cyrilzakka/clinical-trials huggingface dataset:
Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring

The purpose of this study is to assess whether repeated enhanced and prolonged ECG monitoring after ischemic stroke results in a higher detection of atrial fibrillation (/flutter) compared to usual care (at least 24 hour of cardiac monitoring).


Eligibility Criteria:
Inclusion Criteria:

* Recent cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting \> 24h consistent with the territory of a major cerebral artery and categorised as ischemic) and/or a corresponding lesion on brain imaging.
* Stroke symptoms started ≤ 7 days ago.
* Age ≥ 60 years.
* Modified Rankin scale ≤ 2 (prior to index event).

Exclusion Criteria:

* Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG.
* Indication for oral anticoagulation at randomisation.
* Absolute contra-indication against oral anticoagulation at randomisation.
* Intracerebral bleeding in medical history.
* Patient scheduled for Holter-ECG or cardiac Event-Recording monitoring ≥ 48 hours.
* Significant carotid artery or vertebral artery stenosis \> 50% (NASCET classification), significant intracranial artery stenosis suspicious of atherosclerotic origin or acute arterial dissection explanatory of stroke symptoms.
* Implanted pacemaker device or cardioverter/defibrillator.
* Life expectancy \< 1 year for reasons other than stroke (e.g. metastatic cancer).
* Concomitant participation in other controlled randomised trial.
Ozonated Gel Phonophoresis On Chronic Lateral Epicondylitis

Comparison between 2 groups of chronic lateral epicondylitis, to determine the effect of ozonated media phonophoresis on chronic lateral epicondylitis.

40 patients (male and female), patients age would be ranged from 30 to 50 years, would be randomly allocated using sealed envelope into randomly two matched group (A and B), Group A (Experimental): 20 patients would receive ultrasonic with ozonated gel as a coupling medium (phonophoresis) (1 MHz, 1 W/cm2continuous mode) for 5 min. plus, conventional physical therapy program consists of (conventional TENS (100 Hz) for 30 min - hot pack for 20 min- stretching and strengthening exercises, wrist rest splints). 3 times per week for 4 weeks.

Group B (control):20 patients will receive conventional physical therapy program consists of (conventional TENS (100 Hz) for 30 min - hot pack for 20 min- stretching and strengthening exercises, wrist rest splints) 3times per week for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All patients would be diagnosed as chronic lateral epicondylitis from both genders.
* Patients with chronic lateral epicondylitis that diagnosed by orthopedist.
* Positive clinical manifestation in all patients.
* Pain onset is more than 3 months.
* All participants must be medically stable and not be treated with analgesics or any medication which may cause misleading results.
* All patients had body mass index between 18.5 and 29.9 kg/m2.

Exclusion Criteria:

* Subjects would be excluded if they have:

Received intra articular injection from duration less than 3 months.

* Elbow instability.
* History of cancer.
* Pregnancy
* Infection.
* Skin diseases on elbow area.
* Open wound in elbow.
* Shoulder or elbow fractures
* Systemic diseases such as rheumatoid arthritis, Reiter's syndrome, or diabetes.
* Neurological diseases.
* Severe medical or psychiatric disorders.
* Elbow surgery.
* Entrapment of the radial nerve.
* Arthritis and effusion of the elbow.
Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients

To determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness.

The Arrhythmia Management System records rhythm, heart rate, subject-reported symptoms and multiple parameters that include respiration rate, activity and body posture. These biometric data could provide clinicians better insight into the context of the detected arrhythmias, subject-reported symptoms and wellness status. Hence, the purpose of the study to determine the associations among biometric data, arrhythmias, symptoms and subject wellness.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who require monitoring for non-lethal cardiac arrhythmias
* Subjects who have an indication for mobile cardiac telemetry (MCT) monitoring
* Subjects 21 years of age or older

Exclusion Criteria:

* Subjects with an implantable cardiac device such as left ventricular assistive device, pacemaker, implanted cardioverter defibrillator (ICD), cardiac resynchronization therapy device, subcutaneous ICD's, pressure monitors and loop monitors
* Subjects with wearable cardioverter defibrillator, Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time
* Subjects currently hospitalized
* Subjects with a skin condition preventing them from wearing the AMS device
* Subjects who are non-ambulatory
* Subjects who are self-reporting to be pregnant
* Subjects participating in another study
Impact of Introducing Basaglar Insulin to the Treatment Regimen of Youth with Diabetes in Pakistan

This study aimed to determine the effect of introducing Basaglar and insulin pen injection devices on clinical and quality of life (QOL) parameters in children and young adults with type 1 diabetes in Pakistan

Analog insulins are widely used in middle- and high-income countries. However, use of analog insulin remains limited in lower-income countries due to their increased cost and lack of access, and human insulin remains the mainstay of treatment in these settings.

Long-acting (basal) analog insulin such as glargine have the benefit of a longer duration (up to 24 hours) and a minimal peak action, and generally, only one injection per day is required. Although glargine insulin has been shown to reduce the risk of overnight hypoglycemia, consistent improvement in blood glucose control (measured by HbA1c) when compared to human insulin has not been shown, and its impact on quality of life is also inconclusive. Furthermore, these studies have all been done in highly resourced countries.

Life for a Child (LFAC) provides diabetes supplies (insulin, syringes, meters and strips for blood glucose self-monitoring), diabetes-related education, mentoring and technical support to the team managing youth with type 1 diabetes (T1D) managed at Baqai Institute of Diabetology and Endocrinology (BIDE) in Karachi, Pakistan. In 2022, LFAC commenced supplying Basaglar (glargine) insulin with insulin pen devices (HumaPen Ergo ll). This provided a unique opportunity to investigate the effect of introducing glargine (Basaglar) insulin in the low resource setting of Pakistan.

Eligibility Criteria:
INCLUSION CRITERIA:

* Diagnosed with type 1 diabetes according to a combination of clinical (polyuria, polydipsia, and weight loss) and biochemical characteristics (High blood glucose levels (fasting glucose ≥ 126 mg/dL or random glucose ≥ 200 mg/dL) and/or C-peptide levels indicating low insulin production, along with the presence of islet autoantibodies (e.g., GAD65, IA-2))
* Duration of T1D ≥ 12 months at time of enrolment
* Willing to conduct self-monitoring of blood glucose (SMBG) at least twice daily
* No prior use of analog insulin (either long-acting or short-acting)
* Attending BIDE for their routine diabetes care and management
* No history of other significant medical conditions (e.g., severe renal disease or other autoimmune conditions)
* Willing to adhere to the study protocol, including attending follow-up visits and participating in the required education sessions

EXCLUSION CRITERIA:

* Prior use of analog insulin
* Other medical conditions that would interfere with study participation
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza

The main purpose of this study is to understand:

* the symptoms of COVID-19 or influenza- health-related outcomes of people with COVID-19 or influenza (influenza only included in updated study analyses)
* the potential effects of COVID-19 vaccines in people with COVID-19

This study will enroll participants who are:

* 18 years or older
* reported to have symptoms with tests that have confirmed illness. The tests can be taken at any of CVS pharmacy COVID-19 or influenza test sites.

The study will collect vaccine history information from participants who are ready to take part in the study. Participant will be emailed a form with questions about their health related to COVID-19 or influenza during multiple follow-ups over a 6-month period.

This is a prospective non-interventional longitudinal cohort survey study. Repeated measures on PROs including: symptoms (prevalence, frequency, duration, and severity), EQ-5D-5L, and WPAI over 6 months will be collected and evaluated.

COVID-19 Cohort: Participants 18 years or older with test-confirmed COVID-19 illness and at least one patient-reported symptom.

Influenza Cohort: Participants 18 years or older with test-confirmed influenza illness and at least one patient-reported symptom.

All study objectives and outcomes will be assessed separately for the two study cohorts. Influenza cohort is only included in updated study analyses.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Self-reported at least one symptom in the CVS Health pre-test screening questionnaire
* Positive result reported from diagnostic test for COVID-19 (or influenza in updated analysis)
* Evidence of a signed and dated informed consent through electronic consent process indicating that the participant has been informed of all pertinent aspects of the study
* Able to complete the questionnaires by themselves in English or Spanish

Exclusion Criteria:

- No symptoms reported in the study screening questionnaire
Breast Feeding Practice in High Risk Pregnant Women

The American Academy of Paediatrics recognizes multiple benefits of breastfeeding to both the term and premature newborn, particularly with regard to protection from infectious agents. Studies have demonstrated decreased rates of bacteraemia, meningitis, respiratory and urinary tract infections, necrotizing enterocolitis, and otitis media among breastfed infants


Eligibility Criteria:
Inclusion Criteria:

1. Diabetes mellitus.
2. Cardiac disease.
3. Essential hypertension.
4. Chronic chest disease, and/or chronic TB infection.
5. Chronic hepatitis.
6. Neurologic disease.
7. Anaemia (Hemoglobin \<10 gm/dL).
8. Thyroid disease.
9. Multiple pregnancy.

Exclusion Criteria:

* pregnant women \< 34 weeks.
Association of Lumbar MODIC Changes With Chronic Low Back Pain in Southern European Subjects

In this case-control study, cases were chronic LBP patients aged 30-50 in whom a lumbar MRI had been prescribed. Controls were subjects aged 30-50 in whom a cranial MRI had been prescribed for headache, who did not suffer from LBP and had no history of clinically relevant LBP. Two hundred and forty cases and 64 controls were recruited consecutively in Radiology services across six cities in Spain. Imaging findings and subjects' characteristics were gathered through previously validated instruments. Radiologists who interpreted MRIs were blinded to subjects' characteristics. A multivariate logistic regression model was developed to assess the association of Modic changes with LBP, adjusting for sex, age, body-mass index, lifetime exposure to smoking, physical activity, and disk degeneration.


Eligibility Criteria:
Inclusion Criteria:

* For all subjects: age between 35 and 50 years.
* For subjects with LBP: having a diagnosis of chronic low back pain (of 3 or more months' duration) as the reason for an MRI.
* For subjects without LBP: subjects with a cranial MRI (described as normal) for cephalalgia, and who had neither current LBP nor history of LBP.

Exclusion criteria were: history of spine surgery, current pregnancy, scoliosis with \>15º curvature, vertebral fractures, "red flags" for potential underlying systemic diseases (oncologic disease during the previous 5 years, constitutional symptoms -unexplained weight loss, fever, chills-, history of intravenous drug use, or immunocompromised host), or signs suggesting cauda equine syndrome (relevant or progressive paresia, loss of sphincter control or saddle anesthesia).
Effects of Exercise Intensity on ADHD Symptoms

This project investigates the effects of a bicycling exercise at three levels of exercise intensity (low, moderate, and high) on attention deficit/hyperactivity disorder (ADHD) in college students. Specifically, the outcomes of interest in this study are self-reported executive functioning, self-reported functional impairment, and ADHD symptom severity. The hypothesis is that exercise will improve executive functioning, while reducing functional impairment and ADHD symptom severity, and that this response will be most pronounced in the high-intensity exercise group.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of attention deficit/hyperactivity disorder (ADHD) Age 18-16 Student at Kent State University

Exclusion Criteria:

seizures/epilepsy syncope asthma chronic obstructive pulmonary disease (COPD) restrictive lung disease adult respiratory distress syndrome (ARDS) heart problems/defects/heart failure/valve problems liver/kidney disease diabetes mellitus current pregnancy
Preoperative Anxiety on Postoperative Outcome and Sleep Quality in Patients Undergoing Laparoscopic Hysterectomy

Sleep is a naturally occurring state of decreased arousal that is crucial for normal immune and cognitive function. Although surgery and anesthesia techniques have improved in recent years, sleep function and sleep cycles may still be altered perioperatively by surgery and other interventions under general anesthesia.Postoperative sleep fragmentation and poor sleep quality not only lead to hyperalgesia and delayed postoperative recovery, but can increase the risk of potential adverse effects, such as cognitive impairment, chronic pain and emotional disturbances, metabolic disorders, and pro-inflammatory changes. General anesthesia is a medically induced state of hyporesponsiveness that resembles natural sleep. Studies have shown that general anesthesia can lead to circadian rhythm time structure dyssynchrony, resulting in postoperative sleep disturbance, characterized by decreases in rapid eye movement (REM) and slow wave sleep (SWS). Previous studies have also reported that age, preoperative comorbidities, and severity of surgical trauma are independent factors associated with postoperative sleep disturbance. In addition, anxiety is an unpleasant sensation that compromises patients' comfort and well-being. A study by Ruis et al. estimated that 25-80% of patients admitted for surgery experienced preoperative anxiety, including fear of surgery and anesthesia-related fears. Furthermore, preoperative anxiety was recognized as a potential and preventable risk factor for severe postoperative pain and postoperative complications such as increased postoperative morbidity and mortality. Given that several prior studies have reported that preoperative anxiety has an effect on postoperative sleep quality in patients undergoing gynecological surgery, this study aimed to investigate the effect of preoperative anxiety on postoperative outcomes and sleep quality in patients undergoing gynecological surgery. Studying these results could enable us to better manage patients during the perioperative period to promote their postoperative recovery.


Eligibility Criteria:
The inclusion criteria were:

1. age between 18 and 75 years,
2. American Society of Anesthesiologists (ASA) medical status I or II,
3. laparoscopic hysterectomy, elective operation and surgery lasting 1-3 h.

The exclusion criteria included

1. cardiovascular disease,
2. chronic use of analgesics,
3. chronic use of antidepressants,
4. use of sleep-promoting drugs,
5. sleep disorders,
6. sleep apnea syndrome,
7. history of abnormal surgery or recovery from anesthesia,
8. psychosis,
9. patients with impaired verbal communication,
10. unwillingness to provide informed consent.
Phenobarbital vs Ativan for Alcohol Withdrawal in the Intensive Care Unit

Our aim is to compare outcomes of patients with benzodiazepine-refractory alcohol withdrawal syndrome who are treated with either a phenobarbital-based or a lorazepam based protocol.

* This study is a prospective, open-label, randomized, controlled trial.
* The electronic medical record will be used to identify patients who have a diagnosis of alcohol withdrawal or are receiving alcohol withdrawal. Subjects who are anticipated to meet inclusion criteria will be pre-consented for the study using an informed consent process. see informed consent form.
* Subjects will not be enrolled and randomized until they have met inclusion criteria.
* If a patient meets criteria, but is deemed non-decisional or unable to give consent, the patient's medical decision maker will undergo the informed consent process.
* After enrollment, participants will be randomized to either the control group (lorazepam-based therapy) or the study group (phenobarbital-based therapy)
* Personnel unassociated with patient screening, enrollment, or follow up will create the allocation sequence and will use a random, computerized number generator. The allocation sequence will then be transferred to sequentially numbered, opaque envelopes for purposes of allocation concealment. These sequentially numbered envelopes, which are blinded to clinical trial coordinators/physicians, will be handed out in order as patients are enrolled. Clinical trial coordinators/physicians will verify treatment eligibility and informed consent before opening the envelope to obtain the treatment assignment.
* The study group will be placed on the phenobarbital-based protocol as described below in procedures. The control group will be placed on the lorazepam-based protocol, also listed below in procedures.
* All medications in the study are FDA approved. No investigational medicines will be used.
* Data will be collected on each participant as noted below in measurements.
* The data will be analyzed and published as noted above in the statistical analysis plan and data use and management section.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible for randomization if he/she has met one of the following three conditions:

  1. has required more than 10 mg of lorazepam within a one hour time period,
  2. has required more than 30 mg of lorazepam within a four hour time period, or
  3. requires admission/transfer to the intensive care unit for primarily uncontrolled alcohol withdrawal symptoms

     Exclusion Criteria:
* Patients will be excluded from the study if he/she:

  1. has a traumatic brain injury or other neurological condition requiring frequent neurological assessment (stroke, intracranial hemorrhage, active seizures on admission)
  2. has severe hypotension requiring vasopressor support
  3. is less than 18 years of age
  4. is actively pregnant
  5. has an allergy to either of the drugs being studied (phenobarbital or lorazepam)
  6. is already intubated at the time of randomization
DECT in Imaging Patients With Solid Organ Cancer With Intracranial Metastasis

This trial studies how well dual energy computed tomography (DECT) works in imaging patients with solid organ cancer that has spread to the brain. Imaging techniques, such as DECT, may help find and diagnose tumor cells and find out how far the tumor cells have spread in the brain.

PRIMARY OBJECTIVES:

I. To optimize two major parameters of computed tomography (CT) imaging for optimal detection of intracranial metastatic lesions.

Ia. Virtual monochromatic image reconstruction. Ib. Contrast bolus timing. II. To measure the detection accuracy of CT compared to the diagnostic standard of care gadolinium-based "Gamma Knife (GK)" protocol magnetic resonance imaging (MRI).

OUTLINE:

Within 7 days before the standard Gamma Knife MRI, patients undergo DECT scan over 6 seconds at 1.5, 5, 10, and 20 minutes after receiving the contrast agent.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with pathology-proven solid organ cancer
* MRI of the brain with contrast, positive for two or more metastatic lesions

  * One lesion with a single greatest diameter on contrast-enhanced MRI of 1 cm or greater
* Planned treatment with stereotactic radiosurgery

Exclusion Criteria:

* Known allergy to iodine-based contrast agents
* Patients with glomerular filtration rate (GFR) less than 30 or use of hemodialysis
* If prior nephrectomy, GFR less than 60
* Prior central nervous system malignancy
* Prior brain radiation
* Pregnant women are excluded
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors

This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.

This is an open-label, multicenter, Phase 1/1b study of RMC-9805, a selective and orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two arms: RMC-9805 monotherapy arm and RMC-9805 plus RMC-6236 combination arm. Both arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation
* Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
* ECOG performance status 0 or 1
* Adequate organ function

Exclusion Criteria:

* Primary central nervous system (CNS) tumors
* Known or suspected leptomeningeal or active brain metastases or spinal cord compression
* Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
* Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)

Other inclusion/exclusion criteria may apply.
Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard in Patients Undergoing Knee Replacement

Randomized controlled single blind trial for the evaluation of the treatment of the surgical wound healing process with Platelet-Rich-Fibrin compared to the gold standard (without Platelet-Rich-Fibrin) in patients undergoing knee replacement.


Eligibility Criteria:
Inclusion Criteria:

* Males or females undergoing a total knee prosthesis.
* Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
* Hb \> 11 g/dl; Platelet value \> 150.000 plt/mmc;
* Patients with non clinical alteration of ECG;
* Signature of informed consent;

Exclusion Criteria:

* Patients incapable of understanding and of wanting;
* Systemic disorders such as diabetes, rheumatic diseases;
* Patients with malignancy;
* Thyroid metabolic disorders ;
* Abuse of alcohol, drugs and pharmaceutical drugs
* Body mass index \> 40;
Establishment of a Patient Library in Patients With Pruritus Sine Materia

Very little is currently known about the pathophysiology of pruritus sine materia according to the etiology. The creation of this cohort should make it possible to improve our clinical and biological knowledge according to the etiology, by collecting blood, skin, feces, and clinical data.

At inclusion, 52.5 ml of blood will be collected, then an additional skin biopsy and a skin swab. Five questionnaires will be filled in by the patient.

At 6 months, then every years for 5 years, the same 5 questionnaires will be collected as well as the clinical data. However, no more biological samples will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pruritus sine materia
* Collection of consent
* Adult

Exclusion Criteria:

- Refusal to participate in the study