cyrilzakka/clinical-trials huggingface dataset:
A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis

The purpose of this study is to demonstrate the safety of chronic use of abatacept in Japanese Subjects with Rheumatoid Arthritis (RA) having completed clinical studies IM101-071, IM101-034, and also Disease Modifying Anti-Rheumatic Drugs (DMARDs) failures with MTX intolerance.


Eligibility Criteria:
Inclusion Criteria

* The participants who completed the 169 days, full study period of Phase II (IM101-071) and were not administered other biologics between completion of IM101-071 and registration of this long-term study.
* The participants of the Phase I study (IM101-034), who received abatacept, except participants who were withdrawn from the study due to safety problems related to abatacept.
* New subjects with MTX intolerance: rheumatoid arthritis (RA) patients to whom MTX cannot be administered for safety reasons and who present an inadequate response to disease-modifying antirheumatic drugs (DMARDs;excluding MTX) or biologics (new subjects with MTX intolerance: RA patients who present an inadequate response to DMARDs).

Exclusion Criteria

* Women of childbearing potential (WOCBP) who were unwilling or unable to use an acceptable method of contraception.
* Participants who have received non approved or investigational biologics (other than abatacept from previous or ongoing studies in Japan) at registration.
* Participants who have received treatment with any investigational drug within 56 days before registration or five half-lives (whichever is the longest).
* Participants currently receiving treatment with leflunomide, mycophenolate mofetil, calcineurine inhibitors such as cyclosporine and tacrolimus, D-Penicillamine, Cyclophosphamide, or immunoadsorption columns.
* The participants who completed Phase II (IM101-071) are not applicable in the following instances at time of registration: with active vasculitis, symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, breast cancer, or a history of cancer within the last 5 years, evidence of active or latent bacterial , viral infections, any serious or chronic, at risk of tuberculosis (TB), with any opportunistic infections, laboratory values of hemoglobin \< 8.5 g/dL, white blood cells (WBC) \< 3,000/mm\^3, Platelets \< 100,000/mm\^3, Serum creatinine \> 2 times upper limit of normal (ULN), Serum alanine transaminase or aspartate aminotransferase \> 2 times ULN.
A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of a single dose of long-acting growth hormone (NNC0195-0092, somapacitan) compared to daily dosing of Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of GHD (growth hormone deficiency) as defined by two different GH (growth hormone) stimulation tests, peak GH level below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test will be needed. If in accordance with country specific practice, growth hormone deficiency can be defined by only one GH stimulation test, peak GH level below or equal to 7.0 ng/ml.
* Pre-pubertal children at screening. Boys: Tanner stage 1 and age above or equal to 6 years and below 13 years. Girls: Tanner stage 1 and age above or equal to 6 years and below 12 years
* Body weight above or equal to 16.0 kg and below or equal to 50.0 kg
* Stable GH replacement treatment for at least 3 months

Exclusion Criteria:

* History or presence of malignancy
* Overt diabetes mellitus (fasting blood glucose above or equal to 7.0 mmol/l)
Serum Estradiol (E2) Levels in Breast Cancer Patients During Endocrine Therapy by High Performance Liquid Chromatography-tandem Mass Spectrometry (LC-MS /MS)

The investigators intend to conduct a prospective cohort study to detect E2 levels during endocrine therapy in Chinese breast cancer patients using LC-MS/MS methods, and to determine the proportion of patients with premenopausal E2 levels (OFR or E2 insufficiency) during AIs or FUL endocrine therapy. To further explore the correlation between serum E2 levels and the efficacy of endocrine therapy in Chinese patients, so as to ensure the safety and efficacy of endocrine therapy for patients, and pave the way for further providing more accurate individualized treatment programs.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old;
* Histologically confirmed breast cancer;
* Patients with early breast cancer (including natural menopause and artificial menopause using LHRHa), or patients with advanced breast cancer (including natural menopause and artificial menopause using LHRHa) who use AIs (letrozole, anastrozole or exemestane) as adjuvant endocrine therapy, First-line CDK4/6 inhibitors (Palbociclib, Dalpiciclib, Abemaciclib or Ribociclib) +AI endocrine therapy, second-line CDK4/6 inhibitors (Palbociclib, Dalpiciclib, Abemaciclib or Ribociclib) + fluvestrant (FUL) endocrine therapy;
* Patients with needs for hormone testing;
* Standard treatment, complete clinical data, including complete efficacy evaluation and follow-up data.

Exclusion Criteria:

* Breast cancer patients using TAM endocrine therapy;
* In advanced patients, AIs exceeded first-line use (that is, in advanced disease, one endocrine therapy regimen had been used and failed), and FUL exceeded second-line use (that is, more than one endocrine therapy regimen had been used and failed)
Inflammatory and Metabolic Prognostic Assessment in Critically Ill Neurological Patients

The study aims to develop and validate a prognostic prediction model for adverse outcomes in neurocritical patients receiving enteral nutrition based on key inflammatory and metabolic markers. This model will serve as a clinical tool to help physicians identify high-risk patients and guide individualized nutritional support strategies.

A multi-center, prospective case data collection study will be conducted across 19 tertiary hospitals in China. Based on this, a predictive assessment model for poor prognosis in neurocritically ill patients receiving enteral nutrition support will be developed and validated, using key inflammatory and metabolic markers. During the data collection process, comprehensive clinical information will be extracted, including patient demographic data, clinical indicators, and hematological markers. By conducting in-depth analysis and processing of this vast and detailed clinical and laboratory data, a nomogram for predicting poor prognosis in neurocritical care patients receiving enteral nutrition support will be constructed using statistical methods and data analysis techniques in R. Once the model is built, it will undergo rigorous validation on an independent external dataset to ensure its accuracy and reliability. The goal is to create a precise assessment tool for clinicians, helping them to quickly and accurately identify high-nutritional-risk patients, thereby providing a solid scientific foundation for the formulation of individualized nutrition support strategies, ultimately improving the prognosis of neurocritical patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years, no gender restrictions.
2. Within 7 days of disease onset and expected NICU stay of at least 7 days.
3. Eligible for enrollment within 24 hours of NICU admission, with enteral nutrition (EN) initiated and continued for at least 7 days.
4. Non-traumatic severe brain injury patients (including cerebrovascular disease and encephalitis) with a Glasgow Coma Scale (GCS) score ≤12.
5. NRS 2002 score ≥3.
6. Kuwata drinking test ≥ grade 3.
7. Acute Gastrointestinal Injury (AGI) grade 1 or 2.
8. Signed informed consent obtained from the patient or their legal representative.

Exclusion Criteria:

1. Severe malnutrition prior to admission, defined as BMI \< 16 kg/m².
2. Pregnant or lactating women.
3. Receiving hypothermia treatment or core body temperature \< 36°C.
4. End-stage disease with an expected survival time of \< 48 hours, or severe dysfunction of the heart, lungs, or other vital organs, leading to hemodynamic instability.
5. Malignant tumors.
Excia T Cementless EBRA Study

In this Post Market Clinical Follow-up Study (PMCF Study), the short-term clinical and radiological results of the cementless Excia T® prosthesis in routine clinical use shall be assessed and the migration taking place in the first 24 months evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Written patient consent to study participation
* Age \> 18 years
* Indication for primary THA with cementless Excia T® stem

Exclusion Criteria:

* Pregnancy
* THA after fracture
* Rheumatoid arthritis
* Systemic disorders, treated with Cortisone or other pharmaceuticals, potentially compromising the bone quality
* Patient physically or mentally not able to follow the postoperative examination routine
Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis

To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis requiring surgery between 30 to 60 minutes after a bolus of 1 g IV meropenem given during the induction period of anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diagnosis of severe pancreatitis requiring surgery according to the protocol of each Institution.
* Informed consent signed by the subject
* Subjects who have received prophylactic antibiotics for previous invasive procedures different from surgery may be included

Exclusion Criteria:

* Will of the subject not to be included
* Subjects who have not signed the informed consent
* Subjects with known hypersensibility to carbapenems, penicillins, or cephalosporins
Effect of Fluconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects

The primary objective of the study is to evaluate the effect of fluconazole on pharmacokinetics of pyrotinib tablet for oral administration in healthy Chinese adult subjects. The secondary objective of the study is to compare the safety of pyrotinib alone and co-administered with fluconazole.


Eligibility Criteria:
Inclusion Criteria:

1. Participants has given written informed consent with full understanding of the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
4. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);
5. Willing to take contraception or male subjects who can guarantee not to donate sperm during the trial and within 6 months after the last dose; female subjects with fertility who did not use contraception for at least 2 weeks before dosing;

Exclusion Criteria:

1. Allergic constitution or Allergic to a drug ingredient or component;
2. History of drug use, or drug abuse screening positive;
3. Alcoholic or often drinkers;
4. Left ventricular ejection fraction (LVEF) \<50% by echocardiography;
5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system;
6. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases;
7. Participated in a clinical trial and has received an investigational product within 3 months prior to the first dosing day in the current study;
8. Positive value of HBsAg、HCV-Ab、HIV-Ab、TPPA at screening；
9. Blood loss ≥400mL within 3 months before first dosing;
10. Patients who had a positive blood pregnancy test and were breastfeeding at the time of screening.
11. The investigators determined that other conditions were inappropriate for participation in this clinical trial .
Postoperative Vasopressor Usage: SQUEEZE

A prospective multi-centre international observational study of postoperative vasopressor use, designed to answer the question: 'What is the proportion of patients that receive vasopressor infusions? In the management of these patients;

* Are there variations in the practice between clinicians, hospitals or countries? If yes, are they associated with clinical outcome?
* What are the health economic impacts associated with receiving vasopressors?

Postoperative hypotension is a common occurrence following major non-cardiac surgery and the use of vasopressors in the postoperative period to support blood pressure following optimisation of fluid status is commonplace. Receipt of infused vasopressors postoperatively is considered as a surrogate indicator of significant vasodilation. However, the incidence of postoperative vasopressor therapy has never been described.

By contrast to septic shock, there is no uniform definition of postoperative vasoplegia. Receipt of any amount of vasopressor would provide an objective dichotomous definition but a limitation would be the inability to differentiate degrees of vasodilation. Use of a threshold dose of infused vasopressor to determine a definition is uncomfortably arbitrary. There have been trials of different vasopressors to treat postoperative vasoplegia in cardiac surgical patients and we intend to gather data to inform future design in noncardiac surgery.

In addition, there is evidence of substantial variation in the management of postoperative hypotension between centres, countries and continents. The variation is in assessment (cardiac output and invasive monitoring) and environment (post-operative care units, high-dependency units, ICUs) and management (use and choice of fluids and vasopressors/inotropes). We hypothesise that there is also variation in the incidence of organ dysfunction and the use of organ support, and in clinical outcomes including duration of stay and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgery (may be planned or unplanned)
* No plans for return home on the day of surgery, for medical reasons
* Age ≥ 18 on day of surgery

Exclusion Criteria:

* Cardiac surgery
* Obstetric surgery
* Transplant surgery
* Receiving long-term infusions of vasoactive drugs, such as epoprostenol
* Mechanical circulatory support: ventricular assist device, intra-aortic balloon pump, artificial heart or similar
* Already been enrolled in Squeeze

For Cohort B - One additional inclusion criterion:

* Receiving infusion of vasopressors that continues after the patient has left the operating room.
Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -

Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects


Eligibility Criteria:
Inclusion criteria:

* Obese volunteer Subject (BMI\> 30 kg/m2)
* Adults of either sex
* Social security affiliation
* Written informed consent

Exclusion criteria:

* Confirmed OHS at baseline defined by a daytime hypercapnia with PaCO2\> 45mmHg
* Any cause of chronic respiratory failure other than obesity such as COPD, chest deformation, phrenic nerve paralysis, pulmonary fibrosis, neuromuscular disease, a history of mutilating thoracic surgery ...
* Obstructive ventilatory defect with FEV1/ FVC \<70% post-bronchodilator
* Long term oxygen therapy, noninvasive ventilation, continuous positive airway pressure
* Any serious illness involving life-threatening within 3 years after inclusion
* Drug or alcohol abuse
* Pregnancy
Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

This study will assess the rate of objective confirmed tumor response of irinotecan in combination with temozolomide in children with recurrent or refractory medulloblastoma and in children with newly diagnosed high-grade glioma.


Eligibility Criteria:
Inclusion Criteria:

* Cohort 1: Recurrent or refractory medulloblastoma in which current standard treatment approaches have failed; biopsy is not required for recurrent disease.
* Cohort 2: Newly-diagnosed high-grade glioma (World Health Organization \[WHO\] grade 3 or 4)
* Life expectancy ≥ 3 months

Exclusion Criteria:

* Diagnosis of brainstem glioma
* Concurrent administration of any other anti-tumor therapy
* Pre-existing uncontrolled diarrhea
Monocyte Priming When Consuming a Western Diet

To determine the mechanism of monocyte priming in humans, the study team will conduct a complete feeding trial in normal weight and metabolically healthy human subjects (20-45 years of age) using a western diet (WD), characterized as being high-saturated fat, high-fructose, and high-calorie for 8 weeks.

The goal is to challenge metabolically healthy human subjects with a high-calorie, Western diet for 8 weeks to identify the metabolite(s) responsible for monocyte priming and use redox proteomics, RNAseq and Chipseq to determine the genes and pathways involved in monocyte priming in humans. To reflect some key components of the typical Western intake, the Study Team will compose the diet to be high in saturated fat (15% of total energy intake) and fructose (14% of total energy intake) with excess energy intake that is 25% higher than estimated total energy expenditure. A total of 30 participants, including 15 men and 15 women, will complete a run-in phase where weight stability will be achieved on the control diet. After weight is stabilized during the run-in period, participants will enter the experimental phase of the dietary intervention, where overfeeding will begin with additional calories provided by the key nutrients as noted above. Participants will be monitored throughout the feeding trial. After completion of the 8-week overfeeding period, individuals will be allowed to return to a normal dietary intake. All study participants will be given access to counseling for weight reduction should it be needed following the overfeeding period.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-45
* Planning to be available for the entire study period
* Able to speak and read English
* Normal weight (body mass index 18.5-24.9 kg/m2)
* Able to eat the prescribed diet
* Non-smoker

Exclusion Criteria:

* Excessive alcohol consumption
* History of chronic cardiometabolic disease or major risk factor, including diabetes, hypertension, hyperlipidemia, heart disease
* History of prior surgical procedure for weight control or liposuction
* Use of weight loss medications in previous 6 months
* Recent self-reported weight change
* Severe pulmonary disease requiring supplemental oxygen
* Abnormal renal or liver function
* History of non-skin cancer in the past 5 years
* Regular use of medications (prescribed or over-the-counter) that affect blood pressure, lipids, glucose, inflammation, or body weight
* Works night shifts
* Exercise per week \> 420 minutes total for moderate activity or \> 210 minutes for vigorous activity
* Any medical or behavioral indication that would make participation unsafe based on the judgement of the study physician
* Pregnant or lactating women
* Known or discovered intolerances, allergies or difficulty consuming any of the foods included in the study diets
Retrospective Assessment of the Morphology of Acetabular Defects: A 3D Reconstruction Approach

In this study, we aim to develop a statistical shape model and use it to reconstruct the shape of acetabula with severe defects (Paprosky 3a-3b). This will allow us to visualise and assess the morphology of the missing bone. In future studies we will use the obtained results to improve the design of acetabular implants for revision surgery.


Eligibility Criteria:
Trainings dataset for statistical shape model:

* Patients where a bilateral CT of the hip was performed with unilateral pathologies.
* We aim to include an equal amount of scans from each gender and varying ages.

Dataset of defect acetabula used for reconstruction:

* Patients who received a CT scan of the hip after removal of a primary/revision implant (e.g. patients where debridement was performed due to infection.)
* Patients where the defect can be classified as a Paprosky 3a or 3b defect.
Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection

Pilot study to evaluate the impact of extremely early ART in the dynamics of viral reservoir, immune activation and inflammation in patients with HIV-1 infection of less than 20 days (Fiebig stages I-II) compared to patients with infection of 20-100 days (Fiebig stages III-V), to induce HIV functional cure.


Eligibility Criteria:
Inclusion Criteria:

* Men who have sex with men
* Male's between18 and 65 years old
* Less than 100 days of infection
* Patient stage Fiebig I to V
* Negative or Incomplete western blot with negative p31 band

Exclusion Criteria:

* P31 positive band in western blot
* Positive Delta32 CCR5 mutation, HLA-B5701 or HLA-B27 (´late' exclusion criteria)
* Active oncological disease
* Active hepatitis C virus infection
Efficacy of S(+)-Ketamine Administered as a Continuous Infusion for the Control of Postoperative Pain

Background: The use of low-dose continuous infusion of S(+)-ketamine combined with target-controlled intravenous anesthesia with remifentanil and propofol may be related to the control of postoperative pain and of opioid-induced hyperalgesia. The present study aimed to evaluate the efficacy of continuous infusion of S(+)-ketamine given intraoperatively in the control of postoperative pain compared to placebo.

Methods: This is a double-blind randomized controlled trial with 48 patients of both genders aged from 18 to 65 years who underwent videolaparoscopic cholecystectomy. After venipuncture, patients received intravenous parecoxib sodium (40 mg). Target-controlled intravenous anesthesia was induced with propofol and remifentanil associated with rocuronium and adjusted to maintain the bispectral index between 35 and 50. The S(+)-ketamine group (SG) group received a continuous infusion of S(+)-ketamine at a dose of 0.3mg.kg-1.h-1, while the placebo group (PG) received a continuous infusion of saline at the same dose. Postoperative analgesia was measured by a verbal numerical scale (VNS) from 0 to 10 during 12 hours and treated with morphine when VNS score was equal to or higher than 3 at a dose of 0.05 mg.kg-1 when the patient reported pain for the first time and at a dose of 0.025mg.kg-1 on subsequent occasions. Pain scores were recorded in the postoperative care unit (PACU) and at 4 and 12 hours after the end of the surgery The amount of morphine used during PACU stay, from PACU discharge to 4 hours after surgery, and from 4 to 12 hours after surgery, the overall dose of morphine used, and possible adverse effects were also assessed

Eligibility Criteria:
Inclusion Criteria:

* 18 Years to 65 Years ASA I and II Accepts healthy volunteers.

Exclusion Criteria:

alcohol or illicit drugs, H2 inhibitors, opioids, or calcium-channel blockers within the last 10 days chronic pain, myocardial ischemia, psychiatric diseases.