cyrilzakka/clinical-trials huggingface dataset:
Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Documented history of CrCl \<50 ml/min within the 3 months prior to enrollment
* HbA1c ≥7.0% and ≤11.0%

Exclusion Criteria:

* Type 1 diabetes, history of diabetic ketoacidosis or hyposmolar non-ketonic coma
* Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic.
Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction andpREServed Lef venTricle Ejection Fraction (ARREST)

The trial will inform whether detection of ventricular arrhythmias by means of implantable loop recorder (ILR) can help to predict SCD in the large population of survivors of a myocardial infarction with preserved left ventricular function, EF\>40%. This may improve risk stratification in these patients, and can inform on the clinical use of subcutaneous monitors to identify post-infarction populations in need for an intervention to prevent sudden death.


Eligibility Criteria:
Inclusion Criteria

* Informed consent signed
* Documented myocardial infarction in the 7days prior to enrolment
* Age \> 18 yrs
* Left ventricular ejection fraction \>=40% as assessed by echocardiography within 7 days window after MI.

Exclusion Criteria

* subject is unwilling or unable to comply with the study procedures
* documented ventricular tachycardia or survived cardiac arrest outside of an acute coronary syndrome
* Subject has indications for active implanted cardiac medical device (IPG, ICD, CRT).
* contraindications for implantation of a ICM - Planned CABG procedure
A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals

The purpose of this study is to make a cohort event monitoring to see whether and how Shuxuetong injection in hospital results in adverse events or adverse drug reactions.

This is the first academic registry study about adverse events or adverse drug reaction for Chinese medicine injection in mainland China.

It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system.

However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report.

In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area.

To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study.

According to the 'rule of three', 30,000 cases need to be registered at least.

Eligibility Criteria:
Inclusion Criteria:

* all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay
Adjuvanted Influenza Vaccination in U.S. Nursing Homes

This study is powered to prospectively evaluate the relative effectiveness of adjuvanted trivalent influenza vaccine (aTIV; FLUAD) in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the commercially available, standard dose trivalent seasonal influenza vaccine (TIV; Fluvirin).

SUMMARY: A random study sample of up to 1000 NHs within 75 miles of the local area of the 121 cities where the CDC performs weekly influenza surveillance (estimated N= 11,239) may be offered the opportunity for participation; the first 1000 eligible to participate and accepting the offer will be enrolled. Participating facilities will be offered vaccine education for residents and staff, but will be randomly allocated to receive aTIV (FLUAD) vaccine or usual care (TIV) vaccination for their residents.

BACKGROUND: Lower respiratory tract infection (LRI), including pneumonia, bronchitis, and tracheobronchitis, is the leading cause of infectious mortality and hospitalization in older adults , and nursing home (NH) residents. Pneumonia and infection often produce attenuated signs and symptoms in older adults, leading to delayed or even misdiagnosis for this population. Diagnosis is further compromised due to few and sporadic clinician visits with nursing home residents, and reduced access to radiology. LRI may or may not directly lead to hospitalization, but LRIs are associated with considerable other morbidity than can result in hospitalization, including exacerbation of underlying cardiopulmonary diseases. Hospitalization rates for NH residents vary considerably between facilities, but the majority of hospitalizations occur during the 12 weeks during which influenza peaks each year.

OBJECTIVES: The primary objective is to estimate the differences in hospitalization rates during influenza season experienced by long-stay nursing home residents, between facilities using adjuvanted trivalent vaccine vs. standard trivalent vaccine. The secondary objective is to estimate the differences in the likelihood of Activities of Daily Living (ADL) functional decline and mortality rates in the study nursing homes, and influenza outbreaks.

Eligibility Criteria:
Inclusion Criteria:

* Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites

Exclusion Criteria:

* Facilities that used high dose influenza vaccine in residents over age 65 in previous influenza season (2015-16)
* Facilities having fewer than 50 long-stay residents
* Hospital-based facilities
* Facilities with more than 20% of the population under age 65
* Facilities not submitting Minimum Data Set (MDS) data
A Retrospective Analysis: Whether Five Factors Affect PFS in Patients With Locally Advanced Cervical Cancer

In previous studies, the investigators found that five factors were effective in predicting the probability of locally advanced cervical cancer with para-aortic lymph node metastasis.A retrospective study was conducted to explore the influence of 5 factors on PFS in patients with locally advanced cervical cancer receiving radiotherapy and chemotherapy.

In previous studies, the investigators found that five factors were effective in predicting the probability of locally advanced cervical cancer with para-aortic lymph node metastasis.5 factors included positive iliac lymph nodes, histological type, tumor size, positive pelvic lymph nodes on both sides, and maximum lymph node diameter greater than 1cm. Different factors give different scores.If the score is higher than 3, the probability of retroperitoneal lymph node metastasis in patients with locally advanced cervical cancer is significantly increased, and the prognosis of patients is affected. Patients with locally advanced cervix receiving radical radiotherapy were scored based on 5 factors.Patients with scores greater than or equal to 3 points were compared with patients with scores less than 3 points.

Eligibility Criteria:
Locally advanced cervical cancer patients receiving radiotherapy
Mental and Psychological Problems and Insomnia Disorder of Medical Staff in Hospital With Infected COVID-19 Patients

The objective of this study is to clarify the severity of psychological problems and insomnia and the two's relationship with time of hospital medical staff in hospital where its staff are infected with COVID-19.

A cross-sectional questionnaire survey method was adopted to conduct investigations of medical staff in the researched hospital within one week (baseline) and one year (follow-up) after the discovery of COVID-19 infection cases. 360 subjects were included in the baseline. Then, after one year, 199 subjects who participated in the survey at baseline were included as follow-up. The HADS, ASDS and ISI scales were used to assess the anxiety and depression level, acute stress disorder symptoms, and the severity of insomnia of hospital medical staff; self-made questionnaires was to collect demographic information and descriptive content. Comparing the follow-up medical staff with the baseline, the total scores of ASDS, HADS and ISI, each item scores on the ASDS, HADS and ISI. All of above scales are compared between the quarantined and non-quarantined groups, different quarantined groups (home, hotel, hospital) and non-quarantined groups.

Eligibility Criteria:
Inclusion Criteria:

* all medical staff of a third-level general hospital in Beijing who discovered a sporadic case of COVID-19 infection; Volunteer to participate in surveys and follow-ups

Exclusion Criteria:

* Incomplete information fills in, which affects the result analysis
Patients Experiences of Rehabilitation After Reverse Shoulder Arthroplasty

Reverse shoulder arthroplasty is a complex surgical procedure requiring thorough rehabilitation, and its frequency is increasing globally. While previous studies have quantitatively examined postoperative outcomes, such as pain levels and shoulder function, no research has yet explored patients' subjective experiences of the rehabilitation process before and after surgery. Purpose of the study was to explore patients' experiences of undergoing reverse shoulder arthroplasty and the associated rehabilitation process.

Surgery with total shoulder arthroplasty is a procedure that has increased in number in the last twenty years, and it is the third most common prosthetic surgery in the world after hip and knee. There are two types of shoulder arthroplasty, anatomical and reverse. When the rotator cuff is severely impaired or completely dysfunctional, a reverse shoulder prosthesis is used, in which the anatomical positions of the ball and socket are reversed.

There are thus several factors that the treating physiotherapist needs to take into account. Research on reverse shoulder arthroplasty has primarily focused on evaluations using quantitative measures. Qualitative research from the patient's perspective can provide a deeper understanding of their expectations and experiences, offering insights that complement and fill the gaps left by quantitative research. Gaining insight into patients' experiences would be valuable for physiotherapists working with this group, as it may help identify areas for improvement in care to better meet patients' needs.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria encompassed patients who had undergone elective surgery involving reverse shoulder arthroplasty in the Västra Götaland region who demonstrated proficiency in both spoken and written Swedish.

Exclusion Criteria:

Exclusion criteria applied to cases where the study leader had served as the patient's physiotherapist, the presence of neurological disorders, or the occurrence of surgical complications, such as infection or fracture.
Non Obstructive Versus Obstructive Coronary Artery Disease

The goal of this observational study is to study the non obstructive type of ischemic heart disease by identifying unique clinical features , frequency and age group .in patient admitted in coronary care unit , suffered from angina or heart attack. . The main question\[s\] it aims to answer are:

* how it different from classical type of ischemic heart disease ( obstructive coronary artery disease)
* what is frequency and age prevalence of these patient Participants evaluated by history , clinical examination, serum troponin and coronary angiography.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with IHD ( MI, unstable angina ,chronic stable angina)
* \>18 years of age
* patients undergoing CAG for emergency or elective situations.

Exclusion Criteria:

* Patients who were hemodynamically unstable.
* patients with incomplete data
* patients with clinical features of pericarditis or others of non cardiac origin chest pain .
Using NIRS to Evaluate Splanchnic Oxygenation During Blood Transfusion in Preterm Infant

To evaluate the differences splanchnic oxygen saturation in preterm infants receiving red blood cell transfusion with and without enteral feeding, and their outcomes.

using NIRS to evaluate splanchnic oxygenation

Eligibility Criteria:
Inclusion Criteria:

* Infant with gestational age \< 37 weeks
* Planned to receive blood transfusion
* Had received minimum 25 ml/kg/day enteral feeding
* in stable condition

Exclusion Criteria:

* Infant with multiple congenital anomalies
* Infant with suspected/confirmed genetic anomalies
* Parents or family did not sign the informed consent
Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma

This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of BHQ880 as a single agent and following multiple doses will be obtained.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of SMM with high-risk for progression to multiple myeloma

   1. BMPC ≥ 10% and serum M-protein level ≥ 3 g/dL, OR
   2. BMPC ≥ 10%, serum M-protein level \< 3 g/dL, and an abnormal free light chain ratio of \< 0.125 or \> 8.0
2. No previous or current anti-myeloma therapies
3. Patients ≥ 18 years of age
4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1

Exclusion Criteria:

1. Previous treatment with IV bisphosphonates (i.e., pamidronate or zoledronic acid
2. Another primary malignant disease that requires systemic treatment
3. Concomitant Paget's disease of bone, uncorrected hyperparathyroidism, or uncontrolled thyroid disease
4. Clinically significant uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias)
5. Treatment with an investigational product within 28 days before the first dose of study treatment
6. Pregnant or nursing (lactating) women
7. Women of child-bearing potential, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.

Other protocol-defined inclusion/exclusion criteria may apply
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ADC3680B in Healthy Volunteers

This is a First-In-Man study designed to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B after single and multiple doses in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of 18 to 30 kg/m2
* Signed and dated written informed consent prior to admission into the study
* Willing and able to comply with the requirements of the protocol and available to complete the study

Exclusion Criteria:

* Evidence of history of any clinically significant medical disorder
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
Everyday Memory Intervention

Evaluates an intervention designed to improve everyday memory function, contrasting people receiving the intervention with a group that receives traditional memory strategy training.

This project seeks to develop and validate a novel approach to training everyday memory functioning in older adults. The approach (1) trains people to use simple but effective memory skills that have broad applicability in everyday life and (2) shapes a set of skills and habits of mind that will increase the likelihood of effective use of skills and memory aids. It is based on a metacognitive perspective on self-regulation in cognitively demanding situations and informed by recent theories about how suboptimal habit patterns can be altered. The approach has not yet been used in an everyday memory intervention in high-functioning, community-dwelling older adults. The proposed research validates ecological momentary assessment methods to get actual behavioral measures of forgetting in everyday life. It then uses these procedures in a randomized experiment that contrasts the everyday memory intervention group with a traditional memory-strategy training group. The hypothesis is that the everyday memory training intervention will reduce everyday memory errors and memory complaints, whereas the memory strategy training will alter strategy use and memory performance, with little cross-over effect. The hypothesized pattern will establish the explicit benefits of our everyday memory intervention procedures and demonstrate the limitation of standard memory training for that purpose.

Eligibility Criteria:
Inclusion Criteria:

* 70 - 85 years of age
* in fair to good health
* free of major neurocognitive impairment
* English speaking
* endorsed Smartphone and computer users (or willing to learn)

Exclusion Criteria:

* diagnosis of any major neurological problems (e.g. stroke, Parkinson's disease, dementia)
* 1.5 SD below age-normed mean (or lower) on the TICS
* low computer and smart phone literacy
* and poor self-rated health.
A Study to Evaluate the Efficacy and Safety of HBM9161 on Moderate to Severe Thyroid Eye Disease

Primary Objective: To preliminarily evaluate the efficacy of the treatment regimen of HBM9161 680 mg administered subcutaneously weekly and sequentially every other week for 12 weeks in Chinese patients with active moderate to severe TED.

This is a multicenter, randomized, double-blind and placebo-controlled study. The investigational drug is HBM9161 injection, with the indication of TED. Subjects will be randomized to treatment group I, treatment group II, or placebo group. Subjects in treatment group 1 will receive HBM9161 680 mg subcutaneously once weekly (qw) for 12 doses; Subjects in treatment group 2 will receive HBM9161 680 mg subcutaneously once weekly (qw) for 6 doses, followed by HBM9161 680 mg subcutaneously once every two weeks (q2w) for 3 doses; Subjects in placebo group will receive placebo subcutaneously once weekly (qw) for 12 doses. After the 12-week dosing period, there will be a 5-week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent form.
2. Male or female between the ages of 18 and 70 (including boundary values).
3. Active TED associated with a clinical diagnosis of Graves' disease or Hashimoto's thyroiditis with CAS ≥ 3 at the screening visit and baseline (both on a 7-item scale) in the eye with the most severe proptosis.
4. The active period of TED starts within 9 months prior to screening visit
5. Positive anti-TSHR antibody at screening visit.
6. Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol.

Exclusion Criteria:

1. Other uncontrolled concurrent diseases
2. Serious TED requiring surgery or radiotherapy
3. Suffer from autoimmune diseases or ophthalmic conditions other than TED that, in the opinion of the investigator, would impact the assessment of the study drug
4. No significant laboratory abnormalities
The Use of Flecainide for Treatment of Atrial Fibrillation

This prospective observational study will include patients with atrial fibrillation that has indication for treatement with flecainide. Included patients are followed during a 12 month period. During the follow-up period they will have four clinical visits, during which clinical data, advanced echocardiographic data (strain and speckle tracking) and ECGs (Glasgow criteria) will be collected. These data will be analysed in relation to outcome parameters as: maintaining a normal sinus rhythm (arrythmia free health status), number of AF-free months, chances of successful electrical cardioversion, frequency of side effects, risk of pro-arrhythmias and mortality. The importance of these two analyses is to improve the use of flecainide. Hence, today patients with low benefit compared to risk of adverse events are inappropriately treated with flecainide with the "trial and error" approach currently used. On the other hand flecainide is currently underutilized, and patients denied the treatment that could improve their quality of life, prognosis and reduce their risk of cardiovascular adverse events. By investigating novel and promising parameters there is the potential of a better prediction of initiating safe and accurate anti-arrhythmic therapy for patients with atrial fibrillation.

Study synopsis for the Tambocor Prospective study

Inclusion: Patients with atrial fibrillation that admitted to the ward for prior to start of flecainide initiation.

Ethics: Informed Concent prior to inclusion.

Follow up after baseline: 4 visits during 12 month.

End points : Side effects that lead to discontinuation of flecainide. Persistent AF that lead to discontinuation of flecainide.

Evaluated parameters: 12 lead ECG, ECHO: LA, LV, HV strain , Dynamic Heart model: LV and RV.

The follow up visits:

Baseline: Normal ECHO after the first dose of flecainide, ECG and Questionnaire

4 Weeks: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire.

6 month: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire.

12 month: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* All patients with written informed consent who are eligible for flecainide treatment for atrial fibrillation.
* The patients must be followed at the Skånes hospitals northwest and Skånes university hospitals.
* Age \>18 years

Exclusion Criteria:

* Flecainide treatment with other indication than atrial fibrillation (including atrial flutter).
* No secure date for treatment start.
* Age \<18 years
Multi-sensory Intervention Room Application (MIRA) Device in the NSICU

The purpose of this research study is to determine the safety, feasibility, and efficacy of a device, MIRA, on the physical, mental, and cognitive health of Neurosciences Intensive Care Unit (NSICU) patients.

The study device is a Multi-Sensory Stimulation Device named MIRA, which uses commercially available hardware and builds off the SOLUNA software created by Studio Elsewhere, which produces audio and visual immersive experiences. The current device, Model M1, is a prototype developed for sole investigational purposes of this study and is not commercially available.

Participants, who will be patients and staff of the NSICU, will complete questionnaires regarding safety, feasibility, and efficacy. The research team will enroll 20 patient and 15 staff participants. The trial is expected to last 12 months.


Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following criteria:

For NSICU Staff:

* Current employee at NSICU
* Aged \>/= 18

For NSICU Patients:

* Currently admitted to the Mount Sinai Hospital NSICU for any diagnosis OR a Legally Authorized Representative (LAR) for the patient, and expected to stay for at least 48 hours
* Provision of signed and dated informed consent form (ICF)
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Aged \>/= 18
* Any sex or gender identity
* Currently admitted to the Mount Sinai Hospital NSICU for any diagnosis OR a Legally Authorized Representative (LAR) for the patient, and expected to stay for at least 48 hours

Exclusion Criteria

* Not a Mount Sinai NSICU patient
* No LAR present and unable to consent