cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer

This is a multi-center, open-label, Phase 1 clinical study of ZG006 in the US for the treatment of subjects with small cell lung cancer who have failed or are intolerant to available standard treatment. During the dose escalation stage, a standard "3+3" design will be used to assess the MTD/ recommended dose for the subsequent studies.


Eligibility Criteria:
Inclusion Criteria:

* Small cell lung cancer (SCLC), who failed or intolerant to available standard treatments;
* Tissue sample positive for DLL3 expression;
* Life expectancy ≥ 3 months;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
* Female and Male patients must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.

Exclusion Criteria:

* Patients having received any of the following treatments:

  * Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry;
  * Systemic immunosuppressive medications, such as corticosteroid (doses \&amp;gt; 10 mg/day prednisone or equivalent dose) within 14 days prior to the study entry;
  * Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry;
* Patients received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry;
* A history of severe, life-threatening immune-mediated adverse events or infusion-related reactions during previous anti-tumor immunotherapy, including events that led to permanent discontinuation of treatment;
* Active infection (such as acute bacterial infection, tuberculosis, active hepatitis B/C, active syphilis, or active human immunodeficiency virus infection);
* Known allergy to other mAbs or any antibody excipients; the history of a severe allergic reaction, anaphylactoid or other hypersensitivity reactions to humanized antibodies or fusion proteins;
* A female who is pregnant or nursing;
* Patients were deemed unsuitable for participating in the study by the investigator for any reason.
Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma

Radiation-associated carotid vasculopathy is a common late sequelae in patients with head and neck cancer, which correlates with the incidence of stroke. Currently, little is known about the incidence of radiation-associated carotid vasculopahty in the context of intensity-modulated radiation therapy (IMRT).

The aim of this study is to determine whether IMRT will increase the incidence of carotid vasculopathy in patients with nasopharyngeal carcinoma (NPC).


Eligibility Criteria:
Inclusion Criteria:

* signed inform consent
* age more than 18 years old
* ECOG 0-2
* pathologic diagnosed, non-metastatic NPC
* either untreated or treated by definitive IMRT 3 years ago
* did not receive radiation to the head and neck region prior to the diagnosis of NPC
* if the patient received definitive IMRT 3 years ago because of NPC, he or she did not receive a second course of radiation due to local relapse
* no prior surgery of head and neck

Exclusion Criteria:

* prior history of cardiovascular disease before the diagnosis of NPC
* prior radiation to head and neck before the diagnosis of NPC
* prior surgery of head and neck
* pregnant or lactating women
RTA 402 in Patients With Advanced Solid Tumors or Lymphoid Malignancies

This study assesses the tolerability, safety, efficacy and pharmacokinetics of Bardoxolone methyl (RTA 402) in advanced solid tumors and lymphoid malignancies.

Bardoxolone methyl (RTA 402) is a synthetic triterpenoid that has demonstrated significant in vivo single agent anti-cancer activity. This is an open-label phase I dose-escalation study of Bardoxolone methyl (RTA 402) administered orally for the first 21 days of a 28-day cycle.

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Histopathological documentation of solid tumor or lymphoid malignancy.
* Advanced or metastatic cancer that is either refractory to or have relapsed after standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist.
* ECOG performance status of less than or equal to 2
* Adequate liver and renal function as documented by the following laboratory test results within 14 days of starting therapy: total bilirubin ≤ 1.5 mg/dL; AST (SGOT) and ALT(SGPT) ≤ 2.5 ULN or ≤ 5 ULN if liver is involved by tumor; serum creatinine ≤2.0 mg/dL OR creatinine clearance \>60 mL/min.
* Adequate bone marrow function as documented by the following laboratory test results within 14 days of starting therapy: platelets greater than 100,000/mm3, absolute granulocyte count greater than 1,500/mm3, hemoglobin greater than or equal to 8.0 g/dl.
* Completion of prior chemotherapy, hormonal therapy, radiation therapy, biological therapy, or other investigational cancer therapy, for at least 4 weeks prior to study entry and must have recovered from all acute side effects (to CTC grade 1 or less) prior to initiation of RTA 402. Patients who were receiving mitomycin C or nitrosoureas must be 6 weeks from the last administration of chemotherapy.
* Agree to practice effective contraception during the entire study period.
* Life expectancy of more than 3 months
* Able and willing to sign the informed consent form.
* Willing and able to self-administer orally and document all doses of RTA 402 ingested.

Exclusion Criteria:

* Active brain metastases or primary CNS malignancies.
* Pregnant or breast feeding
* Clinically significant illnesses including, but not limited to: Uncontrolled diabetes; Active or uncontrolled infection; Acute or chronic liver disease; Confirmed diagnosis of HIV infection; Uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or uncontrolled cardiac arrhythmia.
* Psychiatric illness that would limit compliance with study requirements.
Dementia Early Recognition and Response in Primary Care

The purpose of this study is to develop and test an educational intervention for dementia in primary care, combining timely diagnosis, psychosocial support around the period of diagnosis and management concordant with guidelines.

Dementia presents many challenges for primary care. Early diagnosis is important as this allows those with dementia and their family care networks to engage with support services and plan for the future. These actions can relieve the significant psychological distress that people with dementia and close supporters may experience , and provide knowledge about the availability of medical and psycho-social support that can improved functioning and morale

The main efforts to improve the identification and diagnosis of dementia should logically be targeted at primary care as this is the first point of contact for most individuals and their carers when faced with experiences of 'ill health'. There is, however, evidence that dementia remains under-detected and sub-optimally managed in general practice . An educational intervention that could enhance clinical practice, improving the skills of practitioners in the recognition of and response to dementia syndromes, could therefore be beneficial to people with dementia and their families, and potentially to health and social services.

Eligibility Criteria:
Inclusion Criteria:

* Patients with memory or other cognitive impairments suggestive of dementia syndrome
* those with a formal diagnosis of dementia, of any type.

Exclusion Criteria:

* Patients and carers who are already involved in concurrent research
* If the key professional feels that an approach to the person with dementia or their carer would be inappropriate, for example the dementia is very severe, or that an approach may increase distress
* and any other important reason that the key professional may have for why the person with dementia or their carer should not be contacted.
Basic Hematological Parameters and Coagulation Profile in Type 1 Diabetic Children

Diabetes mellitus is a group of chronic metabolic diseases characterized by hyperglycemia .Type 1 diabetes is a heterogeneous disease related to the destruction of pancreatic beta cells and is a result of absolute lack of insulin

* Diabetes mellitus has been traditionally looked upon as a disease of adults (except Type I diabetes), however it can affect individuals of any age. Given the peculiarities and problems that it carries, diabetes in children and adolescents poses special challenges to the entire society. Diabetes is the second commonest chronic disease occurring in 1 in every 1500 children by age 5 and in 1 in 350 children by age 8 . Microvascular (retinopathy, neuropathy, and nephropathy) Aim of the research to assess basic hematological parameters and coagulation profiles among type 1 diabetic children and compare them with healthy controls and macrovascular (coronary artery disease, peripheral vascular disease, and cerebrovascular disease) atherothrombotic complications may occur in children and adolescents, depending on the duration of diabetes, the degree of metabolic control, and other factorssuch as genetics . Diabetes mellitus can cause blood disorders such as deformity of red blood cells and increase their adhesion \[6\].It has an effect on the function of red blood cells through the interaction with the membrane and intracellular components . Red blood cell distribution width (RDW) is a measure of the difference in the size of red blood cells. An increase in RDW can be caused by anemia or nutritional deficiencies related to anemia
* Studies have shown that the average number of red blood cells, hemoglobin and hematocrit in diabetic patients is lower than the control group, which indicates the presence of anemia in diabetic patients .


Eligibility Criteria:
Inclusion Criteria:

* Age from one month to 18 year.
* Both sexes.
* Patients known to have type 1 diabetes.

Exclusion Criteria:

* Patients less than one month and more than 18years.
* history of bleeding disorders or anemia unrelated to diabetes.
* Otherc types of diabetes .
A Prospective, Multicenter, Randomized Control Study To Determine Clinical Effectiveness, Patient Wellness and Cost of Pain Related Care of In-Elastic Lumbar Sacral Orthoses Versus Standard Medical Treatment in Patients Presenting With Acute Low Back Pain In Primary Care Centers (The ARREST Study)

The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar sacral orthosis (LSO) as a treatment modality for acute low back pain.

The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar sacral orthosis (LSO) as a treatment modality for acute low back pain.

Eligibility Criteria:
* Inclusion Criteria:

  o Moderate to complete disability (baseline ODI score of 21 to 80 percent)
* Exclusion Criteria:

  * Pregnant patients
  * Patients considering pregnancy
  * Patients in any other investigational device or drug study
  * Patients unwilling to return for follow up
  * Patients unwilling to provide access to medical claims associated with pain management.
Efficacy of Probaclac in Irritable Bowel Syndrome in Children Aged 8 to 18 Years

The aim of this study is to determine the efficacy of the administration of Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™) given twice a day for 4 weeks on digestive symptoms evaluated subjectively in children aged 8 to 18 years with irritable bowel syndrome versus placebo.

This study is a double-blind randomized controlled study. 84 children will included. After inclusion, a 15-day period of observation precedes the randomization at Day 0. Patients receive Probaclac or placebo for 4 weeks. At the end of the treatment period, patients are followed for a 2-week period of follow-up.

4 visits and 4 phone calls are planned during the study.


Eligibility Criteria:
Inclusion Criteria:

* Children 8 to 18 years
* Irritable bowel syndrome according to Rome III criteria

Exclusion Criteria:

* Not able to collaborate
* Known Digestive malformation
* History of digestive surgery (except hernia repair and appendectomy)
* History of known digestive disease (Crohn's, ulcerative colitis, esophagitis, peptic ulcer, celiac disease)
* Symptoms suggestive of organic disease (such as rectal bleeding, weight loss
* History of chronic extra-digestive disease
* Acute gastroenteritis in th e4 weeks prior to inclusion
* Central catheter, artificial cardiac valve, endocardiac prothesis
* Current Antidepressant treatment
* Patients taking a treatment for irritable bowel syndrome unable to cease their current treatment
* Patient taking regularly probiotics and natural products
Dorsal Splint or Circular Cast for Colles' Fracture?

At our hospital, all Colles' fractures deemed suitable for conservative treatment are reduced and immobilised with a plaster of Paris dorsal splint which is converted to a complete cast after 10 days. According to individual factors such as age, general health and radiological results after 10 days, some patients with severe redisplacement are readmitted to hospital for surgery.

The main purpose of this study is to determine whether, during the first 10 days of immobilisation, a complete plaster cast or a dorsal plaster splint best retains the alignment of a reduced Colles' fracture. In addition, we aim to compare the complication rates of the two methods.


Eligibility Criteria:
Inclusion Criteria:

* women 50 years and older
* Colles' fracture due to low energy trauma

Exclusion Criteria:

* high energy trauma
* age under 50 years
* dementia
Spica Casting in Pediatric Femur Fractures: Study of Single Leg Versus Double Leg Spica Casts

Prospective randomized controlled trial comparing use of single leg spica with double leg spica casts in the treatment of pediatric femur fractures in children ages 2 through 6 years old.

Introduction

* double-leg spica casting is the treatment of choice at many centers for the treatment of diaphyseal femur fractures in children 2 to 6 years old.
* Investigators hypothesize that these patients can be effectively treated with single-leg spica casting and that such treatment will result in easier care and better patient function during treatment.

Methods

* Prospective randomized controlled study of patients between 2 and 6 years old with diaphyseal femur fractures
* patients randomly assigned to either immediate single or double-leg spica casting groups after consent was obtained
* Radiographs serially evaluated for maintenance of reduction with respect to length, varus/valgus angulation and procurvatum/recurvatum angulation
* After casts removal, the Activity Scale for Kids (Performance Version) questionnaire and a custom written survey were given to parents evaluating ease of care and function of children during treatment.

Eligibility Criteria:
Inclusion Criteria:

* diaphyseal femur fracture
* age between 2 and 6 years old

Exclusion Criteria:

* underlying bone disorder
* neuromuscular disease
Evaluation of "Plan A"

The purpose of the study is to determine if exposure to the "Plan A" video influences viewers' uptake of LARC, reduces unprotected sexual activity, and increases receipt of STI testing.

The Policy \& Research Group (PRG) is evaluating the "Plan A" video, which was designed to promote effective contraceptive use, use of dual methods of protection (condom use and prescription birth control use), and HIV/STI testing in African/American and Latina young women. The video is approximately 23 minutes in length and is shown immediately prior to a clinical appointment at a reproductive health center. By delivering the intervention prior to a clinic appointment, developers hope to reach high-risk teens at a teachable moment, when they can ask a health care provider about what they have learned. The primary focus of the study is to investigate the impact of the intervention on participants': 1) LARC use; 2) times having sex without a condom; and 3) STI testing. Secondary outcome measures include assessing the impact of the intervention on participants': 1) use of dual methods of protection during vaginal sex; and 2) use of other effective contraceptive methods. Finally, the evaluation will include exploratory analysis of participants': 1) perception of risk and/or severity for pregnancy and HIV/STI infection; (2) intention to use LARC; (3) intention to use other effective contraception methods; (4) provider communication self-efficacy; (5) condom negotiation self-efficacy; and (6) knowledge/awareness of contraception options/LARC.

The control (counterfactual) condition consists of a 17-minute video titled "The Toxic Life Cycle of a Cigarette". The control video, which discusses the effects of smoking, is shown in the same manner as the treatment video: immediately prior to a clinic appointment at a reproductive health center.

All eligible participants who provide the proper consent are randomized and enrolled into the study by a study coordinator who is an employee of the reproductive health clinic. Outcomes will be assessed using self-reported, participant-level data gathered (by way of a questionnaire) at three time points: baseline (enrollment, prior to watching the video); 3-month follow-up (3 months after baseline); and 9-month follow-up (9 months after baseline). The study is taking place at seven clinics within the Planned Parenthood Mar Monte system in California, all of which serve the target population.

Eligibility Criteria:
Inclusion Criteria:

* Be female
* Be 18 or 19 years old
* Self-identify as Latina and/or African-American
* Be visiting a reproductive healthcare provider at the study site
* Be deemed appropriate for the study by study staff/clinic staff with regards to physical and mental health and capacity
* Consent to participate in the study

Exclusion Criteria:

* Knowingly pregnant
* Trying to become pregnant
* Previously enrolled in the study
* Enrolled in studies in the same geographic area that aim to prevent teen pregnancy
Don't Treat Ghosts Anti-MRSA Antibiotics in Osteomyelitis Without Identified MRSA

Osteomyelitis is described as infection and inflammation of the long bone or bone marrow, often due to an open wound, operation, or invasive trauma.1 It is invasive and involves hematogenous seeding or contiguous spread of the infectious organism

This disease can be classified by location of infection, extent of spread, chronicity, and source of infection.3,4 Osteomyelitis can be caused by a variety of organisms, most commonly gram-positive staphylococci.

Osteomyelitis is associated with a high rate of relapse, high disease burden, and high health care costs.3 Following confirmation of disease via imaging and histopathologic examination, treatment consists of antibiotic therapy and, often, surgical intervention.3,5,6 Treatment with antibiotic therapy is often administered for 4-6 weeks when surgical intervention is not performed.6 Antibiotic selection should be guided by microbiology and antimicrobial susceptibilities.4 Thirty to sixty percent of osteomyelitis cases are caused by Staphylococcus aureus.

Eligibility Criteria:
Inclusion Criteria:

* • Admission to any MHS hospital between April 1, 2017 and April 1, 2023

  * \> 18 years of age
  * Documented osteomyelitis location of the lower limb via ICD-10 code
  * Documented imaging of lower limb osteomyelitis during index admission
  * Planned intravenous (IV) antibiotics for at least 4 weeks

Exclusion Criteria:

* • IV antibiotics for less than 24 hours inpatient

  * Planned surgical intervention documented at admission
  * Patients receiving monotherapy with an anti-MRSA agent
  * Positive MRSA culture during index admission
  * Current outpatient antibiotic use on index admission
  * Repeated hospital admission during study period
Impact and Mechanism of Depression on Cardio-cerebral Vascular Events and Arteriovenous Fistula Dysfunction in MHD Patients

Depression is a common psychiatric disorder in patients on maintenance hemodialysis (MHD). It may contribute to poor prognosis in a number of ways, including its effect on platelet function. We aimed to investigate the impact and underlying mechanisms of depression on the occurrence of cardio-cerebral vascular events (CCVE) and dysfunction of arteriovenous fistula (DAVF) in MHD patients.

In this study, MHD patients were recruited and divided into depression and non-depression groups using the Hamilton Depression Scale (HAMD) in this prospective cohort study. Their clinical and laboratory indicators were collected and the occurrence of CCVE and DAVF were recorded through clinical follow-up, and analyzed, and the differences and possible influencing factors of CCVE and DAVF occurrence were assessed between the two groups of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients had undergone dialysis treatment for more than 3 months, and their medical status was stable at the time of enrollment, with an expected survival period of more than 1 year

Exclusion Criteria:

* (1) with communication disorders or mental illness other than depression; (2) a combination of cirrhosis, lymphoma, thrombocytopenic purpura, or other diseases that significantly affect platelet function; (3) complicated with malignant tumors, tuberculosis, severe heart failure, and unstable medical conditions; (4) inability or unwillingness to cooperate with researchers.
Comparison of VieScope vs. Macintosh Laryngoscope for Intubation in Level Cpersonal Protective Equipment Conditions

The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC for aerosol-generating procedures (AGP), medical personnel should be equipped with full personal protective equipment (PPE) for AGP. Therefore, it is reasonable to search for the most effective methods of intubation in those conditions.


Eligibility Criteria:
Inclusion Criteria:

* paramedic
* consent voluntary participation in the study
* none experience in Vie Scope
* none experience in intubation with personal protective equipment

Exclusion Criteria:

* refusal to participate in the study