cyrilzakka/clinical-trials huggingface dataset:
Engage Coaching for Latinos

This study asks: "what behavioral strategies are needed to help socially disconnected Hispanic/Latino caregivers with significant barriers to increasing connectedness?" This study uses a mixed methods approach to adapt a brief behavioral intervention-Social Engage psychotherapy-for use with socially disconnected Hispanic/Latino caregivers. This study is a single-arm clinical trial of Social Engage psychotherapy. We propose to enroll 10 participants for up to 8 weekly individual Social Engage psychotherapy sessions, over up to 3 months. Subjects will be aged 40 and older, and be caregivers for a community-dwelling family member with ADRD, living with (or in close proximity to) the family member with dementia, experiencing elevated caregiving distress and social disconnectedness.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 40 yrs;
2. Hispanic/Latino
3. English or Spanish speaking;
4. Caregiver for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
5. Endorse elevated caregiving distress as measured by a score of ≥ 11 on the 10-item Perceived Stress Scale (PSS-10) and/or a score of 5 or greater on the Modified Caregiver Strain Index (MCSI);
6. Endorse clinically significant loneliness as measured by a score of ≥ 6 on the UCLA Loneliness Scale: Short Form.
7. Has access to e-mail in order to complete the e-consent module in REDCap which will be used in this study.

Exclusion Criteria:

1. Primary language is not English or Spanish;
2. Recent or current psychosis;
3. Significant cognitive impairment on a cognitive screening measure at the HARP screening assessment;
4. Hearing problems that preclude completion of the intervention.
Massage, Meditation, and Tai Chi for Chronic Lower Back Pain

This clinical trial is a preliminary study designed to prepare for a full-scale, randomized clinical trial of the effectiveness of tai chi, mediation, and therapeutic massage for chronic lower back pain in adults.

Despite the common use of complementary and alternative therapies for back pain, little is known about how such therapies compare with each other or with conventional medical therapies in terms of effectiveness and cost. This study will lay the groundwork for a full-scale trial that will evaluate the relative effectiveness and costs of three promising relaxation-related techniques (massage, tai chi, and meditation) that are appropriate for both younger and older adults with chronic lower back pain. The pilot study will identify and resolve unanticipated problems and estimate the sample sizes required for an adequately-powered, full-scale trial.

Participants with chronic lower back pain will be randomly assigned to one of the following groups: tai chi, massage, meditation, or continued usual care (control group). The participants assigned to each intervention will be divided equally between persons under and over age 65.

Eligibility Criteria:
Inclusion Criteria

* Chronic lower back pain
Efficacy of Mydriatic Drops in Premature Infants

Because of the neonatologists reported that some infants had suffered from vomiting, bradycardia, hypotonia, and aspiration risk about 30-60 minutes after the fundus examination in the intensive care unit. The investigators observed the pupil dilation effects and side effects of tipple instillation of phenylephrine 2.5% plus tropicamide 0.5% ophthalmic drop combination which the investigators routinely used in ROP examination.

Purpose: To determine effect and vital change after topical application of phenylephrine 2.5% and tropicamide 0.5% three times for retinopathy of prematurity (ROP) examination in preterm infants.

Methods: Pupillary diameter, blood pressure, pulse rate, and oxygen saturation were monitored before, and after up to 24 hours 60 ROP screening examinations.

Eligibility Criteria:
Inclusion Criteria:

* Infants who were first ROP examinations
* infants born before 32 weeks.

Exclusion Criteria:

* Developmental ocular and/or systemic anomalies.
* Drug use that can affect vital values
* Unstable general condition
* Food intolerance
* Recurrent vomiting.
The Effect of Interscalene Peripheral Nerve Block With 0.25% Bupivacaine vs 0.125% Bupivacaine on Lung Function

Peripheral nerve blocks are used to provide post-operative pain relief. Nerve blocks in the neck, in the interscalene area, provide pain relief after shoulder surgery but can cause temporary weakness or paralysis of the diaphragm. The investigators hypothesized that a lower concentration of bupivacaine would cause less weakness of the diaphragm but still provide good pain relief. Lung function and pain control was studied after interscalene peripheral nerve block with 20 milliliters of 0.25% bupivacaine or 0.125% bupivacaine.

Prior to placement of interscalene brachial plexus peripheral nerve block (ISPNB), diaphragm function was assessed using ultrasound as normal, no movement, or paradoxical. Room air pulse oximetry (SpO2) was recorded. Patients were randomized to receive either 0.25% bupivacaine or 0.125% bupivacaine. ISPNB was performed using a coded syringe of the study drug, so that the anesthesiologists performing the nerve block, the patient, and the nurses assessing the patient were blinded as to the concentration. Patients were given a general endotracheal anesthesia for rotator cuff repair, and opioids were administered at the discretion of the attending anesthesiologist. When patients met criteria for PACU discharge, diaphragm function was again assessed using ultrasound and room air SpO2 was recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients presenting for outpatient rotator cuff repair
* adults
* English as the primary language

Exclusion Criteria:

* evidence of peripheral nerve damage on affected side
* refusal of peripheral nerve block
* pregnant women
* lung disease, including obstructive sleep apnea
* chronic opioid use
* mental handicap
Chronic Stress as a Risk Factor in the Etiology of Coronary Heart Disease

To conduct a prospective, longitudinal, analysis of the psychophysiological effects of chronic exposure to environmental stress. The study took advantage of a unique, naturally occurring experiment caused by the relocation of a major international airport.

DESIGN NARRATIVE:

Studies were conducted on blood pressure and the neuroendocrine effects of noise resulting from the relocation of the Munich International Airport. At the former airport site the investigators monitored people exposed to high levels of noise and then tracked these same individuals as their ambient environment became normal following the shutdown of the airport. At the new airport site, the opposite situation occurred: Individuals living in normal, quiet ambient conditions became exposed to loud aircraft noise. At both sites, control groups were formed who were not exposed to aircraft noise. The study piggybacked onto a German sponsored grant. NIH funds covered the costs of cardiovascular and psycho-physiological data analysis. Measures included biochemical assays of chronic neuroendocrine markers of stress, resting blood pressure, and reactivity of blood pressure during cognitive tasks. Perceptions of community noise levels were also assessed as possible mediators of the stressful effects of chronic exposure to ambient, environmental noise.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
The Effect of Telerehabilitation in Patients With Chronic Low Back Pain

Telerehabilitation enables patients to easily adapt to home exercise programs and to be monitored remotely by their clinicians. The aim of this study is to investigate the effectiveness of the home exercise program, which is integrated into 8-week remote asynchronous video telerehabilitation sessions, on clinical status in terms of pain, functionality, quality of life parameters, as well as patient expectation, motivation, and satisfaction levels.

Low back pain is symptomatic pathology in the region between the twelve ribs and lower gluteal line defined as the lumbar region and sometimes accompanied by radicular symptoms spreading to the lower extremity, but it is not considered as a pathology alone. They are evaluated and treated on the basis of symptom duration, potential cause, the presence or absence of radicular symptoms, and the corresponding anatomical or radiographic abnormalities. Exercise is considered an essential element in the management of physical therapy and rehabilitation in patients with chronic low back pain. However, it has been found in the studies that improvements after physical therapy and rehabilitation applications are not preserved in the long term, and recurrence of chronic low back pain is common. In order to prevent this, physiotherapists need to follow their patients for a long time and to participate in the rehabilitation process. With a more cost-effective treatment model such as telerehabilitation, patients can be followed up more efficiently during home exercise. The aim of this study is to investigate the effectiveness of the home exercise program, which is integrated into 8-week remote asynchronous video telerehabilitation sessions, on clinical status in terms of pain, functionality, quality of life parameters, as well as patient expectation, motivation, and satisfaction levels.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18-65
* Patients who have complained of low back pain for at least 3 months
* Pain and numbness that does not spread to the legs

Exclusion Criteria:

* Patients with cognitive disorders or communications problems to complete assessments or treatment interventions.
* Individuals who have undergone surgical operations on the spine and/or extremities
* Specific pathological conditions (e.g. malignancy, fracture, systemic rheumatoid disease)
* Orthopedic and neurological problems that prevent evaluation and/or treatment
* Complaints of pain and numbness spreading to the lower extremities
* Individuals with a diagnosed psychiatric illness
* Individuals who have received physiotherapy in the last 6 months
* Individuals who use another treatment method during the study
* Individuals with musculoskeletal pain in any other part of the body during work
* Pregnancy
Effect of Whole Body Vibration in Young Females With Smartphone Addiction

Young adults have a high prevalence of smartphone addiction. Many adolescents use their smartphones extensively for communication, which starts out as a habit but eventually turns into an addiction. Numerous studies have shown that adolescents use social media for roughly ten hours every day.


Eligibility Criteria:
Inclusion Criteria:

* High smartphone users according to the Smartphone Addiction Scale Short Version (SAS- SV)
* Body mass index (BMI) less than 30 kg/m²
* Didn't receive regular exercise in the last 6 months.

Exclusion Criteria:

* Medical history of median nerve release, hand or thumb tendon lesion
* Prior hand or wrist fractures
* Medical history of hand injuries, and upper limb skin diseases
* WBV contraindications include (joint issues, acute inflammations, back pain, epilepsy, diabetes, or neuromuscular disorders, or dizziness, any discomfort, and nausea)
AG-73305 Single Ascending Dose Cohort Study in DME

This is a multi-centered, open-labeled, single ascending-dose-cohort study to evaluate 4 dosing cohorts of AG-73305 administered by intravitreal injection in patients with diabetic macular edema (DME).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years of age or older at the screening visit
2. Prior diagnosis of diabetes mellitus (Type 1 or Type 2) as defined by World Health Organization or American Diabetes Association
3. Presence of center-involving DME in the study eye with CST ≥ 325 μm
4. Visual acuity loss in the study eye attributed to DME with screening and baseline ETDRS BCVA letter score of 20 to 55 (20/400 to 20/80 Snellen equivalent) in the sentinel patients and 35 to 70 (20/200 to 20/40 Snellen equivalent) in the non-sentinel patients

Exclusion Criteria:

1. Uncontrolled diabetes mellitus, defined as hemoglobin A1c \> 12.0% at Screening
2. Uncontrolled hypertension with systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg at Screening or Baseline
3. Chronic renal disease
4. Any active infection in either eye
5. Any anti-vascular endothelial growth factor (VEGF) treatment in the study eye within 6 to 8 weeks prior to Baseline
6. Use of Ozurdex (dexamethasone) within 6 months prior to Baseline or any use of Iluvien (fluocinolone acetonide) in the study eye
7. Uncontrolled intraocular pressure (IOP), defined as an IOP \> 25 mmHg, despite anti-glaucoma medications in the study eye at the time of screening or controlled glaucoma that requires management with \> 2 topical hypotensive medications
Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder

This is a multicenter, randomized, double-blind, placebo-controlled, therapeutic exploratory Phase 2 clinical trial designed to evaluate the efficacy and safety of NV01-A02 in pediatric participants diagnosed with Autism Spectrum Disorder (ASD).


Eligibility Criteria:
Inclusion Criteria:

-

Inclusion Criteria:

Children aged 6 to 15 years (inclusive) as of the date of written consent

Individuals who meet all the diagnostic criteria for Autism Spectrum Disorder (ASD) as outlined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)

DSM-5 Diagnostic Criteria for Autism Spectrum Disorder (ASD):

* Persistent deficits in social communication and social interaction across multiple contexts, as manifested by all of the following:

A. Deficits in social-emotional reciprocity

B. Deficits in nonverbal communicative behaviors used for social interaction

C. Deficits in developing, maintaining, and understanding relationships

② Restricted, repetitive patterns of behavior, interests, or activities, as manifested by at least two of the following:

A. Stereotyped or repetitive motor movements, use of objects, or speech

B. Insistence on sameness, inflexible adherence to routines, or ritualized patterns of verbal or nonverbal behavior

C. Highly restricted, fixated interests that are abnormal in intensity or focus

D. Hyper- or hyporeactivity to sensory input or unusual interest in sensory aspects of the environment

③ Symptoms must be present in the early developmental period (but may not become fully manifest until social demands exceed limited capacities, or may be masked by learned strategies later in life)

Exclusion Criteria:

* Individuals weighing less than 16 kg or more than 70 kg

Individuals identified during screening with any of the following medical histories, comorbid conditions, or surgical histories:

* Severe psychiatric disorders (other than autism spectrum disorder) that may affect participation in the clinical trial

  * History of organic brain disease, neurological disorders, or epilepsy/seizures that are not fully controlled by medication or non-pharmacologic surgical treatment (Note: Participants with a history of simple febrile seizures may be included at the investigator's discretion)

    * Severe peripheral arterial disease or coronary insufficiency

      * Presence or history of psychotic symptoms such as delusions or hallucinations (e.g., worsening or recurrence of psychiatric illness)

        * Gastrointestinal diseases (e.g., active peptic ulcers) or history of surgery that may affect absorption of the investigational medicinal product (Note: Participants with a history of simple appendectomy or hernia surgery may be included)

          * Individuals displaying serious self-injurious or aggressive behavior requiring medical intervention during the screening period, as determined by the investigator

            * Individuals with sensory abnormalities such as congenital hearing loss
Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)

Patients are randomized to (arm A) 3 cycles of cisplatin/etoposide, followed by hyperfractionated radiotherapy (hfRT)with concurrent carboplatin and vindesine then surgery and, if no or R1/2-resection, additional hfRT versus (arm B) 3 cycles of cisplatin/etoposide, followed by surgery and then RT.

The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

Patients are randomized to (arm A) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4), followed by hyperfractionated radiotherapy (hfRT; 45 Gy, 2x1.5 Gy/d) with concurrent carboplatin (100 mg/m2) and vindesine (3 mg) (d 1, 8, 15), then surgery and, if no or R1/2-resection, additional hfRT (24 Gy; 2x1.5 Gy/d) versus (arm B) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4),followed by surgery and then RT (1.8 Gy/d) with 54 Gy or, if no or R1/2-resection, 68.4 Gy.

The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

(University of Münster was the lead sponsor; as the trial was implemented in clinicaltrials.gov by the principal investigator after he had moved to University of Heidelberg this account is announced above)

Eligibility Criteria:
Inclusion Criteria:

* non-small cell lung cancer proven by histology
* stage IIIA / stage IIIB
* mediastinoscopy
* performance score ECOG 0,1
* predicted postoperative FEV 1 \> 1.0 l

Exclusion Criteria:

* small cell lung cancer
* cardiac disability (NYHA III/IV)
* prior radio- or chemotherapy
* pregnancy
* other malignancy
Statins in Reducing Events in the Elderly (STAREE) Heart Sub-study

The STAREE-HEART sub-study will examine the effect of statin treatment over a 3-year period compared with placebo on markers of cardiac ageing (myocardial dysfunction). This will include determining global longitudinal strain with transthoracic echocardiography, atrial fibrillation with home measures twice daily for two weeks and changes in biomarkers.

STAREE-HEART is an ancillary study nested in the Statins in Reducing Events in the Elderly (STAREE) double-blind randomised placebo-controlled trial. STAREE is investigating whether statins can prolong good health and maintain independence amongst older people and is enrolling men and women 70 years of age and over who are free from cardiovascular disease, diabetes and dementia. STAREE-HEART will recruit a subset of STAREE participants before they are randomised to STAREE study drug. STAREE-HEART will involve an additional suite of cardiac assessments in these participants and will provide detailed information about the clinical effect of statins on myocardial function.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥70 years living independently in the community who are participants in the STAREE RCT and eligible for randomisation to study medication.
* Willing and able to provide informed consent and accept the STAREE-HEART study requirements, including attendance for an echocardiogram and undertaking home monitoring via ECG.

Exclusion Criteria:

* Known atrial fibrillation or atrial flutter.
* Participants who do not wish to be informed of an abnormality under any circumstances, regardless of severity, will not be enrolled in the study.
Diagnostic Accuracy of Urine Flow Cytometry in Excluding Bacteruria

A more rapid test for bacteriuria is desired. This will exclude the patients not having bacteriuria, which will contribute to a more rapid and accurate diagnosis of infectious diseases. The aim of the study is to investigate the diagnostic accuracy of point-of-care urine flow cytometry on diagnosing and excluding bacteriuria

A prerequisite for the appropriate use of antibiotics is timely access to accurate diagnostic tests, since treatment of acute infections should be initiated within a few hours to avoid serious complications such as bacteremia, sepsis, organ failure, septic shock and death.

The diagnosis of urinary tract infections including acute pyelonephritis (APN) is difficult due to often weak and non-specific symptoms and high incidence of asymptomatic bacteruria in especially elderly patients. The diagnosis is verified by significant bacteriuria in urine culture.

Unfortunately, the time from urine sample to result from urine cultures is more than 24 hours days. Urine test strips are unreliable with low specificity and low predictive values. Therefore, a point-of-care (POC) test is desired, which can provide rapid results and quickly identify a bacteriuria. One such tool may be urine flow cytometry (UFC), which has shown promising diagnostic value for the exclusion of bacteriuria with a high negative predictive value. However, better documentation for its use as an ED diagnostic screening method is needed.

The aim of the study is to investigate the diagnostic accuracy of POC-UFC on diagnosing and excluding bacteriuria? Our hypothesis is that by excluding patients not having bacteriuria, it will contribute to a more rapid and accurate diagnosis

Eligibility Criteria:
Inclusion Criteria:

* Suspicion of acute infections assessed by the receiving physician at the emergency department

Exclusion Criteria:

* If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
* Admission within the last 14 days
* Verified COVID-19 disease within 14 days before admission
* Pregnant women
* Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 \<200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (\>20 mg/day prednisone or equivalent for \>14 days within the last 30 days), Chemotherapy within 30 days)
Neoadjuvant Tislelizumab Plus Chemotherapy for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma

For resectable squamous cell carcinoma of the head and neck , novel therapeutic approaches are still needed to improve outcomes. Neoadjuvant immunochemotherapy is considered as a potentially effective strategy. The purpose of this study is to evaluate the safety and efficacy of neoadjuvant of tislelizumab combined with platinum doublet for resectable locally-advanced head and neck squamous-cell carcinoma .


Eligibility Criteria:
Inclusion Criteria:

1. Patients who voluntarily participate in the project and sign the informed consent.
2. Be 18 years of age on day of signing informed consent.
3. The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1.
4. According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVA tumors confirmed by pathology as head and neck squamous cell carcinoma.
5. Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis.
6. Demonstrate adequate organ function.

Exclusion Criteria:

1. The patient has abnormal blood indicators, abnormal liver and kidney function.
2. The patient has received prior systemic anti-cancer therapy for head and neck squamous cell carcinoma including investigational agents within 3 months of first dose of study treatment.
3. The patient has previously suffered from other tumors , or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy within the past 5 years.
4. The entire clinical research process cannot be completed due to personal, social and economic reasons.
5. Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs .