cyrilzakka/clinical-trials huggingface dataset:
Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach

The purpose of this study is therefore to analyze the genomic profiles of prognosis and radiosensitivity of Human Papilloma Virus (HPV) related tumors from different body sites (oropharynx, uterine cervix, and anus), considering them as a unified entity regardless of the site of origin within the body.

The present study (ICARUS - genomIC RAdiosensitivity viRUS) involves the collection of data (retrospective and prospective) from an extensive cohort of patients with HPV-related tumors of the oropharynx, cervix, and anus.

The aim is to:

1. investigate the role of Cl2 in non-oropharyngeal HPV-related tumors, and
2. compare the Radiation Sensitivity Index (RSI) values of HPV-related tumors in patients who responded to radiotherapy (responders) with those of patients with radioresistant tumors (non-responders).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old)
* Diagnosis of HPV-related squamous cell carcinomas of the oropharynx, uterine cervix, and anus
* Curative intent radiation therapy (exclusive, post-operative, with or without chemotherapy)
* Availability of pre-radiation therapy biopsy sample
* No diagnosis of solid neoplasms and/or hematologic malignancies in the previous 5 years
* Possibility of retrospective and prospective data collection and anonymous submission to the referring center of clinical data related to the patient, pathology, and treatment characteristics (including radiation treatment plan in RT.dose format)
* Ability to obtain written informed consent for the use of data anonymously for research purposes

Exclusion Criteria:

* Patients undergoing surgical treatment
* Patients with local and/or locoregional recurrence
* Patients with synchronous distant metastases at diagnosis
* Patients previously treated with oncologic therapies for tumors of the same anatomical site
Lu's Acupuncture and Moxibustion Treatment on Stroke

There will be successive changes in traditional Chinese medicine rehabilitation for stroke patients with limb hemiparetic through therapy of acupuncture and moxibustion.

There will be difference in stroke outcomes of ischemic stroke patients with limb hemiparetic from acute to chronic phase under Lu' acupuncture and moxibustion.

Eligibility Criteria:
Inclusion Criteria:

* The ages of stroke patients from 40 years old to 70 years old.
* The principle diagnosis according to \<diagnosis-treatment criteria of stroke(trial implementation)\>formulated by Collaboration Acute Brain Diseases of State Administration of Traditional Chinese Medicine in 1996；Ischemic stroke confirmed by CT brain or MRI brain,with stable medical condition and awareness clear.
* Recent stroke from 7 days to 6 months after onset.
* Stroke with limb movement disorder and hypomyotonia，NIHSS≤10，ASHWORTH≤1，GCS\>8.
* Written informed consent by inpatient.

Exclusion Criteria:

* Stroke with conscious disturbance or serious cognitive impairment.
* Stroke with limb spasm；ASHWORTH≥1.
* Having cardiac pacemaker，metallic foreign body in treatment position，or hemorrhagic tendency.
* Being oversensitive to electrical stimulus.
Twin Vaginal Breech Deliveries Before and After Starting Training Skills and Clinical Approach in Labor Ward

In January 2021 Dept of ObGyn of Santo Spirito Hospital Pescara Italy, and in July 2022 Dept of ObGyn of San Giovanni di Dio Hospital Florence Italy, started regular training in management of obstetric emergencies. Twin vaginal deliveries were considered when first fetus is vertex presenting. The present study is evaluating retrospectively the rate of vaginal birth in twins after 34 weeks' gestation in the period 2017-2020, and 2021-2024 for Santo Spirito Hospital Pescara, and 2020-2022 June, and July 2022-2024 for San Giovanni di Dio Hospital Pescara. Incidence of maternal and fetal/neonatal outcomes were considered. Policy in Pescara hospital is based on cultural support of teamworks working in labor ward. Florence policy is based on availability of two teamworks previously skilled for twin vaginal delivery

In the period 2017-2020 before starting of simulator training for obstetrics emergencies, twin birth were collected. Incidence of vaginal birth and incidence of maternal adverse outcome (such as PPH) and fetal/neonatal adverse outcome (such as NICU stay) were recorded. The same outcomes were collected in twin deliveries after 34 wks in the period 2021-2024. Similarly in San Giovanni di Dio Hospital Florence they started this protocol in July 2022. The retrospective data enrollement identified the period January 2020-June 2022 and July 2022-December 2024. Teamworks in Pescara Hospital were supported by continous formation for retaining skills on vaginal birth particularly twin vaginal deliveries. In Florence Hospital two teamworks were supporting patients wondering for a vaginal birth and in the meantime positive results were collected in labor ward

Eligibility Criteria:
Inclusion Criteria:

* twin pregnancies after 34 weeks

Exclusion Criteria:

* multiple pregnancies monochorionic monoamniotic pregnancies gestational age before 34 weeks completed cesarean indication unrelated to pregnancy (placenta previa, maternal diseases, etc)
Effectiveness and Safety of the Levitan Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway

A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation.

A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation. The placement of a breathing tube into the windpipe is a skill that is not easily mastered. In fact, the placement is difficult or impossible using the usual technique in 1-3 of every 100 patients. The ease of placing this breathing tube depends in part on how easily and how much of the vocal cords are able to be seen directly using a laryngoscope.

In a small number of patients, the Levitan First Pass Success (FPS) Scope has been shown to be more effective and easier to insert even in patients who have difficult airways. This study will evaluate the use of the LFS compared to the other conventional laryngoscope in subjects with a simulated difficult airway. The goal of this study is to determine the effectiveness and safety of the LFS in a large number of patients with simulated airway difficulties.

The results obtained during the study may provide useful information to health care providers who cannot place a breathing tube in patients that are either in operating rooms or in emergency situations requiring intubation by paramedics. An example would be a trauma situation where a paramedic is having difficulty attempting an intubation when a patients c-spine is being protected from any movements.

The LFS is an affordable and transportable device, which makes this an attractive asset for health providers in smaller community settings or in paramedic vehicles which may not have the capacity to stock or ability to afford a variety of different scopes and must choose a more limited selection.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status I or II (healthy or mild systemic disease, ex. asthma, high blood pressure)
2. Elective surgery requiring endotracheal intubation
3. English speaking
4. Age 16 - 75 years

Exclusion Criteria:

1. Significant gastroesophageal reflux disease (GERD) that may require alternate induction/intubation techniques
2. Prior history of a difficult intubation requiring an awake tracheal intubation
3. Clinical predictors of a potentially difficult intubation requiring an awake intubation
4. BMI \> 45 kg/m2 (Obesity is a common and important risk factor for difficult intubation)
Study of ARO-DM1 in Subjects With Type 1 Myotonic Dystrophy

This is a Phase 1/2a double-blinded, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of ARO-DM1 compared to placebo in male and female subjects with Type 1 Myotonic Dystrophy (DM1). Participants who have provided written informed consent and met all protocol eligibility requirements will be randomized to receive single (Part 1) or multiple (Part 2) doses of ARO-DM1 or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of DM1
* Clinician-assessed signs of DM1 including clinically apparent myotonia
* Onset of DM1 symptoms occurred after the age of 12 years
* Walk for at least 10 meters independently at Screening
* Subjects of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of study or last dose of study drug, whichever is later. Subjects must not donate sperm or eggs during the study and for at least 90 days following the end of study or last dose of study drug whichever is later.

Exclusion Criteria:

* Inadequately controlled diabetes
* Confirmed diagnosis of congenital DM1
* Uncontrolled hypertension
* History of thromboembolic events
* History of Tibialis Anterior (TA) biopsy within 3 months of Day 1 or planning to undergo TA biopsies during the study period
* Clinically significant cardiac, liver or renal disease
* HIV infection (seropositive) at Screening
* Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at screening
* Untreated or poorly controlled epilepsy
* Treatment with anti-myotonia medication within a period of 5 half-lives of the medication prior to Screening.
* Abnormal coagulation parameters at Screening including platelet count, International Normalized Ratio (INR), prothrombin time, and activated partial thromboplastin time (APTT)
* History or presence of any of the following: hypercoagulable state, nephrotic range proteinuria, antiphospholipid antibody syndrome or myeloproliferative diseases, inability to ambulate, use of hormone-based contraceptives and peri/post- menopausal hormone replacement therapy ≤ 16 weeks prior to Day 1

Note: Additional inclusion/exclusion criteria may apply per protocol
Pre-op Use of Incentive Spirometry in Obese Patients

The purpose of this study is to evaluate the use of preoperative incentive spirometry (IS) as an aid to improve postoperative lung function. The hypothesis is that application of a standardized protocol of preoperative respiratory care teaching and exercise will improve lung performance that will subsequently result in prevention of postoperative pulmonary complications and that increasing the duration of preoperative use better improves lung mechanics postoperatively. The investigators propose to compare a patient population that uses IS as currently prescribed in the routine course of care (only to be familiar with preoperatively, but use postoperatively) against a population that uses IS with a standardized regimen for at least 3 days prior to the operation in terms of preoperative IS volumes, intraoperative pulmonary mechanics, postoperative IS volumes, and incidence of postoperative pulmonary complications.


Eligibility Criteria:
Inclusion Criteria:

* morbid obesity
* bariatric surgery
* must be able to use incentive spirometer

Exclusion Criteria:

* BMI=\<40 kg/m2
* current symptoms of obstructive sleep apnea or actively using continuous positive airway pressure
Correlation Between the Analgesic Effect of Fentanyl Transdermal Patches and Nutritional Status in Cancer Pain Patients

The goal of this observational study is to investigate the correlation and quantitative relationship between the analgesic effect of fentanyl transdermal patches in cancer pain patients and their nutritional status.

Cancer-related pain is one of the most common and unbearable symptoms among patients with malignant tumors. Opioids are commonly used to treat moderate or severe cancer pain. Among them, fentanyl is a synthetic opioid with analgesic adjuvant with a 50\~100 times higher potency than morphine. Due to its small molecular weight, high lipid solubility, and low irritation to the skin, transdermal fentanyl (TDF) is formulated, which is more convenient for patients with intestinal obstruction, swallowing difficulties, and intolerance to oral opioids. According to some research, the TDF demonstrated good cancer pain control for patients switching from morphine or oral oxycodone preparations, and was well tolerated.

However, a part of patients still go through increased breakthrough pain, sleep disturbances, and even accompanied by anxiety and depression when using TDF. Therefore, early identification of cancer pain patients using TDF at risk of ineffectiveness is an essential step in increasing analgesic effectiveness, and improving quality of life.

Some studies discovered different clinical factors such as age, gender, serum albumin, glomerular filtration rate, kidney disease, body mass index (BMI), total protein, alanine aminotransferases have some influence on fentanyl serum concentration and the dose of TDF. Furthermore, the clinical factors seem to have a greater impact on the effectiveness of TDF than the genetic factors which may affect the liver metabolism of fentanyl. Based on these results, we aim to investigate the correlation and quantitative relationship between the analgesic effect of fentanyl transdermal patches in cancer pain patients and their nutritional status. Our purpose is to help clinicians recognize and increase the analgesic effect of TDF according to the patient's risk level.

Eligibility Criteria:
Inclusion Criteria:

* Cancer pain patients admitted to our hospital;
* Cancer pain patients switched from oral sustained-release strong opioid analgesics to fentanyl transdermal patches during the hospital stay.

Exclusion Criteria:

* Patients who have been switched to fentanyl transdermal patches after titration with an analgesic pump;
* Patients using fentanyl transdermal patches in combination with other oral sustained-release strong opioid analgesics;
* Patients using fentanyl transdermal patches in combination with an analgesic pump;
* Patients who have used fentanyl transdermal patches for less than 3 days;
* Patients with postoperative pain;
* Patients with allergies;
* Patients who are pregnant women;
* Patients with missing data.
Study of Tacrolimus Used for Pediatric Patients With Nephrotic Syndrome Based on Pharmacogenomics and Metabonomics

Tacrolimus is recommended to be the first line therapeutic medication within the several immunosuppressive agents when treating refractory pediatric nephrotic syndrome, because of its definite efficacy and low toxicity. But there are still some key problems which hinder the using of tacrolimus in clinic, such as its narrow therapeutic widow, great individual difference of pharmacokinetics. Routine therapeutic drug monitoring(TDM) is needed in practice. But the disadvantage of TDM is hysteresis, which could lead to treatment failure or toxicity. To find out the reasons of great pharmacokinetic difference between patients and find out the individual proper dosage before administration are important for the clinical using of tacrolimus.

It is hot in research of tacrolimus in organ transplant field, such as the association between gene polymorphisms of cytochrome P-450 3A4, 3A5 and multiple drug resistant gene(MDR1) and concentration of tacrolimus. However, there is few study about pharmacogenomics and metabonomics of tacrolimus in patients of nephrotic syndrome.

The aim is to study the relationships between pharmacogenomics, metabonomics of tacrolimus and its efficacy, toxicity and blood concentration in patients of nephrotic syndrome, to find out the exact dosage before administration, to provide reference to individual drug administration.

Investigators will collect data about efficacy and adverse drug reaction(ADR) such as time of efficacy when evaluated, how to evaluate ADR, data of demography, etc.

Eligibility Criteria:
Inclusion Criteria:

1. patients with refractory nephrotic syndrome;
2. patients age ≤14y.

Exclusion Criteria:

1. patients are sensitive to steroid;
2. combined therapy with other immunosuppressive agent;
3. combined using drugs which maybe interact the concentration of tacrolimus;
4. with other malignant disease, such as tumor.
Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

Primary:

To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.

Secondary Objectives:

To describe the safety and tolerability at this dose and schedule


Eligibility Criteria:
Inclusion Criteria:Patients: Who are 18 years of age and older Who have histologically documented adenocarcinoma of prostate Who are currently receiving LHRH agonists KPS greater than 80%Life expectancy greater than 6 months Provide written consent pursuant to regulatory requirements prior to initiation of study procedure Exclusion Criteria:Exclusion Criteria: Patients: Any patient requiring continuous LHRH Any patient who has had an orchiectomy Any patient with painful bone metastases Who have received chemotherapy for prostate cancer Who have a abnormal serum creatine \>2.5 Receiving any investigational drug within the last 28 days Severe uncontrolled infection, diabetes, cardiac disease Patients with fragility fractures, hyperparathyroidism, Pagets renal osteodystrophy will be excluded History of non compliance to medical regimens or unwillingness to return for medical visits
Safety and Efficacy of Probiotics in Bangladeshi Infants

Here the investigators propose to preliminarily investigate the safety and effects of probiotics in infants in Bangladesh through a pilot randomized clinical trial. The investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i) to confirm the safety of administering probiotic strains to infants in low-income countries, ii) to determine the effects of dosing frequency on colonization and persistence of probiotics in the GI tract, iii) to measure markers of intestinal and immune function and microbiota structure.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants.
* Infants 1 -3 months of age at the beginning of the study.
* Parents/guardians of each subject are able to understand study procedures and agree to participate in the study by giving consent.
* Parents and child are planning to remain in Dhaka for the next four months.

Exclusion Criteria:

* Infants with known birth defects.
* Infants who have been hospitalized.
* Infants who have an acute infection or illness at the time of enrolment.
* Infants who are currently taking antibiotics
* Infants \<1 month of age or \>3 months of age.
* Infants three standard deviations below mean on anthropometric measures (will be referred for medical care).
* Infants who are already receiving a probiotic product or treatment.
* A diagnosis or suspicion of immunodeficiency disorder.
* A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.
* Family residence outside of Dhaka or families expecting to move outside of Dhaka in the next 4 months.
A Telerehabilitation Intervention for People With Heart Failure and Chronic Fatigue

This study compares the effectiveness of a 6-week Energy Conservation + Problem Solving Therapy Intervention to Health Education Intervention for reducing the fatigue impact and fatigue level and improving the level of participation in instrumental, leisure, and social activities in people with heart failure associated fatigue. Half of the participants received Energy Conservation + Problem Solving Therapy Intervention, and the other half received Health Education Intervention.

Energy Conservation+Problem Solving Therapy (EC+PST) Intervention: In this study, the EC+PST Intervention will ideally occur twice a week for 6 weeks with each session lasting approximately 30 minutes. The intervention will be individually delivered via telehealth; therefore, participants will receive the intervention in their home to minimize fatigue from the intervention.

Health Education Intervention: The Health Education Intervention will occur once a week for 6 weeks with each session lasting approximately 30 minutes. The Health Education Intervention will be delivered via telehealth; therefore, participants will receive the intervention at their convenient quiet place to minimize fatigue from the intervention.

Eligibility Criteria:
Inclusion Criteria:

(a) a minimum 6 months since diagnosed with HF and 3 months post-hospitalization, (b) reporting of moderate to severe fatigue by scoring ≥4 according to Fatigue Severity Scale, (c) living in the community, (d) having access to the internet or telephone in the place of residence, (e) having functional English fluency, and (f) having functional vision to operate the tablet computer.

Exclusion Criteria:

1. had a score of ≥9 in Short Blessed Test indicating cognitive impairment
2. were classified as having New York Heart Association (NYHA) Functional Classification level IV on their medical record
Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV

This study plans to learn about whether starting HIV treatment very soon after diagnosis is more beneficial than waiting until entering routine clinical care after diagnosis.

Randomized two arm, multi-site (three sites), open label pilot study conducted with laboratory evaluation and visits at entry, 4 weeks, 12 weeks, 24 weeks, 48 weeks and 96 weeks with laboratory evaluations and assessment if participants remain engaged in care.

Participants will be randomly assigned with equal probability to one of two arms:

Arm A: Same day antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) + new diagnosis package with laboratory evaluations and social work referral.

Arm B: Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 15 years and older in Colorado and 19 years and older in Nebraska. A waiver of parental consent is planned for individuals 15-17 in accordance with Colorado law which allows minors to consent for treatment for sexually transmitted infections, including HIV.
* Reactive HIV-1 on an approved fourth generation HIV-1 antibody/antigen test within 72 hours
* Any primary language with access to an interpreter by phone is included.

Exclusion Criteria:

* Pregnancy or intention to become pregnant in the next two years after enrollment
* Symptomatic acute HIV (with fever, rash, influenza-like symptoms)
* Creatinine clearance \<30 mL/min by Cockcroft-Gault equation. (Therapy initiated will be terminated promptly in individuals who are found to have creatinine clearance \<30 mL/min)
* Prior history of known HIV diagnosis
* Negative confirmatory HIV differentiation assays (therapy initiated will be terminated in individuals with negative tests and excluded from the primary analysis)
* Allergy to bictegravir, emtricitabine or tenofovir alafenamide
* Signs or symptoms of opportunistic infection with cryptococcal meningitis, tuberculosis or other infection that requires delay of initiation of antiretroviral therapy (up to the discretion of the site PI)
* Vulnerable populations including prisoners and individuals without decision making capacity
* Concommitant use of medications that are contraindicated with bictegravir, emtricitabine and tenofovir alafenamide including adefovir, carbamazepine, cladribine, dofetilide, fosphenytoin-phenytoin, oxcarbazepine, phenobarbital, primidone, rifampin, rifabutin, rifapentine, St. John's Wort, tipranavir