cyrilzakka/clinical-trials huggingface dataset:
Ivabradine in Patients With Congestive Heart Failure

The aim of this study is to assess the efficacy of Ivabradine therapy in patients with congestive heart failure using the cardiac biomarkers NT-Pro BNP and Neopterin.

* Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University
* All participants have agreed to take part in this clinical study and provide informed consent
* A 3 months, prospective interventional study.
* Sixty ambulatory, clinically stable symptomatic patients with systolic chronic HF (≥ 4 weeks), on optimized standard medical therapy were consecutively included and randomly allocated to the ivabradine group (n=30) and non-ivabradine group (n=30).
* The baseline evaluation comprised physical examination, NYHA class, 12-lead electrocardi¬ography (ECG), Echocardiography, blood sampling for laboratory measurements, including NT-Pro BNP and Neopterin.
* Patients in the Ivabradine group were administered Ivabradine 5 mg twice daily and doses (2.5, 5, 7.5 mg) were to be adjusted upwards or downwards at every visit according to HR at rest and tolerability.
* Patients were followed up after 1 week of initiation of ivabradine therapy then monthly till the end of the study.
* Peripheral venous blood samples were drawn between 8 and 9 am after a 30-min rest in the supine position. Serum samples were frozen at -80°C until assay.
* Levels of NT-Pro BNP and Neopterin were detected using ELISA kits as prescribed by manufacturer.
* Statistical tests appropriate to the study will be conducted to evaluate significance of results
* Results, conclusion, discussion and recommendations will be given

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic HF, on optimized medical therapy according to European Society of Cardiol¬ogy guidelines, with LV ejection fraction (LVEF) \< 35% according to the Simpson method, New York Heart Association (NYHA) class II-III, and sinus rhythm and resting HR \> 70/min were eligible for inclusion in the study.

Exclusion Criteria:

* acute decompen¬sation (acute coronary syndromes and acute HF);
* hemodynamically significant valve disease;
* cer¬ebrovascular events during the previous 6 months;
* dysfunctional prosthetic heart valve;
* obstructive or non-obstructive cardiomyopathy; uncorrected congenital heart disease; active myocarditis;
* a his¬tory of resuscitation from sudden death; an absence of stable sinus rhythm, severe arrhythmias; HR \< 60 bpm; sick sinus syndrome; second-degree and third-degree atrioventricular block;
* severe obesity (body mass index \> 36 kg/m²);
* established or sus¬pected pulmonary diseases (vital capacity \< 80% or forced expiratory volume in 1 s \< 80% of age spe¬cific and sex-specific reference values);
* hemoglobin ≤ 11 g/dL;
* treatment with non-dihydropyridine calcium-channel blockers, class I antiarrhythmic agents, strong inhibitors of cytochrome P450-3A4, or QT interval-prolonging medications;
* acute and chronic kidney failure;
* pregnancy; hypo- and hy¬perthyroidism or acute infections.
A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* post-menopausal women, 50-85 years of age;
* any inflammatory rheumatoid disease including polymyalgia rheumatica;
* receiving treatment with 5-15 mg/day of prednisolone.

Exclusion Criteria:

* previous treatment with an iv bisphosphonate at any time;
* previous treatment with an oral bisphosphonate within the last 6 months, \>1 month of treatment within last year, or \>3 months of treatment within last 2 years;
* treatment with parathyroid hormone in last 2 years;
* inability to stand or sit in an upright position for at least 60 minutes;
* inability to swallow a tablet whole;
* history of major gastrointestinal disease.
Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.

The purpose of this study is to evaluate the safety, efficacy, and functionality of the Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, more than 18 years of age incontinent with liquid to semi-formed stool.
* Non-ambulatory, hospitalized patients.
* History of passage of at least 1 stool in 24 hours.

Exclusion Criteria:

* Patients with suspected or confirmed rectal mucosal impairment or pathology.
* Patients with have undergone descending colon or rectal surgery within the preceding six months.
* Patients with significant hemorrhoids, growth, fissure, stricture, stenosis or local pathology (either benign and malignant) as observed during rectal examination.
* Patients suspected to have impacted stool or is suffering from constipation.
* Patients with confirmed pregnancy or suspected to be pregnant.
* Patients that have planned MRI examination over the duration of the study.
* Patients who have suffered recent cardiac arrest within the preceding 3 months.
* Patients enrolled in another clinical study or clinical trial.
* Patients on oral or IV anti-coagulation (e.g., IV heparin drip, acetylsalicylic acid , Plavix). Subcutaneous heparin or low molecular weight heparin are acceptable).
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection

The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).


Eligibility Criteria:
Inclusion Criteria include:

* ≥18 years of age.
* Weigh ≥50 kg.
* Donor specific antibody identified.

Exclusion Criteria include:

* Any surgical or medical condition that could interfere with the administration of study drug or interpretation of study results.
* History of allergic reaction to C1 Esterase Inhibitor or other blood products.
* Participation in the active dosing phase of any other investigational drug study within 30 days prior to dosing with study drug.
* Pregnancy or lactation.
* Receipt of any experimental agents for AMR within 1 month prior to the first dose of study drug.
* Any infection that causes hemodynamic compromise.
* History of bleeding or clotting abnormality.
Manual Dexterity in Ulnar Styloid Fracture Patients

Fracture of the distal radius (DRF) is a common musculoskeletal system injury. Fracture of the ulnar styloid frequently accompanies fractures of the distal radius and is seen in 50-65% of these cases. The loss of dexterity is common in many musculoskeletal conditions.

The aim of this study was to investigate whether an associated ulnar styloid fracture following a distal radius fracture has any effect on manual dexterity.

Patients who diagnosed with isolated DRF or DRF accompanied with ulnar styloid fracture and applied to hand rehabilitation unit were included in the study. The patients were divided into two groups according to the ulnar styloid fracture presence. USF Group was DRF with ulnar styloid fracture; NON-USF Group was DRF without ulnar styloid fracture.

Pain, range of motion, Quick-DASH, hand grip and pinch strength, Purdue Pegboard Test, Jebsen Taylor Hand Function Test was measured at six month.

A total of 125 patients, 68 female (54,4%) and 57 male (45,6%) were included in the study. The mean age of the patients was 47,15±13,41 (18-65) years. 65 of the patients (52%) had isolated fracture of the distal radius fracture (NON-USF group) and 60 patients (48%) had a concurrent ulnar styloid fracture (USF group).

There was no significant difference in pain between the groups (p\>0,05). Joints range of motion were higher in the NON-USF group than in the USF group. This difference was statistically significant only for flexion and extension (p\<0,05). There was no statistically significant difference in Quick-DASH score between groups (p\>0,05). The injured hand grip and pinch strength values in NON-USF group were greater than the USF group but the difference was not statistically significant (p\>0,05). The manual dexterity and hand function tests showed that there was no statistically significant difference between the groups at six months (p\>0,05).

There is a consensus that ulnar styloid fracture has no effect on overall hand function. But, there is no study dwelled on the manual dexterity. In this study, the effect of ulnar styloid fracture on hand function is more clearly emphasized. In conclusion, concomitant USF does not lead poorer manual dexterity.


Eligibility Criteria:
Inclusion Criteria:

* The criteria for inclusion in this prospective cohort study were; 1) Aged between 18 and 60 years, 2) Diagnosed with isolated DRF or DRF accompanied with ulnar styloid fracture, 3) Primarily fixation after injury

Exclusion Criteria:

* Exclusion criteria were; 1)Radius shaft, ulnar head or ulnar shaft fractures, 2) Pre-existing rheumatological diseases associated with ipsilateral extremity, 3) Comorbid injuries such as tendon or nerve injuries, 4) Coexisting distal radioulnar, radiocarpal or ulnocarpal joint instability problems, 5) Secondarily repair.
The Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and DFUs

This is an observational, single-arm, on-label study. This clinical study will be conducted at up to 2 sites with a total of 10 subjects per site. All subjects will receive standard of care treatment which includes DFU treatments with the dermaPACE device.

The dermaPACE system will be used according to label along with standard of care. perfusion will be measured using TcPO2 methods and also using cleared hyperspectral imaging equipment. The intent of the study is to observe/measure oxygen saturation levels in the area of the treated wound before initiation of dermaPACE treatment, during the treatment period, and two weeks post treatment period

Eligibility Criteria:
Inclusion Criteria:

1. Is male or female ≥22 years of age at Visit 1;
2. Wagnergrade 1 or 2 DFU;
3. In the leg with the target ulcer has an ABI \> 0.70 and \< 1.20 OR if the ABI is \>1.20 has a toe pressure \>50 mmHg at Visit 1
4. Has only one diabetic foot ulcer that is located on the plantar surface of the forefoot that has persisted a minimum of 30 days prior to the first visit.
5. Has Type I or Type II Diabetes Mellitus;
6. HbA1c \< 12% at Visit 1;
7. Patient is willing to comply with all study requirements and treatment visits.
8. Patient is willing to comply with off-loading directions.
9. Patient is willing to comply with offloading instructions

Exclusion Criteria:

* Potential subjects who meet any of the following criteria will be excluded from participating in the study.

A subject who:

1. Is female and is currently pregnant or plans to become pregnant during the study;=, or is a female who is nursing aor actively lactating;
2. Known or suspected systemic infection;
3. Enrolled in another investigational study;
4. Has received growth factor therapy (e.g., autologous platelet-rich plasma, stem cell therapy, becaplermin, cell therapy, dermal substitute, amniotic tissue, extracellular matrix) within 30 days of study enrollment;
5. Subject is currently receiving or has received radiation or chemotherapy within 3 months of study enrollment;
6. Unable to tolerate offloading footwear or total contact casting (TCC);
7. Has active cellulitis either at the site of, or in the surrounding area of, the target ulcer at Visit 1 or 2;
8. Has active Charcot foot at Visit 1 or 2;
9. Has osteomyelitis in the foot or ankle on which the target ulcer is located at Visit 1 or 2
Impact of Patient Education on Benzodiazepine Use in the Elderly

The overall goal of this research is to develop and test strategies to decrease potentially inappropriate medication use among the elderly.

Specifically, the purpose of the study is to determine whether direct patient education is effective in decreasing benzodiazepine use in seniors.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Full benefit members living in a SASH facility
* 60 years old or older
* Using at least 1 active short/medium/long acting benzodiazepine at time of recruitment

Exclusion Criteria:

* Inability to provide consent
* Inability to communicate in English
* Diagnosis of severe mental illness, dementia, seizure disorder
Exercise Post-Diagnosis of Breast Cancer

The investigators are doing this study to determine if there are body composition changes after a 12-week exercise program in breast cancer patients and determine what factors contribute to sustained physical activity after the 12-week exercise program intervention.

The study is enrolling breast cancer patients up to 2 years after their diagnosis in a 12-week exercise program. The participants will either participate in: Group 1-participating in an exercise program with biometric evaluations or Group 2-biometric evaluations but not participating in the exercise program. At the end of the 12-week exercise program, participants in Group 1 will be randomized to either: a) continuing with exercise group classes or b) continuing with exercise individual classes. Both Group 1a and 1b participants will be followed for the remainder of the year and be evaluated for continued physical activity. All Group study participants' biometrics will be assessed at baseline and at the end of 12-weeks, with continued annual medical review follow-up for a total of 5 years.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of breast cancer (within the past 2 years, any subtype, stage I-III)
* Can be undergoing neo/adjuvant treatment (surgery, chemotherapy, radiation or endocrine therapy)
* Participant is willing and able to comply with the protocol for the duration of the study including undergoing scheduled exercise sessions, completing questionnaires and biometric/biomarker studies
* Participant must be able to lie flat on their back for up to 10 minutes
* Participant must be able to stand without aid for at least 2 minutes

Exclusion Criteria:

* Participant with breast cancer recurrence
* Metastatic breast cancer
* Uncontrolled psychiatric disorder that can affect self-assessment
* Pregnant patient
* Participants with any internal artifact (e.g. pacemakers, internal fixation, arthroplasty) or other physical impairment that would alter the body composition assessment
Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease

The purpose of this research study is to survey patients to learn about their beliefs and behaviors related to the management of heart disease and to discuss options for making healthy lifestyle changes. From the information the investigators get from patients, the investigators hope to develop better methods for taking care of patients who have heart disease.

Coronary heart disease (CHD) is a significant health threat among veterans. Compared to their civilian counterparts, veterans experience greater disability, reinfarction, and mortality following myocardial infarction (MI) and other acute coronary syndromes (ACS). High rates of hypertension, diabetes, and cardiac risk behaviors (e.g., smoking) and low socioeconomic status (SES) further increase veterans' CHD-related morbidity and mortality. The proposed pilot project will establish the feasibility of a telehealth nursing intervention for veterans with CHD who are recovering from MI/ACS. The Veterans Heart Attack Representations Telehealth (Vet-HART) intervention is designed to promote adaptive conceptual change in veterans' beliefs (common sense models or representations) about CHD etiology and self-management and facilitate health behavior changes (e.g., smoking cessation, medication adherence, diet management, and increased physical activity). The long-term goal of this research program is to improve veterans' quality of life (QoL) and reduce their CHD-related morbidity/mortality. The proposed project is the requisite next step in attaining that goal.

Eligibility Criteria:
Inclusion Criteria:

* Admission to an inpatient medicine unit for MI, ACS, and coronary angiography
* Age

Exclusion Criteria:

* Altered mental status
* Language barriers
* Dementia or Cognitive Impairment
* Diagnostic Study
* Resident in long-term care facility prior to the present admission
* Planned discharge to a skilled or intermediate care facility or hospice
* Lack of access to a functioning phone
Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure

The purpose of this study is to understand the effects of chloride supplementation on volume-overloaded acute heart failure patients concomitantly treated with IV diuretics.

The overarching goal of this proposal is to develop a comprehensive understanding of the biology and therapeutic potential of sodium-free chloride supplementation. While sodium homeostasis has been the focus of substantial investigation, very little research has been devoted to understanding chloride homeostasis. Thus, this proposal is designed to obtain the full spectrum of information pertaining to chloride, such as novel areas with great interest by the scientific community (i.e. modulation of the WNK-kinase system and the use of exosomes), to more practical/basic questions (i.e. what happens to sodium chloride balance when a patient is challenged with chloride). The proposed outpatient study has been designed to serve as a real world efficacy study. With extensive biobanking and analysis of samples in the proposed setting, there is the potential to be able to deliver a great wealth of information on the biology and therapeutic potential of manipulating chloride homeostasis in heart failure.

Research confirms that many heart failure therapies demonstrate measurable benefit in highly controlled environments, but lack effectiveness when studied in decompensated patients receiving standard decongestive therapies. As such, this study seeks to understand the effects of chloride supplementation on volume-overloaded patients concomitantly treated with IV diuretics.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of decompensated heart failure with at least one objective sign of volume overload (rales, edema, elevated jugular venous pressure (JVP), or weight gain of at least 5 pounds)
* A projected need by the treating clinician for continued treatment with IV diuretics
* Chronic loop diuretic use

Exclusion Criteria:

* Inability to commit to or comply with serial visits for treatment in the Yale Transitional Care Center (YTCC)
* History of severe metabolic or respiratory acidosis within 30 days of enrollment
* Use of metformin, acetazolamide, or any other agent that could predispose to acidosis. Patients who are on metformin may be enrolled if their metformin can be discontinued safely for the duration of the study. Any participants who have consistently elevated Blood glucose readings \> 200 mg/dL while inpatient will not be enrolled.
* Serum bicarbonate level \<20mmol/L
* Estimated glomerular filtration rate \<20 mL/min or renal replacement therapy
* Appears unlikely, or unable to participate in the required study procedures, as assessed by the study PI or research registered nurse (RN) (ex: clinically-significant psychiatric, addictive, or neurological disease)
* Inability to give written informed consent or follow study protocol
Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome

The investigators performed a 12-week, randomized, double-blind, placebo-controlled crossover human trial to evaluate the efficacy and safety of chungkookjang on improvement of metabolic syndrome. The investigators measured decrement of body fat parameters, including Body Fat Mass, Percent Body Fat, Fat Free Mass, Weight and BMI(body mass index), and monitored their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18-29 years old
* BMI(body mass index) ≥ 23 kg/m2 or WC(Waist Circumference) ≥ 90(men), WC(Waist Circumference) ≥ 85(women)
* Able to give informed consent

Exclusion Criteria:

* Allergic or hypersensitive to any of the ingredients in the test products
* The diagnosis of type 1 and type 2 diabetes or fasting glucose ≥ 126mg/dL
* Systolic pressure ≥ 160mmHg, diastolic pressure ≥ 100mmHg
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
The Effect of Nutrition for the Colorectal Cancer Patients Receiving Chemotherapy-randomized Controlled Study

We use clinical trial to explore the effect of nutrition support in colorectal cancer patients receiving postoperative adjuvant chemotherapy.

Colorectal cancer is the most common cancer in Taiwan. Side effects induced by postoperative adjuvant chemotherapy will affect nutrition status and may delay treatment and affect prognosis. Sarcopenia may be noted in some patients and increase the toxicities of chemotherapy. The studies of intervention include nutrition consultant and treatment like protein, fish oil or Vitamin D supplement. Premium amino acids include multiple amino acids and organic Selenium and have effect in inhibition of tumor proliferation according to colorectal cancer cell and animal experiments.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 20
* Radical operation for stage III and stage II with high risk colorectal cancer
* Agree to join the trial and sign the informed consent form

Exclusion Criteria:

* Unable to receive chemotherapy
* Unstable vital sign
* Not suitable after evaluation by Principal Investigator
JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer

This is a prospective, single-arm phase II clinical study to evaluate the efficacy and safety of JS-201 combined with lenvatinib in the treatment of small-cell lung cancer that has failed previous chemotherapy combined with PD-L1. The primary observational endpoint is ORR, and the secondary observational endpoint is PFS, OS. The intervention mode is JS201 300mg i.v Q2w, lenvatinib 8mg po. Qd.


Eligibility Criteria:
Inclusion Criteria:

* 1. The imaging diagnosis is the extensive stage of SCLC
* 2. The patient failed first-line EC+PD-L1 treatment
* 3 PS 0-1

Exclusion Criteria:

* 1. Diagnosed as non-small cell lung cancer
* 2. Women during pregnancy
* 3. Patients with symptomatic brain metastases
* 4. PS≥2