cyrilzakka/clinical-trials huggingface dataset:
A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease

The addition of rituximab to prednisone for the initial treatment of chronic GVHD will increase the overall response rate, enable a more rapid and effective steroid taper.

To determine the efficacy of Rituximab as first line of treatment of chronic GVHD. Efficacy will be defined as he ability to taper prednisone to a dose of 0.25 mg/kg per day by 6 months without clinical or GVHD relapse/ recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Children and adults with a new diagnosis of chronic GVHD- that requires systemic immunosuppressive treatment to a dose of 1mg/kg/day prednisone and who have undergone any type of donor hematopoietic cell graft or conditioning regimen.
* Stable doses of other immunosuppressive medications (e.g. calcineurin inhibitors, mycophenolate mofetil) for 2 weeks prior to enrollment. In addition, these other immunosuppressive medications should not be dose increased.
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
* All subjects must provide written informed consent.

Exclusion Criteria:

* Known life-threatening hypersensitivity to Rituximab or other anti-B cell antibody.
* Treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time of enrollment. Persistent prednisone treatment of acute GVHD that is less than 1mg/kg is allowed.
* Active, uncontrolled infection- CMV reactivation is excluded (i.e. pneumonitis, colitis). Peripheral blood CMV reactivation is allowed as long as it is not associated with CMV disease and is responding to therapy.
* Known Hepatitis B surface Ag positive
* Active malignant disease relapse.
* Pregnancy
* Lactating
* Inability to comply with the Rituximab treatment regimen.
Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

Transversus Abdominis Plane (TAP) block is a useful tool in pain management after abdominal surgery. It is a regional nerve block that targets T6-L1 thoracolumbar nerves running in the plane between internal oblique and transversus abdominis muscle. It is shown to help with post-operative pain management, reducing pain scores and narcotic pain medication use, as well as promoting earlier return to activity and recovery. TAP block became a very popular, safe, and effective therapeutic adjunct for many different abdominal surgeries ranging from obstetric procedures to general surgery procedures like colorectal surgery. Furthermore, it is used in plastic surgery procedures such as Deep Inferior Epigastric Perforator (DIEP) free flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap, as they involve extensive amount of abdominal soft tissue incision. Previous studies have shown that TAP block in these procedures significantly reduce post-op pain and narcotic pain medication use. More recently, Exparel (liposomal bupivacaine) has risen to spotlight for providing a longer, sustained local anesthesia. Various surgical disciplines have adopted this agent as part of their pain management protocol. However, there are no literatures that describe the effect of TAP block using Exparel for breast free flap population. The study hypothesize that delivering TAP block with Exparel (vs. plain bupivacaine) will provide longer regional blocking effect, hence aiding in pain control and recovery postoperatively. The investigators will be analyzing postop narcotic pain medication requirement and pain scores to look into this question.


Eligibility Criteria:
Inclusion Criteria:

* All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center

Exclusion Criteria:

* Subjects with ages \<18 years

  * Allergy to local anesthetic
  * Inability to tolerate standard postoperative pain management regimen (Tylenol, Toradol, and Oxycodone PRN) for any reason
  * Subjects who cannot read or understand English
  * Subjects who are pregnant
Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors

This trial is conducted in Europe. The aim of this trial is to investigate bioequivalence between single-dose liraglutide administered subcutaneously with two different pen-injectors.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18-60 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) greater than or equal to 27.0 and less than 35.0 kg/m\^2
* Bodyweight up to 130.0 kg (inclusive)
* HbA1c (glycosylated haemoglobin) below 6.5%

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner
* History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the trial, as judged by the investigator
* Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin therapy, as judged by the investigator) within 2 weeks before the trial defined as screening
* Significant history of alcoholism or drug/chemical abuse within 1 year from screening, or a positive result of the urine drug screen or alcohol breath test, or consuming more than 21 units of alcohol per week (one unit of alcohol equals about 250 mL of beer or lager, one glass of wine (120 mL), or 20 mL spirits)
* Smoking more than 5 cigarettes, or the equivalent, per day and unable to refrain from smoking during the in-house periods
Effects of Betalains on Cardiovascular Health and Quality of Life

The goal of this randomized, double-blind, placebo-controlled, cross-over trial is to investigate the effects of beetroot-derived betalains on cardiovascular health, sleep and quality of life in healthy middle-aged individuals. The main question\[s\] it aims to answer are:

* Do betalains improve vascular function?
* Do betalains improve sleep?
* Do betalains improve quality of life?

Participants will be involved with the following:

* Consuming a daily betalain-rich or placebo capsule for a month
* Non-invasive cardiovascular measurements
* Wearing a fitness tracker for tracking physical activity and sleep
* Answering questionnaires regarding quality of life

Researchers will compare results between the intervention versus the placebo group to see if any of the study outcomes are significantly different.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 40 and 65 years
* BMI between 25-29.9 kg/m2
* Own a smartphone.
* Able to understand the nature of the study and give informed consent
* Have not gained or lost more than 10% of body weight (within the past 3 months)
* Not currently involved or have participated in another biomedical study (within the last 3 months)

Exclusion Criteria:

* Smoking or vaping (within the last 2 years)
* Vegetarian or vegan (due to capsule material)
* Medical history of chronic disease \[coronary artery disease, previous myocardial infarction (heart attack), stroke, peripheral artery disease, diabetes mellitus, chronic kidney disease, metabolic syndrome, malignancies, etc\]
* Grade II hypertension (blood pressure: \>160/100 mmHg)
* Under medication that can affect the cardiovascular system (within the last 2 months)
* Taking supplements (except vitamin D and iron) (within the last month)
* Intolerances or allergies toward beetroots, dragon fruit or rice hulls
* History of excess alcohol intake or substance abuse.
* Pregnant or planning to become pregnant in the next 6 months
* Under hormonal replacement therapy (contraceptives are allowed)
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema

To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)

A Multi-center Randomized Control Single Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring, a Novel Portable Non-Pneumatic Active Compression Device (NPCD) vs. an Advanced Pneumatic Compression Device (APCD) for Treating Lower Extremity Lymphedema. To evaluate the Dayspring, a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of age
* Capable and willing to sign the informed consent and deemed capable of following the study protocol
* Subjects must have a diagnosis of primary or secondary unilateral or bilateral lower extremity edema or lower extremity phlebolymphedema from chronic venous insufficiency

Exclusion Criteria:

* Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy
* Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
* Subjects with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
* Subjects must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
* Individuals who present with Ankle-brachial Index (ABI) screening score \< 0.8 and \> 1.30, indicating the possibility of Peripheral Arterial disease (PAD)
* Diagnosis of lipedema
* Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
* Diagnosis of acute infection (in the last four weeks)
* Diagnosis of acute thrombophlebitis (in last 6 months)
* Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
* Diagnosis of pulmonary edema
* Diagnosis of congestive heart failure (uncontrolled/uncompensated)
* Diagnosis of chronic kidney disease with acute renal failure
* Diagnosis of epilepsy
* Subjects with poorly controlled asthma
* Any condition where increased venous and lymphatic return is undesirable
* Women who are pregnant, planning a pregnancy or nursing at study entry
* Participation in any clinical trial of an investigational substance or device during the past 30 days
In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)

This pilot study will be a prospective investigation to study the efficacy and safety of In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10 subjects total in this Study. There will be no blinding to treatment.

In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting pregnancy through the use of Assisted Reproductive Technology (ART).


Eligibility Criteria:
Inclusion Criteria

1. 10 women between the ages of 18-34 inclusive at time of signing Informed Consent Form.
2. A diagnosis of PCOS by their primary MD
3. An Antral Follicular Count (AFC) of \> 12 on one ovary on at least one occasion
4. A day 3 FSH level of \<8 IU/mL
5. In good general health off of current medications which may confound response to study medications.
6. Desire to seek pregnancy actively during the study period by IVF-ICSI.
7. A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
8. Male partner able to provide adequate semen sample by ejaculation (no TESE)

Exclusion Criteria

1. Current pregnancy
2. Patients with uncorrected thyroid disease (defined as TSH \< 0.2 mIU/ML or \>5.5 mIU/mL). A normal level within the last year is adequate for entry.
3. Patients with poorly controlled diabetes (HgB A1C over 8.0 ng/dL).
4. Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol.
5. Patients with significant anemia (Hemoglobin \< 10 mg/dL).
6. Patients enrolled simultaneously into other investigative studies that would interfere with this research study.
7. have any contraindications to using birth control pills (oral contraceptives) as determined by the attending physician (e.g. history of thromboembolism or estrogen-dependent malignancy, such as breast cancer, etc.) -
How do Older Adults and Caregivers Feel About Their Medications?

The aim of this study is to study patients' and caregivers' perspectives towards deprescribing using the Revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Older adults' inclusion criteria:

  * age at least 65 years;
  * taking one or more long-term prescription medication;
  * have not participated in this anonymous questionnaire previously
* Caregivers' inclusion criteria:

  * currently an informal caregiver for an older adult (defined as having any role in a family member or friend's management of health and/or medications);
  * care recipient must be at least 65 years of age and taking one or more long-term prescription medication;
  * have not participated in this anonymous questionnaire previously

Exclusion Criteria:

* Older adults' exclusion criteria:

  * inability to complete a questionnaire in English.
* Caregivers' exclusion criteria:

  * caregiver's age less than 21 years;
  * caregiver's inability to complete a questionnaire in English.
Non-Invasive Monitoring Methods in Patients With Acute Brain Injury

Life-threatening mass effect (LTME) arises when brain swelling displaces or compresses crucial midline structures subsequent to acute brain injuries (ABIs) like traumatic brain injury (TBI), ischemic stroke (IS), and intraparenchymal hemorrhage (IPH), which can manifest rapidly within hours or more gradually over days. Despite advancements in surgical management, significant gaps in understanding persist regarding optimal monitoring and therapeutic approaches. The current standard for identifying LTME involves neurologic decline in conjunction with radiographic evidence or increased intracranial pressure (ICP) indicating space-occupying mass effect. However, in critically ill patients, reliance on subjective physical exam findings, such as decreased arousal, often leads to delayed recognition, occurring only after catastrophic shifts have already occurred.

The goal of this study is to determine the association of non-invasive biomarkers with neurologic deterioration, and to determine whether non-invasive biomarker inclusion improves detection of outcome and decline.

The investigators propose to use various non-invasive methods to monitor ICP as adjuncts in detecting deteriorating mass effect. These methods include quantitative pupillometry, radiographic data, laboratory data, and other bedside diagnostic tests available including electroencephalography (EEG), skull vibrations detected via brain4care device, optic nerve sheath diameter assessment (ONSD), and ultrasound-guided eyeball compression. Some of these methods will be measured \*only\* for the purposes of the research study (such as skull vibrations via brain4care). Other measurements, such as quantitative pupillometry, will represent additional measurements beyond those already being collected for clinical care. This research study is necessary to understand the association of these non-invasive biomarkers with neurological decline and outcomes while considering potential confounding factors.


Eligibility Criteria:
Inclusion Criteria:

* Admitted under Neuro intensivist primary or consultative care.
* At least one head computed tomography (CT) scan demonstrating intracranial pathology that may lead to life-threatening mass effect (i.e. traumatic brain injury, ischemic or hemorrhagic stroke, epidural or subdural hematoma, subarachnoid hemorrhage, diffuse hypoxic injury, metabolic cerebral edema, tumor)
* Concern for Life Threatening Mass Effect
* Glasgow Coma Score (GCS) \<9
* Anticipated stay \>24 hours

Exclusion Criteria:

* Comfort measure only
* Any other criteria that the PI deems that makes the patient inadequate for the study
* Sub-exclusion criteria for specific non-invasive measurements include:

  * Orbital injury (pupillometry, ONSD)
  * Traumatic injury or surgery that precludes use of B4C device
* Presence of supratentorial craniectomy or craniotomy that has not healed and is mobile/bone defects/scalp injury \[EEGelectroencephalogram (EEG), Brain4Care\]
* Presence of extensive scalp injury
Infiltration of Gadolinium Injection in Brain MR Scans Using Artificial Intelligence

The purpose of this research is to develop machine learning algorithms to analyze images from brain MRI to confirm that contrast agent has been correctly administered.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a MR brain without and with contrast examination on any GE or Siemens 1.5T and 3T MRI system within Mayo Clinic, Rochester, as part of their care plan.

Exclusion Criteria:

* None
Pulmonary Recruitment Maneuver With 15 and 30 cmH2O Pressure to Reduce the Postoperative Shoulder Pain

Pulmonary recruitment maneuver (PRM) has been shown to reduce postoperative shoulder pain by removing excessive intraabdominal gas following laparoscopic surgery(LS). A recent study demonstrated that compared to PRM in the supine position, PRM at semi-fowler position provides better evacuation of the remaining intraabdominal gas following gynecologic LS.

This study aimed to compare the impact of PRM with 15 cm H2O and PRM with 30 cm H2O on postoperative shoulder pain in patients undergoing gynecologic LS.

Pulmonary recruitment maneuver (PRM) consists of five manual pulmonary inflations where each positive pressure inflation was done for 5 s at a maximum pressure of 30-40 cm H2O in the neutral position. When used after laparoscopic surgery and just before the extubation, PRM has been shown to facilitate the removal of intraabdominal gas and thus reduce the postoperative shoulder pain which is associated with the volume of the gas accumulating under the diaphragm. A recent study demonstrated that compared to PRM in the supine position, PRM at semi-fowler position provides better evacuation of the remaining intraabdominal gas and less postoperative shoulder pain following gynecologic LS. However, whether a PRM with lower pressure is also effective in reducing postoperative intraabdominal gas and postoperative shoulder pain is of question. This study aimed to compare the impact of PRM with two pressures (15 cm H2O or 30 cm H2O) in addition to the semi-fowler position on postoperative shoulder pain in patients undergoing gynecologic LS.

Eligibility Criteria:
Inclusion Criteria:

* Must be scheduled for LS for benign causes
* Must be American Society of Anesthesiologists (ASA) class I or II.

Exclusion Criteria:

* Previous lung surgery
* Preexisting Emphysema
* Previous Pneumothorax
Trial of Spirometry Fundamentals™ in the Primary Care Setting

Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, yet few primary care providers report routine use of spirometry in the provision of care for their asthma patients. Misclassification of asthma severity has been reported when assessment is based on symptoms alone. This misclassification can lead to inadequate treatment that may result in increased morbidity and increased healthcare utilization/cost. However, even when spirometry is utilized to aid in asthma severity classification, primary care providers have a high rate of failing to meet the quality goals for testing established by the American Thoracic Society.

The goal of this study is to evaluate the effectiveness of the Spirometry Fundamentals™ tool in training primary care providers and their staff in producing high-quality flow-volume curves as compared to existing training modalities and to gather information in a 'real-world' setting that can be used to improve Spirometry Fundamentals™.

Currently few self-paced, distance learning programs exist that train staff to perform good quality spirometry tests. This study evaluates the effectiveness of a distance-learning tool for training primary care providers and their medical assistants in the use of spirometry to assist in managing obstructive lung disease (asthma and COPD). This tool is called "Spirometry Fundamentals™: A basic guide to lung function testing". It is a computer-based training program that teaches primary care providers and their staff what spirometry is, how it can be used, the techniques required to perform high-quality spirometry, and clinical interpretation of the spirometric data.

We evaluated the effectiveness of Spirometry Fundamentals in the primary care setting by conducting a randomized controlled trial (RCT). Study participants were primary care physicians (MDs or DOs) and their staff (medical assistants (MAs) or nurses (RNs)) and were recruited as study pairs. The role of the MDs was to utilize spirometry in clinical care by ordering spirometry tests based on their clinical judgment, and the role of the MAs was to perform the spirometry. The patients performed the spirometry as part of their usual care were not considered study subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have internet access in order to transmit spirometry curve and survey data.
* Subjects must have access to a computer with Windows 2000 /Mac OS 10 or higher in order to view Spirometry Fundamentals™.
* Subjects must have access to a ndd Easyone spirometer.

Exclusion Criteria:

* Subjects who lack internet access which will be needed to transmit study data
* Subjects who lack access to a computer with Windows 2000 /Mac OS 10 or higher which will be needed to view Spirometry Fundamentals™.
* Subjects who lack access to a ndd Easyone spirometer.