cyrilzakka/clinical-trials huggingface dataset:
Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in HF Patients (CONFIRM-HF)

A research study to determine if heart failure can be medically managed using data collected from cardiac monitoring devices


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Admission for worsening of HF
* Discharged to home
* Have appropriate cardiac device with OptiVol® implanted for at least 34 days prior to enrollment
* Enrolled in Carelink® system and able to transmit data
* Able to participate for at least 3 months

Exclusion Criteria:

* Post heart transplant or actively listed
* End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support
* Stage IV or V chronic renal dysfunction (GFR \<25 mol/min per 1.73 M2)
* Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen
* Severe pulmonary hypertension not due to left-sided HF
Eradication of Prostate Cancer Using F-989

The purpose of this study is to confirm the findings of an early study with prostate cancer and to expand our knowledge of treating prostate cancer using F-989.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of prostate cancer
* Referred to the study by their treating physician

Exclusion Criteria:

- Any type of treatment before starting study
Brain Organization, Development, and Response to Intervention in Individual Neonates

The goal of this study is to learn about brain connectivity and if massaging babies shortly after birth has an impact. Half of the recruited babies will receive massage daily while the other half will not, and differences will be observed.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Ability to give informed consent

Exclusion Criteria:

* Prisoners (vulnerable population)
* Pregnant women \<18 years of age
* Active psychosis, mania, suicidal ideation (safety)
* Active substance dependence
* Non-singleton pregnancy (e.g., twins)
* Gestational Age \<36 weeks (neonates)
* Neonatal encephalopathy (neonates)
Assessment of the Effects of Extensive Somatosensory Training on Pain Processing

Persistent pain may lead to several alterations in the brain activity and sensory perception (i.e. pain). Around 80% of professional musicians experience prolonged episodes of musculoskeletal pain throughout their careers, a percentage that is four times higher than in the general population. With this background, the intended experiment aims at understanding the role of several biological factors associated to sensorimotor training that can lead to alteration of the brain activity and, consequently, pain processing.


Eligibility Criteria:
Inclusion Criteria:

Healthy men and women Speak and understand English.

General exclusion criteria are:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic or mental illnesses
* Presence of a history of trauma or neurologic entrapment syndromes to the arm regions.
* Lack of ability to cooperate
* Frequent computer gamer ( \> 9 hours/week)
A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)

This is a Phase 2a, multi-center, double-blind, placebo-controlled study evaluating ABI-H0731+ ETV vs ETV alone for the treatment of viremic hepatitis B "e" antigen (HBeAg)-positive participants with cHBV.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female between ages 18 and 70 years
* HBeAg-positive at screening
* In good general health except for cHBV
* HBV viral load ≥2×105 IU/mL
* Hepatitis B surface antigen (HBsAg) \>1000 IU/mL at screening

Key Exclusion Criteria:

* Any prior treatment with lamivudine or telbivudine, previous treatment with an investigational agent for HBV other than ABI-H0731; or any other SOC treatment for \>4 weeks
* Co-infection with HIV, hepatitis C virus (HCV), hepatitis E virus (HEV) or hepatitis D virus (HDV)
* History or evidence of hepatic decompensation (including gastrointestinal bleeding or esophageal varices) at any time prior to or at time of screening
* Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the Investigator or the Sponsor makes the participant unsuitable for the study
* Previous treatment with an investigational agent for HBV other than ABI-H0731 in the last 6 months before screening
* History of hepatocellular carcinoma (HCC)
* Females who are lactating or pregnant or wish to become pregnant are excluded from the study
* Exclusionary laboratory parameters at screening:

  * Platelet count \<100,000/mm3
  * Albumin \<lower limit of normal (LLN)
  * Direct bilirubin \>1.2×upper limit of normal (ULN)
  * Alanine aminotransferase (ALT) \>10×ULN at screening
  * Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is \>ULN but \<100 ng/mL, participant is eligible if a hepatic imaging study prior to the initiation of study drug reveals no lesions suspicious of possible HCC
  * International Normalized Ratio (INR) \>1.5×ULN
  * Glomerular filtration rate (GFR) \<60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.

This study evaluates the benefits and harms of goal directed fluid removal with furosemide versus placebo in critical ill adult patients with fluid overload in the intensive care unit. Half of the patients will receive furosemide and the other half placebo. The treatment will continue until the excess fluid is excreted.

Fluid overload is a common and serious complication in patients admitted to the intensive care unit (ICU). A core element of therapy in the ICU is resuscitation with crystalloid solutions. In many cases fluid accumulate, and patients become fluid overloaded. Several observational studies indicate a detrimental effect of fluid overload in different clinical settings, including patients with acute kidney injury. It is unknown whether this association is causal or if the increased tendency to accumulate fluid is a marker of disease severity and thereby a higher risk of death. The investigators want to investigate this in critical ill patients with fluid overload of 5% or more by randomizing them to furosemide (diuretics) or placebo.

Eligibility Criteria:
Inclusion Criteria: ALL below must be met.

* Acute admission to the intensive care unit.
* Age ≥ 18 years of age
* Fluid overload ≥ 5% of ideal body weight. If possible, all fluids administered before admission to the intensive care unit are to be included in the calculation of cumulative fluid balance.
* Clinical stable (minimum criteria: MAP \> 50 mmHg and maximum infusion of 20 microgram/kg/minute of noradrenaline and lactate \< 4.0 mmol/L)

Exclusion Criteria:

* Known allergy to furosemide or sulphonamides.
* Known pre-hospitalization advanced chronic kidney disease (eGFR \< 30 mL/minute/1.73 m\^2 or chronic RRT).
* Ongoing renal replacement therapy.
* Anuria \> 6 hours.
* Rhabdomyolysis with indication for forced diuresis
* Ongoing life-threatening bleeding as these patients need specific fluid/blood product strategies.
* Acute burn injury of more than 10% of the body surface area as these patients need a specific fluid strategy.
* Severe dysnatremia (p-Na \< 120 or \> 155 mmol/L) as these patients need a specific fluid strategy.
* Severe hepatic failure as per the clinical team.
* Patients undergoing forced treatment.
* Fertile women (women \< 50 years) with positive urine human chorionic gonadotropin (hCG) or plasma-hCG.
* Consent not obtainable as per the model approved for the specific trial site.
Open-Label Study of OTO-201 for Treatment of AOMT

This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.


Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:

* Subject is a male or female aged 6 months to 17 years, inclusive
* Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)
* Subject's caregiver is willing to comply with the protocol an attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has a history of sensorineural hearing loss
* Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation
* Subject has a history of known immunodeficiency disease
Correlation and Rapid Analysis of Neurological Injury Using Markers

Each year, approximately 69 million people worldwide suffer from traumatic brain injuries (TBI), representing a significant burden on public health, society, and the economy. Timely and accurate care can influence short-, medium-, and long-term outcomes, making the reduction of diagnostic delays crucial. TBI diagnostics require careful consideration, as initial evaluations may differ from final assessments, and patient conditions may evolve over time.

In this monocentric, observational, post-market follow-up study we aim to evaluate the Abbott i-STAT™ TBI Plasma Test in detecting circulating brain biomarkers (GFAP and UCH-L1) in adult patients with TBI.

The study involves recruiting 200 adult patients (aged 18-65 years) presenting to the emergency department with TBI over a two-year period. For each participant, a blood sample will be collected as part of routine clinical care and analyzed using the Abbott i-STAT™ TBI Plasma Test within 12 hours of the trauma. The results will be compared with those obtained from cranial CT scans, the gold standard for diagnosing intracranial injuries.

Specifically, the study aims to assess the diagnostic accuracy of the test in excluding intracranial injuries, particularly in cases of mild TBI, and to explore potential correlations between biomarker presence and injury severity. No additional procedures beyond routine clinical care are required, and all collected data will be used exclusively for the study's predefined objectives.

Post-Market Performance Follow-up Study

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 65, male and female, presenting to the emergency department due to TBI, defined as trauma caused by an external force leading to temporary or permanent alterations in consciousness and/or neurological function. TBI severity is evaluated using the Glasgow Coma Scale (GCS).
* Sign of informed consent by patient or legal tutor

Exclusion Criteria:

* Pediatric patients (\<18 years).
* Patients \>65 years, to avoid potential confounding factors such as elevated GFAP levels associated with Alzheimer's disease.
Study of CT and MR in the Lung Cancer

Lung cancer is one of the leading causes of cancer-related deaths in China. Despite advances in systemic therapy and improvement nonsurvival rates for patients with advanced lung cancer, morbidity and mortality remain high.

Recently, many studies reported that patients with positive driving genes such as EGFR(epidermal growth factor receptor,EGFR), ALK(anaplastic lymphoma kinase,ALK), ROS1(c-ros oncogene 1 receptor,ROS1), BRAF (V-raf murine sarcoma viral oncogene homolog B1, BRAF)and so on have clearly targeted drugs, which bring survival benefits to patients. However, about half of patients still lack a clear driving gene target, which may have improved survival due to higher response rates to radiation therapy and other chemotherapy medications.

Development of noninvasive imaging biomarkers such as CT (computed tomography,CT)and MRI (magnetic resonance imaging,MRI)may not only evaluate the response to therapy ,but also could predict the efficacy of drug therapy and whether the driving gene is positive or not, through analysing the relationship between clinical related data and imaging features to find the imaging characteristics for making clinical decisions, and, consequently, contribute to an improved prognosis.

To explore the value of CT and MR using multiple sequences, including T2-TSE-BLADE, T2 maps StarVIBE, and iShim-DWI in evaluating the driving genes and prediction of response to therapy and OS in patients with lung cancer.

Patients with biopsy-proven lung cancer were prospectively enrolled for imaging on CT and a 3T MRI scanner . The MRI protocol included T2-TSE-BLADE, T2 maps,iShim-DWI and StarVIBE sequences, and so on. Patients received treatment according to NCCN( National Comprehensive Cancer Network) guideline. CT and MRI features were analyzed to find the correlation between pretreatment imaging features and driving genes and therapy response. The study will include 400 patients. Inter-reader agreements of TN staging were analyzed excellent for CT and MRI. Diagnostic accuracy of CT and MRI will be calculated separately.

Eligibility Criteria:
Inclusion Criteria:

1. Consecutive patients with preoperative pathologically con-firmed lung cancer by endoscopy and preoperative imaging data were included.
2. No contraindications for MRI examination. No contraindications for iodinated contrast.
3. The patients participate in this study with informed consent.

Exclusion Criteria:

1. The patients couldn't performed MSCT or MR scanning or artefacts affect the evaluation.
2. The patients are extremely anxious and uncooperative about surgery or neoadjuvant therapy .
3. PatientsThe patients refuse to participate in the project.
4. Other situations considered by investigators not meet the inclusion criteria.
Lateral Suspension and Sacropexy for Pelvic Organ Prolapse

Pelvic organ prolapse (POP) is considered one of the commonest gynecologic health problems all over the world. Pelvic organ prolapse (POP) is common and can be seen in up to 50% or more of parous women. The annual aggregated rate of associated surgery for pelvic organ prolapse is in the range of 10-30 per 10,000 women. It is estimated that women have an 11-19% life-time risk of undergoing surgery for POP. This rate is projected to increase over the next 2-3 decades. Apical POP refers any descent of the cervix or the vaginal cuff scar(as after hysterectomy) below a point which is 2 cm less than the total vaginal length about the plane of the hymen. Apical POP is due to defect in apical support with damage to the cardinal and uterosacral ligaments. Apical pelvic organ prolapse is a common issue in our country with significant incidence rate due to many predisposing factors including increasing age, higher gravidity and parity (especially the number of vaginal births)

By one estimate, the demand for health care services related to pelvic floor disorders will increase at twice the rate of the population itself . So we need adequate understanding of the best surgical method for treating apical POP which is accepted worldwide and also must be cost effective with least perioperative complications. Abdominal sacropexy is considered now the gold standard operation for treatment of apical pelvic organ prolapse. In this technique, the mesh is ﬁxed to the anterior longitudinal ligament at the sacral promontory. It is used either with uterine preservation (sacrohysteropexy) or after hysterectomy (sacrocolpopexy) for treatment of vault prolapse .However , many intraoperative complication can occur including hemorrhage or transfusion or both occurred in 4.4% , intestinal injury or rectal injury in 1.6% (0.4% to 2.5%),and ureteral injury in 1.0% of cases. Postoperative complications include paralytic ileus in 3.6%.transient femoral nerve injury and vertebral osteomyelitis . Also, despite that sacropexy provide good apical support, but the high prevalence of cystocele and urinary tract symptoms in patients reaches up to 8% . Consequently, it is not surprising that the majority of failures following sacrocolpopexy occur in the anterior compartment. Lateral suspension with mesh was ﬁrst reported by Dubuisson in 1998 for the treatment of pelvic organ prolapse . The lateral suspension avoids both the risk of vascular injury and nerve damage of sacrocolpopexy with success rate up to 88% of cases.

Eligibility Criteria:
Inclusion Criteria:

* Apical prolapse Stage 2-4 according to POP-Q system
* Uterine preservation or after hysterectomy
* Sexually active or not.

Exclusion Criteria:

* Pregnancy or up to 6 months postpartum.
* Current Urinary tract infection proved by urine analysis or urine culture.
* Patient unfit for surgery.
* Previous suspension operations.
* Uncontrolled diabetic patients.
* Urge incontinence.
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy

The objective of this study is to describe disease progression in study participants diagnosed with early Parkinson's Disease or Multiple System Atrophy - Parkinsonian Type up to 18 months as delineated by clinical and biochemical parameters.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Idiopathic PD
* Diagnosis of MSA-P
* One to six years from clinical diagnosis of PD
* Less than 4 years from clinical diagnosis of MSA with expected survival \>3 years
* Stable medication regimen
* Ability to walk with or without an assistive device

Exclusion Criteria:

* Movement disorder due to known cerebrovascular disease, brain tumor, trauma, exposure to parkinsonian-linked toxicants or other neurological diseases
* Presence of dementia, psychosis, substance abuse or poorly controlled depression
* Prior brain surgery (i.e. deep brain stimulation) or other brain imaging abnormalities
* History of cancer or poorly controlled medical conditions
* Receiving an investigational drug

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Effects of a Ketogenic Diet on Psychological Outcomes

The aim of the study is to investigate how glycemia and ketonemia variations during three different diet protocols: a ketogenic diet without any restriction on calories intake (KD), a calorie-restricted ketogenic-mediterranean diet (KEMEPHY) and a calorie-restricted mediterranean diet (MD) affect appetite, executive functions and mood in overweight young women.

Fifty overweight young women with a body mass index (BMI) greater than 25 will be randomly assigned to a ten days of ketogenic diet (KD), calorie-restricted ketogenic-mediterranean diet (KEMEPHY) or Mediterranean diet (MD). All subjects will begin the prescribed diet at the beginning of their follicular phase. Body composition, fasting blood glucose and β-hydroxybutyrate (BHB), visual analogue scale (VAS) to test appetite as well as psychological tests (one mood test and two cognitive tasks) will be obtained 5 days before the beginning and on the last day of the diet-period.

Eligibility Criteria:
Inclusion Criteria:

* female sex age between 20 and 35 years,
* 25\<BMI\>39.9 kg/m2

Exclusion Criteria:

* smokers,
* subjects under diet-treatment,
* subjects treated for diseases such as diabetes,
* cardiovascular diseases,
* depression,
* subjects doing sport more than 2 hours per week.
Progressive Muscle Relaxation Vs Muscle Energy Technique on Nonspecific Neck Pain in Prolonged Computer Users.

The objective of this randomized controlled trial is to assess the potential effectiveness of Progressive muscle relaxation technique (PMRT) vs Muscle energy technique (MET) as an intervention for releasing trigger points in SCM and upper trapezius in prolonged computer users. The study will be conducted in a workplace setting, where desk-type computer users are expected to regularly engage in their professional activities for ≥ 6 hours throughout the day, intermittently. This study will be conducted at the Outpatient Physiotherapy department of Sindh Institute of Physical Medicine and Rehabilitation, Karachi among 60 patients with nonspecific chronic neck pain on the basis of non-probability purposive sample technique. After taking informed consent, all participants will be randomly allocated into two groups through a investigator (blinded) the same investigator will be screening the individuals, doing baseline assessment, and post treatment assessment while another investigator will be providing intervention. Group 1 will receive Progressive muscle relaxation technique while Group 2 will receive Muscle Energy Technique on sternocleidomastoid and upper trapezius bilaterally. Patients will also be blinded. A total of 12 sessions will be provided. Outcomes will be assessed at baseline and post treatment after 2 weeks intervention.


Eligibility Criteria:
Inclusion Criteria:

* Persons using computer more than 6 hours throughout the day, intermittently both genders.
* Age between 20-45.
* Hypertonicity of trapezius muscle and SCM muscle. Specifically, those workers have neck pain and stiffness (including trouble tilting or turning head). Patients who reported small tightening and spasm at the posterior aspect of their neck are included, also associated with more diffuse neck pain patterns that included the following: headache, (upper back, neck and shoulder pain) numbness/ tingling in the hand/arm.
* Pain intensity of 2 on the NRS and presence of at least one latent trigger point in a taut band in the neck region.

Exclusion Criteria:

* Recent trauma to the cervical region
* Exclusion criteria based on with any serious pathology such as specific neck pain due to disc prolapsed, tumor of cervical spine, whiplash injury, cervical fractures, Cervicogenic headache, and any neurological signs consistent with nerve root compression