cyrilzakka/clinical-trials huggingface dataset:
Isokinetic Parameters and the Amputee Mobility Predictor Scale

There is very limited research examining isokinetic parameters and activity level in patients with amputation.. Therefore, the aims of this study were to illustrate isokinetic measurements including strength and proprioception and to analyze the correlation between those isokinetic parameters and activity level and to predict amputee mobility score. It is hypothesized that muscle strength and proprioception were associated with activity level and could be used to estimate amputee mobility scale score in patients with amputation.

Isokinetic measurements are used in the rehabilitation of amputee patients and to evaluate the effectiveness of rehabilitation. The parameters that are frequently looked at in these measurements are isokinetic muscle strength and proprioception. There is very limited research examining isokinetic parameters and activity level in patients with amputation.. Therefore, the aims of this study were to illustrate isokinetic measurements including strength and proprioception and to analyze the correlation between those isokinetic parameters and activity level and to predict amputee mobility score. We hypothesized that muscle strength and proprioception were associated with activity level and could be used to estimate amputee mobility scale score in patients with amputation

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* Time after amputation ≥ 6 months
* Unilateral or bilateral amputation above the ankle level

Exclusion Criteria:

* Upper extremity amputation
* The presence of musculoskeletal or neurological disease that could cause functional impairment other than amputation
* The presence of neurological deficit
Risk Minimisation Study for Diane-35 and Its Generics

The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing Diane-35 or its generics in a total of five European countries. The primary objective of this study is to measure physician knowledge and understanding of the key information contained in the Diane-35 educational material: Patient information card, and Prescribers' Checklist.

Specifically, the following objectives will be addressed:

* Investigate whether physicians have received any educational material related to Diane-35 or its generics
* Assess physicians' knowledge and understanding of key safety information pertaining to the patient information card
* Assess physicians' knowledge and understanding of key safety information pertaining to the following areas:
* Contraindications relevant to thromboembolism
* Risk factors for thromboembolism
* Signs and symptoms of thromboembolism


Eligibility Criteria:
Inclusion Criteria:

-Physicians eligible to participate will have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics
Management of Acute Cardiogenic Shock at the New Brunswick Heart Centre

In Atlantic Canada, acute myocardial infarction occurs at a rate of 2.9 % of the population and is the most common cause of cardiogenic shock (CS). In many studies, acute myocardial infarction accounts for up to 80% of the patients with CS. While there are different methods of treating patients with CS, the rate of mortality has not significantly improved over the years and remains as high as 50%. Recent studies have shown that a multi-modal, team-based approach can help improve patient outcomes; however, such a standardized approach is yet to be implemented in the New Brunswick Heart Centre (NBHC).

The study aims to understand the difference in outcomes between two groups of patients treated for CS: SHOCK TEAM versus non-SHOCK TEAM. This is a retrospective study of 168 patients using the data from NBHC registry and patient charts. The study duration is 1 year. The primary outcome is hospital survival. Secondary outcomes include time from diagnosis to invasive monitoring and intervention. All data will be analyzed statistically between the two groups. The end goal of the study is to establish standard guidelines to treat CS patients and improve patient survival.


Eligibility Criteria:
Inclusion Criteria:

1) Any patient admitted to the CCU with a diagnosis of CS (SCAI groups C, D or E) at any point during their CCU care.

Exclusion Criteria:

1) CS patients having SCAI groups A, B (this group was used only for preliminary analysis, hence this is the exclusion criteria for all final analyses).
Dyspnea and Biomarkers in a Prehospital Setting

In patients presenting with acute dyspnea in a pre-hospital setting, the early and correct diagnosis may present a significant clinical challenge. Physical examination, chest radiography, electrocardiography, and standard biological tests often fail to accurately differentiate heart failure (HF) from pulmonary causes of dyspnea. Timely differentiation of HF from other causes of dyspnea may permit the early institution of appropriate medical therapy. Brain natriuretic peptide (BNP) and amino-terminal pro-brain natriuretic peptide (NT-proBNP) have been proposed as early markers of HF and demonstrated to be useful for diagnosing and excluding HF in the emergency department. A combination of BNP or NT-proBNP testing and standard clinical assessment has been suggested to be superior to either tool used in isolation. Some previous studies have also suggested that quantitative capnometry (QC) may be useful in differentiating between cardiac and obstructive causes of respiratory distress. Therefore, the investigators hypothesized that a new combination of NT-proBNP testing, standard clinical assessment, and partial pressure of end-tidal CO2 (PetCO2) would optimize evaluation and differentiation of acute dyspnea in a pre-hospital setting.

The aim of this study was to determine the accuracy of combination of QC, NT-proBNP, and clinical assessment in differentiating acute HF from obstructive pulmonary disease (COPD/asthma) as a cause of acute dyspnea in pre-hospital emergency setting.


Eligibility Criteria:
Inclusion Criteria:

* patient had to present with shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea)

Exclusion Criteria:

* age \<18 years
* history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea:

  * pneumonia
  * pulmonary embolism
  * carcinoma
  * pneumothorax
  * pleural effusion
  * intoxications (drugs)
  * anaphylactic reactions
  * upper airway obstruction
  * bronchial stenosis
  * gastroesophageal reflux disorder
* according to the history, clinical status, and additional laboratory tests available in pre-hospital setting (D-dimer, troponin, C-reactive protein)
Pii Ngima: Consequences of Water Insecurity for Maternal and Child Health

This study will implement the validated household-level water insecurity scale developed by study investigators among a cohort of postpartum women in Nyanza, Kenya and will assess a range of outcomes linked to water insecurity, such as viral load, hydration status, maternal depression, stress, food insecurity, and cognitive development.

This study will develop the first well-known household water insecurity scale. Currently, water insecurity cannot be measured at the level of the household or individual, i.e. at the endpoint of water use. Although there are myriad national, regional, community, and hydrological indexes of water availability, to the investigators' knowledge, there is no way of measuring water access at the household or individual levels. Without a comprehensive, validated scale to measure household water insecurity, the scientific, programmatic, and public health communities cannot empirically test the prevalence of household water insecurity access and its potential impacts on economic, nutrition, disease, and psychosocial health pathways and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Women \>18 years of age with infants enrolled into the Pith Moromo (clinical trials ID: NCT02974972) study
* Infants born to pregnant women enrolled in the cohort study

Exclusion Criteria:

* Individuals \<18 years of age that are not infants born to women enrolled in the cohort study
Do Hip Injections Improve Short-Term Biomechanical Outcomes In Patients With Hip Pain

The purpose of this project is to determine the effect of hip injections on hip biomechanics in patients with hip pain.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis patients with hip pain requiring hip injection
* Receiving hip injection
* BMI \< 35

Exclusion Criteria:

* BMI \> 35
* severely impaired intellectual capacity
* dementia, or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol
Serum Fetuin Level in Polycystic Ovary Syndrome

polycystic ovary syndrome is a common gynecological problem

Understanding the pathophysiology and the cause is of much importance for proper management of this problem

Eligibility Criteria:
Inclusion Criteria:

* women who have PCOS in group 1 and who donnot have PCOS in group 2 with age between 20 -42 years

Exclusion Criteria:

* women above 42 years old
The Auxiliary Effects of Fucoidan for Locally Advanced Rectal Cancer Patients

This is a double-blind, randomized, placebo-controlled, parallel study. The main goal is to investigate the auxiliary effects of Fucoidan for the patients with locally advanced rectal cancer who receive neoadjuvant CCRT before surgery. The quality of life is our primary endpoint for this study. The study is an observational study.


Eligibility Criteria:
Inclusion Criteria:

1. Age was more/equal to 20 year-old and less/equal to 80 year-old
2. Diagnosed as locally advanced rectal cancers by pathological biopsy and image study.
3. ECOG performance status within 0 to 2 points
4. Excepted life remaining at least 4 months
5. Females with fertility are willing to use effective contraception during the period of study
6. Willing to follow the test procedures and tracking procedures
7. sign the inform consent form

Exclusion Criteria:

1.Suffering from other primary malignant tumors 2.Females who are pregnant, planning to become pregnant, or breastfeeding 3.Participate in other interventional clinical trial within the first 30 days 4.Suffering from major mental illness such as mental retardation and mental disorders 5.Unable to understand and answer research questions (oral or written) 6.Abnormal laboratory data within 14 days before joining the study 7.Evidence that subject has a severe or uncontrolled disease

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Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial)

To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria
* The current depressive episode must be equal to or greater than 8 weeks in duration
* Subjects must report a history for the current depressive episode of an inadequate response to no more than three adequate antidepressant treatments

Exclusion Criteria:

* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
* Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration.
* Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder
* Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder
Case Studies: Promoting Strategy Use in Functional Activities

The purpose of the study is to provide evidence of feasibility, acceptability, patient satisfaction, and patient perceived benefit of the Multicontext (MC) approach. The project consists of eight case studies of persons with acquired brain injury undergoing acute inpatient rehabilitation who have difficulties in completing multiple step activities due to deficits in executive function and/or visual perception. The MC approach provides a structured occupational therapy framework that provides guidelines for enhancing strategy use and self monitoring skills for person's with acquired brain injury.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* English-speaking
* Confirmed diagnosis of acquired brain injury (ABI) based on radiological assessment
* Able to comprehend multistep directions and participate in conversation as assessed by the Functional Independence Measure (FIM; required score of 4 or above on Comprehension and Expression items)
* Impaired performance (\<2 SD below demographically-corrected normative data) on at least one screening measure of executive functioning
* Able to attend to a cognitive task for at least 10 minutes
* Cognitively independent in basic self-care activities
* Able to read standard size newsprint
* Ability to demonstrate functional use of at least one hand.

Exclusion Criteria:

* Global aphasia or moderate - severe comprehension deficits (as indicated by a FIM comprehension score of less than 4)
* Global cognitive impairment or dementia as indicated by a score of 20 or less on the Montreal cognitive assessment
* History of treatment for substance abuse or hospitalizations for psychiatric disorder, within the past year
* non-English speaking
Improving Cancer Screening and Prevention During the COVID-19 Pandemic in Underserved Populations of Rhode Island

Lifespan Cancer Institute serves over 50% of cancer patients in the state. Rhode Island is known for strong medical care and high rates of cancer screening with mammography and colonoscopy. However, cancer screening has plummeted during the COVID-19 pandemic, in part to closing physician offices and stopping non-urgent medical procedures. In addition, anecdotal reports suggest the public remains concerned about returning to physician's offices and risking possible exposure to COVID-19. As in the United States as a whole, COVID-19 has disproportionately impacted ethnic and minority individuals within underserved communities; and in Rhode Island, African Americans, Hispanics and undocumented individuals living in communities such as Central Falls, Pawtucket, Providence, East Providence and North Providence have had the highest rate of COVID-19. These communities are also impacted by healthcare disparities to access and affordability of healthcare, and as such, may be among the least likely to resume cancer screening.

The Lifespan Cancer Institute will institute a project to address health disparities in cancer screening during the pandemic through the use of a targeted campaign involving social media. The goals will be to re-establish screening in the era of COVID-19 and ensure timeliness of care for those found to be at risk, or are positive for, cancer.

This project will focus on improving breast and colorectal cancer screening during the COVID-19 pandemic in underserved populations of Rhode Island. The investigators will engage the Blackstone Valley Community Health Center. Dr. Don Dizon, a national leader in social media, will be a key participant.

Dr. Don Dizon is a world expert using electronic communication and social media in the oncology practice. Dr. Dizon chairs the Digital Engagement Committee for the Southwest Oncology Group (SWOG) a national cancer institute cooperative group. He is a co-principal investigator of an NIH grant studying electronic patient reported outcomes - the SIMPRO Research Consortium. Dr. Dizon is also head of the American Society of Oncology (ASCO) Educational Committee and is well positioned to disseminate the knowledge gathered from the current project through ASCO activities.

The initial project may be to discuss with the Blackstone Valley Community Health Center the possibility of developing short videos in multiple languages on the importance of cancer screening. The investigators will engage staff and patients of the BVCHC and the community to participate within the videos as a model of community-based participation. These informational videos could be distributed directly to the community via social media platforms. Data will be collecting on the rates of cancer screening including age, sex and race. These data could be compared to different cities within Rhode Island and the United States

Eligibility Criteria:
Inclusion Criteria:

* Increased risk of either colorectal or breast cancer
* Living in an under-served area of Rhode Island

Exclusion Criteria:

- None
Cognitive Behavior Therapy for Treating Anxiety in People With Dementia

This study will evaluate the effectiveness of cognitive behavioral therapy in treating anxiety in older adults with dementia.

Dementia is an illness that causes memory problems; changes in behavior; and difficulty with thinking, making decisions, and carrying out daily activities. Many people with dementia also have anxiety, and yet very little is known about effective treatment strategies for anxiety in this population. Cognitive behavioral therapy (CBT) is a type of psychotherapy that is commonly used to treat anxiety. CBT involves teaching patients skills to help them manage their anxiety, such as relaxation, changing their thoughts, and problem-solving. This study will evaluate the effectiveness of CBT in treating anxiety in older adults with dementia. In addition, the study will determine the effect of the treatment on patients' families and friends, and how families and friends may be able to help patients manage their anxiety. All study participants will name a family member or friend who will also participate in the study.

All participants in this study will answer a preliminary set of questions about anxiety and memory and will then complete a number of activities that involve learning and memory. These evaluations will take approximately 45 minutes. Participants who are selected to continue in the study will answer a second set of questions about mood, memory, concentration, and how they are doing in certain areas of life. These interview questions will take place during 2 sessions and will last a total of approximately 3 hours. Participants will then be randomly assigned to receive either enhanced usual care (EUC) or 8 to 10 sessions of CBT over a period of 10 to 12 weeks. Each CBT session will last about 1 hour and will include meeting with a study staff member to discuss anxiety and how to cope with it. Participants will also complete practice activities at home for about 20 minutes per day. EUC will consist of regular ongoing care from healthcare providers and phone assessments at 1-month and 2-month. Following the 6 month assessment, participants in EUC will be offered a Cognitive Behavior Workshop. Following in-person meetings, CBT participants will receive weekly phone calls for 3 months, followed by biweekly phone calls for the next 3 months. Some of the pretreatment questions will be asked again at 3 months and again 6 months after baseline.

Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's disease that is in the mild or moderate range according to a score of 0.5 to 2.0 on the Clinical Dementia Rating (CDR) Scale
* Significant anxiety as defined by a score of 4 on the Neuropsychiatric Inventory (NPI)
* Agrees to permit participation of a collateral
* English-speaking

Exclusion Criteria:

* Suicidal intent
* Current psychosis or bipolar disorder
* History of substance abuse within 1 month prior to study entry
Antiseptic Sutures and Wound Infection

The aim of this study was to ascertain if the use of Vicryl plus® reduced the number of wound infections after transverse laparotomy comparing to polydioxanon suture.

All patients are treated using clinical pathways (CP) to standardise surgical procedures in our high volume centre. Part of the clinical process management was the standardisation of wound incision and abdominal wall closure.

Wound closure is achieved by a two-layer technique using continuous absorbable loop suture. The suture length to incision length ratio is at least 4:1. The running sutures are 1 cm apart and at least 1.5 cm from the wound edge 14. In the first timeperiod (TP1), the CP step for fascia closure foresees a PDS loop suture (PDS II®, 150 cm, Ethicon GmbH, Norderstedt, Germany). After the recruitment of 400 patients, that CP step is altered to the use of a triclosan-coated polyglactin 910 loop suture (Vicryl plus®, 150 cm, Ethicon GmbH, Norderstedt, Germany). The primary outcome is the number of wound infections. Patients demographic and disease as well as procedure related data are collected in a clinical information system (ISHmed on SAP platform, GSD, Berlin, Germany) prospectively. Risk factors for poor wound healing, such as operation time, patients age, sex, body mass index, blood loss, peritonitis, antibiotics, and performance level classified according to the American Society of Anesthesiologists (ASA), are collected prospectively to compare the two groups.

Eligibility Criteria:
Inclusion Criteria:

* surgical pathologies accessed via transverse abdominal incision
* primary fascial closure

Exclusion Criteria:

* pregnancy
* age under 18 years
* open abdominal treatment
* known hypersensitivity agains PDS/Vicryl/Triclosan
Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve

Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids through a stent is thought to be one of the causes of cholangitis. Stents with antireflux valves are designed to reduce the reflux from the bowel. The purpose of the study is to investigate prospectively whether it is possible to reduce the amount of infection and thus obstruction of biliary stent by using a stent with an antireflux valve compared to a normal stent without an antireflux valve.


Eligibility Criteria:
Inclusion Criteria:

* age 18-89
* biliary obstruction in the lower two thirds of the choledochus

Exclusion Criteria:

* allergy to contrast media
* future pancreaticoduodenectomy
* refusal from the study
* previous stent