cyrilzakka/clinical-trials huggingface dataset:
Impact of Art Therapy on Self-Reported Pain and Anxiety Scores of Patients Waiting to Be Seen in the Emergency Department

The objective of this research is to assess the effects of engaging in coloring activities on patients' self-reported pain and anxiety scores while they wait to be seen by a physician in an emergency department (ED). The current literature on patient visits in the ED highlights the significance of anxiety, stress, and frustration in patient experiences, especially when accounting for long wait times before the physician-patient encounter. The study will address this common problem by looking at the potential impact of nature-themed or geometric shape coloring activities on the ED patient experience as it relates to self-reported anxiety and pain scores. Given that long wait times are increasingly being reported across the country, this study may offer a possible meaningful low-budget, low-resource intervention which could be offered to patients.


Eligibility Criteria:
Inclusion Criteria:

* Triage Pain Score \> 3
* Age \>18
* Able to provide informed consent
* English-speaking
* without concern for aggressive behavior
* Glasgow Coma Scale (GCS) of 15
* Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score \> 6

Exclusion Criteria:

* Concern for aggression risk, including active concern for suicidal or homicidal ideations
* Glasgow Coma Scale (GCS) \<15
* triage acuity requiring critical care evaluation
Thread-Embedding Acupuncture for Functional and QoL Improvement in COPD Patients

The goal of this clinical trial is to learn if thread-embedding acupuncture (TEA) can improve functional capacity and quality of life of chronic pulmonary disease (COPD) patients. The main questions it aims to answer are:

* Does TEA, when combined with standard treatment, improve functional capacity measured by the six-minute walking test (6MWT) and the modified Medical Research Council (mMRC) scale at 1, 2, and 3 months after the intervention?
* Does TEA, when combined with standard treatment, improve quality of life as measured by the COPD Assessment Test (CAT) and the St. George's Respiratory Questionnaire (SGRQ) at 1, 2, and 3 months after intervention? Researchers will compare TEA to sham TEA (a placebo procedure without thread implantation) to determine if TEA leads to meaningful improvements in COPD patients.

Participants will:

* Complete assessment using 6MWT, mMRC, CAT, and SGRQ
* Receive one session of either TEA or sham TEA
* Return to the clinic once a month for follow-up assessments over a 3-month period


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 18 to 70 years.
* Body Mass Index (BMI) ≥18.5 kg/m².
* Diagnosed with stable chronic obstructive pulmonary disease (COPD) based on GOLD criteria.
* Willing to participate in the study until completion and has signed informed consent.

Exclusion Criteria:

* Pregnant women.
* Presence of tumors, wounds, inflammation, or skin infection at the needling area.
* Blood disorders or use of blood-thinning medications (antiplatelets or anticoagulants) with INR \> 2.0.
* Uncontrolled heart disease or diabetes.
* Capillary blood glucose level ≥200 mg/dL (measured using glucometer).
* History of malignancy, uncontrolled epilepsy, or psychiatric disorders.
* Known allergy to stainless steel or polydioxanone (PDO) thread.
* Undergoing acupuncture therapy within the last 2 weeks or thread-embedding acupuncture (TEA) within the last 6 months.
Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release

The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.

This program provides access to OOS AMTAGVI (lifileucel) that does not meet commercial release criteria but does meet Iovance clinical trial release criteria. Patients will be followed for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible for treatment with AMTAGVI per United States Prescribing Information (USPI)
2. Have an AMTAGVI product manufactured for commercial treatment; however, the final manufactured product did not meet commercial release criteria but was deemed safe and acceptable for release after risk/benefit assessment
3. Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and for 12 months after receiving the last protocol-related therapy

Exclusion Criteria:

1. History of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium
2. Ongoing systemic infection
3. Cardiopulmonary or renal disorder which may make patient ineligible for treatment with cyclophosphamide, fludarabine or IL-2, at the discretion of the Treating Physician
4. Experience a significant worsening in clinical status that would, in the opinion of the Treating Physician, increase the risk of toxicities from treatment with lymphodepleting chemotherapy, AMTAGVI product that is out of specification, or IL-2
5. Any other condition, laboratory abnormality and/or pre-treatment assessment that places patient at unacceptable risk if they were to participate in the EAP based on the Treating Physician's judgment
6. Pregnant or breastfeeding
Recognition and Management of Early Mobilization in ICUs : Practice Patterns in China

Despite evidence to support early mobilization（EM）for critically ill patients,current status in Chinese ICUs is unknown.Understanding current practice patterns and challenges is essential to inform future research and strategies.

Practice guideline recommend EM in ICU,feasibility, safety and efficacy are confirmed by evidence-based data.However,the prevalence of EM in ICU patients is still low.Moreover,most of the prevalence studies come from developed countries, such as: Australia and New England the United States and Europe. Many ICUs in non-western countries are suffering from a lack of medical resources including health care personnel and medical equipment.

A retrospective observational study.To access the implementation of Chinese intensive care units and hospitals to early mobilization.Secondary objectives were to evaluate structure and process parameters of Chinese hospitals that were associated with implementation.

Eligibility Criteria:
Inclusion Criteria:Participating ICUs at least six beds ,they could be medical ,surgical or mixed

-

Exclusion Criteria:

* pediatric ICUs
Zalutumumab in Patients With Non-curable Head and Neck Cancer

The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer

This is an open parallel group trial. Patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with Best Supportive Care (BSC) or BSC.

Patients randomized to treatment with zalutumumab in combination with BSC will receive weekly infusions with zalutumumab starting with a loading dose (8mg/kg) followed by weekly maintenance doses until disease progression, intercurrent illness preventing further administration, unacceptable toxicity or patient decision. After Visit 2 the patient should be evaluated for presence of skin rash prior to each infusion to allow dose titration.

Individual dose titration until the patient develops grade 2 skin rash will be applied. The maximum dose used in study will be 16 mg/kg.

Eligibility Criteria:
Inclusion Criteria:

1. Males and Females age ≥ 18 years
2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
3. Failure to at least one course of standard platinum-based chemotherapy

Exclusion Criteria:

1. Three or more chemotherapy regimens other than platinum-based chemotherapy
2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
3. Past or current malignancy other than SCCHN, except for certain other cancer diseases
A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives

This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels in healthy women.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal, non-pregnant, non-lactating women age 18-35 years old
* Body Mass Index (BMI) ≥18 kg/m² and \<30 kg/m²
* Regular spontaneous menstrual cycle
* Others as dictated by Food and Drug Administration (FDA)-approved protocol

Exclusion Criteria:

* Any condition which contraindicates the use of combination oral contraceptives
* Known thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders
* Migraine headaches with focal, neurological symptoms
* Others as dictated by FDA-approved protocol
Study of PAH Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric

Study of PAH Subjects with LTOT Use that have Demonstrated Improved Exercise Tolerance with the use of Inhaled Nitric Oxide

Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Withdrawal Study of Pulmonary Arterial Hypertension(PAH) Subjects with LTOT Use that have Demonstrated Improved Exercise Tolerance with the use of Inhaled Nitric Oxide (INO)

Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form prior to the initiation of any study mandated procedures or assessments
2. Subjects must be enrolled in the PULSE PAH-004 clinical trial and must have been on LTOT and on open-label treatment with iNO 75 mcg/kg IBW/hr for at least 4 months
3. Subjects must have achieved ≥ 30 meter improvement in 6MWD after 4, 8 or 12 months of open-label treatment with iNO 75 mcg/kg IBW/hr as compared to either their PULSE PAH-004 Week 2 end of Run-in OR End of Study (EOS)in PULSE-PAH-004.
4. Subjects are willing and considered in the judgement of the Investigator able to use the INOpulse device continuously for up to 24 hours per day
5. Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) at randomization. All female subjects must use an effective method of birth control to avoid pregnancy.

Exclusion Criteria:

1. Subjects with episodes of worsening of PAH in the last 30 days prior to PULSE PAH-007 Baseline/Randomization
2. Subjects that experience Pulmonary Rebound in PULSE-PAH-004
3. Change in dose or types of PAH specific therapies in the last 30 days prior to Baseline/Randomization
4. Subjects who require treatment with riociguat
5. Subjects who early discontinued drug/device usage due to withdrawal of consent or an adverse event requiring termination from treatment in PULSE PAH-004
6. Women who are pregnant
7. The concurrent use of the INOpulse device with a continuous airway pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP, or any other positive pressure device.
Mindfulness Based Resilience Training

The investigators aim to evaluate the Mindfulness Based Resilience Training (MBRT) intervention for Mayo Clinic employees in order to provide evidence for improved ability to cope with stress and decreased work-related burnout and stress-related symptoms as a result of MBRT training. In addition, the investigators aim to compare the effects of MBRT + smartphone sleep feedback, a smartphone resilience intervention + smartphone sleep feedback, or waitlist control +smartphone sleep feedback in a randomized clinical trial in a sample of 75 Mayo Clinic employees.

The investigators aim to compare the effects of MBRT + smartphone sleep feedback, a smartphone resilience intervention + smartphone sleep feedback, or waitlist control +smartphone sleep feedback in a randomized clinical trial in a sample of 75 Mayo Clinic employees. Specific self-report outcomes include: well-being, stress, anxiety, depression, fatigue, resilience, self-compassion, and burn-out, assessed at pre-, post- and 3-month followup. Objective outcomes, derived from smartphone-driven self-monitoring, include sleep quality and emotional experiencing, assessed throughout the six-week intervention period. The investigators will explore whether changes in objectively measured sleep quality and emotional experiencing will mediate treatment effects on self-report outcomes. The investigators will also explore whether treatment effects are more robust in self-selected versus randomized groups by drawing on the investigators' existing data.

Eligibility Criteria:
Inclusion:

1. Stress subscale of the DASS-21 needs to be a score 5 or greater and
2. Must have a smart Phone, and
3. Ability to attend at least 5 complete sessions.

Exclusion :

1. Stress subscale of the DASS-21 less than 5.
2. Must have a smart Phone.
Study of Neutrophils and Circulating Platelets in Correlation With the Activity of T Lymphocytes in Patients With NAFLD (Nonalcoholic Fatty Liver Disease)

The aim of the study is to define the relationship between neutrophils, platelets and the activity of T lymphocytes in patients with NAFLD (nonalcoholic fatty liver disease).

This study may predict, in the course of hepatic steatosis, specific phenotypic patterns expressed by PMNs and circulating platelets to evaluate their role in disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18
* No alcoholic abuse
* Hepatic steatosis diagnosticated by abdominal ultrasound
* Negative hepatitis B and C tests
* No history of hepatic cirrhosis

Exclusion Criteria:

* Under 18
* History of alcoholic abuse
* Positive serology for hepatitis B or C
* History of hepatic cirrhosis
A Randomised Controlled Trial to Evaluate the Impact of Complement Theory's Live 1:1 Exercise Coaching and Personalised Digital Application on Cancer Survivors' Cost of Care

A Decentralized, Double-blinded, Randomized, 18 month, Parallel-group, Superiority Study to evaluate the impact of Complement Theory's Live 1:1 Exercise Coaching and Personalized Digital Application on Cancer Survivors' Cost of Care

The randomized controlled trial (RCT) aims to evaluate the efficacy of Complement Theory's (CT) personalized and interactive, evidence-backed lifestyle program in reducing healthcare costs and improving health outcomes for survivors across all major cancer types.

Distinct from conventional interventions, CT's program offers live 1:1 coaching through a mobile app, concentrating on Exercise and Meditation, and is enriched with evidence-based advice on Diet, Sleep, and comprehensive lifestyle modifications. This trial is pivotal in assessing the program's effectiveness against an active comparator- expert-recommended lifestyle modification resources suitable for cancer survivors--to isolate the impact of coaching and personalization.

The primary objective is to investigate whether CT's novel approach can more effectively reduce healthcare utilization, through reduction of hospitalizations, urgent care visits, and outpatient visits. Furthermore, the trial seeks to measure adherence to treatment, and significant health outcomes, including improvements in Quality of Life Scores (QoLS) to provide a holistic evaluation of the program's impact on patient care and well-being. As an exploratory effort, the trial will also measure cancer progression, recurrence in Prostate and Colorectal cancer survivors alone.

Eligibility Criteria:
Inclusion Criteria:

* Cancer Type: Breast, Prostate, Colorectal, Lung and Other Cancer
* Cancer Stage: Stage 1 to 4
* Treatment Status: Has undergone any cancer-related treatment in last 12 months
* Age: 21 to 64
* Permission to access to last 1 year digital health records
* Access to smartphone or a tablet

Exclusion Criteria:

* Excludes individuals who have undergone surgery within the last 4 weeks or will undergo surgery in the next 4 weeks
* Participants declared medically unfit by their physicians to do physical exercise
* ECOG Score 3,4 or 5
The Ohio State University Dermatology Biorepository

This study will create and extend a source of clinical specimens for the future study of inflammatory skin disorders.

A variety of molecular techniques can be used to investigate diseases by analyzing protein, DNA, and RNA. Flow cytometry, Polymerase chain reaction (PCR), histology and immunohistochemistry are assays which can identify specific cell populations and provide valuable information regarding the pathologic characteristics of those populations. Flow cytometry analyzes the surface markers of cells. Histology and immunohistochemistry further characterize surface and cellular molecules and aid in the diagnosis of certain skin diseases. Gene expression profiling allows investigators to examine the genes detectable to determine the function of the cells involved, and PCR techniques are useful for the diagnosis of certain conditions and for DNA analysis.

By procuring blood, skin tissue, and swab samples from patients with and without neoplastic and inflammatory skin disorders at the time of their appointments, the hypothesize that future translational research can be conducted on such specimens using the aforementioned techniques to further understand disease mechanisms in cutaneous disorders, and to potentially discover defective function and genetic mutations within cells from patients with neoplastic and inflammatory skin disorders. By establishing a tissue bank, we aim to lay the foundation for future work that will improve our understanding of the biology and natural history of neoplastic and inflammatory cutaneous diseases.

Eligibility Criteria:
Inclusion Criteria:

* Seen by an Ohio State University (OSU) Dermatology provider on the main University Hospital campus, including the James Cancer Hospital, OSU Dermatology East, OSU Dermatology at the Ohio State Eye and Ear Institute, Martha Morehouse Medical Pavilion, and OSU Dermatology at Upper Arlington after the date of approval of this protocol
* Ability to provide informed consent, or parent or legal guardian capable of providing consent for child or mentally handicapped individuals
* Willingness to participate in a research study.

Exclusion Criteria:

* Inability to provide informed consent
Enhancing mHealth Technology to Activate Chronic Care Patients

Multi-site feasibility study designed to assist type-2 diabetes patients in self-care activities. The study includes Bluetooth-enabled medical devices (i.e. scales, blood pressure cuffs, glucometers, and activity monitors) for both intervention and control groups. Those in the intervention group will have the devices linked too a mobile health care environment that provides key benefits that include: device data trending, reinforcing tailored behavioral messages, and enhanced communication with the clinic.

Multi-site phased study, conducted within the Military Health System that includes a user-centered design phase and a patient centered medical home (PCMH)-based feasibility trial.

In Phase I the investigators will assess both patient and clinician preferences and usability regarding the enhancement of the enabling technology capabilities for Type 2 diabetes chronic self-care management. The data from the experience will be coded and analyzed by the research team and the technology will be adapted accordingly before Phase II.

Phase II research is a single-blinded 12-month feasibility study that seeks to include the enabling technology to support diabetes self-care management with tailored behavioral messaging aimed at reinforcing and encouraging self-care behavior based on patients' readiness. We have included safety thresholds that alert patients and clinical team under certain conditions.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18 years or older,
* Ability to understand and read English,
* Be empanelled to one of the target PCMH sites, and
* Diagnosed with type 2 diabetes.

Exclusion Criteria:

* pregnant women,
* non-English speaking patients,
* receiving hospice care,
* active cancer and treatment with chemotherapy or radiation therapy,
* taking Coumadin,
* recipient of gastric bypass or similar procedure,
* diagnosis of uncontrolled hypothyroidism,
* known Cushing's syndrome,
* being treated with oral steroids,
* known liver disease,
* current diagnosis of cognitive impairments which would interfere with use of technology,
* congestive heart failure New York Heart Association class 3 or 4,
* inability to use a mobile device due to cognitive or physical impairments, and
* PAM® score = 4 during initial screening.
Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism

Is post-bariatric body contouring surgery prevent weight regain or no, and what is the effect on the patient's Metabolism? Few literature studies report body contouring surgery to be positively associated with maintained weight loss after obesity surgery but the measures of outcomes are diverse, and the collective magnitude of such an association is unknown.

The changes in gastrointestinal hormones, adipokines, and cytokines as well as in hypothalamic neuropeptides and neurotransmitters resemble the changes observed in the anorexia/cachexia, suggesting that bariatric surgery triggers a catabolic state responsible for loss of appetite and prolonged body weight reduction.

Weight regain after gastric bypass surgery occurs in about half of all patients within 2 years. About 50% of patients eventually gain a little weight back after hitting their low point. We need a more thorough evaluation to determine what factors - medical, psychological, lifestyle - are involved in the weight gain. One of the factors that seem to be responsible for the degree and durability of weight loss is post-bariatric body contouring procedures. However, metabolic consequences of removing excess subcutaneous adipose tissue by body contouring procedures have to a lesser extent been explored


Eligibility Criteria:
Inclusion Criteria:

* Post-bariatric (sleeve) patients will do body contouring surgery.
* Post-bariatric patients has been stable within 5 kg for 3 months
* Age between 20-60 years old.
* patients use the determinant fixed diet.

Exclusion Criteria:

* Age below 20 and above 60 years old.
* Non-compliance with the fixed diet.
* psychotic patients.
* Female patients seeking pregnancy.
* Endocrine causes of obesity.
* Bariatric surgery other than sleeve.
A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

This will be an open label study to investigate the pharmacokinetics (PK) and safety of a single intramuscular injection of penicillin G benzathine in Japanese healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects (of childbearing or nonchildbearing potential) and/or male subjects
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg and \<100 kg.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (history of penicillin hypersensitivity and/or a history of sensitivity to allergens).