cyrilzakka/clinical-trials huggingface dataset:
Emerging From the Haze for Gynecologic Cancer Survivors

At Cedars-Sinai Medical Center, the investigators have developed a novel curriculum for a 6-week psycho-educationally-based, cognitive behavioral program to help patients with subjective cognitive complaints after cancer treatment, titled Emerging from the Haze™ (Haze). Each series meets once a week for 2-2.5 hours for 6 weeks.

The objective of this study is to quantify the impact of a trainee-taught Emerging from the Haze course on gynecologic cancer survivors' self-report of cognitive changes based on the change of FACT-Cog score.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of any stage gynecologic cancer including ovarian, uterine/endometrial, cervical, vulvar, and vaginal cancer
* Treated with chemotherapy solely or in combination with surgery, radiation, and/or hormonal therapy
* Female, age ≥ 18 years.
* FACT-Cog score \< 59 on the PCI sub scale
* Eligible after 2 months (60 ±5 days) of completing all their active cancer treatment with the exception of long-term hormonal treatments
* Subjective complaint of cognitive concerns at time of enrollment
* Must be able to understand and communicate proficiently in English
* Ability to understand and the willingness to sign a written informed consent.
* Agree to complete study surveys

Exclusion Criteria:

* Patients who have significant personality disorders or unstable psychiatric disorders (including active major depression, substance abuse, psychosis or bipolar disorder) as assessed by the interviewing clinician
* Patients with known brain metastases, history of brain metastases or radiation to the brain.
* Patients with a history of stroke or other pre-existing neurological condition that may contribute to cognitive dysfunction.
* Non-English speakers
* Receiving treatment for another malignancy other than breast cancer
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, chronic anemia, uncontrolled hypothyroidism, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Mindfulness Practices for Healthcare Professional Trainees

A newly developed intervention, Mindfulness Based Practices for Health Care Professionals in Training: Clinical Applications, will be piloted to determine the feasibility and accessibility within this population. The purpose of the proposed study is to assess the change in perceived stress at work/school and psychological symptomology; i.e., depression, stress, emotion regulation, and dispositional mindfulness, from pre to post intervention in health care professional students and when compared to a matched control group.

The proposed study aims to investigate an 8-week intervention: Mindfulness Based Practices for Health Care Professionals in Training: Clinical Applications. During the intervention, participants will engage in didactic education, experiential mindfulness practices, including gentle yoga, and group dialogue. The aim of the study is to investigate the feasibility of this intervention in producing measurable differences between the participants and matched controls on their perception of their well-being and clinical work.

Eligibility Criteria:
Inclusion Criteria:

* Students/faculty from any health care department at VCU

Exclusion Criteria:

* Anyone who is not a student/faculty from a health care department at VCU
A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma.

This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of autogene cevumeran (RO7198457) plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
* Life expectancy \>/= 12 weeks;
* Adequate hematologic and end-organ function;
* Naive to prior systemic anti-cancer therapy for advanced melanoma with some exceptions;
* Tumor specimen availability;
* Measurable disease per RECIST v1.1.

Exclusion criteria:

* Ocular/uveal melanoma;
* Any anti-cancer therapy with the exceptions as specified in the protocol;
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases;
* Previous splenectomy;
* History of autoimmune disease;
* Prior allogeneic bone marrow transplantation or prior solid organ transplantation;
* Positive test for Human Immunodeficiency Virus (HIV) infection;
* Active hepatitis B or C or tuberculosis;
* Significant cardiovascular disease;
* Known clinically significant liver disease.
Danish Quality Assurance Project on Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (COPD) in Outpatient Lung Clinics

Danish Quality Assurance Project on Diagnosis and Treatment of COPD in Outpatient Lung Clinics

Study Hypothesis:

Comparison(s):

none

Eligibility Criteria:
Inclusion Criteria:

* Outpatient with the diagnosis or referral diagnosis of COPD.
* COPD must be the primary reason for this outpatient contact (for both new patients and controls).

Exclusion Criteria:

* Any co-morbidity that hampers the diagnosis and treatment of COPD in accordance with the COPD guidelines used locally (e.g. malignant disease, dementia or sequelae of apoplexy).
* Asthma without the presence of COPD
The Effects of Different Gastric Residual Volume Thresholds for Holding Feeding in Internal Medicine.

This is a randomized control trial with a parallel design. Eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the GRV reaches 200 mL, and an experimental group will hold tube feeding when the GRV reaches 300 mL. Enteral feeding will be administered according to the study flow chart.

Background: Malnutrition is a common issue among critically ill patients. which increases hospital stays, costs, and mortality rate. According to the study, the primary reason for nurses to hold enteral nutrition is elevated gastric residual volume (GRV). However, there is still no consensus on the definition of high residual gastric volume, there is currently no consensus among experts and scholars regarding the threshold for holding enteral nutrition. Clinical nurses may prematurely hold enteral nutrition due to concerns regarding potential side effects such as vomiting and choking. The aim of this study is to increase the threshold for holding enteral feeding based on the results of the study, in order to improve nutritional intake in critically ill patients in internal medicine.

Objective: Increase the nutritional intake of critically ill patients in the Department of Internal Medicine by increasing the threshold for holding tube feeding.

Methods: This is a randomized control trial with a parallel design. Eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the GRV reaches 200 mL, and an experimental group will hold tube feeding when the GRV reaches 300 mL. Enteral feeding will be administered according to the study flow chart. The outcome data will collected based on the medical chart including frequency of diet volume ratio (diet received/diet prescribed), incidence of gastrointestinal complications, ventilator days, Ventilator-associated pneumonia, length of intensive care unit(ICU) stay, changes in nutritional indicators, APACHE Ⅱ and Duration of parenteral nutrition use.

Expected result: The results of this study will provide evidence regarding the improved effectiveness and safety of increasing the threshold of GRV in medical ICU and inform future evidence-based practice.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to the internal medicine intensive care unit.
* Patients receive enteral nutrition through a nasogastric tube.
* Patients receiving continuous enteral feeding.

Exclusion Criteria:

* Patients post-abdominal surgery.
* Patients admitted to the intensive care unit due to gastrointestinal disorders (e.g., gastrointestinal bleeding, bowel obstruction).
* Patients receiving palliative care with reduced enteral nutrition.
Registry of Irreversible Electroporation for the Ablation of Prostate Cancer With Use of Nanoknife Device

The aim of this registry is to assess the recurrence of prostate cancer at 1 and 5 years, as well as the change in functional outcomes (e.g. incontinence or erectile function) from baseline. Secondary objectives are to establish which indications lead to treatment with IRE Nanoknife® setting and safety assessment measured by number of complications and adverse events.

This is an international prospective observational multi-center study in which data on consecutive patients for 5 years with prostate cancer who undergo IRE are collected. Data from each patient will be collected at participating centers over a 5-year period. Patients' data at baseline visit (pre-IRE), peri-operative data and follow up for 5 years will be recorded. Follow up data will be collected according to the following schedule:

1 - 2 weeks after surgery

1. st year: every 3 months
2. nd year: every three months
3. rd year: every 6 months
4. th and 5th year: once a year. Data from participating centers will be collected through electronic Case Report Forms (eCRFs), with use of an online Data Management System (DMS), which is located and maintained at the CROES Office. The data collection or patient participation in this study does not interfere with the choice of treatment, sample collection, procedures and the treatment itself, which should entirely follow standard hospital practices, including the follow up.

Eligibility Criteria:
Inclusion Criteria:

* Is diagnosed with histologically confirmed prostate cancer
* Is scheduled for IRE Nanoknife®
* Has signed informed consent form

Exclusion Criteria:

* No specific exclusion criteria are defined.
Ozone Therapy in the Treatment of Digital Ulcers in Patients With Systemic Sclerosis

Digital ulcers (DUs) in scleroderma result from recurrent Raynaud's phenomenon (RP) and microtrauma with high impact on quality of life, management of DUs is a great challenge for clinicians. Medical use of ozone (triatomic oxygen) was initiated in the 19th century. Ozone has multiple therapeutic effects in wound healing due to the property of releasing nascent oxygen, which has been shown to stimulate antioxidant enzymes.

Digital ulcers (DUs) in scleroderma result from recurrent Raynaud's phenomenon (RP) and microtrauma with high impact on quality of life, management of DUs is a great challenge for clinicians. Medical use of ozone (triatomic oxygen) was initiated in the 19th century. Ozone has multiple therapeutic effects in wound healing due to the property of releasing nascent oxygen, which has been shown to stimulate antioxidant enzymes, we aim to assess the effects of ozone therapy on the healing in Scleroderma DUs and the expressions of vascular endothelial growth factor (VEGF), and endothelin-1 type A receptor (ETAR) and angiotensin II type 1 receptor (AT1R) autoantibodies level in the wounds after treatment.

Eligibility Criteria:
Inclusion Criteria:

* systemic sclerosis patients with DUs fulfilling ACR/EULAR criteria for diagnosis 2013

Exclusion Criteria:

* calcinosis ulcer traumatic ulcer vasculitis
Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol for the Prevention of Variceal Rebleeding

Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal rebleeding. Recently several studies compared the efficacy of EBL alone and with a combination of propranolol and EBL. However, the results of recent studies showed discrepancy. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients without previous history of endoscopic variceal treatment.


Eligibility Criteria:
Inclusion Criteria:

* liver cirrhosis
* age between 18 and 70 years
* Successful control of esophageal variceal bleeding within 6 weeks before enrollment

Exclusion Criteria:

* Gastric variceal bleeding
* Patients with systolic blood pressure \<100 mmHg or basal heart rate \<60/min
* Portal vein thrombosis
* Prominent hepatic encephalopathy
* Coexisting untreated malignancy
* Severe cerebrovascular or cardiovascular disease, renal failure
* Previous history of endoscopic, radiologic, or surgical treatment for varices or ascites
* Contraindication to beta-blocker
* Pregnancy
* Refusal to give consent to participate in the trial
Peripheral Nociceptive Effects of Levcromakalim

Intradermal and intramuscular injection of levcromacalim and placebo (sterile saline) on the forehead and forearm of healthy subjects and the following will be investigated:

1. Prevalence and intensity of pain
2. Prevalence and intensity of itching
3. Occurrence and intensity of local redness and swelling
4. Occurrence and intensity of local changes in skin temperature and blood flow


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers of both sexes.
2. 18-60 years.
3. 50-100 kg.
4. Women of childbearing potential must use adequate contraception.

Exclusion Criteria:

1. A history of serious somatic disease
2. Migraine or any other type of headache (except episodic tension-type headache less than once a month)
3. Daily intake of any medication except contraceptives
Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity

The investigators will use exercise training and weight loss to discover localized lipid species related to diabetes risk in people.


Eligibility Criteria:
Inclusion Criteria:

* Obese men and women with pre-diabetes; (BMI 30-40 kg/m2)
* Ages ranging from 30-60 years old;
* Individuals with:

  * impaired fasting glucose (IFG), (between 100-125mg/dl, with post-prandial glucose (\<140 mg/dl 2 hrs after 75g OGTT)
  * impaired glucose tolerance (IGT), (normal fasting glucose \<100mg/dl, with post-prandial glucose (\>140 mg/dl 2 hrs after 75g OGTT)
  * a combination of the two (IFG/IGT) (both impaired fasting glucose (100-125mg/dl), and impaired glucose tolerance (\>140 mg/dl 2 hrs after 75g OGTT), will be verified using oral glucose tolerance testing at initial screening, and
* Sedentary (\<2 hours/week of planned physical activity).

To increase generalizability, and because each subject serves as their own control, women will be enrolled regardless of menopausal status, use of hormone replacement therapy and oral contraceptives.

Exclusion Criteria:

* Regular exercise more than 2 hours/week,
* medications that could affect glucose,
* lipid metabolism,
* thyroid disease,
* history of lung disease,
* pregnancy,
* active cigarette smoking or exposure to second hand smoke, and
* Severe plasma lipid disorders.
Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.

The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to collect blood donation. Sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals of 18 through 50 years of age on the day of informed consent;
2. Individuals who had voluntarily given written informed consent after the nature of the study had been explained according to local regulatory requirements, prior to study entry;
3. Individuals who could comply with study procedures including follow-up;
4. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method.

Exclusion Criteria:

1. Progressive, unstable or uncontrolled clinical conditions;
2. Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study;
3. Abnormal function of the immune system;
4. Chronic clinical significant conditions;

4. Been administered any group B meningococcal vaccine at any time prior to informed consent; 5. Current or previous, confirmed or suspected disease caused by N.meningitidis.
Impact of Energy Drinks and Panax Ginseng on Heart Rhythm

To assess the cardiac effects of an energy drink and Panax Ginseng in healthy volunteers.

Energy drinks are composed of a variety of ingredients such as caffeine, taurine, and panax ginseng amongst others. The safety and efficacy of these ingredients individually and in combination need further exploration. This study is designed to assess the electrocardiographic and blood pressure effects of energy drinks and panax ginseng in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female adults 18-40 years old.

Exclusion Criteria:

* Baseline corrected QT (QTc) interval greater than 440 milliseconds,
* blood pressure at initial screening appointment greater than 140/90 mmHg,
* concurrent use of prescriptions or OTC medications taken on a daily basis,
* pregnant females,
* patients with any baseline ECG abnormalities.
A Virtual Life Story Club Intervention to Improve Loneliness and Apathy in Community-Dwelling Older Adults

Reminiscence therapy is a non-invasive, non-pharmacological intervention that has been shown to improve cognition, mood, functional status, quality of life, and apathy in older adults. Group reminiscence therapy combines structured social engagement and recounting of personal stories that address both social connection (a risk factor for cognitive decline) and cognition. Life story club© (LSC) is an established, non-profit organization that provides virtual, group reminiscence therapy for older adults to reduce loneliness and promote a sense of belonging and has not been formally studied.

The purpose of this study is to explore the feasibility of a LSC© intervention to improve loneliness and apathy in community-dwelling older adults.

This pilot study will be conducted to compare loneliness and apathy in lonely individuals without dementia at baseline who receive a virtual group reminiscence therapy intervention (vGRT). The intervention will be delivered weekly over 12 weeks. Loneliness and apathy will be assessed before and after the intervention as described in the Outcome Measures section of this registration. Feasibility will be assessed using quantitative and qualitative measures including feasibility of screening and enrollment, acceptability, and program satisfaction. Qualitative interviews will be conducted with a subset of 30 individuals to explore acceptability, barriers, and facilitators of the intervention.

This study will provide evidence for the feasibility of a virtual group reminiscence therapy for community dwelling older adults to reduce loneliness and apathy. This approach is both innovative and pragmatic because it will leverage an existing community-based service, with an established infrastructure and track record within the community to deliver the intervention. As such, the proposed research has the potential for broad implications for community-based research and aligns with multiple translational science principles.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 and over
* English or Spanish fluency
* Able to provide informed consent

Exclusion Criteria:

* Dementia based on Aging and Dementia (AD8) score of ≥4 or previous dementia diagnosis
* Severe auditory or visual loss
* Lack of access to internet connection or phone
Association of Plasma Metabolomic Biomarkers with Chronic Ischemic White Matter Injury

The cases were screened according to the inclusion criteria, and after the patients signed the informed consent, the clinical data were collected, the imaging data were evaluated, and blood samples were taken for follow-up measurements. In the early morning of the second day after the patient was enrolled, 5mL of peripheral venous blood was drawn and sent to the neurology laboratory of our hospital for separation, and the detection of plasma metabolomics markers was performed.

In the early morning of the second day after the patient was enrolled, 5mL of peripheral venous blood was drawn and sent to the neurology laboratory of our hospital for separation, and the detection of plasma metabolomics markers was performed.Inluding CRP，Complete blood count，Liver and kidney function indicators，et.

Eligibility Criteria:
Inclusion Criteria：

1. Be older than 45 years old;
2. Patients admitted to the Department of Neurology due to headache, vertigo, anxiety, etc.;
3. There were no symptoms of neurological deficit on physical examination;
4. Able to cooperate with the improvement of brain MRI examination;
5. Sign the informed consent form.

Exclusion Criteria:

1. History of stroke, traumatic brain injury, intracranial tumor, central nervous system infection, active malignant tumor, thyroid disease, autoimmune disease, active or chronic inflammatory disease, severe liver and kidney impairment, etc.;
2. accompanied by neurological deficit symptoms;
3. refusal to participate in the study;
4. Other conditions judged by the investigator to be unsuitable for enrollment.
Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients Undergoing Colonoscopy

Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG still results in lower compliance to the regime and increased cost.

Some high risk factors for inadequate BP have been identified, including old age, constipation, diabetes, the use of narcotics and prior history of inadequate BP. For average-risk patients without the high risk factors, the procedure of BP could be easier. In the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk patients achieved adequate BP. Here investigators hypothesized that compared with the standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while may be accompanied with better tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colonoscopy;
* Patients with average risks for inadequate BP (Patients were identified average-risk if they did not meet any factor of the following risk factors):

  * Constipation
  * Diabetes
  * Parkinson's disease
  * History of stroke or spine cord injure
  * Prior history of inadequate bowel preparation
  * BMI\>25
  * Use of tricyclic antidepressant or narcotics

Exclusion Criteria:

* History of colorectal resection;
* Suspected colonic stricture or perforation;
* Incomplete or complete bowel obstruction;
* Use of prokinetic agents or purgatives within 7 days;
* Toxic colitis or megacolon;
* Pregnancy or lactation;
* Unable to give informed consent;
* Haemodynamically unstable.