cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

The aims of this study are to assess efficacy and safety of patient-controlled analgesia (PCA) when applied to the Emergency Department setting and to compare the efficacy and safety of two PCA dosing regimens.

The safety, efficacy, and dosing of PCA will be assessed in a randomized trial with three treatment arms:

1. PCA with 1.0 mg morphine demand dosing every 6 minutes,
2. PCA with 1.5 mg demand dosing every 6 minutes and
3. a non-PCA comparison group.

All patients will receive a loading dose of 0.1 mg/kg morphine. All patients can receive additional analgesics as needed, at the discretion of the provider.

We hypothesize that morphine supplied via PCA will provide superior analgesia without a greater incidence of adverse events when compared to non-PCA pain management; and that PCA demand dosing of 1.5 mg will be superior to 1.0 mg without more adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the ED with a chief complaint of abdominal pain of less than or equal to 7 days duration
* Age 18 to 65 years
* Patient deemed by the ED attending physician to require IV opioid analgesia

Exclusion Criteria:

* Current use of prescription or non-prescription opioids
* Long-term use of opioids, chronic pain syndrome
* Clinician suspicion of opioid dependence/abuse
* Clinical suspicion of intoxication
* Pregnancy or breast-feeding
* History of chronic obstructive pulmonary disease, history of sleep apnea, oxygen saturation \< 97%
* Systolic blood pressure \< 100 mm Hg
* Use of monoamine oxidase inhibitors, phenothiazines, or tricyclic antidepressants
* History of renal insufficiency/renal failure
* Prior allergic reaction to morphine
* Inability to provide informed consent
* Previous entry of patient into study
Efficacy of a Telehealth Delivered Group Lifestyle Balance for People Post Stroke (tGLB-CVA)

Investigators will conduct a randomized controlled trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-CVA (tGLB-CVA) compared to a 6-month wait-list control (WLC) in partnership with a diverse group of patient partners and peer mentors.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index ≥25
* All types of stroke
* Able to Participate in Physical Activity
* ≥12 months post first stroke
* Have internet, phone, or computer access, or be willing to use one provided by the study team

Exclusion Criteria:

* Contraindications for physical activity
* Low Cognitive Function
* Residing in hospital, acute rehab, skilled nursing facility
* Not fluent in the English language
* Pre-existing eating disorder
* Pregnancy
Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

Probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a combination of probiotic and prebiotics and amine in the treatment of children affected by familial hypercholesterolemia (FH).

FH subjects, aged 6-12 years, consecutively observed a Tertiary Center for Pediatric Nutrition were randomly allocated to two groups of intervention for 6 months: active group, received a low saturated fats diet plus the symbiotic (2.5×109cfu, bid) for 6 months; control group, received low saturated fats diet alone. All children received written indications for low saturated fats diet. The plasmatic lipid profile was assessed by peripheral blood sampling at T0 and T1.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 6 and ≤ 12 years.
* Diagnosis of hypercholesterolemia (LDL cholesterol\> 140 mg / dl)
* Each patient must have shown resistance to dietary therapy lasting at least 6-12 months.

Exclusion Criteria:

* Age \<6 or\> 12 years.
* Patients undergoing drug treatment for hypercholesterolemia.
* Any medical condition that may interfere with participation in this study
* Participation in clinical trials still in progress.
* Taking pre / probiotics for more than 7 days in the 6 months prior to enrollment
Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema

This study is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18 subjects (up to 6 subjects per dose) with Diabetic Macular Edema (DME).

Upon providing informed consent, subjects will be sequentially enrolled into the study. Decision regarding dose escalation will be based on the recommendation from the Data Monitoring Committee (DMC). The first 3 eligible subjects will receive the low dose of AXT107 injection. After the 3 low dose subjects complete a 7-day follow-up, the DMC will review their safety data. If an acceptable safety profile is determined by the DMC, 3 additional subjects will be enrolled to receive the mid dose of AXT107 injection. Upon completion of a 7-day follow-up, review of the safety data, and determination of an acceptable safety profile by the DMC for the mid dose subjects, 3 additional subjects will be enrolled to receive the high dose of AXT107 injection.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older with diabetic macular edema (DME) diagnosis secondary to diabetes mellitus Type 1 or 2
* Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 23 in the study eye
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed inform consent

Exclusion Criteria:

* Any signs of high risk proliferative diabetic retinopathy in the study
* Previously-treated patients who are not responders to anti-VEGF
* Panretinal laser photocoagulation within 6 months and macular laser photocoagulation with 3 months of screening in the study eye

Note: Other inclusion/exclusion criteria apply.
Comparisom of Liquid Nitrogen and Vitamin D3 in The Treatment of Cutaneous Warts

A total of 60 female patients (30 patients in each group) with cutaneious warts diagnosed by a consultant dermatologist on physical examination were included in this study.

In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) while patients in Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness in both groups was ascertained in terms of \> 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.


Eligibility Criteria:
Inclusion Criteria:

* Patient of cutaneous warts presented in dermatology department.

Exclusion Criteria:

* Immunosuppressed patients
* chronic skin diseases like eczema or autoimmune disease
* diabetes mellitus
* cold sensitivity , skin allergies
* pregnancy, and lactation
* periungual warts
Personalized Phage Treatment in Covid-19 Patients With Bacterial Co-Infections Microbials for Pneumonia or Bacteremia/Septicemia

Phage Treatment in Covid-19 Patients with Bacterial Co-Infections

The treatment approach will be to make phage therapy available to institutions who care for Covid-19 patients with bacterial co-infections due to A. baumannii, P. aeruginosa or S. aureus. Patient bacterial isolates will be tested to determine phage susceptibility prior to and during phage therapy.

The primary objectives are to determine the feasibility of developing, producing and providing a personalized intravenous phage for Covid-19 patients who have pneumonia, bacteremia or septicemia due to A. baumannii, P. aeruginosa or S. aureus and to evaluate the safety of intravenous phage in Covid-19 patients along with anti-microbial treatment for pneumonia, bacteremia or septicemia due to A. baumannii, P. aeruginosa or S. aureus.

Eligibility Criteria:
Inclusion Criteria:

* Covid-19 patients with pneumonia or bacteremia/septicemia who have culture-confirmed bacterial co-infection with A. baumannii, P. aeruginosa or S. aureus.
* Patient provided informed and signed consent.

Exclusion Criteria:

* Patient eligible for another APT sponsored trial.
* Patient participating in another clinical trial at the same time or patients \< 4 weeks from participating in an alternative investigational protocol/study
* Patient with known allergy to infusion of phage products
* Patients with a history of Meningitis or encephalitis at time of study entry, Primary immune deficiency disease or tuberculosis or Stroke, transient ischemic attack (TIA), or untreated deep vein thrombosis.
Platelet Function Monitoring in Patients With Acute Myocardial Infarction

This study is being done to learn more about platelet reactivity (how well the small cells in the bloodstream work) in people who undergo Percutaneous coronary intervention (PCI) for stable and unstable (acute myocardial infarction) indications. Stable means you have not demonstrated any acute injury to your heart prior to your PCI; unstable means you have demonstrated some acute injury to your heart prior to your PCI. The investigators intend to determine if there is a change in platelet reactivity from the time of PCI to 30days post-PCI and does this change differ depending upon the conduction in which you present for PCI. This is going to be done with a variety of platelet reactivity assays.


Eligibility Criteria:
Inclusion Criteria:

* Patient \>18 years old.
* Patient scheduled to undergo PCI for either stable CAD or AMI:
* Stable CAD defined as negative cardiac isoenzymes prior to the PCI as well as no resting ECG changes indicative of ACS.
* AMI defined as positive cardiac isoenzymes prior to the PCI and/or resting ECG changes indicative of ACS.

  3. Patients treated with a loading dose of clopidogrel at least 6 hours prior to the blood draw or on a maintenance dose of clopidogrel (of at least 75mg QD) for a minimum of 5 days.

Exclusion Criteria:

* Known allergies to aspirin, clopidogrel, or prasugrel
* Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of the blood draw;
* Patient known to be pregnant or lactating;
* Patient with known history of bleeding diathesis or currently active bleeding;
* Platelet count \<100,000/mm the day of the blood draw;
* Hematocrit \<25% the day of the blood draw;
* On warfarin therapy at the time of the blood draw or the need for warfarin therapy in the subsequent month following the blood draw;
* Known blood transfusion within the preceding 10 days of the blood draw;
* Patient who has received NSAID (not including ASA) within preceding 24 hours of the blood draw;
* Patients presenting with cardiogenic shock;
* Any significant medical condition, which in the investigator's opinion may interfere with the patient's optimal participation in the study.
Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis

This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study (24-week treatment-comparison phase) with an open-label reference arm of active comparator (dienogest) followed by 28-week long-term treatment phase.

The primary objective of this study is to confirm the superiority of BAY86-5300 when administered with an extended flexible regimen for the treatment of endometriosis-associated pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks.

The secondary objective is to investigate the long-term safety of BAY86-5300 in patients treated with an extended flexible regimen for one year, and the bleeding pattern of BAY86-5300 when administered with an extended flexible regimen compared to dienogest.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as having endometriosis by laparotomy or laparoscopy, or by identification of chocolate cyst of endometriosis, or patients with the clinical diagnosis of endometriosis, who fulfill the condition of pelvic tenderness or induration of Cul-de-sac or uterine immobility
* Patient with pelvic pain judged by the highest Visual Analogue Scale (VAS) value of 40 mm or higher which is determined during 2 menstrual cycles before randomization (baseline observation phase)
* Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before randomization (baseline observation phase)
* Patients who do not wish to become pregnant during the course of the study

Exclusion Criteria:

* Patients who have organic diseases of which surgical treatment is prioritized by investigator
* Patients in whom any hormonal therapies, including combined oral contraceptives (COCs) and progestins, have failed for treatment of symptomatic endometriosis (moderate, severe pain)
* Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese Labeling)
* Patients for whom dienogest is contraindicated (according to Japanese labeling of Dinagest Tab 1mg)
Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis

Multiple sclerosis (MS) is an inflammatory, demyelinating disease which affects the central nervous system (CNS). The etiology of MS is unknown, although the immune system appears to play a role. Many different infectious agents have been proposed as potential causes for MS, including Epstein-Barr virus, human herpesvirus 6, and coronaviruses. Recently Dr. Sriram at Vanderbilt University has found evidence for active Chlamydia pneumonia infection in the CNS of MS patients. These findings have been replicated in part by other laboratories.

The purpose of the current study is to test whether antibiotic treatment aimed at eradicating Chlamydia infection will reduce the disease activity in MS. The primary outcome measure will be reduction in new enhancing MS lesions on brain MRI. Forty patients will be entered into the trial. To be eligible, patients must have evidence of chlamydia infection in their spinal fluid and enhancing lesions on their pre-randomization MRI scans. Patients who meet these criteria will be randomized to either placebo or antibiotic therapy, and followed for 6 months on treatment.


Eligibility Criteria:
Patients with unequivocal diagnosis of multiple sclerosis and have evidence of C. pneumoniae infection in the cerebral spinal fluid
The Use of AI to Improve Quality of OGD

Early and accurate recognition of gastrointestinal lesions has implications for public health. The quality of oesophagogastroduodenoscopy (OGD) has great impact on the detection of oesophageal and gastric malignancies. An AI system, Cerebro, has been developed as a real-time recognition of a pre-defined 28 locations. This system would alert the endoscopist if the sites were not inspected with adequate time. The aim of the study is to investigate the use of AI in endoscopists-in-training during OGD to provide a real-time feedback for ensuring compliance to a standardized protocol for examination. The hypothesis is that the use of AI system Cerebro will significantly improve the compliance to the protocol and thereby reduce the blind spot rates of OGD, ensure adequate inspection time and ensure adequate photodocumentation.


Eligibility Criteria:
Inclusion Criteria:

1. All patients aged \>= 18 years old
2. Undergoing diagnostic OGD for evaluation of their symptoms in the Prince of Wales Hospital will be included in the study.

Exclusion Criteria:

1. Patients in which a full endoscopic examination is not required including patients with a specific diagnostic purpose without the need for a full evaluation, follow-up endoscopy within 8 weeks for a previously diagnosed disease or condition,
2. Patients' condition requiring therapeutic endoscopy,
3. Early termination of endoscopy due to patient intolerance, presence of large amount of food residue, presence of mechanical obstruction or for reasons of safety,
4. Patients with altered anatomy such as history of esophagectomy, gastrectomy, gastric bypass surgery, or Whipple's operation,
5. Patient who are not suitable for EGD examination (such as acute peritonitis with suspected perforated bowel)
6. Pregnant females
7. Patients who refuse to participate in the study
8. Patients who are unfit for consent.
Open Label Extension Study of NCT06221852

This is a 12-week open-label extension study for participants completing study NCT06221852.

In this 12-week single arm open label extension study of NCT06221852, the investigators aim to assess the longer term efficacy, safety and tolerability of the ketogenic diet in participants completing the randomized study phase of NCT06221852. Investigators will assess longer term effects on energy metabolism, insulin resistance and psychiatric symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Participants who met original entry criteria in, and completed, the randomized 12-week study of NCT06221852.

Exclusion Criteria:

-No longer meeting original entry criteria from the randomized 12-week study of NCT06221852.
A Phase 3 Study of ALXN2060 in Japanese Participants With Symptomatic ATTR-CM

This prospective study is designed to evaluate the efficacy, safety, and tolerability of ALXN2060 (also known as AG10), as well as to establish its pharmacokinetic and pharmacodynamic profile in Japanese participants with symptomatic ATTR-CM administered on a background of stable heart failure therapy.

Participants will receive ALXN2060 for 12 months (Part A). Following the last visit (Month 12) of Part A, participants will continue the study in Part B, which will last for an additional 18 months (30 months from Day 1), during which all participants will continue to receive oral treatment with ALXN2060. Following completion of Month 30 assessments in Part B, participants will be offered the opportunity to continue to receive ALXN2060 in the Extension Period, which will last until ALXN2060 is approved in Japan or for up to 24 additional months, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

1. Established diagnosis of ATTR-CM with either wild-type TTR or a variant TTR genotype.
2. History of heart failure evidenced by at least 1 prior hospitalization for heart failure or clinical evidence of heart failure without prior heart failure hospitalization manifested by signs or symptoms of volume overload or elevated pressures or heart failure symptoms that required or requires ongoing treatment with a diuretic.
3. New York Heart Association Class I-III symptoms due to ATTR-CM.
4. On stable doses of cardiovascular medical therapy.
5. Completed ≥ 150 meters on the 6MWT on 2 tests prior to Day 1.
6. Left ventricular (LV) wall (interventricular septum or LV posterior wall) thickness ≥ 12 millimeters.
7. Biomarkers of myocardial wall stress: N-terminal pro-brain-type natriuretic pep (NT-proBNP) level ≥ 300 picograms/milliliter (pg/mL).

Exclusion Criteria:

1. Acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening.
2. Hemodynamic instability at screening.
3. Likely to undergo heart transplantation within a year of screening.
4. Current treatment with marketed drug products and other investigational agents for the treatment of ATTR-CM.
5. Current treatment with calcium channel blockers with conduction system effects (for example, verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed.
6. Confirmed diagnosis of light-chain (AL) amyloidosis.
7. Biomarkers of myocardial wall stress: NT-ProBNP ≥ 8,500 pg/mL.
8. Measure of kidney function, estimated glomerular filtration rate by Modification of Diet in Renal Disease formula \< 30 mL/minute/1.73 meters squared.
Patient-Ventilator Dyssynchrony: How is the Effect of Management?

Although patient-ventilator asynchrony is a frequent phenomenon, its course following management is unknown. As the aid of a data recording system, we try to observe the consequence of patient-ventilator asynchrony following management. Our target is aimed at the patients with high asynchronization index ( \> 10%) as this group of patients have been shown to have prolonged course in intensive care unit and are also prone to be tracheostomized


Eligibility Criteria:
Inclusion Criteria:

* patients admitted to respiratory intensive care unit with acute respiratory failure and presence of patient-ventilator asynchrony(AI of more than 10%)
* patient can trigger the ventilator

Exclusion Criteria:

* High oxygen fraction: \> 60%.
* High PEEP need: \> 12cmH2O.
* Hemodynamic unstable: shock
* Central nervous system problem.
* Hyperacitve delirium
* Without informed consent
Cognitive Problems in Veterans With Heart Failure

We assessed the prevalence of cognitive/memory problems in veteran patients with heart failure, and evaluated its relationship to medication compliance.

Heart failure (HF) is a costly, chronic, and complex condition that impacts veterans' quality of life, morbidity, and mortality. In the VA population up to 20% of patients are readmitted for HF within 30 days. Non-adherence to prescribed medication and self-care regimens in patients with HF is known to lead to increased morbidity, including readmissions. Cognitive impairment (CI) has been shown to predict nonadherence in elderly people without HF, however, this link has not been studied in HF populations. In the non-veteran population, HF patients are known to have an increased prevalence of cognitive impairment (CI), however, no existing study has determined the extent and type of CI in veterans with HF.

This pilot study was designed as a descriptive cross-sectional study as a pre-implementation effort with following goals: (1) determine the prevalence of CI in veterans with all-cause HF in an outpatient setting; (2) quantitatively describe the extent of CI in this population; (3) qualitatively describe neuropsychological domains affected by CI; (4) evaluate the association of CI with medication adherence and other clinical variables.

All consenting eligible outpatients in our VA HF clinic underwent a simple screening test for CI (Saint Louis University Mental Status Exam). Demographic and clinical variables were collected by patient interviews and chartg reviews, and included Geriatric Depression Scale and questionnaires about medication-taking behaviors. All subjects were invited back for 30-day direct pill count of all their routinely prescribed medications. Subjects who screened positive for CI were invited back for a modified battery of neuropsychological tests to determine the cognitive domains affected. Subjects will also be followed after the 12-month study period to collect data on hospital readmissions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with established diagnosis of clinical heart failure
* English-speaking
* Able to provide informed consent
* Able to participate in cognitive function testing
* Age over 18

Exclusion Criteria:

* Life expectancy \< 6 months
* Documented dementia requiring a caregiver
BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.

This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women or men \>30 years of age;
* osteoporosis;
* vertebral osteoporotic fracture in past 4 weeks;
* fracture-related pain requiring analgesic treatment.

Exclusion Criteria:

* non-menopausal women;
* current treatment with another bisphosphonate;
* current treatment with class III analgesics.