cyrilzakka/clinical-trials huggingface dataset:
Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure

This a single-center, retrospective, observational study of patients that undergo coronary sinus(CS) lead revision, comparing epicardial lead placement to coronary sinus pacing(CSP) in those that had lead failure.

Cardiac resynchronization therapy with defibrillator(CRT-D) improves quality of life, functionality, and even mortality for select patients with severe heart failure with reduced ejection fraction (HFrEF). It traditionally consists of three leads placed endovascularly into the right atrium, right ventricle, and left ventricle (LV) \[typically placed into the CS\], known as biventricular pacing resynchronization (BVP-CRT), respectively, from which electrical stimulation enables improved cardiac synchrony. Nonetheless, the placement of a CRT-D is not without risks. Lead-related complication is high and CRT-D implantation fails in up to 30% of patients due to lead placement alone.

Epicardial lead placement and CSP have been deemed viable alternatives to CRT-D. It has even been shown to be options in patients that fail conventional BVP-CRT. This is primarily due to increased accuracy, decreased complications, and even durability. However, guidelines for decision between a transthoracic approach and CSP is unclear, even more so after lead failure. Instead, this decision is currently individualized to the patient. There is a lack of prospective and head-to-head data between the two, and this study is aimed to compare transthoracic LV epicardial lead placement and CSP in patients with lead failure after BVP-CRT.

Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years of age
* Patients with HFrEF that underwent BVP-CRT
* Experienced CS lead failure, whether initial or recurrent, subsequently replaced with transthoracic epicardial lead placement or CSP
* Underwent Medtronic, Boston Scientific, or Abbott lead placement

Exclusion Criteria:

* Patients younger than 18 years of age
* Transthoracic epicardial lead placement or CSP performed as the initial approach or for other reasons than lead replacement
* Those for which CRT no longer provides symptom relief or mortality benefit.
Safety of Manganese Restriction in Neonatal Parenteral Nutrition

Participants will be \<= 32 weeks gestational age (GA) neonates randomized to parenteral nutrition (PN) prepared with standard dose trace elements or to PN prepared with standard trace elements minus manganese.

Very preterm neonates \<= 32+6 weeks GA receiving PN will be randomized to receive their PN prepared with standard trace elements containing 5 mcg/kg/day of manganese, or to PN prepared with no added manganese. Randomization assignment will be double masked. All participants will have whole blood manganese measurements at baseline, at 2 weeks of postnatal age, and at 8 weeks postnatal age. Because manganese is present as a contaminant in many of the ingredients used to prepare neonatal PN, this study hypothesizes that neonates randomized to no added manganese in their PN will maintain whole blood manganese concentrations above the lower limit of normal.

Eligibility Criteria:
Inclusion Criteria:

* Inborn admissions to the SHARP Mary Birch Hospital for Women and Newborns neonatal intensive care unit.
* Less than or equal to 32+6 weeks gestational age.
* Initiated on parenteral nutrition as decided by their attending neonatologist.

Exclusion Criteria:

* Continuous exposure to routine care PN containing standard trace element for ≥ 4 hours.
* Congenital liver disease.
* Moribund status or imminent death.
* Any condition that in the judgment of the investigator or attending physician provider precludes participation because it could affect subject safety.
* Lack or refusal of informed consent
A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis

This was an open phase I trial to evaluate the pharmacokinetic, pharmacodynamic, safety and clinical activity profiles of anti-CD22 monoclonal antibody SM03 in patients with active RA.

This was an open phase I trial to evaluate the PK, PD, safety,tolerability, efficacy, and immunogenicity of SM03 in patients with RA. The total study duration was approximately 16 weeks for each participant, including a screening period of maximally 4 weeks, a multiple-dose period of 2 weeks (day 0 \~ day 14), and a post-treatment follow-up period of 10 weeks (day 15 \~ day 84).

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
* Moderate to severe active RA with swollen joint count (SJC) ≥ 6 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
* At screening, either C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes.
* Receiving methotrexate (MTX) 7.5 - 25mg/week (oral) for at least 12 weeks, at a stable dose over the past 4 weeks.

Exclusion Criteria:

* Females who are pregnant, breastfeeding, or planning a pregnancy during the Treatment Period of and 12 months after the last infusion of study drug.
* Rheumatic autoimmune disease other than RA.
* Use of any biological DMARDs for RA within past 6 months.
* Active infection, or history of serious or chronic infection.
* Any significant cardiac disease, moderate to severe chronic obstructive pulmonary disease.
* Allergy or sensitivity to components of the drug vial or any of the materials used for infusion
Japanese Safety and Efficacy Study of Enoxaparin in Patients With Hip Fracture Surgery

The purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous blood clots in patients with hip fracture surgery.


Eligibility Criteria:
Inclusion Criteria:

* femoral neck inside or outside fracture

Exclusion Criteria:

* any major surgery on lower limbs within 3 months
* clinical signs of deep vein thrombosis
* use of non-steroidal anti-inflammatory drugs
* severe hepatic disease or renal insufficiency
Efficacy of Enhanced Recovery After Surgery Pathway for Total Mastectomy

Retrospective analysis of pre and post-Enhanced Recovery after Surgery for Total mastectomy pathway implementation.

Retrospective analysis of pre- and post-Enhanced Recovery after surgery for total mastectomy pathway implementation in patients at Mount Zion Hospital. We examined perioperative opioid consumption, pain scores, post-operative nausea and vomiting, benzodiazepine use, length of stay for the time period before and after implementation of an Enhanced Recovery after Surgery pathway for Total mastectomy. Pathway features included preoperative acetaminophen and gabapentin, minimizing opioids, postoperative NSAIDs, Pecs blocks, and aggressive postoperative nausea and vomiting prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* female patients at least 18 years old undergoing total skin sparing mastectomy at University of California San Francisco Mount Zion hospital

Exclusion Criteria:

* patients undergoing concurrent bilateral salpingo-oophorectomy, flap reconstruction
Motion Sickness Rehabilitation for Virtual Reality

The objective of this study was to investigate the effect of a rehabilitation program on motion sickness. A combined rehabilitation program will be given participants who showed motion sickness symptoms.

In the realm of virtual environments and simulators, a significant hurdle that hampers user engagement resides in the manifestation of adverse effects. These deleterious consequences become apparent during prolonged exposure to virtual settings, with approximately 30% of users grappling with symptoms like nausea and up to 40% reporting eyestrain. Furthermore, users frequently describe a constellation of other discomforting sensations, including headaches, dizziness or vertigo, compromised postural stability, drowsiness, increased salivation, and perspiration. These adverse effects have been documented in scientific literature under various monikers, with 'cybersickness' and 'motion sickness' (MS) being the most prevalent designations.

Motion sickness, a vexing symptom characterized by discomfort experienced during movements unrelated to one's bodily motions, such as those encountered during travel by air, sea, or land, lies at the crux of this issue. The pathophysiological elucidation of the mechanisms underlying MS centers around the notion of sensory conflict or sensory mismatch. This conflict arises from disparities between the sensory information derived from kinaesthetic inputs, the vestibular and visual systems, and the sensory patterns engendered by the virtual environment

Eligibility Criteria:
Inclusion Criteria:

* having stereoacuity score of 3552 arc/s on the Titmus Fly Test

Exclusion Criteria:

* having partial or total vision loss
* being diagnosed with vertigo
* having previous experience of head mounted virtual reality devices
Study of Two Techniques of Rectal Reservoir in Low Anterior Resection of Rectum

The aim of the study CGD-01/2000 was to investigate wheter a transverse coloplasty pouch is able to improve functional results and quality of life after coloanal anastomosis.


Eligibility Criteria:
Inclusion Criteria:

* Low or middle rectal adenocarcinoma without involvement of the anal sphincter
* Neoadjuvant chemoradiotherapy
* Age older than 18 years
* Wexner index of less than 5
* Signed informed consent

Exclusion Criteria:

* Involvement of the anal sphincter
* Wexner index of 5 or more
* Declined informed consent
* Psychological or social problems
SENSE Theatre Intervention for Children With Autism Spectrum Disorder (ASD)

The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.

The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.

Objectives: The purpose of the study is to evaluate and extend the impact of a peer-mediated, theatre-based intervention on children with ASD with an emphasis on social functioning. The 10-session program incorporates theatrical approaches, trained typically developing peers and established behavioral strategies. Previous studies using pre-post designs have reported improvement in several skills, such as face memory, theory of mind and social cognition. A primary objective of this investigation is to utilize a true experimental design while evaluating social ability across multiple levels of analysis including neuropsychological, cognitive, behavioral, and functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

* children diagnosed with autism spectrum disorder with IQ ≥ to 70.

Exclusion Criteria:

* IQ ≤ 70, children with current aggression toward self or others.
The Effectiveness of Palatal Brushing on Denture Stomatitis

Denture stomatitis (DS) is an oral biofilm associated inflammatory disease of the palatal mucosa. It is the most prevalent oral disease and the main indicator of poor oral health among denture wearers, affecting one-third of all complete denture wearers.

The etiology of DS is multifactorial, with documented role of mechanical trauma, bacteria and fungi. Risk factors may include, poor oral hygiene and nocturnal use of dentures. However, the evidence is ambiguous, inconclusive and recurrence following routine antifungal therapy is common.

The proposed study is a phase II clinical trial to evaluate the efficacy of palatal brushing in reducing the colony forming unit (CFU) count and clinical inflammation. The assessment of change in CFU count and clinical inflammation will be carried out at baseline, 3 months and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Wearing a maxillary and mandibular complete conventional denture
* Having moderate to severe signs of denture stomatitis according to Schwartz index
* Providing consent prior to study.

Exclusion Criteria:

* Oral mucosal lesions other than denture stomatitis.
* Systemic conditions which predispose to Candida specie infection such as uncontrolled diabetes and xerostomia.
* History of chemotherapy/radiotherapy.
* Used antibiotics, steroidal or antifungal agents in the 4 weeks prior to the study.
* Scheduled to replace existing dentures with new ones during the length of the trial.
* Already using palatal brushing as a routine oral hygiene procedure.
A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics

This study will look into insulin sensitivity (how the body responds to insulin) and effects of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. The study has two treatment periods, each of which will last about four weeks. One drug (insulin peglispro or insulin glargine) will be administered in each period. Participants will receive both drugs during the study. Participants may remain on stable dose metformin, as prescribed by their personal physician.


Eligibility Criteria:
Inclusion Criteria:

* Stable glycated hemoglobin (HbA1c) less than (\<) 10.0 percent (%)
* Stable dose of either 0.2 to 1.5 units per kilogram per day (U/kg/day) basal insulin or a total daily insulin dose l\<2.0 units per kilogram (U/kg)
* C-peptide \<0.3 nanomole per liter (nmol/L)
* Stable body during the last 2 months

Exclusion Criteria:

* Corrected QT interval (QTc) prolongation greater than (\>) 500 milliseconds (ms) or have any other abnormality in the 12 lead
* Abnormal blood pressure
* A history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus (T1DM)), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Currently treated with oral antidiabetic drugs (OADs) (excluding metformin and dipeptidyl peptidase-4 (DPP4) inhibitors), or glucagon-like peptide-1 (GLP-1) agonists or intend to use over-the counter or prescription medication, herbal medications, or nutritional supplements that affect PG or insulin sensitivity, impact on hypoglycemic awareness or promote weight loss within 4 weeks prior to randomization
* Fasting triglycerides (TGs) \>400 milligrams per deciliter (mg/dL) (4.52 millimoles per liter (mmol/L))
* Have used systemic or inhaled corticosteroids/glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) within 4 weeks prior to randomization
* Currently receive insulin by pump or insulin degludec
* Poorly controlled diabetes or known to have poor awareness of hypoglycemia
* History of gastroparesis or gastrointestinal malabsorption
* Require treatment with any drug other than insulin to treat diabetes
* Previous history of proliferative retinopathy
* Excessive consumers of xanthines
A Single and Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Japanese Subjects

This is a single centre, Double blinded, Randomised, Placebo-controlled, Parallel group study to access the safety, tolerability, and pharmacokinetics of Inhaled AZD9164 after administration of single and Multiple Ascending doses in Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese subjects with suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) between 18 and 27 kg/m2 and a body weight between 50 and 85 kg
* Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
Sleep, HIV Disease Progression, and Function in HIV Infected Children and Adolescents

This study is a first step in approaching the gap existing between understanding sleep abnormalities, alterations in sleep-regulating cytokines and HIV-1 disease regulating cytokines, and abnormal higher cortical function.

BACKGROUND:

In the growing number of HIV infected youth and young adults, it is important to study the effects of HAART treatment on sleep patterns and related neurocognitive and psychosocial function.

DESIGN NARRATIVE (including primary and secondary outcomes):

Using validated sleep questionnaires and actigraphy measurements, overnight polysomnography (PSG, sleep study) will assess the degree of abnormal sleeping patterns and daytime sleepiness in HIV infected children and HIV uninfected children (control group).

The following peripheral blood levels will be measured over a 24-hour period, at multiple time points, in all participants: TNF-alphaRI and IL-6 (sleep-regulating cytokines); IFN-gamma and IL-12 (cytotoxic or TH1 cytokines); and IL-10 and IL-1RA (inflammatory or TH2 cytokines). This will help to determine the association between alterations in sleep-regulating cytokines and HIV disease progression (CD4+ T-cell count, HIV-1 RNA level).

Neurocognitive and neuropsychological tests will be performed on all participants to determine if there is an association between lack of normal sleeping habits, alterations in sleep-regulating cytokines and HIV-1 disease progression cytokines, and neurocognitive/neuropsychological performance.

Computer analysis of electroencephalography (EEG) will be performed during wakefulness and all stages of sleep to determine if greater disease severity, sleepiness, sleep disruption, and neurocognitive impairment is associated with increased amounts of slow activity. Improvement in these related factors will be associated with normalizations of these parameters. For some of these quantitative measures, the findings may be more significant for particular brain regions; for example, frontal regions in the case of attention problems.

Eligibility Criteria:
Inclusion Criteria:

HIV Group

* HIV-1 infection

Control Group

* Family members and friends of HIV-1 infected children

Exclusion Criteria:

HIV Group

* Pregnancy

Control Group

* Pregnancy
* Asthma
* Sleep apnea
PK Study of T-817 in Subjects With Hepatic Impairment

The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment compared to matched healthy control subjects.

The secondary objective is to determine the safety and tolerability of single-dose T -817MA (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.


Eligibility Criteria:
Inclusion Criteria:

For subjects with mild, moderate or severe hepatic impairment

1. Adult male or female, 18 - 75 years of age
2. Must weigh at least 50 kg and have a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m2
3. Have mild, moderate or severe defined by Child-Pugh classification hepatic impairment

For Matched Healthy Control Subjects Healthy adult male or female subjects will be matched 1:1 to a specific subject in the mild, moderate, or severe hepatic impairment cohort based upon age, weight, gender, and smoking status

Exclusion Criteria:

1. Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
3. History or presence of hypersensitivity or idiosyncratic reaction to the study drug, related compounds, or inactive ingredients.
4. Female subjects who are pregnant or lactating.
Dietary Lipids as Primary Modulators of Carotenoid Absorption in Vegetables

The purpose of this research study is to determine how dietary fats and oils influence the absorption of beneficial plant pigments (carotenoids) from vegetables. The study will examine changes in blood carotenoids in response to eating a salad with different fats/oils.


Eligibility Criteria:
Inclusion Criteria:

* Age range: 18-50 years.
* Body mass index (BMI: weight (kg)/height (m2)) ranging from 20-29 kg/m²
* Weight stable (\<4.5 kg change within the last 3 months),
* Constant habitual activity pattern, not to exceed activities of a recreational level over the past 3 months.
* Must be pre-menopausal
* Have clinically normal blood profiles (specifically normal liver and kidney functions and fasting blood glucose of ≤110 mg/dl)
* Non-smoking
* Non-diabetic
* No current or planned pregnancy
* Not using any hormone-based contraceptive, e.g., pill, patch, injection, implants, etc.
* No current use of medication affecting lipid profile
* No intestinal disorders including lipid malabsorption, lactose intolerance
* No heavy consumption of alcohol (\>2 drinks per day)
* No current use of dietary supplements that affect cholesterol, (e.g. Benocol or fiber supplements) or a willingness to discontinue their use during the study.

Exclusion Criteria:

* Menopausal
* Diabetic
* Currently pregnant
* Currently using any type of hormone-based contraceptives, (e.g., pill, patch, injection, implants, etc.)
* Use of lipid altering medications