Computed Tomographic Angiogram

Study Type: Observational Study Design: Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective

The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque. Using MDCT, the researchers prospectively investigate the relationship between the presence of coronary plaques and cardiovascular events

Eligibility Criteria:
Inclusion Criteria:

* Patients with known or suspected coronary artery disease

Exclusion Criteria:

* Irregular heart beat
* Known allergy towards the contrast agent
* Renal dysfunction
* Impossible breath-hold
* Acute coronary syndrome patient
Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome

Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk patients.

However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH) level post trigger with single injection of GnRH agonist, which might be related to the shorter duration and lower amount of LH induced by GnRH agonist.

Our aim is to study dual trigger with GnRH agonist and human chorionic gonadotropin (hCG) for preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH antagonist protocol.


Eligibility Criteria:
Inclusion Criteria:

* patients with polycystic ovarian syndrome
* patients with polycystic ovarian morphology on ultrasound
* patients who previously experienced an ovarian stimulation cycle, with a high response to gonadotrophins

Exclusion Criteria:

* patients undergoing coasting
* patients with past ovarian surgery
Investigation on the Efficacy of Oral Carnitine Challenge Test Based on a Gut Microbiota Functional Test

This study seeks to enlist healthy volunteers to form a validation cohort. The purpose is to confirm the observed correlations between the gut microbiome and the capacity to produce trimethylamine N-oxide (TMAO), which will be assessed using the oral carnitine challenge test (OCCT).

Carnitine, a nutrient widely found in meat, can promote the use of fatty acids by mitochondria to produce energy in the human body. It was previously thought to be beneficial in helping the body consume fat for energy and might be helpful for muscle training or weight loss. However, some human populations have harmful bacteria in their intestines that compete with the body for the use of carnitine. These bacteria metabolize carnitine to produce potentially harmful Trimethylamine N-oxide (TMAO). This might be one of the reasons why long-term consumption of red meat, which is rich in carnitine, is associated with a higher risk of cardiovascular disease. Therefore, understanding the functional state of one's gut microbiota and whether it is suitable to consume foods rich in carnitine can greatly aid in long-term dietary and health planning. In recent years, we have established an oral carnitine challenge test that (OCCT) can distinguish whether the intestinal bacteria in a subject produce a large amount of TMAO in the body. This was published in the Gut journal in 2019 and is expected to provide dietary or nutritional supplement recommendations for personalized nutrition for the test subjects. However, the value of the carnitine challenge test in distinguishing between high TMAO producers and low TMAO producers, and whether it can serve as an effective reference for whether a subject is suitable to consume large amounts of meat or take carnitine supplements, still needs further experimental verification. This study seeks to enlist healthy volunteers to form a validation cohort. The purpose is to confirm the observed correlations between the gut microbiome and the capacity to produce TMAO, which will be assessed using the OCCT.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 20 and above who are willing to participate in the trial.

Exclusion Criteria:

1. Under the age of 20
2. History of gastrointestinal surgery
3. History of malignant tumors
4. Those who have used antibiotics, probiotics, or carnitine supplements within the past month will be excluded
5. Liver cirrhosis
6. End-stage kidney disease