cyrilzakka/clinical-trials huggingface dataset:
The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy

Premix insulin is widely used, with high proportion of positive insulin autoimmune antibody in patients with type 2 diabetes. The positive insulin autoimmune antibody may affect blood glucose control. We aim to explore the management for the positive insulin autoimmune antibody and blood glucose control in these patients, and investigate the immune cells changes with the change of different glucose lowering drugs.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes;
* Treated with premix insulin, two or three injections a day, single drug or combination of oral hypoglycemic drugs;
* The treatment regimen was stable for more than 2 months;
* With positive insulin antibody

Exclusion Criteria:

* Patients treated with GLP-1 agonist in the last 3 months;
* Allergic to insulin;
* Impaired liver and renal function (ALT 2.5 times higher than the upper limit of normal value; serum creatinine was 1.3 times higher than the upper limit of normal);
* A history of drug abuse and alcohol dependence;
* Used systemic glucocorticoids therapy in recent 3 months;
* Patients with infection or stress within four weeks;
* Patients who cannot tolerate FGM;
* Pregnant or preparing to become pregnant;
* Considered unsuitable to participate by the investigator.
Study on the Influence of Forest Therapy on Healing Experience in Botanical Gardens.

The forest healing system is an important topic of alternative therapy in recent years. To study the influence of Forest therapy, the establishment of a pilot experimental model system in which both environmental factors and type of activity are necessary. Therefore, a system based on the Taipei Botanical Garden was introduced by this study.

The forest healing system is an important topic of alternative therapy in recent years. Forest therapy began in 1989 when the psychology professor Kaplan put forward the "Attention Restoration Theory(ART)". Awareness has a positive benefit. To study the influence of Forest therapy, the establishment of a pilot experimental model system in which both environmental factors and type of activity are controlled can greatly reduce the errors caused by the site and the content of the activity. Therefore, a randomized controlled crossover experiment based on the Taipei Botanical Garden was introduced by this study.

Eligibility Criteria:
Inclusion Criteria:

* 20-35 years old youth (not limited to men and women)
* Those who have the ability and physical strength to walk for more than 120 minutes
* Subjects must voluntarily join the study

Exclusion Criteria:

* People who smoke or chew betel nuts
* People who have the habit of drinking (drinking more than five standard glasses in any situation)
* Drug addiction (including narcotic drugs and non-narcotics) habitual
* Those who have taken psychosomatic drugs in the past 30 days
* Participating in another clinical trial at the same time, or in the follow-up period of an interventional trial
* Those diagnosed with major injuries
* Women who are currently pregnant or breastfeeding
* Conditions where other subjects cannot cooperate (for example: unable to participate after random assignment, and not signing the subject's consent form)
A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products

This study is a randomised cross-over, open-label, confinement study conducted in 24 male or female snus and cigarette consumers. The study investigates 5 different nicotine containing products in a cross-over fashion. The study incorporates pharmacokinetics evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety evaluation.

During the study participation, subjects come for two visits to the clinic, including a 5-day confinement period.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m
* Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator
* Dual user of snus and conventional cigarettes for ≥1 year, with a minimum weekly consumption of two or more snus cans and \>5 cigarettes, and who is willing and able to use brands with nicotine content ≥1%

Exclusion Criteria:

* History of any clinically significant disease or disorder
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first use of IP
* Positive for HIV, hepatitis B or C
* After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:

  * Systolic blood pressure \<90 or \>140 mmHg, or
  * Diastolic blood pressure \<50 or \>90 mmHg, or
  * Pulse \<40 or \>90 bpm
* Alcohol or drug abuse
* Use, or history of use of anabolic steroids
* Allergy/hypersensitivity to drugs with a similar chemical structure or class to nicotine
* Excessive caffeine consumption (daily intake of \>5 cups)
* Female subjects who are pregnant or breastfeeding
Reliability of Dosing With NovoLog® Mix 70/30 FlexPen® Compared With Vial and Syringe

This trial is conducted in the United States of America (USA). The aim of this trial is to compare desired (target) with actual target amounts of insulin dispensed using NovoLog® Mix 70/30 FlexPen® and vial and syringe in subjects with type 2 diabetes mellitus. No insulin is administered in this trial - insulin is dispensed into an empty vial.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Insulin naive
* No previous experience administering injections

Exclusion Criteria:

* Any condition that, in the Investigator and/or Sponsor's opinion, could interfere with the results of this trial
Project IntERact V2

The present study is evaluating the efficacy of a behavioral intervention to reduce risky firearm carriage among a high risk sample of youth reporting recent firearm carriage and ownership of a smartphone.

Firearms are the leading cause of death for U.S. youth; 60% due to homicide. This study will test the efficacy of a behavioral intervention at reducing risky firearm behaviors among a high-risk community sample of youth (age 16-24) that report past 3-month firearm carriage and smartphone ownership. The behavioral intervention consists of 3 remotely delivered therapy sessions integrating motivational interviewing (MI), cognitive behavioral therapy (CBT), and care management (CM), supported by a smartphone APP that facilitates therapist contact, conducts automated daily assessments, delivers between session tailored therapy content, delivers just-in-time Global Positioning System (GPS)-triggered notifications upon entry into high-risk locations, and aids with utilization of local resources. Recruitment will proceed in two high-risk communities (Flint, Saginaw), including through the main Emergency Departments/trauma centers that are located in both cities. Given elevated rates of firearm violence among socio-disadvantaged youth with disparities in access to community services, the proposed intervention, if found to be efficacious, has the potential for significant public health impact.

Eligibility Criteria:
Inclusion Criteria:

* Flint or Saginaw Youth between the ages of 16 to 30 reporting past 3-month firearm carriage and ownership of a smartphone, including those seeking care for any reason at Hurley Medical Center or Covenant Medical Center Emergency Department.
* Can provide consent (age: 18-30) or youth assent and parental consent (age: 16-17) for the study.

Exclusion Criteria:

* Incarcerated (i.e., in active policy custody and not able to provide informed consent)
* Presenting to the ED for active suicide ideation or attempt, sexual assault, and/or child abuse
* Unable to provide informed consent due to mental status (e.g., alcohol intoxication, acute psychosis) or medical instability.
* Participants will be excluded if firearm carriage is exclusively for legal work (e.g., police), hunting, or target shooting.
Intraileal Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions

The distal ileum, where the glucagon-like peptide 1 (GLP-1) releasing cells predominate, is an important organ in mediating glycemic control. However, the distal ileum is not easy to access and the correspond in vivo research remains to be difficult. The investigators intend to recruit subjects who underwent rectal surgery with simultaneous protective ileostomy and evaluate hormone secretion and glycemic excursions via ileostomy glucose or saline infusion, and quantify the glucose absorption rate within the distal ileum.


Eligibility Criteria:
Inclusion Criteria:

* Male and postmenopausal females aged 18 - 75 years
* Body mass index (BMI) 20 - 35 kg/m2
* With protective ileostomy due to benign or malignant rectal surgery

Exclusion Criteria:

* History of postoperative adjuvant chemotherapy
* Other significant illness, including epilepsy, cardiovascular or respiratory disease
* Impaired renal or liver function (as assessed by calculated creatinine clearance \< 90 mL/min or abnormal liver function tests (\> 2 times upper limit of normal range))
* Donation of blood within the previous 3 months
* Participation in any other research studies within the previous 3 months
* Females who are pre-menopausal
* Inability to give informed consent
* Vegetarians
Telehealth Treatment for Opioid Use Disorders

This study aims to use an Opioid Use Disorder (OUD) Telehealth Platform to reduce overdose events. This telehealth platform will be pilot tested to evaluate its preliminary efficacy in terms of motivating engagement in medications for OUD (MOUD), as well as its feasibility, acceptability and satisfaction to both first responders/providers and participants.

The primary objective of the study is to assess effects of enrollment in a comprehensive telehealth platform, in adults with moderate or severe opioid use disorder with a history of at least one opioid overdose. Thirty adults with moderate or severe opioid use disorder with a history of at least one opioid overdose will be enrolled and the primary endpoint will be attendance at first appointment for medication for opioid use disorder at 30 days.

Secondary aims include assessing engagement in the first MOUD appointment at 90 days and self-report of the number of subsequent overdose events at 30 and 90 days. Exploratory aims include feasibility of intervention, readiness and intention to engage in treatment, acceptability and satisfaction of intervention, and comparison of MOUD engagement with data from previous in-person studies.

Eligibility Criteria:
Inclusion Criteria:

* Can speak, read and write in English
* Provision of signed and dated informed consent form
* Have a history of at least one opioid overdose
* Screened positive for OUD, moderate or severe, based on the Diagnostic and Statistical Manual-5th Edition
* Have a working cell phone number and working device that can access a web browser and receive texts (i.e., smartphone, tablet or computer) OR be willing to use a device provided by the study team
* Can provide a working email address OR be willing to create one

Exclusion Criteria:

* Current use of buprenorphine, methadone, or naltrexone for a substance use disorder
* Pregnancy or lactation
* Known current suicide risk based on participant self-report
* On parole or incarcerated at time of enrollment based on participant self-report
Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis

The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects \> or equal to 18 years of age.
* Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) obtained within the prior 96 hours of the screening visit.
* Subjects who received no more than one prior dose of an echinocandin or polyene.

Exclusion Criteria:

* Subjects with hypersensitivity to anidulafungin, other echinocandins or azoles.
* Presence of confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.
* Subjects with infected prosthetic devices which cannot be removed within 24 hours
The Cheeky Study: A Novel Delivery System for CAB-RPV LA

This is a single-arm implementation study of a novel integrated delivery model of CAB-RPV LA for transwomen living with HIV.

CAB-RPV LA as a monthly injectable could address disparities in viral suppression among trans women living with HIV. This study is designed to enroll a diverse population of trans women living with HIV who receive HIV care within collaborating primary care clinics. This study proposes using mixed methods to tailor and evaluate implementation and client outcomes when CAB-RPV LA is delivered through this integrated delivery model.

This will be a 9-month pilot study among 40 participants who will be provided CAB-RPV LA through an integrated trans-friendly delivery model using 4 implementation strategies to improve the adoption and integration of CAB-RPV LA delivery to trans women. These strategies are aimed at all levels of implementation - system, clinic, provider, and patient to maximize impact. The 4 strategies are a patient-centered injection site (Bridge HIV, SFDPH), patient-centered adherence support (peer health navigation and SMS platform with reminders and communication with staff), provider education, and improved clinic communication strategies.. CAB-RPV LA is being provided as standard of care and is not paid for by the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Male sex at birth and gender identity other than male
* Willing and able to provide written informed consent
* HIV-infected, confirmed by laboratory testing (can be via medical record)
* Eligible to receive CAB-RPV LA per FDA-approved label
* Virologically suppressed at the last visit within the last 6 months (HIV RNA \<50 copies/ml)
* Interested in initiating CAB-RPV LA for HIV treatment and willing to receive injections at Bridge HIV
* Currently receiving HIV care by a care provider at one of the collaborating primary care clinics.
* Has a cell phone and active service
* Able to understand, read, and speak English

Exclusion Criteria:

* Unable to receive gluteal injections
* Plans to move away from the site area within the next 9 months.
* History of known or suspected drug resistance that would compromise the CAB-RPV regimen

  * Rilpivirine: L100I; K101E; V106I and A; V108I; E138K and A, G, Q, R; V179F and I; Y181C and I; V189I; G190E; H221Y and H/L; F227C; and M230I and L; K103N+K238T, K103N+E138G+K238T; Y188L
  * Cabotegravir: Q146L; S153Y; I162M; T124A; Q148H, K; C56S; V72I; L74M; V75A; T122N; E138K; G140S; G149A; M154I; and N155H
* Prior hypersensitivity to cabotegravir or rilpivirine
* Current or expected use of any of the following medications:

  * Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin
  * Antimycobacterials: rifabutin, rifampin, rifapentine
  * Systemic glucocorticoids: more than a single dose of dexamethasone
  * Herbal: St John's Wort
* Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Correlation of Protection Against Varicella in an Exploratory Study

This study consists of two parts. Part 1 is a retrospective cohort study and part 2 is a prospective cohort study. In Part 1 ,the scaled logit model was used to assess the correlation between varicella-zoster virus (VZV) antibody titers using fluorescent-antibody-to-membrane-antigen assay (FAMA) 30 days after varicella vaccine immunization and the risk of subsequent varicella breakout/disease , to determine the protective threshold for achieving FAMA antibodies. Part 2 was to validate the model in part 1.

Part 1 was based on a previous Phase Ⅲ, randomized, placebo-controlled clinical trial (NCT02981836) conducted from 2016 to 2017. The analysis data of part 1 was from historical serum, historical varicella cases and additional one year case monitoring conducted as an extension of the Phase III study.

Part 2 was conducted based on close contacts of varicella cases. All close contacts without varicella symptoms will be recruited and followed up for 14 days to monitor the occurrence of the varicella cases. Part 2 aimed to compare the differences of FAMA antibody titers in varicella breakthrough cases, non-breakthrough cases, and non-cases at the time of exposure to validate/calibrate the model established in part 1.

Eligibility Criteria:
Inclusion Criteria:

* 1-12 years children who were the siblings or children of the indicator varicella cases, or the deskmates/roommates of the indicator varicella cases;
* Having close contacts with the indicator varicella cases at least 2 days during the period from 5 days before the onset and 2 days after the onset;
* Without varicella vaccination history or having varicella vaccination history (the last dose of varicella was manufacured by Sinovac, with an interval of \>30 days before enrollment)
* Subjects/legal guardian can understand and sign the informed consent;
* Being able to provide legal proof of identity.

Exclusion Criteria:

* Without varicella history;
* Body temperature ≥37.0℃ on the day of enrollment, or skin rash on the head, torso, and limbs;
* Having any confirmed or suspected immunodeficiency disorder, including tumor patients undergoing chemotherapy, human immunodeficiency virus (HIV) infection, continuous use of steroid hormones for more than 30 days (prednisone equivalent ≥2mg/kg days in children), or having other immunosuppressive disorder as determined by the clinician;
* The investigators considered that participation in this study was not appropriate for various other reasons.
The Impact of Oral Health in HIV Patients on Antiretroviral Therapy

This is a prospective cohort study designed to investigate the range of metabolic abnormalities observed in patients living with HIV on antiretroviral therapy. This study will also explore the concurrent role of poor oral health in supporting and driving chronic immune activation and inflammation in HIV infection.

This is a prospective cohort study designed to investigate the range of metabolic abnormalities observed in patients living with HIV (PLWH) on antiretroviral therapy (ART). This study will also explore the concurrent role of poor oral health in supporting and driving chronic immune activation and inflammation in HIV infection.

Following enrollment in study, patients will be followed up every 6 months for approximately 2.5 years (30 months). During this period, comprehensive medical records will be obtained, and study data will be updated every 6 months; questionnaires will be handed to patients periodically to assess quality of life and effects of xerostomia on QoL; social history will be assessed using TAPS; oral health will be evaluated every 6 months and blood, saliva, and oral swabs collected every 6 months. DXA scan and panoramic radiographs will also be taken at baseline and 24 months.

At the end of the study, caries rate, periodontal health, bone loss, QoL, salivary quantity and composition, presence or absence of white/red lesions, as well as inflammatory cytokines and immune activation markers will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Has been diagnosed with HIV (as documented by a prior laboratory report of positive HIV-1/2 antibody and/or detectable HIV RNA, available for review by the study team)
* Has received antiretroviral therapy for at least 12 months
* Able and willing to provide informed consent prior to initiation of study procedures
* Willing and able to comply with all study procedures, and likely to be available for the duration of the study

Exclusion Criteria:

* Has been diagnosed with the following xerostomia-related autoimmune conditions: Sjorgen's and sarcoidosis
* Has never received radiation therapy to the head or neck (including radioactive iodine therapy)
* Was taking anti-osteoporotic agents (biphosphonates, denosumab) prior to HIV diagnosis.
* Women who are pregnant at the time of enrollment.
Thyroid Hormone Values and Anti-thyroid Peroxidase Antibody Positivity in Recurrent Pregnancy Loss

The aim of this study is to compare the thyroid hormone values and anti-thyroid peroxidase (anti-TPO) levels of women with a diagnosis of recurrent pregnancy loss (RPL) and healthy pregnancies. The primary objective is to find out the relationship between recurrent pregnancy loss with thyroid hormone levels and anti-TPO positivity.


Eligibility Criteria:
Inclusion Criteria:

* women with 2 or more pregnancy loses
* for controls women with least one healthy baby

Exclusion Criteria:

* any other metabolic disease
* women with one miscarriage
Cell-Wave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium

Extracorporal shock wave therapy is performed prior to cell therapy for induction of therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in patients with chronic ischemic heart disease following anterior myocardial infarction.

Shock waves can induce growth factor expression in the ischemic myocardium and might augment homing of autologous bone marrow mononuclear cells which are injected intracoronary 24 h following shock wave therapy

Single center, Phase I-II Study (Safety, Feasibility and Efficacy) Double-blind, randomised trial (Cell therapy), single blind (Shockwave)

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic ischemic heart disease
* Patients with anterior myocardial infarction \> 3months
* EF \< 50% or NYHA II-IV
* Age 18-80
* Informed consent

Exclusion Criteria:

* Ventricular thrombus
* Infarct \< 3 months.
* Active infection or fever
* Chronic inflammatory disease (e.g M. Crohn, Rheumatoid Arthritis)
* HIV Infection oder active Hepatitis
* Neoplastic disease w/o complete remission within 5 years
* Stroke \< 3months
* Creatinine \> 2 mg/dl
* Relevant Liver disease (GOT \> twice the upper limit).
* Anemia (Hemoglobin \<10 mg/dl)
* Thrombocytopenia \< 100.000/µl
* Allergies to Aspirin, Clopidogrel, Heparin
* History of bleeding disorder
* History of coagulopathy
* Gastrointestinal Bleeding \< 3 months
* Surgery or Trauma \< 2 months
* Pregnancy
* Mental Retardation
* Participation in other clinical study \< 1 month