cyrilzakka/clinical-trials huggingface dataset:
Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP\~T vaccine is consistent.

The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP\~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series.

The secondary objectives are:

* To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series
* To assess the overall safety in each group one month after the third dose of the primary series.


Eligibility Criteria:
Inclusion Criteria :

* Two months old infants on the day of inclusion
* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
* Informed consent form signed by one or both parents or by the guardian and two independent witnesses
* Able to attend all scheduled visits and to comply with all trial procedures
* Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.

Exclusion Criteria :

* Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency
* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received since birth
* Any vaccination in the four weeks preceding the first trial visit
* Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
* Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
* Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
* Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of seizures
* Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Prospective Observational Study on Ustekinumab (Stelara) Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease

The main purpose of this study is to assess ustekinumab's ability to induce clinical response and remission ("effectiveness") at Week 16 and remission at Week 52 and Week 104 in participants with Crohn's disease (CD). Response and remission will be assessed using clinical parameters. Retention rate at week 52 and 104 will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a diagnosis of CD confirmed by investigator
* Participants with active CD who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic therapy or have medical contraindications to such therapies
* The participant must sign informed consent before enrollment in the study. The consent form permits extraction of data from SWIBREG at baseline and during participation of the study and linkages to the Patient Registry (Patientregistret), SCB's registry USA for occupational details (Longitudinell integrationsdatabas for sjukforsakrings- och arbetsmarknadsstudi er), the Social Insurance registry on long-term sick leave (Forsakringskassans register gallande sjukskrivningar) and the Prescription registry (Lakemedelsregistret)
* The participant must have been initiated on treatment with ustekinumab within the last 2 weeks (that is including those who already discontinued) or started on ustekinumab treatment less than (\<) 3 months ago if treatment start was documented in SWIBREG within 2 weeks of onset and has a record of Harvey Bradshaw Index (HBI) when starting ustekinumab

Exclusion Criteria:

* The participant is enrolled in a clinical trial (randomized or non-randomized) in which the treatment of CD is dictated by a study protocol. If the participant is participating in another observational study (non-interventional), the participant may be included in this observational study
* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the start of the study or the first data collection time point
* Participants who started ustekinumab despite contraindications for use
* Participants with planned stop of treatment with ustekinumab within 24 months from onset of treatment, that is bridging to other treatment or pregnancy planned
Short-term Effects of Physiotherapy on LCI

Although some studies have brought some evidences about the efficacy of positive expiratory pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly understood what is the contribution of this technique in modifying peripheral ventilation inhomogeneity, a typical feature of patients with Cystic Fibrosis (CF).

The aim of this study is to investigate how PEP-MASK affects ventilation inhomogeneity in children and adolescents, with moderate to normal CF lung disease by the change in acinar airways (Sacin), lung clearance index (LCI) and conductive airways (Scond) indexes derived from nitrogen multiple-breath washout test (N2MBW).

Investigational device: PEP-MASK=Positive Expiratory Pressure delivered through a face mask.

Standard Operating Procedures used for evaluating CF lung disease and ventilation inhomogeneity.

Sample size: Based on preliminary data collected on seven subjects who performed nitrogen multiple-breath washout test before and after PEP-MASK, assuming a variation of 20% of Sacin, the study requires a sample size of 18 subjects.

Eligibility Criteria:
Inclusion Criteria:

* CF diagnosis
* Patients hospitalized for a scheduled intravenous antibiotics cycle and regularly followed-up by the CF Centre
* ≥ 15 kilograms
* FEV1 ≥ 40%predicted
* Ability to perform NMBW test
* Ability to perform spirometry
* Willing to adhere to protocol procedures
* Patients in treatment with PEP-MASK

Exclusion Criteria:

* Pulmonary Exacerbation within two last week
* Burkholderia cepacia infection
* Patients in lung transplantation waiting list
* Patients undergoing non invasive mechanical ventilation or oxygen therapy
A Clinical Validation Study to Evaluate the Diagnostic Accuracy of a Cough-based Auxiliary Diagnosis Algorithm for COPD

Cough is one of the most common symptoms in COPD patients, and its different characteristics in amplitude, frequency and waveform can be analyzed by intelligent algorithms for the auxiliary diagnosis of COPD. The current study is to conduct external clinical validation of COPD auxiliary diagnosis algorithm and lung function prediction algorithm, and preliminatively verify the performance of the algorithm, with the ultimate goal of developing a portable and rapid COPD auxiliary diagnosis and condition assessment tool that can be used at home.


Eligibility Criteria:
Inclusion Criteria:

* patients with stable COPD were recruited for this study. Inclusion criteria were age ≥40 years and a diagnosis of COPD

Exclusion Criteria:

* Exclusion criteria were acute exacerbations of respiratory symptoms within the past 2 weeks or significant comorbid cardiovascular, neurological, musculoskeletal, immunological, or infectious diseases.
A Study of HS-20124 in Patients with Advanced Solid Tumors

HS-20124 is a novel DAR-8 antibody-drug conjugate （ADC） targeting CDH6. In preclinical studies, it inhibited tumor cell growth expressing CDH6 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20124 in Patients With Advanced Solid Tumors.

This is a Phase 1a/1b open-label, multicenter study with dose escalation and dose expansion cohorts to evaluate the safety, tolerability, PK and preliminary efficacy of HS-20124 in patients with advanced solid tumors.

The dose escalation will utilize rolling-6 design. In phase of dose expansion, preliminary efficacy will be evaluated in planned expansion cohorts that include patients with specific advanced solid tumor types.

Eligibility Criteria:
Inclusion Criteria:

1. At least age of 18 years at screening;
2. Histologically or cytologically confirmed, locally advanced or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable
3. At least one extra-cranial measurable lesion according to RECIST 1
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1
5. Life expectancy \>= 12 weeks
6. Men or women should be using adequate contraceptive measures throughout the study;
7. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential
8. Signed and dated Informed Consent Form

Exclusion Criteria:

1.Treatment with any of the following:

1. Previous or current treatment with CDH6 targeted therapy
2. Any cytotoxic chemotherapy and small molecule targeted anticancer drugs within 21 days or five half-livesprior to the first scheduled dose of HS-20124
3. Prior treatment with a monoclonal antibody or investigational agents within 28 days prior to the first scheduled dose of HS-20124
4. Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20124
5. Major surgery within 4 weeks prior to the first scheduled dose of HS-20124 2. Subjects with previous or concurrent malignancies 3. Inadequate bone marrow reserve or organ dysfunction 4. Evidence of cardiovascular risk 5. Evidence of current severe or uncontrolled systemic diseases 6. Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20124 7. Severe infection within 4 weeks prior to the first scheduled dose of HS-20124 8. Subjects with current infectious diseases 9. History of neuropathy or mental disorders 10. Pregnant or lactating female 11. History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20124 or any of the components of HS-20124
Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection

This study was conducted to compare the effects of intrathecal versus intravenous dexmedetomidine administration in patients undergoing Transurethral resection of the prostate under spinal anesthesia.

Multiple prostatic pathologies become evident in the elderly males. Of them, benign prostatic hyperplasia is one of the most prevalent issues in aging men and transurethral resection of the prostate (TURP) still represents the standard surgical treatment.

Most transurethral resection of the prostate (TURP) procedures are performed under spinal anesthesia. Spinal anesthesia has many advantages including, easy application, low cost, decreasing the risk of aspiration, decreasing intraoperative bleeding, eliminating the need for mechanical ventilation together with the decreased risk of intraoperative cardiac events or post-operative hypoxic episode.

The management of post-operative pain following spinal anesthesia using a short-acting anesthetic still constitutes a major problem for anesthesiologists and pain physicians. However, the duration and efficacy of spinal anesthesia could be improved by adjuvants.

Dexmedetomidine is an alpha 2 receptor agonist that have antinociceptive action for both visceral and somatic pain. At low doses, it has sedative and hypnotic effects without having a negative impact on respiration. Multiple studies have reported that intrathecal and intravenous administration of this drug could prolong the duration of spinal anesthesia and post-operative analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Cases aged between 50 and 70 years
* Having class I or II according to the American society of anesthesiologists (ASA)

Exclusion Criteria:

* Cases with heart block
* Dysrhythmia
* Contraindications for spinal anesthesia
* Known allergy to the study medications
* Classified as ASA class \> II
* Alpha 2 agonist or antagonist therapy.
Ventricular Assist Device (VAD) Research Registry and Blood Sub-Study

This study is meant to predict the outcome of VAD therapy, by forming a VAD registry for quality assessment, research, and real-time monitoring of patients on VAD therapy. The goal is to optimize the use of VAD therapy for patients, to create an online quality measurement tool for VAD treatment, and to create algorithms to estimate the prognosis for patients getting a VAD.

Patients eligible for VAD are being sampled before surgery for plasma as well as peripheral blood cells. After surgery patients are being sampled again at 24 h and 7 days. Inflammatory response is being monitored on gene expression as well as cell level and on cytokine level in relation to the outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years of age
2. Subject is treated with a VAD at the Butterworth Campus, Spectrum Health.

Exclusion Criteria:

1. Subject is less than 18 years of age.
2. Known prisoners of the state.
3. Subject is pregnant.
4. Non- English speaking patients will be excluded from the blood sub-study
Action Regulation Behavioral

Parkinson's disease (PD) is a neurodegenerative disorder involving a part of the brain that is responsible for motor control, which not only results in changes or disruptions in movement, but also cognitive dysfunctions. Given that the decline of muscle control such as tremors, with difficulty walking or the ability to switch tasks once in movement, greatly affects the quality of daily life. Action regulation is a critical executive function (cognitive control over behavior), which includes actions such as suppressing activity when selecting between options, making decisions about stopping unwanted or inappropriate actions, and switching to new actions in response to environmental changes. Parkinson's disease (PD) has been shown to disrupt action inhibition which can be considered a measure to the progression of PD.

The purpose of this research study is to better understand the mechanism of action regulations in PD patients and how action regulations in PD can be improved using dopaminergic treatment, which is a drug that either releases or involves dopamine, which is a neurotransmitter involved in sending signals to nerve cells.

You are asked to participate in this research study because you are receiving a dopaminergic medication for treatment of your Parkinson's disease. There is currently no theory that integrates the mechanisms of action regulation into a unified framework, which this study aims to address. The researchers hope to learn more about the mechanisms of action regulation in PD patients and to help decrease action regulation disruptions in PD patients. This study will help characterize the motor behavior of PD patients.


Eligibility Criteria:
For Parkinson's Disease Patients:

Inclusion Criteria:

* Diagnosis of Parkinson's Disease by a movement disorder neurologist
* Levodopa responsive with clearly defined "on" periods, with at least 30% improvement in UPDRS III scores on vs off
* Willingness and ability to complete the behavioral experiments for up 3.5 hours
* No vision or hearing problems that impair ability to participate with the proposed tasks as assessed by the study investigators

Exclusion Criteria:

* Patients with history of secondary Parkinsonism, stroke, or progressive central nervous system disease other than Parkinson's Disease
* Patients with a disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocol including cognitive decline, diagnosed forms of dementia, significant memory impairment (MoCA\<23), or hearing loss that prevents adequate communication with researcher

For Healthy subjects:

Inclusion Criteria:

* No history any diagnosed neurological disease(s), including movement disorders or cognitive decline
* No vision or hearing problems that impair ability to participate with the proposed tasks as assessed by the study investigators
TEE Training for Anaesthesiologists

This study aims to find out the best sequence of teaching and learning events (i.e. first lecture and then simulated training or first simulated training and then lecture) in the acquisition of knowledge on Transoesophageal Echocardiography among trainee and specialist anaesthesiologists.

Basic Transoesophageal Echocardiography (TEE) is an essential skill in the armamentarium of an anaesthesiologist. Currently, majority of the TEE teaching is being done in the form of didactic lectures with only a few teaching centres offering simulation. TEE skill acquisition includes both technical and cognitive skills. Most of the studies done in TEE teaching have concluded that TEE simulation is an essential part of TEE skill training. The study team wanted to find out what is the best sequence of teaching to achieve the maximum skill acquisition in TEE.

In National University Hospital, Singapore, the Cardiac subdivision of anaesthesia specialists are accredited in TEE (American or European exams) and perform independent decision making in cardiac surgical theatres while the surgery is on-goingto facilitate dynamic decision making such as adequacy of valve repair, global LV function and emerging complications if any. The study team realised that TEE skills are also required for decisions beyond the cardiac surgical theaters where on the spot critical decisions making is required eg: in polytrauma and sudden unexplained hypotension or hypoxia in non-cardiac or ICU patients.

There are existing induction modules and prior teaching avenues in the department of anaesthesia such as the Cardiac Anaesthesia Simulation Training (CAST) module targeted at junior trainee's level. With initiative to equip every practicing anaesthesiologist with the vital skill of TEE image acquisition, the department of anaesthesia is launching a teaching program that is an in house training session. The study team aims to understand through this study the ideal sequence of teaching intervention to facilitate optimal learning and retention.

Eligibility Criteria:
Inclusion Criteria:

* All anaesthesia doctors in Singapore with no prior experience in TEE.

Exclusion Criteria:

* All anaesthesia doctors in Singapore with prior experience in TEE.
Adverse Events With Magnesium Sulfate

To investigate in pregnant women the adverse pulmonary effects of magnesium sulfate (MgSO4), a commonly used drug for tocolysis or arrest of labor.

BACKGROUND:

Preterm labor is a major public health concern in the United States. The delay of labor, particularly for idiopathic preterm labor, is important because it allows further fetal development and the opportunity to administer steroids which improve fetal lung maturity. It is now common for MgSO4 to be administered to delay labor. The most dangerous adverse event with MgSO4 treatment is the development of pulmonary edema which may lead to maternal adult respiratory distress syndrome and death with associated fetal morbidity and mortality. The estimates of the frequency of this complication vary from 0 to 8 percent. Therefore, improved understanding of the pulmonary toxicity of this therapeutic agent is clinically important.

DESIGN NARRATIVE:

There were three phases in the study. The first, a retrospective cohort study, examined the incidence rate of pulmonary edema when MgSO4 was administered as a tocolytic agent. The second, a case-control study nested within the cohort, examined the relationship between the patient and other clinical factors and the incidence of pulmonary edema in patients treated with MgSO4. The third phase used the results of the case-control study to develop and validate a predictive index to define a group of patients at increased risk of developing pulmonary edema associated with MgSO4.

Patients were identified using ICD-9-CM codes for preterm labor and delivery. The medical record was reviewed to determine exposure to MgSO4 as a tocolytic agent, excluding patients who received MgSO4 for other indications. Cases were defined as probable when patients met the clinical definition for pulmonary edema, including chest X-ray findings. The medical charts of both cases and a random sample of non cases were then reviewed in detail and the data from these groups were compared. The primary analysis of these case-control data included unadjusted analysis and multivariable explanatory models to provide insight into the risk factors for pulmonary edema associated with MgSO4. The data from the case-control study were used to develop a clinical predictive index. The predictive rule was then validated in a separate patient population.

Eligibility Criteria:
No eligibility criteria
An Observational Study to Learn More About the Use of Darolutamide as a Part of a Combination Therapy in Belgian Men With Metastatic Hormone-Sensitive Prostate Cancer in Routine Medical Care

This is an observational study in which only observations from routine clinical practices will be made. Participants will not receive any advice on treatment or any changes to healthcare as a part of the study.

In this study, medical records data of Belgian men with metastatic hormone sensitive prostate cancer (mHSPC) who had received or are receiving treatment with darolutamide in combination with androgen deprivation therapy (ADT) and docetaxel will be studied.

mHSPC is a cancer of the prostate gland, a male reproductive gland found below the bladder. Metastatic means that the cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with hormone-therapy such as androgen deprivation therapy (ADT).

ADT lowers the level of androgens, male hormones, and slows down the growth of cancer cells. However, in some cases, ADT alone is not sufficient for the treatment of mHSPC and doctors recommend a combination of treatments.

The study drug darolutamide, in combination with ADT and docetaxel is an approved treatment for mHSPC. Darolutamide aims to work by blocking the androgens signals to slow the growth of the cancer cells. Docetaxel is a medicine used to treat different types of cancer and works by stopping the growth and spread of cancer cells.

The main purpose of this study is to learn more about the real-world use of darolutamide in combination with ADT and docetaxel in Belgian men with mHSPC.

To do this, researchers will study the following information about participants who are already prescribed this combination treatment by their treating doctors in real-word condition:

* Participants' cancer characteristics before starting the treatment, and
* Participants' treatment history The data will be collected between July 2024 to September 2024, from eligible participants' medical records.

Study doctors will only look at the medical records of adult men with mHSPC in Belgium.

In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with mHSPC
* Patients treated with darolutamide (Nubeqa, BAY1841788) in combination with ADT and docetaxel according to local reimbursement
* Initiation of treatment with darolutamide (Nubeqa, BAY1841788) in this indication between the index date (should be before 15MAR2024) and start of data collection.

Exclusion Criteria:

* Participation in an investigational program with interventions outside of routine clinical practice
* Contraindications according to the local reimbursement