cyrilzakka/clinical-trials huggingface dataset:
Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement

The purpose of this study is to determine whether early intervention with neuromuscular electrical stimulation (NMES) for muscle strengthening immediately after total knee arthroplasty (TKA) is more effective than voluntary exercise alone in countering changes in quadriceps muscle activation, force production, and function in older adults.

Osteoarthritis (OA) is a chronic degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. To alleviate pain and disability associated with knee OA, over 400,000 total knee arthroplasty (TKA) are performed each year in the United States, and future projections indicate that by the year 2030, more than 750,000 TKAs will be performed per year. While TKA reliably reduces pain and improves function, the recovery of force and function to normal levels is rare, which predisposes patients to future disability with increasing age. A month after TKA, impairments in quadriceps force are predominantly due to reflex inhibition, but are also influenced, to a lesser degree, by muscle atrophy. Neuromuscular electrical stimulation (NMES) may offer a promising alternative approach to override quadriceps reflex inhibition and prevent muscle atrophy to restore normal quadriceps muscle function more effectively than voluntary exercise alone, especially when applied within the first days after surgery.

The overall goal of this study is to evaluate the efficacy of NMES initiated 48hrs after TKA as an adjunct to standard rehabilitation. NMES is expected to more effectively restore normal quadriceps muscle function to produce greater quadriceps force by decreasing reflex inhibition. Patients will be randomized into one of two rehabilitation groups: 1) the standard rehabilitation group or 2) standard rehabilitation + NMES.

Eligibility Criteria:
Inclusion Criteria:

* 50-85 years of age
* Scheduled for a primary unilateral TKA
* Cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study

Exclusion Criteria:

* History of uncontrolled hypertension or uncontrolled diabetes
* Body mass index greater than 35 kg/m\^2
* Neurological, vascular or cardiac problems that significantly limit function
* Moderate or severe osteoarthritis or other orthopedic conditions in the non-operated lower extremity that limit function
An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort

This is a controlled, randomized, subject-masked, 3x3 crossover, non-dispensing, contralateral study. Twenty subjects will be recruited based on their scores (with their habitual lenses) from the Contact Lens Dry Eye Questionnaire-8 and examined on four occasions.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. They are of legal age (18 years) and capacity of volunteer.
  2. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  3. They must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  4. They have worn the same brand of soft spherical contact lenses for at least the previous three months, by self-report.
  5. They are defined as 'symptomatic' contact lens wearers (CLDEQ-8 score of 20-37) with their habitual contact lenses.
  6. They are willing to wear their lenses for approximately 14 hours on study days.
  7. They have a wearable pair of spectacles, if applicable.
  8. They agree not to participate in other clinical research for the duration of this study.
  9. They can attain high contrast logMAR visual acuity of 0.20 or better in their habitual contact lenses in each eye.

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. They have an ocular disorder, which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder, which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They have had cataract or corneal refractive surgery.
  5. They are pregnant or breast-feeding by self-report.
  6. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV), by self-report.
  7. They have any known hypersensitivity or allergic reaction to any of the known ingredients in the anesthetic.
  8. They have a history of severe allergic reaction or anaphylaxis.
  9. They have a history of cardiac disease or hyperthyroidism.
  10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
  11. They are an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  12. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  13. They have grade 3 or greater of any of the following ocular surface signs which would contraindicate contact lens wear: corneal edema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
Impact of Genetic Counseling for Individuals With Mental Illness

People who have experienced mental illnesses like schizophrenia, bipolar disorder or schizoaffective disorder often have a poor understanding of the causes of their illness, and that they are often very worried about how the illness affects their families. In particular, affected individuals worry that there is a high chance that any children that they have will become affected with the same illness. Often, because of this fear, affected individuals choose not to have children.

Genetic counseling is a process where information about the causes of illnesses, and about chances for family members of individuals with these illnesses to become similarly affected is provided in a supportive environment by a specially trained healthcare professional. This study will investigate whether genetic counseling can reduce perceptions of risk and stigma, and increase perceived control and knowledge about the causes of the illness, amongst individuals who have a major mental illness.

We will recruit 120 individuals who have a personal history of a major psychiatric disorder (as defined above). Each participant will be randomized into one of 3 groups of approximately equal size: one of which will receive genetic counseling within 1 month after enrollment (GC), another will receive the educational brochure within 1 month (EB), and the last will be assigned to waitlist (WT). After randomization (but prior to intervention for GC and EB groups, and within 1 month after enrollment for the WT group) we will gather baseline information regarding the 4 outcome measures (perceived risk and control, stigma, and knowledge). We will re-assess the 4 outcome measures immediately post-intervention for GC and EB groups. A further follow-up (for all groups) will be conducted two months after enrollment (which is 1 month post intervention for GC and EB groups).

Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* Have been diagnosed with schizophrenia, bipolar, or schizoaffective disorder
* Reside in BC, and be able to attend 3 study visits over 1.5 months
Study of Inhaled Iloprost in Pediatric Pulmonary Hypertension (PH) After Surgery

The aim of this study is to determine whether inhaled iloprost can be used to prevent and treat PH and PHC while in children after operation of CHD

Pulmonary hypertension (PH) is a significant contributor to the postoperative morbidity and mortality of congenital heart disease. Inhaled iloprost has been approved for the treatment of adults with PH, but little is known about the effects in children with PH.

Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels without side affecting the systemic circulation. There is no RCTs of iloprost have previously been performed in this indication.

Eligibility Criteria:
Inclusion Criteria:

Before corrective procedure for CHD, two of bellow ten criteria should be met

1. Pulse SaO2 smaller than 93% in left-right shunt CHD case (in room air)
2. EKG: right ventricular hypertrophy, right atrial dilatation
3. Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessal in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement
4. Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt
5. Under-filling of pulmonary capillary, 'pruning' of the peripheral blood vessels
6. Pp/Ps greater than 0.75
7. Qp/Qs smaller than 1.5
8. PVR grater than 9 Wood Unit/m2
9. Rp/Rs graeter than 0.5

Exclusion Criteria:

After corrective procedure for CHD:

1. Deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation
2. Severe arrhythmia led to low cardiac output
3. PLT smaller than 50,000\*109/L and obvious bleeding
The Effects of a 16-Week Individualized, Intensive Strength Training Program in Patients With Rheumatoid Arthritis

To assess the effects of a 16-week individualized, intensive strength training program in patients with rheumatoid arthritis. Primary and secondary outcomes include: strength and body composition, function, disease activity, pain, quality of life.

We hypothesized that improvements would be seen in all of the above outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Males and females with RA
* Over 18 years of age
* ACR Functional Class I and II
* Taking Remicade \>4 months

Exclusion Criteria:

* Presence of comorbid conditions contraindicated to exercise, including, but not limited to:

  1. heart disease
  2. severe osteoporosis: (if \>50 years): T score \< -3.0 for hip or spine excluded; T score \<-2.5 for hip or spine w/o current treatment)
  3. (all potential subjects) previous non-traumatic fractures
  4. uncontrolled BP
* BMI \>40
* Regular use of assistive walking device which would interfere with ability to lift weights
* Currently or within the last 3 months participating in aerobic exercise \> 150 minutes a week
* Currently or within the last 3 months participating in any regular strength training activities
* Presence of neurological impairment that directly limits ability to perform exercise
* Participation in concurrent exercise study
* Any reason for which the investigator deems it would not be in the patient's best interest to continue in the study
* Plans to move away from site within next 1 year
Changing Tactics? Optimizing ECT in Difficult-to-treat Depression

The goal of this randomized controlled trial is to address which treatment strategy (continue right unilateral (RUL) ECT or switch to bitemporal (BT) ECT speeds up recovery and has the least impact on memory function, in case of early non-response during an acute course of ECT for difficult-to-treat depression.

The main questions it aims to answer are:

* Assess the antidepressant efficacy and cognitive impact of the continuation of an ongoing treatment with RUL ECT compared to switching the treatment technique to BT ECT, in patients failing to show an early response to an acute course of ECT for major depression;
* Assess group and subject-specific trajectories of depressive symptom severity and neurocognitive performance during the acute ECT course and up to 3 months post-treatment.

Participants treated with ECT for depression, showing no 'response' (≥50 percent decrease in depressive symptom severity compared to baseline) after 4 treatment sessions, will be randomized to either switch to BT ECT or continue with RUL ECT. Mood and neurocognitive assessments will be performed at baseline, after 4 ECT sessions (before randomization), after 8 ECT sessions, at the end of the acute course and 3 month after the acute course.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
* Age 18 or older
* Diagnosis of major depressive disorder (DSM-5 296.21-30) or bipolar disorder, depressed (DSM-5 296.51-54; 296.84), confirmed by MINI (Mini International Neuropsychiatric Interview)

Exclusion Criteria:

* Contra-indication for general anesthesia
* Non-Dutch speaking
* Diagnosis of schizoaffective disorder or schizophrenia, confirmed by MINI
* Diagnosis of substance use disorder in the past six months, confirmed by MINI
* Diagnosis of neurocognitive disorder or intellectual disability alongside a MoCA score \<23
* Previous ECT course in the past three months
* Participation in an interventional Trial with an investigational medicinal product or device
* Pregnancy
Efficacy and Mechanism of rTMS on the Symptoms of Pleasure Deficit in Adolescent Depression

(1) Primary objective: to collect data on the score of pleasure deficit scale before and after repetitive transcranial magnetic stimulation treatment in adolescent depressed patients, and to verify its efficacy and safety in adolescent depressed patients in combination with the changes of clinical symptoms; (2) Secondary objective: to explore the relevant hemodynamic mechanisms in adolescent depressed patients before and after repetitive transcranial magnetic stimulation treatment.

Depression is one of the most common mental disorders among adolescents and is characterized by persistent low mood. According to a global statistical report released by the World Health Organization, about 350 million people worldwide are affected by depression, with the adolescent population being particularly prominent. Epidemiologic surveys in the Chinese region show that the prevalence of depression in adolescents is about 3.0%. The study points out that age is one of the key factors affecting major depression. Pleasure deficit, a reduced capacity for the experience of pleasure or a lack of appropriate emotional responses to rewards and positive stimuli, is a core symptom of depression and is considered a key internal phenotype of the illness. Repetitive transcranial magnetic stimulation is a treatment for major depressive disorder that delivers a series of equally spaced pulses through repetitive TMS. Studies have shown that rTMS stimulation of the dorsolateral prefrontal cortex can significantly improve symptoms of pleasure deficit. Thus, rTMS may be an effective treatment option for depressed patients with pleasure deficit.

Eligibility Criteria:
Inclusion Criteria:

1. Age 10-19 years old (both 10 and 19), gender is not limited;
2. Meet the criteria for diagnosing MDD in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
3. First episode or relapse, monophasic or bipolar depressive disorder;
4. No history of any form of antidepressant treatment (including medication, physical and psychotherapy) within 2 weeks prior to enrollment;
5. Habitual right-handedness;
6. Deficit of pleasure scale (DARS) \<22 points;
7. Score \>17 on the 17-item version of the Hamilton Depression Scale (HAMD-17);
8. After fully understanding the safety of rTMS, they were willing to actively cooperate with the treatment and signed an informed consent form.

Exclusion Criteria:

1. Complicated with psychotic symptoms;
2. Comorbidity with major psychiatric disorders such as schizophrenia, delusional disorder, delirium, neurocognitive disorder, intellectual disability, and other mental disorders caused by other diseases;
3. History of primary neurologic disease or brain injury;
4. History of electroconvulsive therapy;
5. Contraindications to rTMS treatment, including cardiac pacemakers, neurostimulators, artificial metal heart valves, intracranial aneurysm clips, cochlear implants, and other types of metal implants (with the exception of oral supports);(6)History of epilepsy.
Influence of a Inhaled Corticosteroid Therapy Versus Corticosteroid + LABA Therapy on the FeNO of Asthmatic Children

The purpose of the study is to investigate, whether the FeNO concentration of asthmatic children is influenced differently by inhaled corticosteroid compared to inhaled corticosteroid + long acting beta agonist. The study hypothesis is that the FeNO concentration is more decreased in patients with a combination therapy compared to those with a corticosteroid mono therapy.


Eligibility Criteria:
Inclusion Criteria:

* allergic asthma since \> 6 months equal or lower corticosteroid therapy before study entry FEV1\>50%

Exclusion Criteria:

* severe asthma respiratory infection within the last 4 weeks smoking
A Study of Ultra-fraction Radiotherapy Bridging CART in R/R DLBCL

This is a single-arm single center study to prospectively evaluate the safety and efficacy of ultra-fraction radiotherapy bridging CAR-T therapy in relapsed/refractory diffuse large b cell lymphoma


Eligibility Criteria:
Inclusion Criteria:

1. Over than 18 years old
2. Histologically confirmed DLBCL(by central pathology review before enrolment)
3. Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT), or being ineligible for or not consenting to ASCT
4. Measurable disease at time of enrollment (the maximum diameter of cross section ≥1.5cm)
5. Life expectancy ≥12 weeks
6. Able to receive radiotherapy evaluated by specialist

Exclusion Criteria:

1. Prior radiation therapy within 1 year of infusion
2. Pregnant or nursing (lactating) women
3. Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
4. Previous solid tumor within 3 years, previous or concurrent hematological malignancy
5. Severe organ dysfunction: left ventricle ejection fraction (LVEF) \<40%; DLCO \<40%; estimated glomerular filtration rate (eGFR)\<30mL/min/1.73 m2; total bilirubin \>3 ULN
6. HIV positive patients, active replication of or prior infection with hepatitis B or active hepatitis C( HCV RNA positive );
7. Other conditions that the investigator may exclude due to risks or other possibilities
Oral Feeding During Established Labor at Our Institution

Current French guidelines allow oral intake of clear fluid in women in established labor under epidural analgesia. To date, no study assessed how these guidelines are followed in clinical practice. This study aims to assess the current practices as to the fasting during the labor at our institution, while assessing the experience and the expectations of the parturients (level of comfort or discomfort related to fasting).


Eligibility Criteria:
Inclusion Criteria:

* All adult woman who has been in labor in our hospital

Exclusion Criteria:

* Patient refusal
* Elective cesarean section, or emergency cesarean section in a woman not in labor
* Intrauterine fetal death
* Therapeutic abortion
* Patient consent not available (for example, in case of severe post-partum hemorrhage)
Tap Water Intake and Perceptions in US Latinx Adults

The purpose of this exploratory cross-sectional investigation is to evaluate associations between tap water perceptions, water consumption behaviors, and hydration status in Latinx adults (18 - 65 y). The objective is to identify perceptual determinants that explain the associations between tap water avoidance and plain water intake and hydration status in Latinx adults.

Aim 1: Characterize the degree to which individual- and community-level factors uniquely predict the perception that tap water is not safe in Latinx adults.

Aim 2: Evaluate household income, education level, and US nativity as potential moderators of the associations between predictors and perceptions of tap water safety.

Aim 3: Evaluate the influence of tap water safety perceptions on plain water intake and 24-h hydration status, after adjustment for predictors of tap water safety perceptions, in a sub-sample of Latinx adults.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Hispanic or Latinx
* English- and/or Spanish-speaking
* Interested in participating in both study phases
* Live in Phoenix, Arizona

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Currently use diuretics
* Do not have access to a desktop, laptop, tablet, or smartphone
* Do not have internet access
Timely Administration of IV Magnesium Sulfate in Patients With a Moderate Asthma Exacerbation

This study aims to identify whether early administration of magnesium sulfate in moderate asthma exacerbations can potentially avoid admission, decrease length of stay in the emergency department (ED), decrease length of stay (LOS) in the general hospital floor vs pediatric intensive care unit (PICU), and decrease the need for respiratory support.

Patients ages 5-17 presenting to the OU Children's Hospital Emergency Department from October 2023 to July 2024 will be assigned a respiratory score (RS) upon presentation. Those with a RS between 6-9 (moderate exacerbation) will be screened for inclusion. Eligible patient will then be approached for consent. First line asthma therapies including bronchodilators and steroids will not be delayed for the consent process. Patients who consent will be randomized to the control vs. experimental group once consent is obtained.

The study will not be blinded once a patient is randomized to a group, the provider will know whether the patient will receive weight-based IV magnesium within the first hour (experimental group) or receive standard weight-based IV magnesium sulfate per the provider's clinical judgement (placebo group). Magnesium sulfate dosing for the experimental group will be as follows:

15-19 kg: 750 mg

20-29 kg: 1000 mg

30-39 kg: 1500 mg

\>40 kg: 2000 mg

Enrolled patients will have their clinical course reviewed and data obtained regarding LOS in ED and hospital stay, need for respiratory support, and or PICU LOS if applicable.

Eligibility Criteria:
Inclusion Criteria:

* Ages 5-17 years old
* Presents to the ED with a respiratory score in the "Moderate" range (6
* Parent(s)/Caregiver(s) speak English

Exclusion Criteria:

* Patients with chronic medical conditions including chronic pulmonary disease (other than asthma), cerebral palsy, congenital heart disease, tracheostomy dependent, myasthenia gravis patients
* Patients who are pregnant
* Parent(s)/Caregiver(s) do not speak English