cyrilzakka/clinical-trials huggingface dataset:
Single Dose Escalation Study of ONO-9054 in Healthy Volunteers

The primary objective of this study is to evaluate the safety and tolerability of ascending single doses of ONO-9054 administered as a single drop in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to evaluate the pharmacodynamic (PD) profile.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects, aged 18-64 inclusive
* Body mass index (BMI) of 19-35 kg/m2 (inclusive)
* IOP measurement oculus uterque (OU, both eyes) \< 21 mm Hg (inclusive) at screening and Day -1
* Best corrected visual acuity (BCVA) 20/30 or better (Snellen Equivalent) at both the screening visit and Day -1

Exclusion Criteria:

* Any history of severe ocular trauma in either eye at any time
* Any history of previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of the screening visit in either eye
* Current or chronic history of ocular infection within the past 3 months of screening visit in either eye OR ongoing or recurrent ocular inflammation in either eye
* At the ophthalmic investigator's discretion, any subjects who have a history of any significant ocular conditions in either eye that would contraindicate the use of the study medication, or that might affect the study conduct, or the interpretation of the study results
* Use of any non-diagnostic topical ophthalmic solutions except for sponsor-recommended tear substitutes from admission to the study unit through the duration of the study
* History of clinically significant drug or food allergy, positive HIV, hepatitis B or C at screening
Alterations in Intestinal Microbiota, Metabolites, and Immune Cells in Allo-HSCT

This research project delves into the critical role of gut immunity in the occurrence and progression of acute graft-versus-host disease (aGVHD) post allogeneic hematopoietic stem cell transplantation (allo-HSCT). Addressing the current gaps in understanding the involvement of intestinal microbiota, metabolites, and cellular metabolism in clinical aGVHD, the study involves comprehensive analyses on 200 allo-HSCT patients and 50 healthy volunteers. By scrutinizing changes in gut microbiota, metabolites, and immune cell metabolism, the research aims to shed light on their roles in allo-HSCT and their correlation with post-transplant complications. The findings are poised to offer crucial insights for diagnosing and prognosticating complications following transplantation.

The intestinal immune system plays a pivotal role in the onset, progression, and evolution of acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the precise contributions and mechanisms underlying the involvement of intestinal microbiota, metabolites, and cellular metabolism in immune regulation during clinical aGVHD remain unclear.

This research initiative aims to collect peripheral blood, fecal, and urine samples from 200 patients before and after transplantation as well as 50 healthy volunteers. Comprehensive analyses, including metagenomics, 16S rRNA sequencing, transcriptomics, metabolomics, single-cell sequencing, as well as assessments of immune cell function and inflammatory cytokines, will be conducted. Additionally, longitudinal follow-up observations will be performed to monitor post-transplant complications, relapse and immune reconstitution.

By investigating the dynamics of gut microbiota, metabolites, and cellular metabolism and analyzing their correlation with changes in immune responses, this study seeks to elucidate the roles of intestinal microbiota, metabolites, and immune cell metabolism in the context of allo-HSCT. The findings are anticipated to provide insights into the correlation between these factors and outcomes of allo-HSCT patients, contributing valuable evidence for the diagnosis and prognosis assessment of complications following transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic disorders undergoing allo-HSCT.

Exclusion Criteria:

* Patients with confirmed pathogenic intestinal infections and severe systemic infections at the time of sampling.
* Diagnosis of autoimmune diseases, metabolic disorders, and chronic gastrointestinal diseases.
* Pre-transplant diseases not in complete remission.
* Post-transplant hematopoietic engraftment failure or pre-engraftment mortality.
Improvements in Pneumonia Status After Oral Care Intervention in Taiwan

The correlation between improvement in oral health, reduction in oral bacterial concentration, and status of pneumonia hospitalization remains unclear. To determine the effects of professional oral care intervention on the index of oral health, salivary and sputum bacterial concentrations, and pneumonia hospitalization status of nursing home residents using a quasi-experimental study. Two nursing homes were on demand selected as the intervention and control groups; in the intervention group, weekly professional oral care was administered in addition to regular oral care by trained dental hygienists. Demographic data and oral health status were analyzed. Total salivary and sputum bacterial concentrations were determined using real-time polymerase chain reaction.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* 51 year-old and above
* Being bedridden for ≥ 6 months
* Positive sputum production
* Difficulty in swallowing reported by caregivers

Exclusion Criteria:

* Below 51 year-old
* Patients or family refused any oral care
Smoking Cessation Treatment With Transdermal Nicotine Replacement Therapy - 1

The purpose of this study is to look at how feasible it is to incorporate a state-of-the-art smoking cessation treatment program into community substance abuse treatment programs and its impact on substance abuse and cigarette smoking.


Eligibility Criteria:
Inclusion Criteria:

* Patient is alcohol or drug dependent, in Outpatient Drug-Free or Opiate Substitute program and is interested in quitting smoking

Exclusion Criteria:

* Patient is psychotic
* Use of smokeless tobacco
* Use of other smoking cessasation product
* Pregnancy
* Patient has hyper-tension, heart problems, or skin condition
fMRI and Ghlrein in Obesity and Binge Eating Disorder

Binge Eating Disorder (BED) may be associated with he development of obesity. However, the pathogenesis of BED is currently unclear, thus making the development of treatment and prevention strategies for BED difficult. Differences in the mechanisms regulating food intake may go some way to reveal potential mechanisms for BED.The purpose of this study is to investigate the responses of key gut-derived hormones that are associated with the regulation of food intake and functional brain activity to food cues using fMRI in BED patients and weight matched controls.

Participants will attend the laboratory on two separate occasions following an overnight fast. Following baseline measures they will be provided wither with a 600mL (600kcal) liquid meal (Fed condition) or a volume matched amount of plain water (Fasted condition) to consume within 15 min in a randomized crossover design. Blood samples will be collected for during the subsequent 120min to measure the glucose, insulin and gut hormone responses, and subjective appetite ratings will be collected. 1500mg of acetaminophen will be added to each of the test drinks so that the appearance in the blood can be used as a proxy measure of gastric emptying. Participants will then undergo a 45min brain scan to assess the responses to visual and auditory food cues.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* BMI 30-50 kg/m2
* Weight stable (\<5% change in body weight during past 3 months)
* Right handed

Exclusion Criteria:

* Smokers
* Regular use of medications
* Current or intended participation in a weight-loss program (diet or exercise)
* Females who are pregnant or lactating
Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery

The goal of this is to improve durability of total joint replacements in patients, thereby improving clinical outcomes and implant performance. To reach this objective, our research program would like to assess the safety, efficacy, performance, and durability of FDA approved biomaterial and implant designs used in joint replacements.

The objective of the investigation will be to determine the mechanism of material failure and identify any design features that put the implant at risk for early failure. Normally all implants are discarded. The investigators will collect the implants indicated for removal and if there are impressive findings the investigators will perform research on the implants, otherwise the implants will be discarded. All patients will be followed prospectively after informed consent is signed. The implants that are chosen for research will be assessed for implant wear and failure at a lab appropriate for evaluating the particular concern.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will be undergoing revision total joint surgery will be asked to participate in this study.

Exclusion Criteria:

* Patients who are not undergoing revision total joint surgery.
Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma

This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of malignant melanoma in advanced stage or recurrent after surgery, and not amenable to further surgery or local therapy.
* Presence of measurable disease
* Age \> or = 18 years and \< or = 75 years
* Performance status (ECOG) 0 - 2 (Appendix 2)
* Life expectancy ³ 3 months
* Adequate bone marrow function (ANC ³ 2,000/mmc; PTL ³ 100,000/mmc; Hb ³ 10 gr/dl), normal liver and renal function (bilirubin \< 1.25 x N, creatinine \< 1.25 x N, SGOT, SGPT \< 3 times upper normal limit of testing laboratory.
* Written, informed consent prior to study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
* Prior surgery \> 3 weeks from initiating .
* If palliative radiation is needed, in case of non target lesions, it must be given prior to initiating chemotherapy. If palliative radiation is required during the study the patient should be permanently discontinued from further treatment.
* Adequate contraceptive measures during study participation for sexually active patients of child bearing potential must implement.

Exclusion Criteria:

* Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.
* Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed)
* Known HIV disease.
* Concurrent treatment with other experimental drugs.
* Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy
* Pregnant or lactating females Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.

Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed) Known HIV disease. Concurrent treatment with other experimental drugs. Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy
The Status of Helicobacter Pylori Infection Among Children Visiting Assiut Children Hospital

The aim of this study is to estimate the prevalence of Helicobacter pylori infection among Egyptian children attending to healthcare facilitates using different diagnostic tools.

The prevalence of H. pylori infection, which has a ubiquitous distribution, varies depending on socioeco- nomic factors and age. in the context of a decreased trend in H. pylori prevalence, at least 50% of the world's hu-man population are carriers of the microorganism, with a prevalence much higher in developing countries than in developed countries. H. pylori infection was evaluated in 286 Egyptian school children, and the overall prevalence was \> 72%. Acquisition of the infection occurs mostly in early childhood; therefore, a better understanding of the epidemiology and the risk factors associated with H. pylori infection in the pediatric population is important to clarify the natural history and complications of the infection and programming eradication strategies.

Currently, little data exist regarding the epidemiology of H. pylori associated infection in our region., especially in children. Therefore, this study aims to determine the prevalence of H. pylori among children.

Eligibility Criteria:
Inclusion Criteria:

* All children (\<18 years) attending healthcare facilities for any reason will be enrolled after informed consent of their parents to participate in the study.

Participants will be recruited from the following sources:

1. Children with non-GI symptoms (ophthalmology, ear, nose, and throat , chest departments .. etc)
2. Children with GI symptoms undergoing upper GI endoscopy (from GI endoscopy units).

Simple questionnaire will be used to collect demographic data, socioeconomic status, dietary habits, and gastrointestinal complaints from parents of all participants before testing for Helicobacter pylori.

Exclusion Criteria:

1. Patients refusing to be enrolled in the study.
2. For any diagnostic test other than serology (stool antigen, rapid Urease test, urea breath test, histopathology) the following patients will be excluded:

   * Children received any antibiotics in the last month
   * Children received bismuth compounds in the last month.
   * Children received proton pump inhibitors in the last 2 weeks.
   * Children presenting with upper gastrointestinal bleeding.
28-day Mortality Prediction for Critically Ill Patients in the Intensive Care Unit: Physician-nurse vs. Score

There are several scores for predicting mortality within 28 days in the intensive care unit, including APACHE 2, MPM 2 and MODS. These models for predicting mortality can help intensive care physicians to identify patients at high risk of mortality, thus helping them in the decision regarding their admission to the ICU and the management of their care during hospitalization. However, it is not entirely clear whether these models can predict mortality better than an experienced ICU physician or nurse.

The purpose of the study is to compare the ability of a senior ICU physician and nurse to predict mortality within 28 days in intensive care patients and between the predictive ability of three models for mortality prediction, as well as to investigate what were the parameters that particularly influenced the mortality prediction of the medical and nursing staff.

The study will be performed as a prospective observational study and will include approximately 2000 patients. For each patient admitted to intensive care, the risk of mortality will be calculated according to APACHE 2, MPM 2 and MODS. In addition, an independent evaluation by 3 specialist ICU physicians and an experienced ICU nurse will be carried out. The medical and nursing staff's reasons for the risk provided by them will be presented.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the ICU between 1.1.2025 and 1.1.2027.

Exclusion Criteria:

* Patients who were hospitalized in the ICU for less than 72 hours.
Multiple Myeloma and Exercise

This study will establich the feasibility of weight lifting exercise among patients with multiple myeloma, determine if weight lifting exercise increases lean body mass among patients with multiple myeloma and obtain further preliminary data on toxicity and pharmacokinetics of high-dose melphalan.

This is a prospective, single-institution, pilot study of a 3 month weight lifting program designed to increase musle hypertrophy prior to starting stem cell collection and receiving high-dose melphalan, in patients with multiple myeloma. We will use this exercise intervention while patients are receiving initial induction chemotherapy in the 3-6 month period before they receiv high-dose melphalan. The primary study endpoint is to determine the feasibility of recruiting and retaining multiple myeloma patients to an exercise intervention trial. The secondary study endpoint is to determine whether the weight lifting program increases lean body mass as intended.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed multiple myeloma
* 1 year since start of treatment for myeloma
* Patient and treating physician in agreement to proceed with autologous transplant, with a planned time betwwen study enrollment and transplant of 10 weeks
* Age 18 years.
* Able to walk for 6 minutes unaided.
* Body mass index 50 kg/m2
* Serum creatinine 2.5 mg/dL
* Ability to understand the informed consent document and willingness to consent. Written informed consent must be obtained from all patients before study entry.

Exclusion Criteria:

* Recent (in the past 6 months) participation in progressive weight lifting exercises or who already exercise regulary (3 times a week of moderate intensity aerobic exercise).
* Plan to move out of the area during the study intervention.
* A psychological, social, or logistical barrier that the principal investigators feel would preclude completion of the study protocol.
* Plan for use of any anti-myeloma treatment other than melphalan (the use of total body irradiation will NOT
ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers

The purpose of this study is to evaluate the safety of ALLN-346 in healthy volunteers, in this first in human, single ascending dose study. ALLN-346 is an enzyme that degrades urate in the gastrointestinal tract.

This is a Phase I, randomized, double-blind, placebo-controlled single ascending dose study of orally administered ALLN-346. The study will evaluate the safety and tolerability, inflammation and immunogenicity, pharmacokinetics and pharmacodynamics of ALLN-346 in healthy volunteers. The study consists of a Screening Period, a Treatment Period of 3 days, which includes 1 single day of dosing and 3 days of in-house observation, and a safety Follow-up Period through Day 28 following dosing.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Incapable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation
* Good general health as determined by medical history and physical examination
* Normal clinical laboratory test results and ECG

Exclusion Criteria:

* Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurological, psychiatric disease or history of hyperuricemia
* Any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines
* Positive screen results for drugs of abuse, alcohol, or cotinine or recent history of drug or alcohol abuse
* Clinically significant abnormal findings on physical examination, vital signs or on electrocardiogram (ECG)
* Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody
* Received treatment with or exposure to an Investigational drug or device within 30 days prior to or during Screening
* Per Investigator judgment, is not an ideal clinical study candidate
Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection

The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic hepatitis b patients with e antigen positive based on the detection of interferon gene mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.

Patients with e antigen positive chronic hepatitis b were enrolled in the study. Age, sex, symptoms (e.g., fever, fatigue, poor appetite, jaundice) were recorded in the study. We also observed the laboratory test results including the levels of white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), platelet (PLT), alanine transaminase (ALT), aspartate transaminase (AST), hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), and hepatitis B virus (HBV) DNA; detection of gene mutation (IFNA2 p.Ala120Thr), levels of interferon receptor (IFNAR2).

Eligibility Criteria:
Inclusion Criteria:

1. Chronic hepatitis b Patients who should receive anti-HBV therapy according to guideline and are willing to receive interferon therapy;
2. Hepatitis B e antigen positive.

Exclusion Criteria:

1. Patients received anti-HBV therapy in the past 6 months;
2. Patients with liver cirrhosis or hepatocellular carcinoma or other malignancies;
3. Patients with other factors causing active liver diseases;
4. Pregnancy or lactation women;
5. Patients with HIV infection or congenital immune deficiency diseases;
6. Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications.
7. Patients with other reasons not suitable to receive interferon therapy.
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate or azathioprine OR must either have or have had a history of corticosteroid dependency (that is an inability to successfully taper corticosteroids without a return of the symptoms of ulcerative colitis \[UC\]) OR required more than 3 courses of corticosteroids in the past year
* Moderately to severely active UC (as defined by baseline Mayo score of 6 through 12 \[endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist\], inclusive), including a (sigmoidoscopy or colonoscopy) sub score greater than or equal to (\>=2)
* If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to the first administration of study intervention at Week 0. Participants who receive parenteral nutrition are not permitted to enroll in the trial
* No history of latent or active tuberculosis prior to screening
* Must be up to date with all immunizations (that is, measles, mumps, rubella, and varicella) in agreement with current local immunization guidelines for immunosuppressed participants before Week 0

Exclusion Criteria:

* History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric (including suicidality), or metabolic disturbances
* History of malignancy or macrophage activation syndrome or hemophagocytic lymphohistiocytosis
* Have UC limited to the rectum only or to \<20 percent (%) of the colon
* Presence of a stoma
* Presence or history of a fistula
* Contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor (TNF-alpha) therapy per local prescribing information