cyrilzakka/clinical-trials huggingface dataset:
Videographic Feedback and Walk Rehabilitation in Post-Cerebrovascular Accident

Cerebrovascular Accident affects the majority of the elderly population and its frequency is constantly increasing. The resulting deficits are numerous and lead in particular to an alteration in the quality of walking and autonomy. Numerous rehabilitation techniques have been described. In practice, correction instructions are often given by the therapist while the motor activity is being performed. Walking is a complex activity, as is the processing of dual-task information in elderly stroke patients. It therefore appears interesting to separate the time of motor realization and that of correction instructions. Investigators therefore propose firstly to film the patient during the performance of a walking activity and then, secondly, to analyse the video with the patient, which thus represents a source of delayed feedback. The main objective of the study is to observe the effects of this practice on walking speed. Investigators are comparing two groups of patients: the control group receiving conventional rehabilitation and the experimental group receiving conventional rehabilitation plus sessions with the video tool. They expect to observe a greater improvement in walking speed in the experimental group.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization for a first episode of Cerebrovascular Accident less than six months old, or nth stroke less than six months old, with no previous sequelae;
* Able to walk at least 10m without stopping, with or without technical assistance, but without human assistance, under supervision;

Exclusion Criteria:

* Palliative or life-threatening situation;
* A patient whose guardian or trustee is not readily available to provide information about the patient
* Neuro-cognitive disorder that prevents understanding of instructions, as determined by the clinician;
* Severe speech or language disorder that prevents the protocol from being carried out correctly;
* Hemineglect;
* Any previously known pathology altering the gait pattern, at the clinician's discretion (recent neurological, traumatological or orthopaedic pathologies, etc.);
* Visual disorder preventing viewing of the video;
* Hearing disorder preventing comprehension.
A 6-Month Extension Study of OTO-104 in Meniere's Disease

This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this open-label extension study.


Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:

* Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3 (104-201508) clinical study.
* Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria

Exclusion Criteria includes, but is not limited to:

* Subject is pregnant or lactating.
* Subject has a history of immunodeficiency disease.
* Subject has experienced an adverse reaction to intratympanic injection of steroids.
Validation of Lophius Kits T-Track® CMV and T-Track® EBV in Hemodialysis Patients

Cell-mediated immunity (CMI) and in particular T cells play a critical role in the rejection of transplanted organs. Thus, in transplant recipients a life-long and individualized immunosuppressive medication is required to avoid graft rejection. However, a too weak suppression of CMI causes acute and chronic graft damage leading to transplant loss, whereas a too potent suppression of CMI supports opportunistic infections and reactivation of persistent viruses.

One of the biggest challenges in the field of transplantation is to provide a personalized immunosuppressive and antiviral therapy based on reliable assessment and monitoring of CMI. This could lead to a reduction of graft rejections and virus reactivations in transplant recipients.

With the development of both assays T-Track® CMV and T-Track® EBV, Lophius Biosciences GmbH has implemented its novel proprietary T-activation technology for an improved assessment of the functionality of CMI in cytomegalovirus (CMV)- and/or Epstein-Barr virus (EBV)-seropositive individuals. In contrast to other existing systems the Lophius assays open up the opportunity to characterize the functionality of CMI as an entire network.

The planned clinical multicenter study aims to verify the suitability of the two assays for a reliable assessment of the functionality of CMI.

Hemodialysis patients have been identified as an appropriate patient cohort for investigating the clinical sensitivity of the Lophius assays as these patients closely resemble kidney transplant recipients prior to an immunosuppressive therapy.

The determination of the functional CMI in the course of an immunosuppressive treatment may in future enable physicians to optimize the individual immunosuppressive and antiviral therapy in transplant recipients to reduce the risk of rejection as well as virus reactivations and associated diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patient being hemodialysis-dependent due to end-stage kidney disease
* Male or female patient at least 18 years of age
* Written informed consent

Exclusion Criteria:

* Patient requires ongoing dosing with a systemic immunosuppressive drug
* Patient has received immunosuppressive therapy within the last three month
* Patient is known to be positive for HIV or suffering from chronic hepatitis infections
* Patient has significant uncontrolled concomitant infections or other unstable medical conditions that could interfere with the study objectives
* Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator
Efficacy of Oral Exercise Training in Oral Frailty

As the elderly grow older, the quality and function of skeletal muscle are affected. Sarcopenia is commonly seen in the elderly, due to the loss of skeletal muscle mass and function, often resulting in loss of activity and weight. Oral frailty refers to the status of oral function decline. Several studies indicate the relationship between sarcopenia and oral frailty, which is assumed to be the predictor of sarcopenia. Oral frailty may also progress to presbyphagia over time, causing higher risk of malnutrition, dehydration, pneumonia, and poor quality of life. In addition, recently, the use of ultrasound can measure the distance and speed of the hyoid bone displacement, thus more clearly assessing the swallowing function. The investigators aim to analyze whether oral exercise training can promote the oral and swallowing performance of the residents with oral frailty, and the feasibility of ultrasound as swallowing function evaluation.

The investigators' study will enroll participants from residential long-term care facilities according to the screening of oral frailty. The participants will be equally arranged to experimental and control groups. The intervention strategies will be given after institutional education training. Oral exercise training will be performed by facility's primary caregiver with professionals' remote supervision for 12 weeks. Evaluation tools include hand grip strength, 6-meter walking test, body composition analysis check (BIA), repeated saliva swallowing test, eating dysfunction scale (EAT-10), Functional Oral Intake Scale (FOIS), quality of life questionnaires, tongue muscle strength test and ultrasound swallowing function test.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or older
* Currently consuming food orally

Exclusion Criteria:

* Previously diagnosed with dysphagia
* Progressive central nervous system or motor disorders (e.g., dementia, Parkinson's disease)
* New-onset central nervous system disease within the past 6 months (e.g., stroke, traumatic brain injury)
* New-onset head and neck cancer within the past 6 months
Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia

The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.

This is a multicenter, randomized, double-blind, 12 week study with a 52-week open-label follow-up to evaluate the safety and efficacy of LCP-AtorFen (the combination of atorvastatin and fenofibrate) in the treatment of hyperlipidemia.

After a wash-out phase, eligible patients will be randomized on a 1:1:1 ratio to either LCP-AtorFen, atorvastatin or fenofibrate for 12 weeks. After the completion of the 12-week phase, all eligible patients will be offered to receive open-label LCP-AtorFen for another 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of dyslipidemia (non-HDL-C \>130 mg/dL and Triglycerides \> or equal to 150 mg/dL and \< or equal to 500 mg/dL).
2. Subject may be currently on a statin or other lipid-lowering therapy but must be willing and able to washout for 8 weeks if on a fibrate or high-dose niacin, 6 weeks if on a statin or low-dose niacin per day, or 4 weeks if on a bile acid sequestrant, ezetimibe, or \>1000 mg of fish oil per day.
3. Other inclusion criteria might apply

Exclusion Criteria:

1. TGs \> 500 mg/dL.
2. History of coronary heart disease (CHD), transient ischemic attacks, stroke or revascularization procedure in the six months prior.
3. Presence of an aortic aneurysm or resection of an aortic aneurysm within six months.
4. Poorly controlled diabetes mellitus (glycosylated hemoglobin \>8.0% )or diabetes mellitus requiring insulin therapy.
5. Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial dysbetalipoproteinemia.
6. History of pancreatitis.
7. Known allergy or sensitivity to statins or fibrates.
8. Poorly controlled hypertension.
9. Other exclusion criteria might apply.
Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy

The aim of this study will be to evaluate the the effect of Thera Togs soft orthotic undergarment on modulation of the spinal geometry and mobility in sagittal plan in children with spastic diplegic cerebral palsy.

Forty children with spastic diplegic CP will be assigned and randomly distributed into two equall groups (A\& B). Control group (A) will receive conventional rehabilitation program for postural correction 2 hours/3 sessions' weekly/3 successive months. Study group (B) will receive conventional rehabilitation protocol as in group (A) plus wearing TheraTogs soft orthotic undergarment. Children evaluation will be carried out before and after the intervention programs to assess postural deviations using the Formetric system.

Eligibility Criteria:
Inclusion Criteria:

* Have a definite diagnosis of spastic diplegia obtained from medical files or personal physicians and supported by magnetic resonance images (MRIs).
* Their weight should be less than 40 kg.
* The degree of spasticity in the affected lower extremity will ranged between grades (1, 1+\&2) according to Modified Ashworth Scale.
* The levels of gross motor function will be selected at level II according to Gross Motor Function Classification System.
* The children will be included have the ability to stand alone for five minutes.
* Children should be able to understand and follow instructions.
* The degree of the spinal kyphosis ,for all participated children , in sagittal plane should be not more than 55° as Kyphosis above 55° is considered as fixed hyper-kyphosis while

Exclusion Criteria:

* Children with GMFCS levels III, IV, and V or use any assistive mobility devices
* Children suffering from allergic problems in their skin.
* Children with visual, auditory or cognitive deficits.
* Fixed and significant deformities of the lower limb and spine.
* Children with surgical interference for the lower limb and spine within the previous 2 years.
* Children with seizures.
* Children with fixed hyper-kyphosis (kyphotic angle is more than 55°).
* Children who used any medications (e.g., steroids) that affect growth or body composition.
Treatment of Refractory Urinary Retention Secondary to Benign Prostatic Hyperplasia (BPH) With Dual Five Alpha Reductase Inhibition Combined With an Alpha Blocker

To determine whether the addition of a dual Five Alpha Reductase Inhitor (Dutasteride) will alleviate urinary retention secondary to BPH in who have failed a voiding trial without a catheter. Following treatment with an Alpha Blocker alone.


Eligibility Criteria:
Inclusion Criteria:

1. Males betewen the ages of 50 and 90 years of age.Written informed consent.
2. Men with acute urinary retention attributed to bladder outlet obstruction caused by BPH, who have failed atleast 1 week trial of alpha blocker treatment.
3. PSA level equal to or greater than 1.5ng/ml and equal to or less than 15 ng/ml.

Exclusion Criteria:

1. Urinary retention attributed to a neurogenic or myogenic bladder dysfunction.
2. Use of psychotrophic medications.
3. Use of antichollinergic medications.
4. Prostate cancer.
5. Allery to five alpha reductase inhibitors.
6. Prior prostate surgery.
7. Urethral stricture.
8. Bladder calculi.
9. Invasive bladder cancer.
10. Inability to understand or agree with the requirements of the study.
11. Any investigational drug received within 30 days prior of study entry.
Medical Nutrition Therapy Program for Pregnant Women With Diabetes

No dietary strategies have been designed and proved for Mexican pregnant women with diabetes. This is a randomized clinical trial of pregnant women with pregestational type 2 diabetes and gestational diabetes that were followed every two weeks until labor to assess the impact of the MNT program on metabolic control, maternal and fetal nutritional status and cost effectiveness. Participants were randomly assigned to one of three medical nutrition therapy (MNT) groups: the MNT 1 group (n=38) received usual medical treatment, counseling from a nutritionist and diabetes educator, using carbohydrate counting (40-45% of carbohydrates)with an intensive educational component; MNT2 group (n=50) had the same treatment, but included only low-moderate glycemic index foods; and NO-MNT group (n=45) received the current hospital treatment. All women will receive a glucose meter so they do self glucose monitoring (pre and postprandial) 2 times a weeks 6 times a day. Weight gain, dietary consumption and glucose concentrations will be evaluated every two weeks. Fetal outcomes (weight, length and presence of complications)will be measured at labor.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women with gestational diabetes (Freinkle´s classification: type A2 and B1) or pregestational type 2 diabetes.
* less than 30 weeks of gestation
* women who plan to attend their pregnancy at the institution (INPerIER)

Exclusion Criteria:

* women with type 1 pregestational diabetes or gestational diabetes type A1.
* women with multiple pregnancies
* women with renal or hepatic disease
* women who could not follow the dietary recommendations within the study
Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine

The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with major depressive disorder.

The U.S. Food and Drug Administration approved vortioxetine to treat major depressive disorder in 2013. Researchers believe vortioxetine may improve pattern separation and pattern completion (i.e., a neurological function) in people with major depressive disorder; thus, this research study aims to determine how vortioxetine increases a person's ability to think. The current study is an open label trial, therefore, all participants will receive vortioxetine. Furthermore, participants receive the vortioxetine at no cost. It will take participants 6 weeks to complete this study. Participants are asked to come to the Mass General Hospital campus for 1 screening visit which includes a full psychiatric evaluation, and 5 additional study visits. During study visits, participants will meet with a clinician and then complete computer based cognitive tests.

Eligibility Criteria:
Inclusion Criteria:

1. Meets Diagnostic and Statistical Manual of Mental Disorders (Versions 4 and 5) criteria for and Major Depressive Disorder.
2. Hamilton Depression Rating Scale-17 score greater than 18.
3. Men and women between ages \>=18 and 65.

Exclusion Criteria:

1. Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5) criteria for schizophrenia, schizoaffective disorder, obsessive compulsive disorder.
2. Unable to follow instructions or otherwise unable to participate in the trial.
3. Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, partner with vasectomy)
4. Patients who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk.
5. Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease.
6. History of seizure disorder.
7. The following Diagnostic and Statistical Manual of Mental Disorders (Version 4) diagnoses (any current or past history, except substance abuse disorders):

   Organic mental disorders, schizoaffective disorder, delusional disorder, psychotic disorders not elsewhere classified.
8. History of multiple adverse drug reactions or allergy to the study drugs.
9. Patients with mood congruent or mood incongruent psychotic features
10. Current use of other psychotropic drugs.
11. Clinical or laboratory evidence of hypothyroidism.
12. Patients who have failed to respond during the course of their current major depressive episode to at least one adequate antidepressant trial, defined as six weeks or more of treatment with citalopram 40 mg/day (or its antidepressant equivalent)
13. Patients who have had electroconvulsive therapy within the 6 months preceding baseline.
14. Concomitant use of serotonergic agents
15. Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5) criteria for bipolar disorder
Feedback and Rewards to Increase Motivation for Therapy in Stroke Rehabilitation

High motivation is a predictor for good therapy results in physical therapy \[Grahn 2000\]. The investigator want to show that it is possible to increase patients motivation for stroke rehabilitation by providing them objective performance feedback about the patients therapy progress.

High motivation is a predictor for good therapy results in physical therapy \[Grahn 2000\]. Additional focus on motivation and rewards has fallen on the topic of stroke rehabilitation since it was shown in an animal model that the brain centers involved with motivation and rewards are crucial to motor learning \[Hosp 2011\].

The investigators goal is to target the overall motivation for therapy. During the guided therapy sessions the therapists will be the main motivators and the investigators do not want to interfere with that. But the amount of guided therapy sessions is often limited due to economical reason rather than therapeutic ones. Therefore patients are encouraged to do training on their own if possible and to be active during the patients stay in the rehabilitation clinic. The investigators target the patients motivation to train by themselves and be active but also the patients attitude towards the guided therapies. It is known that performance feedback can improve motivation \[Harackiewicz 1979\]. Therefore the investigators want to use the data about therapy progress to produce feedback for patients visualizing the patients progress and efforts during the patients stay in the clinic.

The investigators will compare patients who receive normal therapy to patients who receive normal therapy plus performance feedback regarding a variety of motivation measures.

Eligibility Criteria:
Inclusion Criteria:

* First time Inpatient at the Cereneo rehabilitation clinic

Exclusion Criteria:

* Rey-Figur Kopie \<= 25 AND Rechnerisches Denken WIE \<=5
* Becks Depression Inventar (BDI) \> 17
* Major aphasia preventing understanding of study materials (according to the treating physician).
Factors Influencing Quality of Bowel Cleansing for Colonoscopy in Patients With Colorectal Cancer Surgery; Prospective Observational Study

The aim of this study is to clarify the factors influencing quality of bowel cleansing for colonoscopy in patients with colorectal cancer surgery and confirm the adequate bowel cleaning method for patients with colorectal cancer surgery. Through this, ultimately in patients with a history of colorectal cancer who have high risk of colorectal cancer, it could be possible to detect cancerous lesions early and increase the survival rate.

This study is based on observational study Subjects are the patients with colorectal cancer surgery who visits the out patients clinic for follow-up colonoscopy The patient's medical records on the basis of information collected at the point of the colonoscopy performed Quality of bowel cleansing is calculated with the Boston bowel preparation scale Patient compliance and satisfaction are measured.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 20
* patients who underwent colorectal cancer surgery
* patients who underwent follow-up colonoscopy as a conventional medical procedures

Exclusion Criteria:

* age \< 20
* patients who have ileus or bowel obstruction
* patients in pregnant status
* Patients who did not consent to research
Reactive vs. Proactive Pain Control in IBD

The investigators will compare two physician behaviors for managing pain in patients with IBD: proactive vs. reactive. Both the proactive and reactive behavior/strategies are standard of care at the institution in which the study will be performed. The PROACTIVE strategy is an IBD-specific analgesic orderset (built into our EMR and approved by the institution's Pharmacy and Therapeutics committee), the REACTIVE strategy is a traditional "reactive" analgesic prescribing (prescribing medications only when patients have pain). The PROACTIVE IBD-specific analgesic orderset consists of medications which have evidence for use in IBD-related pain. This orderset is an educational guide, it does not force any order. The reactive prescribing habits could contain an array of pain medications depending on what the provider wants to prescribe.

Aims:

Aim 1: To assess whether there is a difference in pain scores or functional activity among hospitalized patients with IBD between reactive vs proactive physician behaviors.

Aim 2: To assess whether there is a difference in inpatient opioid-prescribing between reactive vs proactive physician behaviors.

Aim 3: To assess whether there is a difference in health care utilization, including length-of-stay and 30-day readmission, between reactive vs proactive physician behaviors.

Prospective, investigator-blinded, single-institution randomized-control trial . Consecutive adult patients with IBD (Crohn's disease or ulcerative colitis) admitted to the hospital will be screened for eligibility, and eligible patients will be approached and consented to participate. Subjects will be randomized to receive the P.A.I.N.-Sparing bundle or usual care. Patient randomization will be stratified by provider to avoid bias, using a web-based in-house system (RANDI3). Subjects will also be provided with a fitness tracker (Fitbit(R)) to measure functional status during their hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Adults with confirmed IBD diagnosis
* Admitted for primary IBD-related sign or symptom

Exclusion Criteria:

* Admitted for primary non-IBD complaint
* Surgery in the last 30 days
* Alternative (non-IBD) GI diagnosis determined
* Age \<18
* Pregnancy