cyrilzakka/clinical-trials huggingface dataset:
Feasibility of the Lee Silverman Voice Treatment®-BIG Intervention in Stroke

Evaluate feasibility (acceptability, subject recruitment/retention, willingness to be randomized, and adherence rates) of delivering the Lee Silverman Voice Treatment®-BIG (LSVT®BIG) intervention with individuals with chronic stroke. Evaluate preliminary effect of the LSVT®BIG intervention on motor function and occupational performance with individuals with chronic stroke.

Literature suggests the Lee Silverman Voice Treatment®-BIG (LSVT-BIG®) program is an effective intervention for individuals with Parkinson's Disease (Ebersbach et al., 2015); however, no literature or research exists on the use of this program as an intervention for individuals with stroke. Therefore, this project aims to measure the effectiveness of the LSVT®BIG program with one individual with a stroke to determine if LSVT®BIG is a feasible and effective occupational therapy intervention for this population. The LSVT®BIG program is an intensive program with hands-on treatment sessions 4 days per week for 4 weeks. Clients complete home exercises every day that enhance the hands-on treatment and help promote carry-over of skills learned to daily tasks. The investigators have completed two case studies with clients with chronic stroke who demonstrated improved outcomes in upper extremity motor function and occupational performance. The purpose of this study is to test the LSVT®BIG intervention with a larger clinical population and to demonstrate that LSVT®BIG is an effective and feasible treatment option for improvement in occupational performance and upper extremity motor function with individuals with stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Diagnosis of first-ever ischemic stroke at least 6 months prior as confirmed by medical records
3. Has more than a moderate stroke (NIH Stroke Scale \> 20)
4. Can read and write English. To ensure participants can understand instructions in clinic and home exercise sessions

Exclusion Criteria:

1. More than moderate motor deficits (Fugl-Meyer UE Assessment \< 32/66)
2. More than mild cognitive impairment (Mini-Mental Status Examination \< 24)
3. More than mild balance deficits (Berg Balance Scale \<45)
4. Minimal or no impairments from their stroke (NIH Stroke Scale \< 6)
5. Currently receiving occupational therapy or physical therapy services
6. Has had more than one stroke
A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma

The purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be managed with filgrastim (a Granulocyte-Colony Stimulation Factor that is used to help control neutropenia) in patients with a type of cancer called soft tissue sarcoma.

This is a multicenter, open-label (identity of the assigned study treatments will be known to patients and study staff) study to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which the neutropenia (low white blood cell counts) is manageable with the use of filgrastim (an agent used to manage neutropenia) and associated with clinically acceptable number of side effects severe enough to continuation of treatment in patients with recurrent or persistent soft tissue sarcoma (STS, a malignant tumor that attacks the body's infrastructure of fat, muscles, nerves, joints, blood vessels, or deep skin tissues). Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Doxorubicin (50 to 75 mg/m2) will be given as a 10-15 minute intravenous (i.v.) infusion on Day 1 via a central venous catheter which is a tube placed into a large vein. Trabectedin (0.9 to 1.3 mg/m2) will be given as a 3 hour i.v. infusion, immediately following the administration of doxorubicin. Dexamethasone 20 mg will be given within 1 hour before the start of each doxorubicin i.v. infusion and filgrastim will be administered according to manufacturer's instructions.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of soft tissue sarcoma, recurrent or persistent
* Signed informed consent obtained for all patients before performing any study-related procedures

Exclusion Criteria:

* Patients treated with more than 1 prior chemotherapy regimen (including adjuvant (or other additional) therapy)
* Previous exposure to anthracyclines (a class of drugs used in cancer chemotherapy, example is Doxorubicin) or trabectedin
* Less than 4 weeks since radiation therapy
* Known metastases (spread) of cancer to the central nervous system
* Other ongoing serious illness present at the time of enrollment as determined by the Investigator
The Inland Northwest Colon Cancer Survivor's Study

The overall purpose of this study was to address the following questions by describing the trajectory of early survivorship in individuals who undergo both surgical and medical management of colon cancer. What are the changes in quality of life, demands of illness, sexual function, and peripheral neuropathy, following curative resection during the first year of treatment and recovery? Is there an interaction between exposures to chemotherapy and changes over time in these outcomes?

The population of interest included colon cancer survivors of both sexes, 18 to 90 years of age, who underwent one of two types of surgical resection and who may receive adjuvant chemotherapy. The prospective design with two cohorts representing exposure to chemotherapy (chemotherapy vs. no-chemotherapy) described the changes in quality of life, demands of illness, sexual function, and peripheral neuropathy, which occurred following curative resection. An analysis of the interaction between time (four measurement occasions) and the independent variable of chemotherapy group by mean values of quality of life, sexual function, peripheral neuropathy, and demands of illness addressed the central thesis question.

Specific Aims

1. Examine the relationships among quality of life, demands of illness, sexual functioning, and peripheral neuropathy, for the total sample and by chemotherapy group.
2. Examine changes within-subjects (four measurement occasions), between-group (chemotherapy, no-chemotherapy) differences, and the interaction between time and chemotherapy group for quality of life, demands of illness, sexual functioning, and peripheral neuropathy across four measurement occasions.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female at least 18 years of age
* Biopsy Proven Colon Cancer
* Plan to undergo open, laparoscopic or robotic surgical colectomy.

Exclusion Criteria:

* Persons with rectal cancer
* Surgical resection below the rectal sigmoid junction
* Does not speak or read English
* Scheduled to receive radiation therapy during the data collection period
* Diagnosis of metastatic colon cancer (Stage IV)
* A previous history of cancer diagnosed with the past five years with the exception of early basal cell or squamous skin cancer or early stage melanoma
Health Economic Research on Oral Nutritional Supplements for Hospitalized Patients With Nutritional Risk

The goal of this observational study is to evaluate the treatment effect and health economic impact of oral nutritional supplements(ONS) in hospitalized patients with nutritional risk. The main questions it aims to answer are:

* To evaluate the effect of ONS on clinical outcomes in hospitalized patients with high nutritional risk
* To evaluate the health economic impact of ONS in hospitalized patients with high nutritional risk Data was collected from patients admitted to peking union medical college hospital between January 1, 2018 and December 31, 2020.

The inclusion criteria were as follows: (1) age≥18 years old; (2)length of hospital stay≥3days; (3) Only ONS was used as enteral nutrition or no enteral nutrition was received.

Exclusion criteria were: (1) age\<18; (2) length of hospital stay\<3 days; (3) the patients who received enteral nutrition other than ONS (such as tube feeding); (4) emergency admissions; (5) the patients who transferred from other hospitals; (6) pregnancy or lactation

We collected the following data through the hospital big data query and analysis system:

1. Basic information: gender, age, height, weight, medical insurance, etc.
2. Clinical information: admission paths, admission time, admission departments, discharge time, discharge unit, length of stay, mode of payment；
3. Disease Information: admission diagnosis, disease coding at admission, the first discharge diagnosis, the coding of first discharge diagnosis, the second discharge diagnosis, the third discharge diagnosis, outcome (recovery, improvement, not cured, death, transfer to another hospital)
4. Operation information: surgical name, surgery code,
5. oral nutritional supplement: drug names, unit price
6. laboratory examination: hemoglobin, albumin, prealbumin
7. hospitalization costs: total cost, self-pay cost, other cost, the type of medical insurance； Researchers will compare ONS group to see the clinical outcomes and health economic impact.


Eligibility Criteria:
Inclusion Criteria:

1. age≥18 years old;
2. length of hospital stay ≥3days;
3. Only ONS was used as enteral nutrition or no enteral nutrition was received.

Exclusion Criteria:

1. age\<18;
2. length of hospital stay\<3 days;
3. the patients who received enteral nutrition other than ONS (such as tube feeding); (4) emergency admissions;

(5) the patients who transferred from other hospitals; (6) pregnancy or lactation
Protracted Effect of the Ultrasound-guided Saphenous Block

This study focuses on optimizing the postoperative pain treatment after major foot and ankle surgery by prolonging the duration of the ultrasound-guided saphenous block. The currently used single shot saphenous block only covers half of the pain intensive period from the saphenous territory, which results in a sharp, break-through pain requiring opioids. The hypothesis is that this protracted mixture will keep the patients free of pain without the use of opioids for the entire pain intensive period and thus increase rehabilitation and patients' satisfaction.

Half of the patients will receive a single shot saphenous block with 10 mL bupivacaine-adrenalin and 1 mL of sodium chloride solution, while the other half will receive 10 mL of bupivacaine-adrenalin and 1 mL of dexamethasone.

The block is strictly a sensory block because it is a selective, sub-sartorial saphenous block at mid-thigh level without any anesthetic effect on the femoral nerve.

The adjuvant dexamethasone has increasingly become a subject of interest regarding a protracted effect, which has been shown in several studies. However, the precise mechanism of action remains speculative, and the results are contradictory regarding the discussion whether the effect is systemic or local. The effect may stem from decreased nociceptive C-fibre activity via a direct action on glucocorticoid receptors and inhibitory potassium channels. Another suggestion is a vasoconstrictive effect, which reduces the systemic uptake of local anaesthetics or a systemic anti-inflammatory effect.

Prolonging the effect of the single shot saphenous block by adding dexamethasone will reduce the need for opioids, which will reduce the risk of adverse effects like nausea, vomiting and respiratory depression. Furthermore, newer studies show that inadequate pain alleviation in the early postoperative period is a risk factor in developing chronic persistent pain.

Eligibility Criteria:
Inclusion Criteria:

* Elective ankle or hind foot surgery either: (1) total ankle arthroplasty, (2) ankle arthrodesis or (3) subtalar arthrodesis
* Age ≥ 18
* American Society of Anaesthesiology Classification I-III
* Informed consent both orally and in writing after the patient has fully understood the protocol and its limitations.

Exclusion Criteria:

* Communication problems or dementia
* Allergies to any medical product used in the study
* Neuropathy of the sciatic or femoral nerve prior to the operation
* Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral vascular disease
* BMI \> 35
* Pregnancy
* Daily use of opioids
* Coagulation disorders
* Infection at the site of injection or systemic infection
Investigating the Role of Active Versus Chronic Coronary Artery Calcification on Acute Myocardial Infarct

The investigator aims to determine the feasibility of understanding the process of active versus chronic calcification using Na-F PET scan and contrast CT scan of the heart.

The patient cohort will consist of patients diagnosed to have either acute coronary syndrome (ACS) (comprising of either unstable angina pectoris or acute myocardial infarction) or suspected coronary artery disease (CAD). The PET images will be compared to images obtained from standard contrast CT of the coronaries. This study will provide additional insights about active versus non-active calcification amongst patients with ACS or suspected CAD.

Contemporary techniques used to visualize coronary artery calcification include standard non-contrast computed tomography (CT) of the coronaries measuring amount of calcium deposition in the coronaries, contrast CT and more recently, using sodium-fluoride (Na-F) positron emission tomography (PET) to image coronary and valvular calcification. Na-F has been shown to accumulate in areas of active calcification where contrast CT of the heart has been shown to accumulate in areas of chronic calcification. The investigator aims to determine the feasibility of understanding the process of active versus chronic calcification using Na-F PET scan and contrast CT scan of the heart.

The patient cohort will consist of patients diagnosed to have either acute coronary syndrome (ACS) (comprising of either unstable angina pectoris or acute myocardial infarction) or suspected coronary artery disease (CAD). The PET images will be compared to images obtained from standard contrast CT of the coronaries. This study will provide additional insights about active versus non-active calcification amongst patients with ACS or suspected CAD.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of acute coronary syndrome
* Patients referred for workup of suspected coronary syndrome
* Able to provide written, informed consent.
* Age between (including) 50 years to 89 years old.

Exclusion Criteria:

* Pregnant \& Lactating women
* weight \<=180kg
Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting

The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.

This is a Phase 2 multiple site, single-arm, open-label study designed to evaluate the safety of rThrombin in subjects of age 2 to 75 years who are receiving a partial- or full-thickness autologous sheet or mesh grafts following burn or traumatic skin injury. After establishing eligibility, study participants will be treated with topical spray rThrombin at the skin graft recipient site during autologous skin graft surgery. There will be a 1-month follow-up period after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Autologous skin grafting with sheet or mesh grafts following burn or traumatic skin injury

Exclusion Criteria:

* Known antibodies or hypersensitivity to thrombin or other coagulation factors
Computational Prediction and Experimental Validation of Gastric Cancer Associated Neoantigens

This study is to develop methods for identification of neoantigens from patients with gastric cancer.

Gastric cancer (GC) is the fourth most common cancer type and one of the leading causes of cancer-related death in Vietnam. Immunotherapy using checkpoint inhibitors (CPI) in combination with certain types of chemotherapy has been clinically shown to offer survival benefits for patients diagnosed with advanced stomach cancer. However, clinical outcomes of CPI are associated with the quantity as well as the quality of neoantigens which arise due to mutations in coding regions of cancer associated genes. Such neoantigens can be presentable by cancer cells to the host adaptive immune system and activate antitumor responses. Hence, the identification of neoantigens would be of significance for immunotherapeutic approaches. Recent data published by the Tumor Neoantigen Selection Alliance (TESLA) indicate that a large proportion (98%) of predicted neoantigens are not immunogenic and ineffective in activating anti-tumor responses. In the present study, we aim to develop a comprehensive pipeline incorporating both computational prediction tools and experimental validation assays to enhance the accuracy of neoantigen identification.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female patients aged 15 years and older
2. Diagnosed with advanced gastric cancer (T2-4b/N0-3/M0-1 stage, according to the eighth edition of the American Joint Committee on Cancer TNM (AJCC TNM) system)
3. Treatment-Naive
4. Not known for other concomitant cancers
5. Provide written informed consent

Exclusion Criteria:

1. Insufficient tumor tissues (less than 1 cm3)
2. Unable to sign informed consent
3. Underwent treatment
Genetics of Interstitial Cystitis

The cause of interstitial cystitis is unknown. However, it tends to run in some families suggesting that there may be a genetic susceptibility to the disease. For instance, the disease is found 17 times more commonly in first-degree relatives (parent, sibling, or child) of patients with interstitial cystitis than in the general population. Furthermore, if one twin has interstitial cystitis, the disease is much more common in identical co-twins than fraternal co-twins. This evidence suggests that, in some families, genes that make a person susceptible to interstitial cystitis are being passed from one generation to the next.

The University of Maryland School of Medicine and the National Institutes of Health are performing a study to identify these genes for susceptibility for interstitial cystitis. This study is entitled the Maryland Genetics of Interstitial Cystitis (MaGIC) study. The MaGIC study will investigate several hundred families with two or more blood relatives with interstitial cystitis. The study will seek to find changes in genes that are found far more commonly in family members who have interstitial cystitis than in those who do not have the disease.Identifying these genes should lead to a better understanding of the cause of interstitial cystitis. Finding the cause is the first step to finding the cure.

This is a national study which is conducted by telephone and mail, and in which you can participate entirely from your home.


Eligibility Criteria:
Inclusion Criteria:

* Have interstitial cystitis, or painful bladder syndrome.
* Have at least one blood relative with interstitial cystitis, painful bladder syndrome, or urinary symptoms similar to yours.
* Are 13 years of age or older.
* Are available for a telephone, mail, or website interview.
* Live in the USA or Canada.

Exclusion Criteria:

* Are less than 13 years of age.
* Have Parkinson's disease, Multiple Sclerosis, Spina bifida, or another neurologic disease that preceeded your interstitial cystitis symptoms
High Intensity Focused Ultrasound in Uterine Myoma

Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal (FSH \< 40 IU/L)
* Symptomatic uterine fibroids
* Willing to contracept during study period

Exclusion Criteria:

* Pregnant or willing to be pregnant in future
* Cancer in female reproductive organ is suspected or diagnosed
* Inflammation in female reproductive organ
* Poorly controlled systemic disease
* Hematocrit \< 25%
* Glomerular filtration rate(GFR) \<= 30ml/min
* Cannot tolerate contrast-enhanced MR or Contrast-enhanced ultrasound(CEUS)
* Cannot lie down
* Previous treatment for leiomyoma, any of ① myolysis, ② myomectomy within 1 year, ③ hormonal therapy longer than 7 days within 4 weeks
* Cannot count the number or measure volume of leiomyoma using MRI
* Leiomyomas are inadequate (location, volume, number) for intervention
* Diameter of leiomyoma is over 5 cm
* Leiomyoma is not enhanced
* Lactating women
* Cannot communicate properly
* Participating or have participated in other trials within 30 days
Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care

This small randomized pilot study will evaluate feasibility and preliminary outcomes of an audio-delivered mindfulness program to reduce psychological distress for mothers with an infant in neonatal intensive care, as compared with an active control condition.

An estimated 400,000-480,000 infants in the U.S. with serious medical conditions are cared for in neonatal intensive care units (NICUs) each year. Maternal stress exposure related to infants' NICU stays is an under-appreciated public health problem with negative implications for maternal and child health and wellbeing. Flexible, effective intervention strategies have potential to improve maternal mental health and parenting, promoting positive emotional and behavioral outcomes for both mothers and infants.

In the investigators' successful pilot research, the investigators developed an audio-delivered mindfulness program to help NICU mothers reduce rumination and worry, cultivate a state of calm awareness, and promote self care. In this small randomized pilot study, the investigators will randomly assign mothers with an infant in the neonatal intensive care unit (NICU) to receive either the mindfulness intervention or an active control program (audio-delivered education on infant care and development).

This study will evaluate feasibility of all key research aspects, including recruitment, randomization, intervention and control conditions, and assessments, in preparation for a future larger-scale study. This study will also assess preliminary intervention outcomes to identify potential program benefits.

Eligibility Criteria:
Inclusion Criteria:

* female
* 18 to 50 years old
* mother of an infant currently being treated in the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center NICU
* able to speak English

Exclusion Criteria:

* known to have serious psychopathology
* infant medically unstable/ progress is poor