cyrilzakka/clinical-trials huggingface dataset:
Feasibility of a High-intensity Interval Training Program in Persons With Multiple Sclerosis Who Have Walking Disability

There is considerable evidence to support the efficacy of moderate intensity continuous (MIC) exercise benefitting clinically-relevant outcomes in persons with multiple sclerosis (MS). However, persons with MS who have walking impairments (pwMS-wd) are severely deconditioned and may achieve superior benefits by engaging in high-intensity interval training (HIIT), especially while utilizing adaptive equipment, such as with recumbent arm/leg stepping (RSTEP). Of the published studies on HIIT in MS, HIIT yielded significant improvements in cardiorespiratory fitness in all but one study. In those studies that directly compared HIIT to MIC exercise, the data indicated a potential superiority of HIIT as compared to MIC in improving physiological conditioning in a time efficient manner. However, this evidence is specific to those with MS with mild to moderate disability engaging in cycle/arm ergometry and an investigation of HIIT in pwMS-wd is needed as the feasibility and potential benefits of engaging in HIIT in pwMS-wd is relatively unknown.

The primary aim of the proposed study is to assess the feasibility of a 12-week, RSTEP HIIT program in pwMS-wd. The secondary aim is to examine changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depressive symptoms as clinically-relevant efficacy outcomes following the 12-week, RSTEP HIIT intervention. It is hypothesized that the intervention will be feasible and lead to positive changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depressive symptoms. This work is informed by recently published data, which indicate that a single bout of RSTEP HIIT taxes the cardiorespiratory system significantly more than MIC exercise, yet without untoward effects on walking, gait, cognition, mood, or enjoyment. These data suggest that RSTEP HIIT may be an acceptable, safe, and tolerable stimulus for chronic exercise training.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or over
* a self-reported diagnosis of multiple sclerosis
* self-reported Expanded Disability Status Scale (EDSS) score \< 8.0 or Patient Determined Disability Steps (PDDS) scale score ≤ 7.0
* relapse free in past 30 days
* willing and able to visit Berry College or University of North Texas on three testing occasions and twenty four training occasions
* asymptomatic status for maximal exercise testing; (g) physician approval for undertaking exercise testing
* a self-reported ability to speak, read, and understand English

Exclusion Criteria:

* Any persons who do not meet the inclusion criteria
Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes (SONATA Study)

Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.


Eligibility Criteria:
Inclusion Criteria:

* person who signed on ICF
* Type 2 diabetic patient who have microalbuminuria or overt proteinuria
* In case of hypertension patients, who keep the same medication steadily over last 4 weeks

Exclusion Criteria:

* patients who have hypersensitivity on sarpogrelate or other salicylic acid
* patients who should keep the antiplatelet agent because of acute cardiac disease or peripheral vein disease
* patients who took other anticoagulant agent within 1 month
* patient who take ACEI OR ARB but not controlled(over 150/100mmHg)
* Type 1 diabetes patients
* Patient who have cardiac or liver problem
* Cr: \>1.8mg/dl or GFR: \<40ml/min
* malignant tumor patients
Nonsurgical Periodontal Care for Diabetes Patients: A Case-Control Study

Diabetes mellitus (DM) and periodontitis are two chronic diseases that are interconnected. The coexistence of these conditions leads to increased severity of periodontitis and challenges in controlling blood glucose levels in diabetic patients. The aim of the present study was to evaluate both the influence of periodontal disease and its treatment in patients with DM in terms of a reduction in glycosylated haemoglobin levels at 3 and 6 months after treatment.

A sequential, nonprobabilistic, controlled, prospective and longitudinal case-control study was carried out at the University Dental Clinic of the Morales Meseguer Hospital in Murcia, Spain. Thirty diabetic patients were divided into two groups. Participants were assigned to either the periodontal treatment group (test group), which received oral hygiene instructions along with scaling and root planing utilizing ultrasound and Gracey curettes, or the nonperiodontal group (control group), which received oral hygiene instructions along with supragingival removal of plaque and calculus using ultrasound. Periodontal and endocrine-metabolic variables were evaluated at baseline and at 3 and 6 months. Clinical periodontal variables such as the plaque index (PI), bleeding on probing (BOP), periodontal probing depth (PPD), clinical attachment level (CAL), and glycosylated haemoglobin (HbA1c) levels were assessed.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria included individuals who met the following specifications: diagnosed with diabetes mellitus, aged 18 years or older, exhibited moderate or advanced periodontitis (clinical insertion loss of 2 mm interproximally or exceeding 3 mm vestibularly or linguodistally in more than 2 nonadjacent teeth), and possessed an HbA1c level between 5.5 and 11. Additionally, participants were allowed to participate in the study only if they did not have any significant diabetic complications and completed the informed consent forms indicating their willingness to participate in the present study.

Exclusion Criteria:

* The exclusion criteria were as follows: patients previously diagnosed and treated for periodontal disease; pregnant or lactating patients; individuals who had taken antibiotics, antiseptics, or medications that could affect the host response during the month prior to the periodontal assessment; patients with uncontrolled DM; and patients who did not sign the informed consent form.
Transcutaneous Electrical Nerve Stimulation (TENS) for Advanced Cancer Pain Patients

Pain is the most common symptom (ca. 80% of patients) on German Palliative Care units and thus, pain control plays a central role in palliative care.

Transcutaneous electrical nerve stimulation (TENS) is a complementary treatment option for patients who experience suboptimal pain control. However, the evidence for the efficacy of TENS in cancer patients is not unambiguous.

The present study is a double blind, placebo-controlled cross-over trial with a short-term follow-up.

The primary aim of this study is to evaluate the efficacy and safety of TENS for cancer pain reduction in advanced cancer patients.

The secondary aim is the explorative identification of subgroups that benefit or do not benefit from TENS.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer pain (caused by tumor or therapy; or associated with tumor) ≥ 3 on an 11-point NRS the last 24 hours
* Age: ≥ 18 years
* Patients receive at least 24 hours palliative care: on palliative care ward, palliative care consultant service or acute pain consultant service

Exclusion Criteria:

* Verbal or cognitive inability to use TENS or to answer the questionnaire
* High probability of dying within the next week
* Pain that is not directly or indirectly related to tumor

Contraindications: Jones (2009) \& Disselhoff (2012)

* electronic implants like pacemakers
* Metal implant on electrode site
* Arrhythmia
* Pregnancy
* Epilepsy
* Dermatological conditions or frail skin on electrode site
* Anamnestically known distinct allergy regarding electrodes

Drop-out criteria after inclusion:

* Patients that decide to stop TENS treatment (at any time or any reason).
* Further treatment is not indicated due a rapid deterioration of the patients' clinical status according to the treating physician.
Upper Extremity Rehabilitation With the BURT Robotic Arm

The overall objective of the proposed study is to carry out usability and design-evaluation assessments of the BURT robotic device for delivering long-term intervention in stroke survivors. The BURT is an upper extremity robotic device that enables the user to see and feel engaging games that encourage intensive therapy. The investigators intend to recruit up to 10 stroke survivors over the course of the study. Participants will train their arm with the BURT for 18 sessions over approximately 6 weeks then participate in a question/answer formatted discussion with research staff to discuss the usability of the device. The investigators will also assess participant's arm function at baseline and after the training sessions.


Eligibility Criteria:
Inclusion Criteria:

* Male and female, age 18-80;
* Having had a stroke (ischemic or hemorrhagic) at least 6 months prior to study
* Moderate to severe upper-limb motor impairments (score of 15-45 out of 66 on the Fugl- Meyer Scale);
* Community dwelling;
* Able to physically fit in the device.

Exclusion Criteria:

* Current participation in rehabilitation program targeting upper extremity function;
* Cognitive impairment resulting to inability to follow instructions or inability to sustain attention for more than 10 minutes;
* Visual impairments not corrected with lenses (visual loss);
* Aphasia sufficient to limit comprehension and completion of the treatment protocol;
* No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy;
* Increased muscle tone (passive movement is difficult);
* Previous diagnosis of neurological diseases other than stroke;
* Other conditions affecting function of the stroke affected upper limb;
* Individuals who present with the following: open wounds, fragile skin, active infection
A Study on the Effect of Education Training on Parents With Autism Based on Denver Model

The goal of this clinical trial is to test the effects of parent training based on Denver model on parents' disease cognition level, coping style, parenting guilt, depression, anxiety and stress, quality of life, etc . The main question\[s\] it aims to answer are:

* What is the status quo of autistic parents' disease cognition level, coping style, parenting guilt, depression, anxiety and stress, and quality of life
* Whether education and training based on Denver model can improve autism parents' disease cognition level, coping style, parenting guilt, depression, anxiety and stress, and quality of life

Participants will receive educational training based on the Denver model. The researchers will compare the Denver model of early intervention with parents who receive regular autism health guidance to explore the effect of early intervention Denver model


Eligibility Criteria:
Inclusion Criteria:

* The child meets the diagnostic criteria for autism in the fifth edition of the American Diagnostic and Statistical Manual of Mental Disorders, and has been diagnosed by a physician；
* Parents of children aged 12-60 months with autism；
* Be the father or mother of the child, live with the child and take the main care of the child；
* Father ≥22 years old, mother ≥20 years old；
* Clear mind, normal intelligence, with normal cognitive ability.

Exclusion Criteria:

* Suffering from serious heart, liver and kidney diseases and mental illness;
* There are other family members suffering from serious illness or mental illness.
Connect to Quit for Smoking

The purpose of this research study is to examine the effectiveness of an intervention designed to reduce smoking in low income veterans within a regional United States Veterans Administration(VA) health care system. A proactive, personalized, coordinated system of care "Connect to Quit (CTQ)" is rooted in the Chronic Care Model. CTQ treats smoking as a chronic condition, like hypertension or diabetes, that requires long term treatment with appropriate combinations of behavioral therapy and pharmacotherapy. CTQ will be evaluated in the context of three (3) VA Pittsburgh Healthcare System (VAPHS) medical practices.

Approximately 40 Primary Care Providers (PCPs), including non-physicians, in the VAPHS and their patients will be recruited and randomized to either Connect to Quit (CTQ) or Usual Care (UC), existing Veterans Health Administration (VHA) services. After PCPs are enrolled, we will begin recruiting their patients who meet eligibility criteria. The desire to quit smoking is not required for participation in the study, as the point of CTQ is to engage smokers at every level of readiness to quit. Target enrollment is 660 participants, approximately 330 in each treatment arm. Participants will be followed for a minimum of 2 years and a maximum of 4. Investigators will measure abstinence (biochemically-validated, 30 day point-prevalence) throughout the study, assessed every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years or older
* Veterans seen by a primary care physician within the VAPHS
* Household income not more than $36,000 annually
* Smoke at least 1 cigarette per day

Exclusion Criteria:

* Smokeless tobacco (snuff or chew) users
* Non-cigarette (e.g., pipe) smokers
* Non-English speaking patients
* Can not be enrolled in another smoking cessation related clinical trial at the time of enrollment
Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)

This study is a randomized prospective trial with 6-month follow up. A non-inferiority hypothesis is tested. A new developed treatment and education programme for type 1 diabetic patients (PRIMAS) will be tested compared to an established treatment and education programme (German DTTP). Primary outcome variable is glycemic control at 6-month follow up. Secondary outcome variables are: diabetes knowledge, diabetes related distress, depressive symptoms, diabetes self-efficacy, self-care behavior, attitudes towards diabetes and insulin treatment, hypoglycemia awareness.

Both programmes consists of 12 lessons with a length of 90 minutes. Eligible type 1 diabetic patients in a diabetologist practice are pooled and randomised either to the new developed PRIMAS programme or to an established education programme for type 1 diabetic patients (DTTP - Treatment and education programme for intensified insulin treatment) as an active comparator.

Eligibility Criteria:
Inclusion criteria:

type 1 diabetes, diabetes duration \> 4 weeks, age 18 - 75 years, BMI 20 - 40 kg/m², A1c 7 - 13 %, ability to understand, speak and write German language, written informed consent.

Exclusion criteria:

current treatment of psychological or psychiatric disorder, dementia or severe cognitive impairment, severe organic disease (e.g. terminal renal disease, cancer with poor prognosis), preventing a regular participation in the training course, pregnancy.
Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of csPCa in Lesions With PI-RADS Score 3

The purpose of this study was to explore the effectiveness of 68Ga-PSMA PET/MRI for improving the detection of csPCa in lesions with PI-RADS score 3. This study is a prospective, observational study, single-center research. After recruiting patients who are suspected prostate cancer with a mpMRI PI-RADS version2 score of 3 and willing to perform prostate biopsy to identify the diagnosis, 68Ga-PSMA PET/MRI will be performed. Lesions will be reaccessed based on PET/MRI findings and compared with the pathological results.


Eligibility Criteria:
Inclusion Criteria:

* males over 18 years old suspected for prostate cancer
* serum PSA between 4ng/ml and 20ng/ml in recent two months
* mpMRI PI-RADS version2 scores 3 in recent two months
* willing to undertake prostate biopsy
* no evidence of non-cancerous factors interfere PSA level, such as catheter insertion, bladder stones, urinary tract infections or drug (e.g. finasteride)
* ECOG 0-1

Exclusion Criteria:

* history of prostate biopsy or other operations
* history of prostate cancer associated treatment
* contraindications for MRI or PET examination (e.g. claustrophobia, pacemakers, hip metal implants, hyperglycemia, glomerular filtration rate less than 50 ml/min)
* not suitable for prostate biopsy (e.g. coagulation dysfunction, skin infection at perineal puncture site)
Virtual Reality Analgesia in Labor: The VRAIL Pilot Study

The purpose of the proposed study is to evaluate the feasibility of using immersive Virtual Reality (VR) during labor. We will also explore whether VR distraction is helpful for reducing subjective pain during labor, even if this pain is severe or excruciating. We predict that VR is feasible in this setting and that VR distraction will reduce acute pain and anxiety during labor.

This study used an over the counter consumer product to create a virtual reality experience so that we could assess whether there was a decrease in perception of pain.

Eligibility Criteria:
Inclusion Criteria:

* Any woman giving birth for the first time at or after 32 weeks
* Low risk pregnancy without obstetric complications
* In first stage of labor for vaginal delivery
* Desires non-pharmacologic alternative for pain control

Exclusion Criteria:

* Younger than 18 or older than 45 years of age
* Presence of fetal or placental anomaly
* High risk pregnancy or anesthetic concerns (BMI\>40, difficult airway, hemorrhage, nonreassuring FHR, malpresentation)
* Current use of pharmacologic analgesia including neuraxial anesthesia
* Not capable of answering study measures using numeric rating scale
* Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
* Any form of contact precautions
* Severe hearing or vision deficits
* Susceptibility to motion sickness
* Seizure history
* History of psychiatric disorder, chronic pain, migraines, or addiction
* Delirium, psychosis, any form of developmental delay, or Organic Brain Disorder
* Requiring an interpreter for communication
Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures

Background:

A predictive factor is a measure that predicts treatment response. Decisions on internal fixations of lower limb fractures should regard predictive factors to personalize (e.g. age) treatment. However for most potentially influencing factors valid data on the predictive value is sparse.

Objectives:

The objective of this study is to identify predictive factors and quantify their predictive ability for treatment failure in patients with limb fractures treated with osteosynthesis.

Methods:

Patients Adult patients (≥18 year) with isolated fractures scheduled for urgent or semi-urgent surgery using internal fixations because of lower limb fractures.

The predictive value of the following exposures will be analyzed:

* Age
* Gender
* Diabetes
* Smoking status
* Body Mass Index
* Open fractures
* Peripheral arterial disease

Outcome The outcome will be (time to) reoperation of the same fracture because of failure of internal fixation due to nonunion or implant failure.

Study design A prospective observational cohort study will be performed. Sample size 300 patients will be included.

Statistical analysis:

For the main analysis a multivariate stratified Cox proportional hazard model will be used. The Model will be stratified according to the indication. In the Cox proportional hazard model all predictive factors will be entered simultaneously to quantify the independent influence (adjusted for all other factors) of each factor. The strength of prediction will be described with hazard rations and their corresponding 95% confidence intervals.

see study protocol: https://uni-wh.de/fileadmin/user_upload/03_G/07_Humanmedizin/05_Institute/IFOM/IFF-PROFAK_Protocol.pdf

Eligibility Criteria:
Inclusion Criteria:

Adult patients (≥18 years) with isolated fractures scheduled for urgent or semi-urgent surgery using internal fixations because of the following lower limb fractures will be included:

* Tibia fractures
* Femur fractures
* Ankle fractures
* Calcaneal fractures

Exclusion Criteria:

* Periprosthetic fractures
* Insufficient knowledge of the German language
* Strong cognitive impairment
Synovial Aspiration and Serological Testing in Two-stage Revision Arthroplasty of Prosthetic Joint Infection

The two-stage protocol is gold standard in terms of infection control treating prosthetic joint infections of total hip and total knee arthroplasty. The antibiotic pause for diagnostic reasons before reconstruction (stage two) is discussed concerning persistence of infection and development of resistant bacterial strains. Serological markers and synovial analysis are common use to exclude persistence of infection.

The investigators therefore asked 1) is the serological testing of c-reactive protein and leukocytes a valuable tool to predict a persistence of infection and 2) what is the role of synovial aspiration of PMMA Spacers on hip and knee joints.


Eligibility Criteria:
Inclusion Criteria:

* Patients with periprostheitc joint infection

Exclusion Criteria:

* Reinfection in history
Correlation Between Quality of Life and Aerobic Physical Fitness of Patients With a Systemic Right Ventricle

Congenital heart disease (CHD) is the most common congenital malformations. The right ventricle in the sub-aortic position, or "systemic right ventricle" is one of these complex cardiac diseases. Several studies show that adults with CHD and especially systemic right ventricle have reduced exercise capacity. In addition, studies have shown that there is a correlation between alteration of aerobic physical capacity and alteration of right ventricular systolic function.

Understanding and assessing the determinants of the physical capacity of patients with systemic right ventricles and evaluating their quality of life could allows us to improve their therapeutic management and also to expand patient indications to a program cardiac rehabilitation. This can benefit them on their exercise capacity, their tolerance to exercise and their quality of life.

The aim is to study the correlation between the quality of life and the aerobic physical fitness of patients with a systemic right ventricle and to determine the clinical and paraclinical parameters that have an impact on the aerobic physical fitness of these patients. The quality of life of patients with a systemic right ventricle will be compared to that of the general population.

100 patients will be enrolled in this study. 25 sites will participate to the enrollment, belonging to the French national network for complex congenital heart diseases (M3C) .

Patient is included during his annual medical check-up. Quality of life questionnaire and other examinations are performed during this site visit. Its is a part of his usual care. No supplementary visit, directly related to the research, are necessary.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient with a right ventricle in the systemic position
* Patient having undergone an annual assessment in accordance with the ESC (European Society of Cardiology) 2010 recommendations: clinical examination, ECG, echocardiography, cardiopulmonary exercise test (with VO2)

Exclusion Criteria:

* Objection of the patient
* Impossibility of performing an exercise test
* Inability to understand and / or complete the questionnaire
LTFU Study of Subjects With Cervical SCI Who Received AST-OPC1

This is a LTFU study for cervical SCI subjects that were administered AST-OPC1 cells in the main study AST-OPC1-01.

Study AST-OPC1-02 is a Phase 1/2a open-label, multi-center long term follow-up (LTFU) study for twenty-five (25) subjects with cervical SCI that were administered AST-OPC1 cells in the main dose-escalation study AST-OPC1-01. The purpose of this study is to monitor long-term safety in subjects for 15 years post AST-OPC1 administration.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who received AST-OPC1 under Study AST-OPC1-01
* Reconfirmation of consent for long-term follow-up

Exclusion Criteria:

•Subjects who, for geographic or compliance reasons, are inappropriate candidates for participation in a long-term follow-up study in the opinion of the Investigator