cyrilzakka/clinical-trials huggingface dataset:
A Study of NIDO-361 in Patients With SBMA

The purpose of this study is to evaluate the safety, tolerability, and efficacy of NIDO-361 in adult patients with Spinal and Bulbar Muscular Atrophy (SBMA).


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory male
* Documented SBMA diagnosis confirmed by DNA genetic testing
* Able to complete six-minute walk test (6MWT)

Exclusion Criteria:

* Clinically significant cardiovascular, endocrine, hepatic, renal, pulmonary, gastrointestinal, neurologic, immunologic, malignant, metabolic, psychiatric, or other condition that, in the opinion of the Investigator, precludes the participant's safe participation in the study or would interfere with the study assessments
* Inability to undergo MRI (mild sedation may be allowed)
Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury

This purpose of this study is to evaluate the evaluate the efficacy of Magnesium Isoglycyrrhizinate Injection in the prevention of antineoplastic chemotherapy related acute liver injury.

Total subjects: 2040, experimental group of 1360 patients, control group of 680 patients. According to the study subjects receiving antineoplastic chemotherapy, subjects are stratified randomize.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18-75 years;
2. Patients with malignant tumor accord with chemotherapy indication, candidate to a chemotherapy treatment, disease is not restricted;
3. Accorded with the following chemotherapy plan: included cis-platinum, ≥60mg/m2/course; included oxaliplatin, ≥85mg/m2/course; included cyclophosphamide, ≥600mg/m2/course; included gemcitabine, ≥60mg/m2/course;
4. ECOG≤2;
5. Estimates survival time≥3 months;
6. TBIL≤1.0×ULN, ALT、AST≤1.0×ULN; blood examination, uronoscopy, stool examination, renal function tests and electrocardiogram are normal;
7. Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks).

Exclusion Criteria:

1. Patients with partial liver radiotherapy;
2. Hepatitis B or C virus replication in the state, the patient will need antiviral therapy;
3. Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;
4. Patients combined with cellular immune therapy;
5. Within 2 weeks of application or currently possible applications of drugs(polyene phosphatidylcholine, reduced glutathione, tiopronin and other hepatoprotective and choleretic drugs), interference with the study;
6. Pregnancy, or patients during breast feeding;
7. Patients have known hypersensitivity to Glycyrrhizin;
8. Patients are participating, or have participated in other Clinical studies of new drugs within 4 weeks.
Rheumatology Informatics System for Effectiveness

The RISE Registry is an enhanced version of the ACR's Rheumatology Clinical Registry (RCR) and allows for a simplified entry process, while establishing a best-in-class resource to manage your patient population and improve patient care.

RISE provides participants with an infrastructure for robust quality improvement activities leading to improved patient outcomes, patient population management and quality reporting related to rheumatic diseases and drug safety. RISE gives physicians and researchers the information they need to optimize patient outcomes, meet reporting requirements, and make discoveries that advance rheumatology.

RISE helps providers benchmark performances on key rheumatology clinical quality measures and align with best practice standards. The RISE benchmarking tool allows providers to view the details of their patient population against established rheumatology quality metrics. RISE allows access to aggregate data from other participating sites so providers can view their patient population in comparison to other RISE participants.

RISE is integrated into an electronic health records (EHR) system, bringing a single point of entry into one solution for filing for quality-based incentive payments, avoiding penalties, complying with reporting requirements and tracking caseloads for quality monitoring and improvement initiatives. RISE collects the data needed to meet current federal reporting requirements.

Participating in RISE helps push the field of rheumatology practice forward. RISE provides a source of information on patient outcomes and quality care for rheumatology leading to new discoveries, better understanding and a source of comparative effectiveness research.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age and older with one of the following diagnoses: rheumatoid arthritis, osteoarthritis, gout

Exclusion Criteria:

-
Insulin Dependent Gestational Diabetes Mellitus: Randomized Trial of Induction of Labour at 38 and 40 Weeks of Gestation

To evaluate the impact of induction of labour at 38 weeks with the induction of labour at 40 weeks in women with insulin dependent gestational diabetes mellitus on maternal and fetal outcome.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women with insulin dependent gestational diabetes mellitus

Exclusion Criteria:

* chronic inflammatory disease,
* autoimmune disease,
* pre-existing diabetes mellitus,
* previous cesarean section,
* multiple pregnancies
Physical Exercise for Patients With Head and Neck Cancer

The goal of this trial within cohorts study is to determine and compare physical performance, muscle strength, fatigue, quality of life, body composition, nutritional status, physical activity, treatment tolerability of radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT), and healthcare related costs in patients with head and neck cancer (HNC) with and without a 10 week physical exercise intervention (PEI) during RT, CRT or BRT ((C/B)RT).

Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI twice a week for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.

Researchers will compare patients who undergo the PEI with patients who did not undergo the PEI to see if there is difference in physical performance, muscle strength, fatigue, Quality of Life, body composition, nutritional status, physical activity, treatment tolerability of (C/B)RT , and healthcare related costs in patients with Head and Neck Cancer (HNC) with and without a 10 week Physical Exercise Intervention (PEI) during (C/B)RT).


Eligibility Criteria:
Inclusion Criteria:

1. patients with HNC who are scheduled for (C/B)RT,
2. ≥18 years of age,
3. sufficient Dutch writing and reading skills,
4. a Karnofsky performance status (KPS) \>60,
5. able to walk ≥60m without a mobility aid, and
6. no contraindication for physical activity as measured with the physical activity readiness questionnaire (PAR-Q).

Exclusion Criteria:

1. recurrence of HNC and/or
2. secondary HNC.
Prediction of Claustrophobia During MR Imaging

The objective of the study is to search for possible predictors for claustrophobia during magnetic resonance (MR) imaging. A claustrophobic event shall be defined by an incomplete examination, or a complete examination that requires coping actions by the staff. Coping actions may consist of the administration of sedatives, prism glasses, an MR imaging test run with the patient, a pause, the prone position, an escort in the scanner room, and supportive communication. The investigators hypothesize that there is a difference between patients with and without events in their scores on the Claustrophobia Questionnaire and several further psychometric questions. Other factors may also favour events like patient characteristics, examined region, duration of the examination and scanner type. Therefore, predictors could identify patients who are likely to experience claustrophobia during MR imaging so that they can receive the appropriate support by the staff to complete their examination. Thus a larger patient population could benefit from MR imaging.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients and outpatients referred to MR imaging with a clinical indication of any part of the body
* Mentally and physically able to fill out a questionnaire
* Sufficient German language skills

Exclusion Criteria:

* Age under 18 years
* Patients from the Intensive Care Unit
* Severe emergencies
* Surgery during MR imaging
* Participation in other studies
* Fetal and prenatal examinations
* Referral from medical jurisprudence
A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the body) of NNC 151-0000-0000 in subjects with rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* CZ: Age between 18 and 65 years (both inclusive)
* A diagnosis of rheumatoid arthritis of at least three months before entry in trial
* Active rheumatoid arthritis (RA)
* Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks before trial drug administration

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Body mass index (BMI) less than 18.0 or more than 38.0 kg/m2 (inclusive)
Myocardial Function Assessment in Patients With Coronary Artery Disease Using Noninvasive Myocardial Work

Noninvasive pressure-strain loop (PSL) derived myocardial work (MW) are more sensitive than conventional echocardiographic parameters in quantitative assessment of early myocardial dysfunction. The aim of this study was to assess left ventricular (LV) myocardial function in symptomatic patients with coronary artery disease using the promising method.

Methods: Transthoracic echocardiography was performed on patients with angina or equivalent symptoms before coronary angiography. Images were stored and imported into the software for further offline analysis of PSL-based MW. MW analysis were carried out on each patient for global and regional myocardial function assessment.


Eligibility Criteria:
Inclusion Criteria: Patients who were hospitalized for coronary angiography with angina or equivalent symptoms.

-

Exclusion Criteria: Acute coronary syndrome, left main stem coronary disease, left ventricular ejection fraction (LVEF) below 55%, observed resting regional wall motion abnormalities (RWMAs), non-sinus rhythm, intraventricular block, previous cardiac surgery, severe valvular heart disease, hypertrophic cardiomyopathy, myocarditis, pericardial diseases, pulmonary hypertension, and poor image quality.

-
Physiological, Microbiological and Metabolomic Effects of Fruit Products

This study is a randomised, parallel group, controlled trial, comparing the effects of fruit products as to their physiological, microbiologic and metabolomic effects on the gut, as well as their effects on the dietary intake and quality in healthy people with constipation.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18-65 years.
2. Individuals meeting the Rome IV criteria for functional constipation, in addition to having \<7 bowel movements per week and hard or lumpy stools present in ⩾25% of their defecations (defined as Type 1 \& 2 of the Bristol Stool Form Scale).
3. Individuals who are willing to consume fruit products for 4 weeks.
4. Individuals who consume \<30g of fibre per day
5. Individuals with a BMI of 18.5-29.99 kg/m2.
6. Individuals able to give informed consent.

Exclusion Criteria:

1. Females who report to be pregnant or lactating.
2. Regular consumers of the fruit products used in the intervention arm 1 (3 or more portions per week).
3. Allergy, intolerance or dislike of the fruit products used in this intervention.
4. Sulphite allergy or sensitivity.
5. Ongoing alcohol, drug or medication abuse.
6. Major medical condition (diabetes, psychiatric or current eating disorders), gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease) or history of previous GI surgery, except cholecystectomy, appendicectomy and haemorrhoidectomy.
7. Medications which affect their gut physiology, function and symptoms in the last 4 weeks, and individuals who are not willing or cannot discontinue them.
8. Frequent use of rescue laxatives.
Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis

Approximately 30% of patients with rheumatoid arthritis have an inadequate response to anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second anti-TNF or change of biologic, with a different mechanism of action, such as abatacept, rituximab and tocilizumab. No controlled trial compared these two strategies face to face. The present objective is to investigate the issue whether one of these strategies could have a better efficacy in a pragmatic trial in the setting of current practice.


Eligibility Criteria:
Inclusion Criteria:

* Active and erosive rheumatoid arthritis with a DAS28 equal or greater than 3.2
* Inadequate response to a 1st anti-TNF
* Stable or no treatment with any DMARDs, or oral corticosteroids (\< or = to 10 mg/day of prednisone equivalent)during the preceding month

Exclusion Criteria:

* Counter-indication to other anti-TNF, abatacept, rituximab or tocilizumab
* Pregnancy
* Age \< 18 years
* Impossibility to give informed consent
* Impossibility to be followed for 12 months
Effects OF NMES With and Without Dynamic Bracing on Spasticity and Movement Quality in CP

The study aims at comparing Neuromuscular electrical Stimulation with and without dynamic bracing on spasticity and movement quality of lower limb in Children with Cerebral Palsy

Cerebral palsy (CP) is a lifelong motor impairment caused by an early brain injury and affects 2-3 per 1,000 live births. It is a complex medical condition that negatively impacts cognition, language, sensations, movement, and gait patterns. It is normally carried out using a comprehensive approach that incorporates numerous approaches targeted at minimizing symptoms and improving functional outcomes.

NMES (Neuromuscular and Muscular Electrical Stimulation) is an instrument that provides electrical impulses to nerves, causing muscles to contract, while dynamic bracing use muscle power to pre-compress soft tissue to produce the high forces required to control specific pathological diseases.

The hip adductors, the knee flexor muscles, and the ankle and foot muscles (gastrocnemius and soleus may experience increased tone, causing the ankles to be held in a plantar-flexed (pointed downward) position) are targeted with NMES in the lower extremity to reduce the spasticity \& improve the quality of movement in CP children. Investigating how combining NMES with dynamic bracing benefits lumbar disc bulge patients adds to the growing body of evidence supporting multimodal treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 5 to 12 years.
* Able to walk with or without an assistive device. Classification as level I-II on the Gross Motor Functional Classification System (GMFCS).
* Able to stand with or without support for 1 minute.
* Classification as levels I-III on the Manual Ability Classification System (MACS); and the ability to follow and accept verbal instructions.
* Muscle tone scored ≥2, according to Modified Ashworth Scale.

Exclusion Criteria:

* Orthopedic Surgical intervention (e.g. tendon lengthening in lower limb) within the previous 12 months
* Treatment with botulinum toxin in the calf muscles within the previous 6 months
* Presence of structural deformities at the lower limbs and trunk, or instability in the ankle joint, which could compromise the child's safety and performance of the motor task
* Severe affective or psychiatric impairments;
* Serious vision or hearing problems
* Any neurological impairment (epilepsy or any other disease that would interfere with physical activity)
A Study of Ramosetron Plus DX, Dexamethasone, Compared to Granisetron Plus DX for the Prevention of Vomiting and Nausea

The purpose of this study is to compare the efficacy and safety of ramosetron plus dexamethasone injection with granisetron plus dexamethasone injection for the prevention of chemotherapy-induced vomiting and nausea.


Eligibility Criteria:
Inclusion Criteria:

* Subject with age between 20-74 years old (inclusive) of either sex
* Cancer subject is scheduled to receive the designated chemotherapy programs
* Subject without symptoms of vomiting for at least one week before dosing trial medication
* Subject with ECOG performance status scale no greater than 2
* Subject has signed the written informed consent form

Exclusion Criteria:

* Subject has received radiotherapy to the abdomen or pelvis within 4 weeks before entering this study
* Subject has received the designated chemotherapy programs within 6 months before entering the study
* Subject has known heart failure or myocardial infraction or with laboratory abnormalities at screening
* Subject has known concurrent diseases that may cause vomiting
* Subject has taken medications that could influence the outcome of the study within 3 days before entering the study
* Subject with a history of allergy or intolerance to ramosetron, granisetron or dexamethasone
* Female subject who is pregnant or breastfeeding
* Subject with life expectancy less than 3 months
* Subject participated other investigational drug trial within 1 month before entering this study
Comparing Two Training Methods for Opioid Wizard

The prevalence of opioid use disorder (OUD) and opioid-related deaths has risen dramatically in recent years. Effective treatments, including medications for opioid use disorder (MOUDs; e.g., buprenorphine-naloxone and methadone) are under-utilized. There are few evidence-based interventions for changing attitudes toward Opioid Use Disorder (OUD) in the general public and especially among healthcare clinicians. This study proposed an innovative intervention to change attitudes of Primary Care Clinicians (PCCs) toward persons with OUD. Study participants were stratified into one of two online learning courses: the intervention training was compared with an attention-control training.

Primary care offers an ideal setting in which to treat OUD; however, few clinicians are waivered to prescribe buprenorphine and of those who are waivered, less than one-third do prescribe. One potential barrier to increasing access to MOUDs are primary care clinician (PCC) attitudes towards people with OUD.

This study used a randomized controlled trial design to examine a novel intervention to change attitudes towards people with OUD among PCCs. PCCs in clinics randomized to the intervention in COMPUTE 2.0 (PCCs in 15 of the 30 clinics randomized in the parent study) were randomized 1:1 to the intervention or comparison training, stratified by clinic and waiver status. Training was conducted via MyLearning, an online learning software. All PCCs were asked to complete a brief training (25-35 minutes for both trainings) on the shared decision-making tool (SDM) called the Opioid Wizard, which alerts PCCs to screen, diagnose, and treat people with OUD. PCCs in the intervention arm heard patient narratives designed to shift attitudes about patients with OUD. PCCs in the comparison training had training on using the SDM tool. The PCCs were asked to complete a survey of attitudes and intentions to get waivered to prescribe buprenorphine immediately following the online training. Use of the CDS was monitored in both groups for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Primary Care Clinician: Had to be a family physician, general internist, adult-care non-obstetric nurse practitioner, or a physician assistant
* Had to practice at a study-eligible primary care clinic already involved in the main study intervention arm

Exclusion Criteria:

PCCs were ineligible to participate if they had fewer than 5 eligible patient encounters between Sep 2020 and Feb 2021.
IMTN Study- International Prospective Multicenter Trial on Clinical NOTES

Objectives: Since 2007, natural orifice surgery evolved from theory and animal research to clinical applications, but is still limited in the literature to small casuistic reports. A preliminary prospective evaluation of postoperative results of the early casuistic of Natural orifice Surgery for many indications may show advantages and disadvantages of the methods. The IMTN Multicenter Trial for Clinical NOTES was and early results are described.


Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to elective surgery

Exclusion Criteria:

* emergency surgery High ASA risk patients
Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone

Effective respiratory ventilation is achieved by moving the right amount of air to and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone.

Poor manual ventilation technique is a well-documented problem which occurs irrespective of a provider's qualifications or experience. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery among providers. The device is attached to a bag valve mask (i.e. manual resuscitator) and employs a flow limiting valve mechanism to minimize excessive pressure in the airway system without venting air by capping peak flow rates at 55 L/min. For an average adult with normal lung compliance and resistance, this corresponds to a maximum airway pressure of approximately 20 cmH2O which minimizes air entry into the stomach. In this superiority study, the investigators will use a two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone with respect to airway pressure.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who are scheduled for non-emergency surgery with general anesthesia (w/artificial airway) at Rhode Island Hospital.
* American Society Of Anesthesiologists Physical Status 1 and 2

Exclusion Criteria:

* American Society of Anesthesiologists Physical Status \>3 (e.g. respiratory disease)
* Oropharyngeal or facial pathology