cyrilzakka/clinical-trials huggingface dataset:
Multiple Effects of Dual-Task Focused Training in Individuals with Chronic Stroke

The aim of this study is to comprehensively investigate dual-task-focused training on balance, functionality, anxiety, healthy function and quality of life in chronic individuals. Stroke is a clinical condition that occurs as a result of deaths in the brain blood and is an important public health problem, ranking third among the causes of death in the world and first among the diseases that cause disability. There are a limited number of studies in the literature investigating the effectiveness of dual task training in stroke rehabilitation.

Unlike other studies in the literature, this designed study evaluates balance, functionality, anxiety, cognitive functions and quality of life in addition to walking, making it unique. In the light of all this information, the hypothesis of the study is as follows: Application of dual-task-oriented training in addition to the regular physiotherapy program in individuals with chronic stroke affects balance, functionality, anxiety levels, cognitive functions and quality of life. It is planned to include 40 participants who meet the inclusion criteria in the study. After giving the necessary verbal and written information about the study, participants who receive informed consent will be randomized and divided into 2 groups of 20 people each. Group 1 will receive 30 sessions of traditional neurological rehabilitation program every day for 6 weeks. In Group 2, in addition to traditional neurological rehabilitation, a dual-task-oriented training program will be applied for a total of 12 sessions, twice a week. Participants will be evaluated twice, before and after treatment. Researchers will record personal information through a socio-demographic data form. Balance will be evaluated with the Berg Balance Test, functional status will be evaluated with the 10 Meter Walk Test and Timed Up and Go Test, anxiety level will be evaluated with the Beck Anxiety Scale, cognitive functions will be evaluated with the Verbal Fluency Test, and Standardized Mini Mental Test and quality of life will be evaluated with the Stroke Specific Quality of Life Scale.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to work
* Being between the ages of 40-70
* Being diagnosed with stroke
* Those who are not bedridden or wheelchair bound

Exclusion Criteria:

* People with sensory impairments (those with severe hearing and vision loss)
* Those with incompletely unioned fractures
* People with infection
* Those who have vestibular problems and balance problems
* Those who cannot cooperate due to psychiatric or cognitive problems
* Serious heart failure etc. those with systemic disease
* Bilateral involvement
* Accompanying serious orthopedic problem
Type 2 Diabetes Self-management Intervention for Low-income Women

The purpose of this study is to assess the extent to which a culturally appropriate, self-management intervention that combines patient education with a patient outreach liaison strategy improves outcomes associated with type-2 diabetes among low-income diabetic women.

In recent years, the prevalence of diabetes has significantly increased among women and because of the expected fast growth rate of minority populations, the number of women in these groups who will be diagnosed with diabetes is also expected to increase significantly over the coming years. Among women from minority groups diabetes is the fourth leading cause of death while it is the seventh among non-Hispanic White females. Non-compliance to diabetes self-care is a major concern for type 2 diabetic women of racial/ethnic groups because of the existing socio-economic and environmental barriers. Often, these women live in poverty; have less than a high school education as well as language barriers and inadequate health literacy, which further place them at risk for complications, and the daily activities of diabetes self-care are implemented within the context of family responsibilities and patient's priorities.

This study is a 12-month randomized controlled trial designed to compare a lifestyle intervention group (combination group) and a control group (education only group). Participants assigned to either group will receive three group education sessions (baseline, 3 and 6 months) with an emphasis on self-management.

Eligibility Criteria:
Inclusion Criteria:

1. Low-income women ages 21 and older; With type 2 diabetes ( fasting plasma glucose \> 126 mg/dl);
2. At risk of developing diabetes related complications (treatments goals from The American Diabetes Association Standards of medical care) as defined by:

   * HbA1c \>8.0 %
   * Any of the metabolic clusters such as Pre-prandial plasma glucose \> 130 mg/dl; Obesity (BMI \>25 kg/m2, or waist circumference \>88 cm (\>35 in); Hypertension (Systolic \>130 and Diastolic \> 80 mmHg); Hyperlipidemia (Triglycerides \>150 mg/dL; HDL\<50 mg/dL; LDL \>100 mg/dL)

Exclusion Criteria:

* Participants will be excluded if they are currently pregnant, have conditions (i.e., end stage diagnosis) or behaviors likely to affect conduct of the trial, and unwilling to accept treatment assignment by randomization.
Biomarkers in Plasma Specimens From Patients Treated on Study CALGB-80303

RATIONALE: Studying plasma samples from patients with pancreatic cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from patients with pancreatic cancer treated on study CALGB-80303.

OBJECTIVES:

* To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for overall survival (OS) in study BO17706 can be replicated in study CALGB-80303 using the same Immunological Multiparameter Chip Technology (IMPACT) assay.
* To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for progression-free survival (PFS), and other circulating biomarkers in study BO17706, can be replicated in study CALGB-80303 using the same IMPACT assay.
* To explore the relationship between efficacy and other biomarkers measured in the plasma samples.

OUTLINE: The samples required for this study are stored in the CALGB Pathology Coordinating Office at The Ohio State University from patients enrolled on protocol CALGB-80303. No additional samples are required from patients.

The following markers are analyzed in EDTA plasma samples using the Immunological MultiParameter Chip Technology (IMPACT) a Roche proprietary multiplex enzyme-linked immunosorbent assay (ELISA) platform: VEGF-A, VEGF-C, VEGF-R1, VEGF-R2, E-selectin, VEGF-R3, IL-8, bFGF, PDGF-C, ICAM-1, and PlGF.

Eligibility Criteria:
Patients must have been registered to CALGB-80303

* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Locally advanced or metastatic disease
The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma

RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (MM) patients.

PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression.

Primary endpoint:

1) To assess the rate of objective clinical complete response (CR) or partial response (PR)

Secondary endpoints:

1. To define toxicity profile according to NCI CT-CAE V. 3
2. To assess the overall survival (OS)
3. To estimate disease control rate (DCR) (proportion of patients with best response of CR+PR+SD) according to the modified Recist criteria
4. To assess the progression-free survival in treated patients according to modified Recist criteria
5. To evaluate qualitative and quantitative changes in cellular and humoral immune responses

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed MM
* Have received only one prior systemic chemotherapy platinum-based regimen for advanced MM
* Measurable disease, defined at least 1 unidimensionally measurable lesion \> 20 mm by conventional techniques or \> 10 mm by spiral CT scan (modified RECIST criteria)
* Disease not amenable to curative surgery
* No known brain metastasis
* Age 18 and over
* Performance status 0-2
* Life expectancy \> 12 weeks
* Adequate hematologic, hepatic and renal function
* Platelet count \> 75000/mm3
* Absolute granulocyte count \> 1000/mm3
* Hemoglobin \> 9 g/dL
* Bilirubin total \< 1.5 x ULN (Upper limited normal), except patients with documented Gilbert's syndrome, who must have a total bilirubin \< 3.0 mg/dl
* AST and ALT \< 2.5 x ULN ( \< 5 x ULN if documented liver metastasis are present)
* Creatinine level \< 2mg/dl or calculated creatinine clearance \> 60 mL/min as determined by the Cockcroft Gault equation.
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Patient must be willing and able to provide written informed consent, and the trial have to be approved by the institutional review board at each institution

Exclusion Criteria:

* Symptomatic chronic inflammatory or autoimmune disease
* Active hepatitis B or C
* Prior treatment with tremelimumab or other anti-CTLA-4 antibody or anti-PD1, anti-PDL-1 agents
* Clinically relevant cardiovascular disease
* History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent
* Uncontrolled active infections
* Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational agents
* History of other malignancies except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma of cervix, unless the patient has been disease-free for at least 5 years
Acute Exposure to High Altitude on Pulmonary Artery Pressure and Right Heart Function (Echo) Under Exercise

Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (2500m above sea level) on pulmonary artery pressure and right heart function (Echo) under exercise.

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

Several times within the exposure, the pulmonary artery pressure and the right heart function will be assessed by echo under exercise.

Eligibility Criteria:
Inclusion Criteria

* Informed consent
* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding
Venous thromboEmbolism Risk Profiles in Chinese hoSpitalized patiEnts (VERSE Study)

Venous thromboembolism (VTE) is a complex multifactorial disease, mainly manifested by deep vein thrombosis (DVT) and pulmonary embolism (PE). VTE events increase the length of hospitalization and treatment costs and seriously affect the quality of life of patients, so it is increasingly appreciated to identify high-risk patients with VTE and take preventive measures. The Padua prediction score (PPS) and Caprini risk assessment model (RAM) are widely used in clinical practice as common risk assessment scales in medical and surgical departments, respectively. And D-dimer levels have been considered as a well indicator to rule out acute VTE. Previous epidemiological studies on VTE have found the risk of VTE is significantly higher in hospitalized patients than in the general population and the prophylaxis decisions vary among countries, hospitals and departments, indicating current in-hospital VTE prevention strategies are far from optimal and it's imperative to regionalized control of VTE. Therefore, a single-institution-based risk profile study of in-hospital VTE patients is designed to explore current situation of VTE occurrence and predictive efficacy of widely used risk assessment models as well as D-dimer in one of the general hospitals in Beijing, China.

In this study, the investigators recruited adult inpatients attending Tsinghua Chang Gung Hospital in Beijing from June 2018 to April 2020, screened for patients with a hospital stay over 3 days and new-onset of VTE during hospital stay, and identified the in-hospital VTE patients after excluding patients who presented for DVT and/or PE. Similarly, negative patients were selected by not having a VTE during hospital stay. The diagnosis of VTE was confirmed as the occurrence of a critical value alert during hospitalization, which was predefined as ultrasound/radiology report of DVT or/and PE. Data was collected from the TEACH database of Beijing Tsinghua Chang Gung Hospital affiliated with Tsinghua University.

Patients baseline characteristics were extracted from database. VTE risk assessment was conducted with either Caprini risk assessment model (surgical patients) or Padua prediction score (medical patients). The evaluation was started upon admission and regularly repeated depending on the patient's condition. The last evaluation was conducted before discharge. The D-dimer values during hospitalization were also collected.

The rate of in-hospital VTE, distributions of in-hospital VTE patients and the receiver operating characteristic curves were analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and over, male or female
2. Inpatients with a hospital stay over 3 days
3. With or without new-onset of VTE during their stay

Exclusion Criteria:

1. Patients who presented for DVT and/or PE
2. Patients who were admitted in emergency department
Minimizing Peri-operative Time Delays, Maximizing Operating Room Efficiency: A Pilot Study

The primary objective is to prospectively identify Operating Room (OR) time delays from the time the patient who is undergoing total laparoscopic hysterectomy enters the OR to exiting the OR. This analysis will be used to identify root cause(s) leading to OR delays and define areas for improvement. The secondary objective is to identify any improvements in OR time delays and OR utilization following implementation of a standardized framework developed to increase OR efficiency.

Time delays in the operating room play a role in increasing wait time length, number of cancelled cases, health care expenditure and resources. Furthermore, it inconveniences patients and families, and delays care. Minimally invasive surgery (laparoscopy) affords same-day discharge, faster recovery, and decreased morbidity. However, performing laparoscopy requires special equipment and multiple steps during set-up that can lead to time delays if not performed efficiently. Multiple factors have been identified to contribute to inefficient care delivery including: communication error, equipment failure, lack of teamwork among nursing, surgical or anesthesia teams, and duplication of tasks.

OR delays due to inefficiency can result from a chain of intraoperative events including technical factors (ie. equipment failure or case complexity) and from non-technical human factors (ie. communication errors or lack of coordinated teamwork within and between OR teams). "The intraoperative period is the period in which the surgical team may have the most influence" on efficiency. Objective measures of intraoperative OR delays and identification of their causes can lead to the development of a standardized framework that could be generalized to any surgical discipline to improve OR efficiency.

The primary objective of this study is to prospectively identify OR time delays from the time the patient enters the OR who are undergoing total laparoscopic hysterectomy (laparoscopic gynecologic procedure that involves several potential areas for inefficiency) to case completion and exiting the OR. This analysis will be used to identify root cause(s) leading to OR delays and define areas for improvement. The causes of delays can be reported back to the team members through formative performance-based feedback. The secondary objective is to identify any improvements in OR time delays and OR utilization following implementation of a standardized framework developed to increase OR efficiency.

Eligibility Criteria:
Inclusion Criteria:

* Total laparoscopic hysterectomy cases performed by Minimally Invasive Surgery gynecologist at St. Michael's Hospital

Exclusion Criteria:

* Procedure converted to laparotomy
* Patients who desire future child bearing potential
* Procedures performed by hysteroscopy or laparotomy
* General gynecologist surgeon (i.e. non-Minimally Invasive Surgical specialist)
The SMART-LV Pilot Study

The goal of this pilot study is to evaluate the prospective performance of an image-based, smartphone-adaptable artificial intelligence electrocardiogram (AI-ECG) strategy to predict and detect left ventricular systolic dysfunction (LVSD) in a real-world setting.

The SMART-LV pilot study will be a prospective cohort study in outpatient clinics at the Yale New Haven Hospital. Participants who have undergone a 12-lead electrocardiogram (ECGs) with either a high (≥80%) or low (\<10%) probability of LVSD on AI-ECG algorithm, but without an echocardiogram done in the clinical setting for at least 90 days after the ECG, will be identified by electronic health record (EHR) and invited for a limited echocardiogram/cardiac ultrasonogram for assessing LV ejection fraction. The goal of the study is to evaluate the feasibility of recruiting patients and performing the study after pursuing a screening on 12-lead ECGs. The procedure currently used for detection of LVSD, echocardiograms, are inaccessible and expensive. Therefore, while AI-ECG-based algorithms using a smartphone- or web-based application can broaden access to screening, a thorough evaluation for this indication is needed before clinical adoption. The investigators intend to use the results as pilot data for sample size and drop-off rate estimation for a subsequent larger prospective cohort study aimed at validating the performance characteristics of the model in a screening setting.

The validation of this accessible ECG-based screening strategy, that can be directly used by clinicians using a smartphone or web-based application, can transform the early identification of LVSD before the development of symptoms, thereby allowing broader utilization of evidence-based therapies to prevent symptomatic heart failure and premature death.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Patients who have undergone a prior echocardiogram.
* Patients with a prior diagnosis of left ventricular dysfunction, based on a documented low ejection fraction (EF) in the medical record.
* Patients with an intermediate predicted probability of low EF (10 to 80%)
* Patients with a prior diagnosis of heart failure as determined by International Classification of Diseases-10 diagnosis code for heart failure.
* Research opt-out patients
Carious Tissue Selective Removal on Permanent Posterior Teeth.

This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of selective removal of carious tissue in deep lesions of posterior teeth. Three different materials will be used as liners (VitreBond ™Plus, BioDentine™, and Theracal™ LC). Post-operative pain, clinical, and radiographic success will be evaluated at one, two, and five-year follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment with the three materials used.


Eligibility Criteria:
Inclusion Criteria:

* Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form.
* Understands and is willing to comply with all study procedures and restrictions.
* Not presence of clinically significant and relevant abnormalities of clinical history or oral examination.
* Diagnosis of normal pulp or reversible pulpitis.
* No presence of periapical periodontitis
* Posterior teeth

Exclusion Criteria:

General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities.

Specific: Impossibility of restoration, diagnosis of irreversible pulpitis or necrosis, preoperative pain
Optimizing Postpartum Contraception in Women With Preterm Births

The purpose of this study is to examine the effectiveness of focused family planning counseling on the uptake and continuation of highly effective contraceptive methods (defined as the intrauterine device, implant, and both male and female sterilization methods including vasectomy, tubal ligation and Essure) during the postpartum period in women who have recently experienced a preterm delivery.

The investigators hypothesize that women with a recent preterm birth (PTB) will be more likely to initiate and continue using a highly effective method of contraception when provided with focused family planning counseling.


Eligibility Criteria:
Inclusion Criteria:

* Women who deliver a premature infant that is between the gestational ages of 24 weeks 0 days and 36 weeks 6 days at our institution.

Exclusion Criteria:

* Women who have delivered via cesarean section and have also had a sterilization procedure at the time of the cesarean section.