cyrilzakka/clinical-trials huggingface dataset:
ArmeoSenso - Home Therapy and Assessment for Patients With Arm Impairments Based on Wearable Movement Sensors

stroke, spinal cord injury, rehabilitation, home therapy, upper limb, arm, virtual reality, interia sensor,

* Trial with medical device


Eligibility Criteria:
Inclusion criteria:

* 18 years old
* Stroke or spinal cord injury in prehistory
* Motor deficits of the upper limb (s)
* Lifting the paretic arm against gravity possible AND
* Minimum amount of movement in the horizontal plane of 20 x 20 cm
* Ability and willingness to participate in the study

Exclusion criteria:

* Severe aphasia
* Severe dementia
* Severe depression
* Relevant restriction of vision, which can not be compensated by aids (eg hemianopia)
Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female subjects at least 40 years of age and no older than 80 at Visit 1.
* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
* Average f the -60 and the -30 min pre-dose FEV1 assessments must be \< 80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations.
* Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol

Key Exclusion Criteria:

* Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
* Current diagnosis of asthma or alpha-1 antitrypsin deficiency
* Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
* Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
* Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period
* Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
* Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.
* Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
* Congestive heart failure (CHF) New York Heart Association (NYHA) Class III/IV)
* Clinically significant abnormal 12-lead ECG
* Abnormal liver function tests defined as aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing
* Cancer not in complete remission for at least five years
* History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI

Other protocol-defined inclusion/exclusion criteria may apply
To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis

To demonstrate that CT-P13 is equivalent to China-approved Remicade at Week 14, in terms of efficacy as determined by clinical response according to the change from baseline in disease activity.


Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of rheumatoid arthritis
* Has active disease as defined in DAS28 Criteria

Exclusion Criteria:

* Has a history of tuberculosis (TB) or a current diagnosis of TB
* Has previously received a biological agent
* Has previously received a tumor necrosis factor alpha (TNF α) inhibitor
* Allergies to any of the excipients of infliximab or hypersensitivity to murine and/or human proteins or immunoglobulin products
* Pregnant or lactating
Nesfatin-1 Level in Patients With Type 2 Diabetes, Insulin Resistance and Obesity

This research was planned to determine the level of nesfatin-1, known as satiety hormone, in type 2 diabetes, insulin diabetes and obesity patients and to determine whether there is a relationship between patients' energy intake levels. Additionally, it was aimed to evaluate the relationship between patients' nesfatin-1 values and serum glucose, insulin, lipid concentrations.

Nesfatin-1 levels of patients with type 2 diabetes, insulin resistance and obesity will be measured. In addition, patients' daily food consumption will be taken and the amount of energy they receive will be calculated daily. The relationship between the level of nesfatin-1 in the blood and the energy received will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Insulin resistance
* Obesity disease

Exclusion Criteria:

* Pediatric individuals
* All patients who are hospitalized,
* Liver disease
* Cancer patients
* Disease related to the gastrointestinal tract
* Nephrological disease such as chronic kidney failure, acute kidney failure, nephrotic syndrome
* Neurological disease
Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode

The purpose of this study is to determine the feasibility of preserving low-frequency acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode.


Eligibility Criteria:
Inclusion Criteria:

* No previous cochlear implant experience
* 18 years of age or older
* Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the ear to be implanted
* Aided monosyllabic word score of 10-50% in the ear to be implanted
* Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear
* English language proficiency
* Willingness to participate in all scheduled procedures outlined in the protocol

Exclusion Criteria:

* Previous inner ear surgery
* Cochlear malformation or obstruction that would preclude full insertion of electrode array
* Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
* Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures
* Evidence of central auditory lesion or compromised auditory nerve
Assessment of Oral Health in Minors Incarcerated At Fleury Merogis: Retrospective Observational Study

The goal of this study is to assess the oral health of males juveniles incarcerated at Fleury-Mérogis over a given period.

The goal is also to understand the needs of these patients and improve their care in prison while raising awareness about oral health to achieve lasting results.

Hypothesis: Incarcerated juveniles often grew up in precarious conditions. Is their DMFT (decayed, missing, filled permanent teeth) index higher than the "standard" juvenile population? Public interest: Understanding the needs of these juvenile patients, public health data.

By comparing our results to those of the "standard" population (non-incarcerated minors) through a literature review regarding the DMFT index in these patients, we will determine whether incarcerated juvenile patients represent a population at risk of developing oral pathologies. Oral disease prevention for these patients to raise awareness of the importance of oral hygiene and follow-up dental appointments outside of the prison system. The earlier these patients are educated, the greater the chance they will develop better habits throughout their lives.

This is a retrospective observational study in which we will collect data from the first dental consultation between June 2024 and December 2024.

The primary objective is to assess the oral health of minors incarcerated at Fleury-Mérogis using the primary outcome measure, the DMFT index.

77 male minors are included in the study. Data will be collected retrospectively by the research team from their medical records.

The data will be collected by the research team in a pseudo-anonymized form in an electronic CRF (case report form) and then analyzed by the biostatistician at the Clinical Research Unit of the Centre Hospitalier Sud Francilien.

Eligibility Criteria:
Inclusion Criteria:

* Male minor patients incarcerated at the Fleury-Mérogis Prison between June 2024 and December 2024
* Patients who have had a dental check-up

Exclusion Criteria:

- Patients and/or those with parental authority who have been informed and have objected to the use of their data.- Female patients and/or those with parental authority over the newborn who have objected to the use of their data.
Inpatient Obesity Intervention With Phone Follow-up

In this study we sought to determine whether inpatient weight loss counseling with post discharge phone follow-up would result in weight loss at six months. Secondary endpoints included weight change from baseline, changes in waist-to-hip ratios, assessment of weight perceptions and changes in patient reported health outcome measures. To our knowledge, this is the first randomized trial designed to evaluate the effects of an obesity intervention with post-discharge follow-up in an inpatient general medicine population.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-65 years old
* Body mass index between 30-50 kg/m2
* Admitted to an internal medicine service

Exclusion Criteria:

* acute medical conditions known to affect weight (heart failure, cirrhosis, end-stage renal disease on dialysis, nephrotic syndrome, or pregnancy)
* Charlson comorbidity index \>3
* moderate to severe major depression
* prolonged steroid use (\>2 weeks)
* initiation of medications known to affect weight
* non-English speaking
* precontemplation stage of change
Effectiveness of Tai Chi on Cardiac Autonomic Function and Symptomatology in Women With Fibromyalgia: a Randomized Controlled Trial

Fibromyalgia (FM) is an idiopathic disease affecting approximately 3% of the world population, primarily diagnosed in middle-aged women. Although FM is mainly characterized by chronic pain and fatigue, reduced muscular strength and flexibility are common symptoms associated with the presentation of the disorder. Interestingly, the etiology and underlying mechanism of FM are not completely understood, but previous findings suggest that autonomic dysfunction may explain some of the FM symptoms.

Compared to age-matched healthy individuals, patients with FM have an attenuated autonomic function which is associated with a reduction in vagal tone and increase in sympathetic activity. Therefore, autonomic function is a worthwhile target intervention in individuals with FM. Although traditional exercise ( both aerobic and resistance) has been shown to effectively improve HRV parameters and FM symptoms, most FM patients display a decline in adherence to traditional exercise and continue to experience considerable pain and fatigue years after the original diagnosis ultimately requiring medication to control their symptoms.Thus, new approaches are needed to improve autonomic function and clinical symptoms in patients with FM, which will ultimately improve their physical and emotional functioning leading to a better quality of life.

Tai Chi (TC) is a form of ancient Chinese martial art which integrates slow movements, controlled breathing and mental concentration. TC training is safe for special populations and has previously shown to decrease pain, fatigue as well as other FM related symptoms.However, the potential role of TC training on autonomic function is largely unexplored.

The investigators hypothesis is that 12 weeks of TC training would improve our primary outcome of autonomic function through improvements in sympathovagal balance, and the secondary outcomes measures of FM symptoms (pain, fatigue and sleep quality), strength and flexibility.

The purpose of this study is to examine the effects of 12 weeks of TC training on on cardiac autonomic function, FM symptoms (pain, fatigue and sleep quality), strength and flexibility. The specific aim of the study is:

- To evaluate the effects of 12 weeks of TC training on autonomic function arterial function by assessing heart rate variability

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia
* Sedentary

Exclusion Criteria:

* Known pulmonary, cardiovascular, renal, adrenal, pituitary, severe psychiatric or thyroid diseases.
* Use of hormone replacement therapy during the 6 months prior to the study.
* Any medication changes in the previous 12 months.
* Current participation in psychological or physical therapy
* History of steady exercise or received exercise training in the last year
Bronchial Response to Mannitol and Inflammation in Steroid Naive Asthmatics.

Study on the relationship between the response of the airways to a bronchial provocation test with mannitol and the degree of airway inflammation in asthma patients.

Study on the relationship between the response of the airways to a bronchial provocation test with mannitol and the degree of airway inflammation in asthma patients.

Eligibility Criteria:
Inclusion Criteria:

* Steroid naive asthma.
* Non-smoker

Exclusion Criteria:
Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia

To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders \[DSM\]-IV-TR criteria and made by a specialist in psychiatry) and acute exacerbation of schizophrenia requiring hospitalization
* Total PANSS score of ?60 at screening
* History of schizophrenia of ?10 years (from onset of prodromal symptoms)

Exclusion criteria:

* Axis-I DSM-IV-TR diagnosis other than schizophrenia
* Less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic
* Currently taking celecoxib or other selective cyclo-oxygenase 2 inhibitors, or other antiinflammatory medication
Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer

The aim of this prospective randomized study is to compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer.

Early closer is defined as postoperative days 8-12 and delayed as later then 3 months.

Inclusion criteria is aged 18 years or older with rectal carcinoma, requiring rectal resection with a protecting ileostoma.

A CT-water-soluble contrast enema examination per rectum is performed at day 7, to evaluate the anastomosis in all patients. The patients will be randomized after the "intention-to-treat" principle, before the primary operation.

If there is no radiologic signs of contrast leakage ore other contraindications for early closer as septic episodes ore missing bowl movements the early closure will be preformed.

Primary end point is the rate of either postoperative death or postoperative complications occurring at 90 days after the rectal resection.

Major and minor postoperative complications (anastomotic leakage, post operative death, anastomotic fistula, postoperative peritonitis, pneumonia etc) and stoma related complications (prolapsus or peristomial eventration, erosive peristomal dermatitis, dehydration with hydroelectrolytic disorders, occlusive syndrome) would be registered.

LARS score and EORTC QLQ-30 will be sent preoperatively and after 3, 6, 12 and 24 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 years or older.
* All patients with rectal carcinoma, requiring elective rectal resection with primary anastomosis and an protecting ileostoma
* Written informed consent was obtained from all patients

Exclusion Criteria:
Comparative Effects of Conventional Physical Therapy, Kinesio Taping and ESWT in Upper Trapezius MPS.

There is no study in the literature comparing both kinesiotaping and Extracorporeal Shock Wave Therapy (ESWT) with conventional physical therapy in upper trapezius myofascial pain syndrome. In this study, we aimed to make this comparison.


Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 1 active trigger point in the upper trapezius muscle, exacerbation of pain when this point(s) is pressed, painful limitation of cervical lateral flexion and extension.

Exclusion Criteria:

* Having a history of spine and upper extremity surgery, neuromuscular disease, active rheumatologic disease, active infection, malignancy, having previously applied ESWT or Kinesio Taping to the back and neck region.
Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)

This study will evaluate the referral to harm reduction services (HRS) including syringe services, naloxone overdose prevention, substance use treatment referral, HIV, HCV, and STD testing and referral and linkage to care through capacity building of existing programs through client services data.

This is a prospective longitudinal Type 1 Hybrid Implementation Effectiveness Study on the expansion of harm reduction services for people who inject drugs (PWID) and people who use opioids (PWUO) residing in high risk areas of rural southern Illinois. This study record describes one component of the larger Ending transmission of HIV, HCV, and STDs and overdose in rural communities of people who inject drugs (ETHIC) study Community Response Plan (CRP) framework, specifically the expansion of harm reduction services intervention (HRS). The aim is to assess the effectiveness of expansion of evidenced based harm reduction services through our CRP framework comprising: a) geographically targeted recruitment based on hot spot and vulnerability analyses, b) community engagement, c) recruitment via Respondent Driven Sampling (RDS), d) expanded surveillance for HIV and HCV, and e) concomitant HCV and opioid use treatment capacity expansion through the Extension of Community Healthcare Outcomes (ECHO) model. Examination of facilitators and barriers impacting implementation of service delivery is evaluated through mixed methods process evaluation. The Type 1 Hybrid design is supported by conditions including the existing evidence based for benefits and minimal harm of "harm reduction services" and strong base for applicability of this intervention in the study setting (ie rural opioid use)

Eligibility Criteria:
Inclusion Criteria:

* 15 years of age and older
* Injected any drug in the past 30 days
* Used any opioids non-medically in the past 30 days
* English speaking
* Able to provide informed consent at the time of the study visit

Exclusion Criteria:

* Less than 15 years of age
* Not injected any drug in the past 30 days
* Not used any opioids non-medically in past 30 days
* Non-English speaking
* Has not injected any opioid drug to get high in the past 30 days
* Unable to provide informed consent at the time of the study visit
Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor

Primary Objective:

To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants ≥18 years old.
2. Participants with Stage V chronic kidney disease who received a kidney transplant from a deceased donor to whom they were sensitized.
3. History of prior exposure to HLA (human leukocyte antigen):

   * Prior solid organ or tissue allograft
   * Pregnancy
   * Blood transfusion
   * Prior exposure to specific donor's HLA

Exclusion Criteria:

1. Has received treatment with eculizumab at any time prior to enrolling in this study.
2. Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased donor.
3. History of severe cardiac disease.
4. Prior splenectomy.
A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers

This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained from the subject
2. Male or female subject is aged between 18 and 65 years
3. Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2
4. Free from any clinically relevant illness or disease incl. skin disorder that may adversely affect the safety of the subject or the integrity of the study

Exclusion Criteria:

1. Presence or history of a clinically significant medical condition or other condition that might interfere with the safety, tolerability and PK assessment of ointment YR001, or place the subject at an unacceptable risk as a subject in this study.
2. Pregnant or lactating women.
3. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.
4. Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the skin areas to be dosed that may interfere with study assessments and treatment response.
5. Have active infectious disease.
6. Subjects treated with another investigational drug, biological agent, or device
7. Participation in another interventional clinical trial before entering, or during the trial, or previous participation in this clinical trial.
8. Evidence of clinically important cardiac conduction abnormalities at screening as judged by ECG.
9. Active untreated mental or psychiatric disorder.
10. Any major surgery within 6 months of screening.
11. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.

13. Drug or alcohol abuse history.