cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50)

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of golidocitinib and benmelstobart combination treatment in patients with relapsed or refractory extranodal natural killer/T cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects fully understand and voluntarily participate in this study and sign informed consent.
2. Pathologically confirmed extranodal natural killer/T cell lymphoma (ENKTL).
3. Age ≥18, no gender limitation.
4. Treatment failure to at least one line of asparaginase-based therapy.
5. Eastern Cooperative Oncology Group performance status of 0-2
6. Expected survival ≥ 3 months.
7. At least one measurable lesion that meets Lugano 2014 criteria.
8. Sufficient organ function.

Exclusion Criteria:

1. Invasive NK-cell leukemia or NKTCL that has progressed to leukemia.
2. Accompanied by hemophagocytic lymphohistiocytosis.
3. NKTCL with central nervous system invasion.
4. Previously treated with JAK inhibitors.
5. The patients have contraindications to any drug in the combined treatment.
6. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
7. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
8. Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
9. Mentally ill persons or persons unable to obtain informed consent. The investigators think that the patient is not suitable for the study.
Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm

Enhanced Recovery After Surgery (ERAS) protocols were developed to standardize perioperative practice in colon surgery to reduce morbidity, improve recovery, and shorten length of stay (LOS). Better protocol adherence translates into fewer readmissions and complications, and better 5-year survival. Preoperative elements, especially nutrition and immunonutrition, are topics that need further development to become the standard of care. It has been widely reported that the prevalence of malnutrition reaches 40% in cancer patients at the time of diagnosis. Impaired nutritional status at the time of surgery and cancer-induced inflammation, along with postoperative inflammatory responses to major surgery, increase the risk of postoperative complications, along with a decrease in perceived quality of life.

Immunonutrition can modulate inflammation and reduce postoperative infections and shorten length of stay by counteracting the immune response induced by cancer. Adipose tissue has been shown to be a relevant source of inflammatory mediators, which may play a role in the promotion of tumor cachexia.

The present study is a multicenter randomized control study (RCT) designed to evaluate the effect of preoperative immunonutrition in patients with colorectal cancer eligible for elective minimally invasive procedures, evaluating in particular surgical site infection and length of hospital stay. A biopsy of subcutaneous adipose tissue and visceral adipose tissue will also be performed, in order to evaluate the differences between inflammatory infiltrate, degree of fibrosis and cross-sectional area of adipocytes compared to controls.


Eligibility Criteria:
Inclusion Criteria:

* primary colorectal neoplasms eligible for elective surgery, undergoing minivasive resections.
* 20 to 85 years old, with no difficulties in oral intake
* BMI ranging from 18 to 40.

Exclusion Criteria:

* emergency surgery,
* converted procedures,
* major intraoperative complications,
* concomitant chronic disease such as chronic renal failure, rheumatic and hematological disease, chronic inflammatory bowel diseases,
* synchronous cancer,
* previous bowel resections or bariatric surgery,
* presence of preoperative stoma.
Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established practice) or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are followuped at 1 week, 1 month, 3 months, 6 months \& 12 months. CT scan of the orbits are performed preop, 6 months \& 12 months. End point is the 12 month follow-up appointment. Visual acuity, range of motion, enophthalmos \& diplopia are assessed in follow-up.

Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established practice) or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are followuped at 1 week, 1 month, 3 months, 6 months \& 12 months. CT scan of the orbits are performed preop, 6 months \& 12 months. End point is the 12 month follow-up appointment. Visual acuity, range of motion, enophthalmos \& diplopia are assessed in follow-up.

Eligibility Criteria:
Inclusion Criteria:

* age: 20 - 70 years facial trauma with orbital fractures

Exclusion Criteria:

* No other coexistent conditions eg. diabetes, heart disease, etc
Vitamin D Deficiency and Atopic Dermatitis

Atopic dermatitis is a chronic skin disease characterized by a defective skin barrier, inflammation, and increased propensity for skin infections. Vitamin D is a fat-soluble vitamin that is primarily acquired through local production in the skin after ultraviolet light exposure but can also be obtained through natural and supplemental dietary sources. This randomized controlled trial will examine the effects of vitamin D repletion on atopic dermatitis severity in patients with diagnosed deficiency. The investigators hypothesize that pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency will have improved cutaneous disease after treatment with high dose as compared to standard dose vitamin D.


Eligibility Criteria:
Inclusion Criteria:

* Serum 25-hydroxyvitamin D level \<20 ng/ml (\<50 nmol/L)
* Diagnosed with atopic dermatitis by a CHW pediatric dermatologist
* Age 1-18 years old
* Primary residence in Milwaukee County
* Moderate and severe atopic dermatitis (Severity Scoring of Atopic Dermatitis \[SCORAD\] score greater than 15)
* On clinic protocol treatment for their atopic dermatitis (desonide ointment twice daily for the face and groin, triamcinolone 0.1% ointment twice daily for other areas)
Tamoxifen Pharmacogenetics and Clinical Effects

The purpose of this research is to try to identify which women who take tamoxifen are likely to suffer from hot flashes or are more likely to have other side effects or benefits from the drug. The researchers will do so by determining whether there are mutations that normally occur in human DNA that might influence the way individuals respond to medications.

The study will test the following hypotheses.

1. There is a relationship between genetically distinct metabolic profiles of tamoxifen and the frequency and severity of hot flashes in women on chronic tamoxifen therapy.
2. Genetically distinct metabolic profiles for tamoxifen effect lipid profile, bone turnover metabolites and bone mineral density, and coagulation factors.
3. Different genetic profiles of estrogen responsive genes influence the pharmacodynamic effects of tamoxifen in cardiovascular system.

Eligibility Criteria:
Inclusion Criteria:

1. 18-years or older
2. Women with a prior breast cancer or who are at a high risk for developing the disease and about to start tamoxifen therapy.
3. Participants must not be treated with concomitant chemotherapy or hormone therapy other than tamoxifen. They must not have ovarian ablation or currently being treated with radiation therapy and/or chronic corticosteroids.
4. The participant must not be taking anti-hot flash therapy (clonidine, bellergal, megestrol acetate). Vitamin E, selective serotonin reuptake inhibitors, or herbal remedies are allowed provided that the participant has been taking the remedy for at least 4 weeks and intends to continue the remedy for at least the first month while on the study, and allows for one-month follow up evaluation (hot flash diaries and blood samples).
5. The participant must not be pregnant or lactating.
6. The participant is able and willing to sign an informed consent.
Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia

The objective of this study is to assess the analgesic sparing effect of adding Dexamethasone to Bupivacaine in Quadratus lumborum block in patients undergoing Laparoscopic cholecystectomy under general anesthesia.

Background: The QLB is an effective analgesic technique for various abdominal wall incisions. The QLB covers T7 to L2 dermatomes by the spread of LA drugs either into the paravertebral space or in the thoracolumbar plane, through iliohypogastric and ilioinguinal nerves, A and C fiber nociceptors, mechanoreceptors and high-density network of lumbar sympathetic fibers.

Objective: To assess the analgesic sparing effect of adding Dexamethasone to Bupivacaine in Quadratus lumborum block in patients undergoing Laparoscopic cholecystectomy under general anesthesia.

Patients and Methods: Sixty patients scheduled for elective Laparoscopic cholecystectomy surgeries under general anesthesia were included in this study, they were divided into two groups. Group A (perineural dexamethasone and bupivacaine group) \[n=30\] Those cases will receive 2ml volume of dexamethasone (8mg) combined with 18 ml of bupivacaine of 0.25% concentration. Group B (perineural bupivacaine group) \[n=30\] Those cases will receive perineural 18 ml bupivacaine (0.25%) combined with 2 ml normal saline.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients aging \> 18 years of both sexes.
2. Patients undergoing Laparoscopic cholecystectomy surgeries (duration of operation 50-80 minutes).
3. ASA physical status classes I - II.

Exclusion Criteria:

1. Patient's refusal of procedure or participation in the study.
2. ASA classes III or above.
3. Coagulopathy and bleeding disorders.
4. Local skin infections
5. Body mass index \>40kg/m2
Understanding the Psychological Benefits and Neurophysiological Mechanisms of Qigong in Older Adults

One goal of the study is to evaluate the efficacy of qigong to alleviate depressive symptoms and enhance cognitive function in comparison to mindfulness-based intervention, physical exercise, and waitlist control. The other goal is to explore the changes in neurobiological markers that may explain the qigong-related effects on depressive symptoms and cognitive function. The main research questions are:

* Is the 12-week qigong training more effective than mindfulness-based intervention, physical exercise, and waitlist control to alleviate depressive symptoms?
* Is the 12-week qigong training more effective than mindfulness-based intervention, physical exercise, and waitlist control to enhance cognitive function?

Participants are older adults aged 60 or above. They were randomly assigned to qigong training, mindfulness training, physical exercise training, or wait-list which all last for 12 weeks. Their changes before and after the 12-week period in depressive symptoms, neurobiological markers, and cognitive functions are assessed.


Eligibility Criteria:
Inclusion Criteria:

* 60 years or older;
* With mild or severer levels of depressive symptoms as indicated by the Geriatric Depression Scale (GDS-8) scores of 5 or above, or Depression Anxiety and Stress Scale-21 (DASS-21) depression subscale scores of 4 or above
* Self-identified as physically stable and without life-threatening diseases.
* Be able to communicate in Cantonese or Mandarin.

Exclusion Criteria:

* Have a history of practicing or receiving training of any form of mind-body or regular exercises (including tai chi, yoga, and qigong, or regular physical activity \> 3 times/week) during the month prior to intervention
* Have changed medications or the dose of medications prescribed for their health condition in the one month prior to study enrollment
* Have severe cognitive or language impairment based on the assessment with Montreal Cognitive Assessment (MoCA)
* Taking medication or undergoing electroconvulsive therapy, psychotherapy, or psychoeducation for a psychological or psychiatric condition
* Unable to demonstrate satisfactory standing balance
CommunityRx-Hunger

CommunityRx-Hunger (CRx-H) is a hospital-based intervention that addresses food insecurity and other health-related social needs such as transportation, housing, utilities, and safety. Study team members are recruiting caregivers at the time of their child's hospital admission at a large urban children's hospital. For Aim 1, the primary outcome is self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. For Aim 2, the primary outcome is satisfaction with care compared between food secure and food insecure caregivers.

CommunityRx-Hunger (CRx-H) is a double-blinded randomized controlled trial aimed at increasing self-efficacy among caregivers with food insecurity in the household. CRx-H is recruiting primary caregivers of hospitalized children at a large urban children's hospital at the time of admission. Aim 1: Researchers are studying whether the intervention will increase self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. Aim 2: Researchers will enroll and randomize caregivers with and without food insecurity to the intervention to compare satisfaction with care.

Eligible, self-identified caregivers will complete a baseline survey during the child's hospital stay, followed by phone surveys at 7, 30, 90, 180 days, and 12 months. Caregivers randomized to the intervention will receive a tailored list of resources to address food insecurity and other health-related social needs, plus a brief educational component delivered by a trained member of our research team. Cases will receive a "booster" dose of the resource list prior to discharge. After discharge, cases will receive proactive text messages about those same community resources.

All caregivers (regardless of research arm) will receive a series of text messages related to the study such as reminders to schedule the phone survey with a member of the research team.

Eligibility Criteria:
Inclusion Criteria:

* Native English or Spanish speaker
* Living in 1 of 27 zip codes in the study's target region
* Self-identify as a primary caregiver of a child \<18 years old hospitalized in a large urban children's hospital
* Ability to send and receive text messages
* Access to a mobile phone and agrees to receive text messages from the study

Exclusion Criteria:

* Previous participation in a CRx research study.
* Caregivers of newborns in the hospital
* Patient hospital stay is less than 24 hours
* Patient hospital stay is 30 days or more
* Patient has an eating disorder as indicated in the EMR
Safety and Preliminary Efficacy Study of V404 PDS in Uveitis

This study is intended to evaluate the safety of V404 PDS in patients with chronic non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide clinically measurable benefit over an extended period of time in patients with chronic non-infectious uveitis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Confirmed diagnosis of active uveitis
* Sufficient lens/media clarity
* Meet best-corrected visual acuity criteria
* Willing and able to use contraception

Exclusion Criteria:

* Pregnant, breast feeding
* Uncontrolled glaucoma
* Intraocular surgery or periocular/intraocular injections within 6 weeks
* Periocular or intraocular steroid within 3 months
* Prior vitrectomy
* Prior corneal transplant
* Prior fluocinolone implant
* Allergy or sensitivity to study drug
* Participation in other trial within 30 days
* Abnormal liver function
* History of positive serum tuberculosis test
Sarcopenia in Chronic Lung Diseases

Inclusion criteria A)Outpatients with COPD (chronic obstructive pulmonary disease) or ILD (interstitial lung disease) from department of Chest medicine in Taichung Veterans General Hospital, judged by the doctor that they do not need hospitalization or emergent treatment.

B) Patients who agree to provide the ID card number to the research team for usage as a link to the National Health Insurance research database and Health bank to explore the continuity of care and the use of medical resources

This study is a prospective, multi-center, and non-invasive cohort study. All participants are diagnosed with Asthma, COPD and ILD. We use SARC-Calf questionnaire, Frailty questionnaire and Grip strength as a tool for prescreen. According to the 2019 Asian Sarcopenia Consensus, participants are examined by SARC-Calf questionnaire, grip strength test and a physical performance test, including sit-stand test, short physical performance battery (SPPB), gait speed test and six-minute walk test. Bioelectrical impedance analysis (BIA) and Dual-energy X-ray absorptiometry (DXA) are applied to all participants by to analyze body composition. Participants are further classified into no Sarcopenia group, Sarcopenia group, and severe Sarcopenia group to derive the prevalence.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatients with COPD (chronic obstructive pulmonary disease) or ILD (interstitial lung disease) from department of Chest medicine in Taichung Veterans General Hospital, judged by the doctor that they do not need hospitalization or emergent treatment.
2. Those who meet the conditions for frailty diagnosis after assessment by the Frailty Scale
3. Patients who agree to provide the ID card number to the research team for usage as a link to the National Health Insurance research database and Health bank to explore the continuity of care and the use of medical resources
4. Age\>=20

Exclusion Criteria:

1. Patients who refuse to sign the consent form
2. Patients who are bed ridden or unable to walk due to physical disabilities
3. Patients with terminal cancer or human acquired immunodeficiency syndrome
4. Patients with edema (pitting edema +2)
CAREgiver Study for Patients Undergoing HSCT

The investigators will use a single arm design and deliver a new supportive intervention entitled, "Ready to Connect, Actively Relax and Exercise (CARE)." The purpose of the study is to describe the feasibility, acceptability, and potential effectiveness of the Ready to CARE intervention. Effectiveness outcomes include caregiver self-efficacy, distress, and coping style, and patient quality of life, symptom burden, and healthcare utilization.

During the first phase of this study, the investigators enrolled caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT) into a descriptive study. The investigators used quantitative and qualitative measures to describe the caregivers self-efficacy, distress, and coping style, and solicit their opinions about how to improve our supportive care for caregivers.

Informed by those data, the investigators now will study the effectiveness of the supportive intervention.

The long-term goal of this research is to develop a pragmatic, replicable intervention that supports caregivers and promotes the health and well-being of the caregiver-HSCT patient dyad.

Eligibility Criteria:
Inclusion Criteria:

* Providing informal, unpaid care for a person who is 18 years of age or older and is scheduled to receive an allogeneic or autologous HSCT within the next three months.
* The caregiver's loved one ("patient") undergoing the transplant will be asked to enroll in the study to provide data regarding quality of life and symptom burden and to allow access of the medical record to ascertain healthcare utilization data. (Caregivers will not be excluded from the study if the patient declines to enroll.)

Exclusion Criteria:

* Under the age of 18 for either caregiver or patient.
Post-Vaccination Biological Collection

Introduction: Vaccination is a powerful weapon in the fight against infectious diseases, which has led to dramatic reduction in mortality and complications from some diseases. In this respect, vaccination is a real worldwide public health challenge (WHO). Thus, vaccine research benefits from an exponential development of knowledge in immunology and biotechnology. In particular, the advent of recent tools ("omics", new cytometric assays) and the description of new categories of immune cells (Tfh, BReg...) have revolutionized the characterization of immune responses, particularly post-vaccination. To study of the immune response following vaccination remains essential in order to define the immunological correlates to vaccine protection. This response also varies according to parameters related to the vaccine (type, adjuvant, dose, regimen...) and to the vaccinated host (genetics, age, morbidity, treatment ...). Analyzing with new generation immune assays, new data on immunological responses post-vaccination from a clinical cohort is therefore essential to better define these correlates.

Objective: To develop new vaccines (HIV, emerging infectious diseases) the investigators use a "System vaccinology" method to decipher the mechanisms of immune responses set up against vaccines currently being developed or marketed, specifically in specific populations (patients with primary immune deficiency, sickle cell patients, solid organ transplanted patients, COPD).

Method: Description of the genetic, molecular and cellular mechanisms of the immune response to vaccines recommended for adults, in particular influenza and pneumococcal vaccines, but also other mandatory vaccines (MMR,...) or vaccine for travelers (yellow fever, ...) as part of routine care in different population categories (healthy subjects, HIV+ subjects, COPD patients, ...), using qualitative and quantitative immunological assays: transcriptional analysis of the dynamic innate immune response, analysis of the lymphocytes B \& T responses (phenotype, repertoire analysis, functional analysis including T reg and TFH populations, antibody response), genetic analysis in the context of primary immune deficiencies) Conclusion: The data generated will allow the best possible analysis of vaccine responses according to vaccines and vaccinated populations, providing important information for the research developed within the department.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Informed and consented
* Need to be vaccinated for routine care

Exclusion Criteria:

* Person under guardianship or safeguards
* Pregnant or breastfeeding woman
* No affiliation to a health insurance scheme