cyrilzakka/clinical-trials huggingface dataset:
Phase 2 Study of KHK4577

This study is an randomized double-blind placebo-controlled study to evaluate the efficacy and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis. Pharmacokinetics of KHK4577 will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Subject has signed voluntarily the written informed consent form to participate in this study.
* Subject has been diagnosed as atopic dermatitis according to Guidelines for Management of Atopic Dermatitis (2009).
* Rajka \& Langeland criteria of \>/= 4.5 at screening visit
* Investigator's Global Assessment (IGA) score of \>/= 3 at screening visit

Exclusion Criteria:

* Evidence of skin disorders/conditions that would interfere with the assessment of the effect of the study drug.
* Subject received photochemotherapy or systemic immunosuppressants within 2 weeks prior to informed consent.
* Subject has any active infectious disease(except localized infection) which needs to treat with systemic antibiotics(eg. antibacterial, antifungal or antiviral drugs) within 4 weeks prior to informed consent.
* Subject has complications / history of drug abuse or alcoholism.
* Subject has drug allergy or history of allergic reaction to a drug medicine.
* Subject has a significant concurrent medical conditions as defined in the study protocol.
* Subject is breast-feeding, pregnant or planning to become pregnant in this study period.
Does the Presence of Preoperative Proteinuria Predict Postoperative Acute Kidney Injury in Obese Patients Undergoing Elective Laparoscopic Surgery?

Acute kidney injury (AKI) is a common, but significant complication after elective surgery which is associated with an increased risk of mortality, major adverse cardiac events, prolonged length of hospital stay, and increased cost per episode of care.

Acute kidney injury (AKI) is a common, but significant complication after elective surgery which is associated with an increased risk of mortality, major adverse cardiac events, prolonged length of hospital stay, and increased cost per episode of care. Obese patients are at increased risk of postoperative AKI when compared to normal weight patients; however current methods to assess preoperative renal function in this patient population (such as measurement of serum creatinine and calculation of the estimated glomerular filtration rate) have previously been demonstrated to overestimate their true renal function. , Preoperative proteinuria has previously been determined to be predictive of the development of postoperative AKI in patients of all weights undergoing cardiac surgery. Published reports on the prevalence of proteinuria in obese patients span a wide range: from 8- 43%. The investigators aim to determine the predictive value of preoperative proteinuria on the development of postoperative AKI in patients presenting for elective laparoscopic bariatric surgery at NYULMC. The investigators hypothesize that preoperative proteinuria will be associated with an increased incidence of AKI within 48 hours after elective laparoscopic bariatric surgery. Furthermore, since there is a wide range of reported prevalence of proteinuria in the bariatric patient population, part of the value of the study will be to provide a more definitive assessment of the prevalence of proteinuria in this surgical population.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Subjects undergoing elective laparoscopic bariatric surgery at NYULMC, including gastric banding, sleeve gastrectomy, and Roux -en-Y gastric bypass
* Surgery scheduled at least one day after Pre Admission Testing visit

Exclusion Criteria:

* Pre-existing end stage renal disease (CrCl \<30ml/min and/or need for hemodialysis)
* Medical history of systemic disease known to cause proteinuria: monoclonal gammopathy, multiple myeloma, primary amyloidosis, diabetic nephropathy, acute myeloblastic leukemia, myoglobinuria, free hemoglobinuria (i.e intravascular hemolysis)
* Known pregnancy
* Diagnosis of AKI within 6 months of surgery
* Diagnosis of cognitive dysfunction (i.e. mental retardation/developmental delay, dementia, delirium)
* Any subject who the study team feels would be unable to comply with all protocol procedures.
Evaluation of CD47, "Do Not Eat Me" Signal Expression in Chronic Myeloid Leukemia

Chronic myeloid leukemia is a myeloid neoplasm characterized by the overproduction of mature granulocytes . Cluster of differentiation 47 (CD47) is a membrane protein, which is over-expressed by virtually all cancers and regulates many signaling systems associated with tumor growth and invasion. Following CD47 binding to the inhibitory receptor (signal regulatory protein, SIRPα) on macrophages, the CD47-receptor complex sends a "do not eat me" anti-phagocytic signal to prevent phagocytosis . This balance is tipped by cancer cells, which adopt the "self" signal and upregulate CD47 expression to evade immune surveillance and subsequent destruction. Elevated expression of CD47 has been observed in ovarian carcinoma cell lines , murine myeloid leukemias , leukemic stem cells and several solid tumors .

Flow cytometry revealed high surface expression of CD47 on 73% of samples collected from the bone marrow of multiple myeloma (MM) patients .

High CD47 expression on six different primary effusion lymphoma (PEL) cell lines compared to peripheral blood mononuclear cells (PBMC) was found . Additionally, in acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and several non-Hodgkin's lymphoma (NHL) subtypes, increased CD47 expression is correlated with adverse clinical outcomes .

Hematological malignancies, even at onset, present with widespread bone marrow and peripheral blood involvement and many are still without effective systemic curative therapies . Most CML patients have deep and durable responses when treated with BCR::ABL1 tyrosine kinase inhibitors, which might be influenced by long-term toxicities during the treatment .

CD47 "don't eat me signal" expression not evaluated in CML. the aim of the study To detect CD47 expression by flow cytometry in CML patients. To study the correlation between BCR::ABL1 gene and CD47 expression in CML patients . Evaluation of the role CD47 as predictor of CML patient outcome


Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years
* both sex
* CML patients, who fulfill the WHO 2022 criteria

Exclusion Criteria:

* Patients with other haematological neoplasms (ALL,CLL, plasma cell myeloma)
Knowledge of Cardiovascular Risk Factors in Chronic Kidney Disease Patients

The aim of this study is to assess knowledge of cardiovascular risk factors, physical activity levels, health literacy and perceptions of benefits and barriers to exercise in patients with chronic kidney disease and compare them with healthy people.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic kidney disease
* Being aged 18-65
* Voluntary participation in the study

Exclusion Criteria:

* Having cognitive problems
* Being illiterate
Inflammation and Coagulation Factors for Predicting Cerebral Edema After SAH

Explore the role of Inflammation and coagulation factors in cerebrospinal fluid for predicting persistent cerebral edema after subarachnoid hemorrhage


Eligibility Criteria:
Inclusion Criteria:

* Subarachnoid hemorrhage patients admitted to our neurosurgery department with modified Fisher Scale 3-4, with a confirmed radiographic diagnosis.

Exclusion Criteria:

* Angiogram-negative patients, patients with a history of trauma or previous brain injury (stroke, hemorrhage, surgery et al. which left associated chronic changes on CT), arteriovenous malformation, radiological data lost, accompany with serious comorbidities before subarachnoid hemorrhage onset (such as coagulation defects, uncontrollable hypertension, and arrhythmia et.al.), initial radiological data performed more than 3 days after SAH onset
Patient Compliance to Self-collection for Detection of HPV-DNA

A study to investigate the compliance of unassisted women to self-collection of specimens for Hybrid Capture (HC) for detection of Human Papilloma Virus (HPV) DNA compared to Pap smear collection by medical personnel, as screening method to identify precursor lesions of cervical cancer.

Women living in the community of the Morro dos Macacos, Vila Isabel, Rio de Janeiro, were randomly allocated for self-collection of specimens for HC II for detection of HPV-DNA or to Pap smear collection by medical personnel, as screening method to identify precursor lesions of cervical cancer.

The compliance was measured by the delivery of the specimen obtained by self-collection or to attend to a visit at the community health center to be submitted to Pap smear collection, within a week.

Eligibility Criteria:
Inclusion Criteria:

* Women between 25-59 years-old
* Not pregnant
* Had held their last Pap smear for over a year
* Could read.

Exclusion Criteria:

* Women with previous hysterectomy
* History of cervical cancer or its precursors
* Bearers of some state of chronic immunosuppression (such as HIV ou autoimmune diseases)
* Those who underwent self-collection of their specimen during menstrual period
Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer

There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.

Gastric cancer is one of the most common cancers in Vietnam . Despite recent advances in multimodality treatment and targeted therapy, surgery remains the first option of treament for this disease. For resectable gastric cancer, complete removal of macroscopic and microscopic lesions and/or combined resections and also regional or extended lymphadenectomy should represent worldwide now.

Laparoscopic gastrectomy for locally advanced gastric cancer AGC have commonly used for treatment of AGC, especially in Japan, Korea and China. However, the real role of laparoscop for treament of (AGC) is still controversial in term of technical feasibility, safety and oncologic aspect for T4a stage.

Paragastric inflammatory strands may occur in T4a tumor so that laparoscopic technique is difficult to radically perform. Peritoneal seeding of malignant cells, intra- and postoperative complications, trocarts metastasis may risk during procedures. Despite, some studies have demonstrated the safety and the short-term benefits of LG for T4a gastric cancer, the number of these studies and sample sizes have been still inadequate to give good evidence for applying it. and long-term oncologic outcomes There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.

Eligibility Criteria:
Inclusion Criteria:

* patients with histologically confirmed adenocarcinoma of the stomach, surgical staging of sT4aN0-3M0 according to the 7th edition of the American Joint Committee on Cancer/Union Internationale Contre le Cancer (AJCC/UICC) staging system

Exclusion Criteria:

* intraoperatively detected bulky lymph nodes
* inadequate lymphadenectomy (D0, D1, D1+)
* macroscopic residual tumor (R2)
* an American Society of Anaesthesiology (ASA) score of \> IV
* concurrent cancer or history of previous other cancers
* previous gastrectomy
* neoadjuvant chemotherapy
* complications such as bleeding or perforation required emergency gastrectomy.
Relaxation Response Training for PTSD Prevention in US Military Personnel

The purposes of this study are to evaluate the acceptability and utility of a mind-body intervention on a convenience sample of Soldiers (n=120) who have screened positive through RESPECT-MIL for symptoms that may lead to post-traumatic stress and to test the effectiveness of this Relaxation Response (RR) intervention designed to decrease the physiological and psychosocial effects of stress and trauma. The study aims to enhance the psychological health of Soldiers with a RR intervention designed to promote self-awareness of physiological responses to stress and the ability to increase relaxation responses.

Specific Aims:

1. Demonstrate that trainers can be trained effectively to deliver the intervention, a mind-body skills training program based on the Benson-Henry Institute's standard RR training curriculum and tailored to a military population.
2. Evaluate feasibility, acceptability, and compliance to the training program in an active duty military population.
3. Compare outcomes on sleep disturbance, PTSD, stress-related symptoms, quality of life, and psychosocial variables related to resilience of Soldiers who receive the 6-week training program to promote the Relaxation Response to those Soldiers who do not receive the intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, male and female volunteer individual military Service Members, DoD civilians or approved contractors working for DoD, primarily from multidisciplinary healthcare providers.
* Willingness to participate in the research project.
* Committed to the entire period of time of the research project.
* Currently working or stationed at Ft Bliss, Texas.
* No impending orders for deployment/ TDY/ PCS/ ETS or retirement for at least 8 weeks from the day of study enrollment.
* Able to read and speak English.
* Capable to consent.

Exclusion Criteria:

• Diagnosed with severe PTSD or other mental health issues disclosed as self-reported
A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)

The purpose of this study is to determine if the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).


Eligibility Criteria:
Key Inclusion Criteria:

* Informed consent and assent (as applicable for participants less than or equal to (\<=) 18 years per Institutional Review Board/Ethics Committee (IRB)/Ethics Committee (EC) as appropriate.
* Male or female participants between the ages of 12 months and 18 years inclusive (primary cohort) or birth to 18 years inclusive (exploratory cohort) at time of consent, with a body weight greater than or equal to (\>=) 5 kilogram (kg).
* Cholestasis as manifested by total sBA greater than (\>) 3\*upper limit of normal (ULN)
* An average AM ItchRO(Obs) score \>= 1.5 during the 4 weeks leading to the baseline visit
* Diagnosis of PFIC based on:

  a. Primary cohort: i. Participants with 2 documented mutant alleles in ABCB11 (PFIC2); participants without bile salt export pump (BSEP) function (biallelic truncating mutations in ABCB11) will not be enrolled into the primary cohort. b. Exploratory cohort: i. Participants with PFIC1/3/4 or PFIC2 with biallelic truncating mutationsiii.Infants from birth to \<12 months of age with PFIC ii. Participants with PFIC after internal or external (eg, PEBD) biliary diversion surgery with unsatisfactory pruritus control or where biliary diversion was reversed.

Key Exclusion Criteria:

* Chronic diarrhea requiring intravenous fluid or nutritional intervention for the diarrhea and/or its sequelae.
* History of surgical disruption of the enterohepatic circulation (applies to primary cohort only).
* Liver transplant
* Decompensated cirrhosis (international normalized ratio \[INR\] \>1.5, albumin \<30 gram per liter \[g/L\], history or presence of clinically significant ascites, variceal hemorrhage, and/or encephalopathy).
* ALT \>15\*ULN at screening.
* History or presence of other liver disease.
* History or presence of any other disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs, including bile salt metabolism in the intestine (example \[eg\], inflammatory bowel disease), per investigator discretion.
* Liver mass on imaging
* Known diagnosis of human immunodeficiency virus (HIV) infection.
* Any prior cancer diagnosis except for in situ carcinoma or cancers treated within 5 years of the screening visit (Visit 0) with no evidence of recurrence.
Avoiding Low-value Treatments in Older Women With Early-stage Breast Cancer: Piloting a Patient Decision Aid

The aim of this study is to learn whether participants find a patient guide to breast cancer treatment decisions acceptable and appropriate for use.

This study seeks to adapt and pilot test de-implementation strategies targeting low-value breast cancer treatments which have persisted despite national recommendations. Breast cancer is an ideal setting in which to study de-implementation given it is common, well-studied, typically presents at an early-stage, and care is provided primarily in a community setting.

Eligibility Criteria:
Inclusion Criteria

* Early stage breast cancer that is hormone receptor positive (HR+) and human epidermal growth factor negative (HER2-)
* Meet criteria for omission of sentinel lymph node biopsy (SLNB)
* Receiving care at Michigan Medicine

Exclusion Criteria

* Non-English speaking
* Male patients (current data does not support omission of SLNB in men)
Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI

This trial looks to study the safety and feasibility of using oxygen-enhanced molecular MRI to understand how cancer cells use oxygen differently than normal cells. Cancer cells tend to utilize (or not utilize) oxygen differently than normal cells. By using the oxygen-enhanced molecular MRI, researchers will be able to create spatial "maps" depicting areas of abnormal oxygen utilization unique to cancer. This type of information may be useful for diagnosing new cancers, understanding various "subtypes" of cancer that might utilize oxygen differently, or this information may be useful for evaluating new drugs that impact cancer metabolism.

PRIMARY OBJECTIVES:

I. Determine the safety, feasibility, and sensitivity of oxygen-enhanced molecular magnetic resonance imaging (MRI) in healthy volunteers.

II. Measure oxygen-enhanced molecular MRI characteristics in human brain tumors.

OUTLINE:

Participants undergo arterial spin labeling (ASL) MRI scan and amine chemical exchange saturation transfer spin-and-gradient echo echo-planar imaging using amine proton CEST echo spin-and-gradient echo (SAGE) EPI (CEST-SAGE-EPI) while breathing normal room air (21% oxygen). Patients then undergo another ASL MRI and CEST-SAGE-EPI while breathing medical grade air (100% oxygen). Total ASL MRI and CEST-SAGE-EPI imaging scan time is 60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers will include persons who at the time of scans do not present with known neurological conditions that might impact tissue imaging results
* Patient participants should have suspected or pathology-confirmed diagnosis of a brain tumor (any histological subtype including brain metastases)
* All participants must be able to obtain an MRI scan and must be able to safely breathe high concentrations of oxygen

Exclusion Criteria:

* Participants with contraindications to MRI including metal implants
* Participants who are deemed not able to or not safe to breath high concentrations of oxygen
Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery

The purpose of this study is to compare the impact of treatment with cooled magnesium sulfate and cold water-soaked pads on perineal pain and swelling following vaginal delivery.

Assessment of appropriateness for each patient to take part in the study will be performed approximately 2 hours following delivery. Those patients who consent to participate in the trial will be allocated to treatment groups in a double-blinded, randomized manner. Women in the study group will receive treatment with pads soaked in a cold aqueous solution of magnesium sulfate at 33% (w/v) concentration, while those in the control group will receive treatment with pads soaked in cold water.

Nurses will initiate treatment according to the group to which the patient was randomized. Said pads will be given the patients routinely 5 times a day at regular times.

A physician will assess the perineal swelling according to visual (photographed) scale in which severe, moderate, light and no swelling will be defined. Measurement of swelling in centimeters (maximal length and breadth); photography, by a medical photographer or the examining doctor, of the perineal area with a centimeter ruler, before, during and after treatment (photography is dependent on patient approval and is not a precondition to participation in the trial.); and additional examination, on the above basis, will be performed regarding hemorrhoids in the event that a patient has complained of such.

A nurse will assess the perineal pain and swelling on a scale ranging from 0 to 10 prior to the patient being given the pad and an hour following treatment. An additional assessment by the same method will be performed regarding hemorrhoid pain. Any analgesia administered will also be recorded.

Likewise, for follow-up purposes a blood test for serum magnesium concentration will be taken before and after treatment.

Period of follow-up will be 48-72 hours from childbirth.


Eligibility Criteria:
Inclusion Criteria:

* parturients following normal vaginal birth or vacuum-assisted vaginal delivery
* reporting of perineal pain equal to or greater than 3 on a 0-10 scale

Exclusion Criteria:

* parturients following cesarean section
* lack of consent to take part in the study
* parturients interested in early discharge (within 48 hours of childbirth)
* girls under 18 years of age
Frequency of Palpebral Involvement in Adult With Atopic Dermatitis

Atopic dermatitis is a common inflammatory skin disease, resulting from genetical, immunological and environmental factors. Head and neck are among the most frequent involved areas, almost 50% in adult patients according to most publications. Palpebral involvement is also common and a source of major quality of life impairment for patients.

However, the real frequency of this palpebral involvement is unknown, only estimated about 20% in few studies. The treatment of this location remains difficult, regarding to the thickness of palpebral skin and proximity of the eye.

To our knowledge, no prospective studies about allergological skin tests (such as patch-tests) in atopic patients with palpebral involvement had been conducted.

Finally, atopic dermatitis is frequently associated with ophthalmological diseases such as conjunctivitis, keratoconus or cataract, which belong to the minor criteria of Hanifin and Rakja classification.

A better knowledge of the atopic dermatitis palpebral involvement and the associated factors seems to be needed to improve the treatment and the quality of life of patients


Eligibility Criteria:
Inclusion Criteria:

* Atopic Dermatitis according to the revised Hanifin and Rakja criteria (UK Working Party)
* Oral consent
* Valid social insurance

Exclusion Criteria:

* Personal history of uncontrolled asthma
* No social insurance
* Protective measures
* Age under 18
* Pregnancy or breast-feeding