cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, Pharmacokinetics, Radiation Dosimetry, and PET Imaging Properties of 89Zr-labeled hNd2 (NMK89) in Patients With Pancreatic Cancer

This trial will be a non-randomized, Phase I trial to evaluate safety, tolerability, biodistribution, radiation dosimetry, pharmacokinetics and PET imaging properties following an infusion of 37 MBq (1 mCi) of 89Zr-labeled hNd2\* (NMK89) in patients with pancreatic cancer that are positive for MUC5AC. Image acquisition is conducted using a PET/CT machine.

\* hNd2: Recombinant humanized Nd2 (anti-human MUC5AC monoclonal antibody)


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide informed consent.
2. Male or female ≥ 18 years of age.
3. Histologically confirmed diagnosis of pancreatic adenocarcinoma.
4. Willing to provide biopsy specimens for purposes of confirmation of MUC5AC expression.
5. Confirmed MUC5AC expression at pre-screening.
6. Measurable disease.
7. Female patients of child-bearing potential must have a negative serum pregnancy test within 30 days prior to infusion of NMK89.
8. Willing to comply with the study protocol requirements.
9. Willing to provide a tumor resection specimen or biopsy specimen, if the patient undergoes tumor resection or biopsy between Day 16 and Day 60.

Exclusion Criteria:

1. Known hypersensitivity to the investigational medicinal product (IMP) or any of the excipients.
2. History of another primary cancer within the 2 years prior to enrollment, except for the curatively treated in situ cancers.
3. Exposure to any investigational treatments within 30 days prior to the planned date of infusion of NMK89.
4. Ongoing toxicity ≥ Grade 2.
5. Pleural effusion or peritoneal fluid ≥ Grade 3.
6. Active hepatitis B, hepatitis C, HIV, or other progressing infectious disease.
7. Uncontrolled diabetes.
8. Autoimmune disease or idiopathic thrombocytopenic purpura.
9. Exposure to any radiopharmaceuticals.
10. Planned antineoplastic therapies on the planned date of NMK89 infusion.
11. Use of bevacizumab or any other anti-angiogenic agent.
12. Uncontrolled intercurrent illness.
13. ECOG PS: ≥ 2.
14. Participants do not have adequate organ and marrow function.
15. Female patients that are pregnant or breast-feeding.
16. Positive urine screen for illegal drugs, or abuse of prescribed drugs at Screening.
17. Participants with contraindications to contrast agent injection used for diagnostic CT.
18. Deemed inappropriate to participate by the investigator.
Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care

High-throughput oxygen therapy is known as an alternative to non-invasive ventilation, with a benefit in terms of survival in non-hypercapnic respiratory failure patients.

The use of high-throughput oxygen therapy is well studied in stable chronic obstructive pulmonary disease (COPD) patients and has as known effects the decrease of transcutaneous CO2 and respiratory rate, and the increase in the inspiratory/expiratory time report, in the tidal volume and in the forced expiratory volume per second.

In the event of an exacerbation, high-flow oxygen therapy has shown to be beneficial in terms of increased mean airway pressure, tidal volume with a decrease in hypercapnia, and respiratory rate.

The net effect on the CO2 pressure is linked to the CO2 clearance of the dead anatomical space by the high throughput. The effect can be compared with the one of non invasive ventilation in a stable COPD patient.

Oxygen therapy, even in patients with non-hypoxic COPD at rest, has benefits in terms of performance and improvement of quality of life. High-throughput oxygen therapy has also shown a benefit in COPD patients in revalidation units, in terms of exercise performance and oxygenation.

However, the reconditioning of critical patients in acute situations, by means of nasal goggles, has never been studied.


Eligibility Criteria:
Inclusion Criteria:

* Acute respiratory insufficiency type I, oxygen partial pressure (PaO2) \<60 mmHg under oxygen without hypercapnia.
* Invasive arterial pressure measure

Exclusion Criteria:

* Hemodynamic instability
* Patient under continuous high throughput oxygen therapy
* Left cardiac insufficiency
* Arteritis of the lower limbs
* Neuromuscular pathology
* Osteo-articular limitations
* Hemoglobin inferior to 8g/dl
Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus

The purpose of the study is to get data of prevalence of testosterone deficiency in patient with T2DM in Russian Federation

Clinical and Epidemiological Characteristics and Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus Under Routine Clinical Practice (DESTINY)

Eligibility Criteria:
Inclusion Criteria:

* Male 45-60 years old
* Diagnosis of T2DM according to approved standards
* Signed Informed Consent Form

Exclusion Criteria:

* Prepubertal hypogonadism of any genesis;
* Sexual and developmental disorders;
* Absence of at least one of the testicles;
* Cryptorchidism, including in the anamnesis;
* Injuries and / or surgical interventions on the genitals with loss of at least one of the testicles;
* Established diagnosis of panhypopituitarism in accordance with current recommendations / standards;
* Androgen therapy, administered at the time of the study or in the anamnesis;
* Admission of anabolic steroids;
* Alcoholism or drug addiction;
* Insolvency.
Frequency of Axial Spondyloarthropathy Among Patients Suffering From Fibromyalgia

Fibromyalgia Syndrome (FMS) is a non - inflammatory condition characterized by the presence of chronic, widespread musculoskeletal pain and tenderness; FMS is considered to be the result of increased processing of pain by the central nervous system.

Axial spondyloarthropathy is the hallmark of Ankylosing Spondylitis (AS), an inflammatory joint disease involving the axial spine, the sacroiliac joints as well as peripheral joints.

Although FMS and AS differ vastly in their pathogenesis, a considerable clinical overlap may exist between these conditions. Both disorders typically cause chronic nocturnal back pain and disturbed sleep may accompany either condition. In addition,the investigators have previously described an increased prevalence of (secondary) FMS among female AS patients.

This overlap may have important clinical implications since the presence of comorbid FMS may lead to increased severity results on commonly used instruments in the evaluation of disease activity in AS, such as the BASDAI and BASFI .

Recently, the Assessment of Spondyloarthritis international Society (ASAS) has published updated classification criteria for axial spondyloarthropathy. These criteria, which are summarized in table 1, are based on the evaluation of patients suffering from chronic back pain with an age of onset of less than 45.

Objective:

The objective of the current study is to evaluate the prevalence of axial spondyloarthropathies among FMS patients, utilizing the new ASAS criteria.


Eligibility Criteria:
Inclusion Criteria:

Patients fulfilling American College of Rheumatology criteria for classification of Fibromyalgia:

* Widespread pain lasting over three months
* Tenderness in at least 11 of 18 points

Exclusion Criteria:

* Patients with known inflammatory joint disease prior to the study
* Patient not able to give informed consent
* Pregnant women
Adherence to New Oral Anticoagulation Therapy in Turkey

This study will compose a national database of drug adherence and investigate the factors that affect drug adherence in patients taking new oral anticoagulation therapy in Turkish Population.

NOACs have several clinical and pharmacological advantages over warfarin however suboptimal adherence is one of the most common causes of failure to respond to medications and outcomes.

This observational multicenter, retrospective study, will compose a national database of drug adherence and investigate the factors that affect drug adherence in patients taking new oral anticoagulation therapy in Turkey.

Social support and adherence to therapy factors that may affect drug adherence and adverse events will be assessed by self-report questionnaires.

Non-adherence will be tested for demographic, clinical, awareness of NOAC therapy and socioeconomic factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old
* Outpatients using a NOAC for at least 3 months duration, with a primary diagnosis of new-onset, non-valvular atrial fibrillation
* Patients signed patient informed sheet and informed consent form

Exclusion Criteria:

* Patients under 18 years old
* Patients refused to sign informed consent form
Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty

The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Adult subject 22 years or older
* Clinical indication for total shoulder replacement due to primary diagnosis of arthritis. Primary arthritis for this study includes osteoarthritis, and/or traumatic arthritis.
* Scapula and proximal humerus must have reached skeletal maturity
* Subject with a Constant Score ≥ 20
* Willing and able to comply with the protocol
* Willing and able to sign the informed consent (or the Legally Authorized Representative will sign for the subject)

Exclusion Criteria:

* Lack of sufficient sound bone to seat and support the implant such as:

  1. Rapid joint destruction, marked bone loss or bone resorption;
  2. Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and
  3. Osteomalacia
* Metal allergies or sensitivity, including a known allergic reaction to implant metals (e.g., nickel) or polyethylene
* Infection at or near the site of implantation, including:

  1. Glenohumeral joint infection
  2. Osteomyelitis
* Distant or systemic infection
* Medical conditions or balance impairments that could lead to falls
* Prior open shoulder surgery on the shoulder to be treated in the study including failed rotator cuff surgery, but excluding successful shoulder arthroscopy
* Any full thickness rotator cuff tear at the time of surgery or a nonfunctional rotator cuff
* Excessive glenoid bone loss defined by preoperative computed tomography (CT) scans of the shoulder which show insufficient glenoid bone, or insufficient bone identified at the time of surgery
* Metabolic disorders which may impair bone function
* Nonfunctional deltoid muscle
* Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint)
* Known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
* Currently, or within the last 6 months, or planning to be on chemotherapy or radiation
* Currently taking \> 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery
* Female subjects who are pregnant or planning to become pregnant within the study period
* In the surgeon's opinion, the subject is unable to understand the study or be compliant with the follow up or have a history of non-compliance with medical advice
* History of any cognitive or mental health status that would interfere with study participation
* Alcohol or drug abuse
* Engages in manual labor or sports activities that could affect shoulder outcome
* Currently enrolled in any clinical research study that might interfere with the current study endpoints
Safety and Feasibility of Reversible Induction Strategy

This study would explore the safety and feasibility of a reversible induction strategy for uncertain difficult airway. This reversible induction strategy would include high flow nasal canular oxygenation support, short-term effect anesthetic including Propofol and Remifentanil for sedation and analgesia and Sugammadex would be used for reverse the muscle relaxant.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old,\<65 years old
* Signed informed consent
* Undergoing selective operation （ time of operation is over two hours）
* ASA classification I-II
* Mallampati classification 3-4
* suspicious difficult airway, but the anesthetists decide to try to rapid induction

Exclusion Criteria:

* Patients with several dysfunctions of liver, kidney or heart)
* Patients with a full stomach or have other risk factors of reflux aspiration
* Any medicine was taken before surgery, which might enhance or mitigate the effects of muscle relaxant
* Infection of the mouth or nose
* Allergy history of any medicine which would be used in this study
* Pregnant and lactating women
* Patients with neuromuscular disease
Bone Formed Labial to the Implant in Relation to the Horizontal Gap Dimension in Immediate Implant Placement.

Palate implant placement in extraction sockets, with a minimum of 2 mm between the implant and the inner side of the facial socket wall, has been advised as a step towards a 3D restorative-driven posture. The buccal gap left by this palatal location is identified by the term "jumping gap" or "jumping distance," which describes the capacity of bone to fill the void and bridge the horizontal gap. The gap is made up of a vertical and horizontal component. Significantly, this gap denotes the future buccal bone that will directly contribute to the buccal contour and impact the soft tissue levels, thus influencing the implant's final appearance. Consequently, it is now considered desirable to have a bigger horizontal gap since more newly created buccal bone is predicted to occur in areas with larger horizontal gaps.


Eligibility Criteria:
Inclusion Criteria:

* anterior maxillary teeth
* Immediate implant placement

Exclusion Criteria:

* fractured apical part of the root
* teeth with apical resorption or displacement
Effect of Postpartum Hemorrhage Management Education Given with Kahoot Method on Knowledge, Self-Confidence in Intervention and Motivation Levels of Midwifery Students

This study was planned to investigate the effect of postpartum hemorrhage management training given with the Kahoot method on the knowledge, self-confidence in intervention and motivation levels of midwifery students. The research population will consist of third-year students studying at the Department of Midwifery, Hamidiye Faculty of Health Sciences (HSBF), Health Sciences University (SBU) in the spring semester of the 2024-2025 academic year (N: 80). In this semi-experimental pre-test and post-test design and control group planned study, in order to determine the sample size; the data were normally distributed, the standard deviation of the main mass was estimated as 1 and the effect size (effect size, difference) was estimated as 0.8. For the analysis to be conducted, it was calculated that the highest power value of the study would be 0.942182 if two independent n₁=40, n₂=40 samples were taken at a significance level of 5%. In addition, the adequacy of the sample size in the study will be evaluated with post hoc power analysis after the data are collected.

Students who volunteer to participate in the study will be assigned to the intervention and control groups using the computer-aided simple random sampling method. Computer-aided randomization will be used in the study, and the number of cases will be entered through the program with the URL address https://www.randomizer.org and random assignment will be made to the intervention and control groups. Before the data collection forms begin training, the "Informed Voluntary Consent Form" will be shared with the students participating in the study and their approval will be requested. The "Introductory Information Form", "Postpartum Hemorrhage Management Information Form", "Self-Confidence/Competence Scale in Patient Intervention" and "Motivation Scale Regarding the Teaching Material" will be applied to the students who agree to participate in the study.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research.
* Having internet access,
* Having a smart phone,
* Being an active student in the 3rd year of the Department of Midwifery at Hamidiye Health Sciences Faculty, University of Health Sciences.

Exclusion Criteria:

* Being a passive student in the 3rd year of the Midwifery Department of Hamidiye Health Sciences Faculty, University of Health Sciences.
* Not meeting the inclusion criteria.
Appropriate Timing of HAART in Co-infected HIV/TB Patients

To study the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment by comparing the composite end point of death rate, hospitalization rate and adverse drug reactions at week 48, 96 and 144.

The growing epidemic of HIV poses a serious public health threat in many countries, including Thailand. Mortality is clearly reduced in HIV and tuberculosis (TB) co-infected patients who initiate antiretroviral therapy (ART) after the treatment of TB, but the optimal timing to initiate ART is one of the major concern for patients concurrently receiving both therapies. To date, the prospective, randomized, control trial to study the optimal timing to initiate ART in the patients is still limited. In addition, the current recommendation to start ART in patients co-infected with HIV and TB is still based on expert opinions. Here, the investigators plan to investigate the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment by comparing the composite end point of death rate, hospitalization rate and adverse drug reactions at week 48, 96 and 144 at Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand.

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years of age
2. HIV-1 infected patients
3. Naïve to antiretroviral treatment
4. Baseline CD4 cell count \<350 cells/mm3 at enrolment
5. Diagnosed as having active tuberculosis by clinical features or positive acid fast stain or positive TB culture; and receiving rifampicin containing antituberculous regimen
6. Signed inform consent

Exclusion Criteria:

1. Serum transaminase enzymes ≥ 5 times of upper normal limit or total bilirubin ≥ 3 times of upper normal limit
2. Serum creatinine ≥ 2 times of upper normal limit
3. Lactation or pregnancy
4. Receiving any immunosuppressive agents
An Observational Study to Collect Information on the Safety of Gadolinium-Based Contrast Agents in Patients in India

This is an observational study in which data from patients undergoing enhanced MRI using gadolinium based agents (GBCAs) are collected and studied.

An MRI is a test that uses strong magnets and radio waves to make detailed pictures of the inside of the body. The contrast agents commonly used in MRI are gadolinium based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd), which helps to increase the signal intensity and contrast in MRI.

GBCAs have been used worldwide for MRI scans. GBCAs are generally considered safe. In some cases, there have been reports of mild to moderate side effects. There have also been reports indicating that small traces of Gd might stay in the body for an extended period after scans. However, there is no clear evidence that this causes any serious or long term problems in patients with normal kidney function.

There are different brands of GBCAs such as Gadovist and Magnevist. Knowledge about the safety of Gadovist and Magnevist in the Indian population is limited.

This study aims to enhance the currently available information on GBCAs and gather more information on the safety of Gadovist and Magnevist in the Indian population during GBCA enhanced MRI procedures in routine practice.

To do this, researchers will collect the following information:

* any possible medical problems occurring immediately after receiving GBCAs (Gadovist and Magnevist), and after 4 and 12 weeks of receiving GBCAs
* frequency of reporting medical problems after the use of GBCAs (Gadovist and Magnevist)

Patients will be asked to take part in the study only after confirming that they need a GBCA enhanced MRI, and the GBCA brand is already identified.

Data will be collected from February 2024 to September 2024. Healthcare professionals will collect safety data from selected sites which frequently conduct GBCA enhanced MRIs for patients who have not received GBCAs before.

Every patient scheduled for an MRI with contrast agents will be followed up at approximately 4 and 12 weeks after the GBCA enhanced MRI.

In this study, only safety data from routine practice are collected.


Eligibility Criteria:
Inclusion Criteria:

* GBCA-naïve male/female patients of at least 18 years of age.
* willing to participate in the active surveillance and agree to be contacted by phone after 6 (±2) weeks after the MR scan for brief interviews.

Exclusion Criteria:

* None.
Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging

Children 2-11 years of age who are given the influenza vaccine (inactivated influenza (IIV) or live attenuated influenza vaccine (LAIV)) as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. Children enrolled in this study will be observed daily for an eight-day period starting on the day of vaccine administration, and then continuing over the next 7 days, and then weekly for 42 days. On the day of enrollment and nightly for the next seven days, the parent will report via text message what their child's highest temperature is. If fever is present, they will then be prompted for additional information including other symptoms, antipyretic use and medical care sought. On day 3 as well as weekly from day 7 through day 42 post-vaccination, parents will be asked via text message about breathing problems, specifically cough, wheezing and chest tightness. They will also be asked about medications taken and care sought. The purpose of this study is to assess the feasibility of collecting this data.


Eligibility Criteria:
Inclusion Criteria:

1. are 2 through 11years of age,
2. have a visit at a study site anytime during the study period,
3. receive first dose or second dose of LAIV4 or IIV in the season,
4. the parent has a cell phone with text messaging capabilities, and
5. the parent and child \> 7 years of age speaks English or Spanish at the Columbia sites or English at the Boston site.

Exclusion criteria:

1. presence of fever ≥100.4 at time of vaccination,
2. administration of any antipyretic in the 6-hour period prior to vaccination,
3. stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
4. parent only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
5. enrollee is a child \>7 years of age who only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
6. parent's inability to read and send text messages,
7. sibling already enrolled this season (OR cell phone # already used for another child)
8. chronic medical condition considered by ACIP to be a precaution or contraindication for LAIV1 (except for asthma),
9. current asthma exacerbation, or exacerbation in the last 2 weeks
10. use of oral or other systemic steroid within the last 2 weeks