cyrilzakka/clinical-trials huggingface dataset:
Unravel MGUS (Monoclonal Gammopathy of Unknown Significance)

This is a study to investigate the functional consequences of paraprotein production in MGUS (Monoclonal Gammopathy of Unknown Significance).

Monoclonal gammopathy of unknown significance (MGUS) is a common haematological condition. It is characterised by proliferation of a B lymphocyte clone and it's associated antibody (paraprotein). In most cases there are no clinical symptoms, however, in a small number of individuals there may be an interaction of the paraprotein with a molecule expressed by the body (self antigen). This can have effects on the normal function of this molecule and/or cause disease.

The study aims to investigate the functional consequences of paraprotein production in MGUS.

Eligibility Criteria:
Inclusion Criteria:

Participants must comply with the following criteria in order to be eligible for the study:

* Be aged ≥18 years at the time the informed consent form is signed
* Have a confirmed and documented Monoclonal Gammopathy of Unknown Significance (MGUS) diagnosis
* Read and understood the participant information sheet, and signed an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent form prior to any study- specific evaluation

Exclusion Criteria:

Participants will be excluded from joining the study if they match any of the criteria below:

* Pre-existing diagnosis of myeloma/lymphoma
* Participation in a therapeutic clinical study within 28 days or (5 half lives, whichever is longer) of enrolment or during this study
* Any other reason the Clinical Investigator (CI) considers the participant should not join the study
An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG

Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome are individually dosed and treated for 12 weeks

Ferring Pharmaceuticals A/S has developed a new ZOMACTON 10 mg formulation. The formulation provides a higher concentration and thereby a smaller volume to be administered. ZomaJet Vision X is a needle-free injection system. It sends a thin jet of ZOMACTON through the skin and into the subcutaneous tissue without the use of a needle. The mode of administration is referred to as "transjection". By use of ZomaJet Vision X, both transjection and reconstitution of ZOMACTON 10 mg can be done without using a needle. The rationale of the study is to describe the local tolerability of the new ZOMACTON 10 mg administered by ZomaJet Vision X.

Eligibility Criteria:
Subjects between the ages of 3 and 17 years (both inclusive) with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome. Subjects have for a minimum of 6 months prior to study enrolment been receiving growth hormone therapy
The Effect of Trimetazidine on Mitochondrial Function, Myocardial Performance, and Invasive Hemodynamics in Patients Diagnosed With Wild-Type Transthyretin Cardiac Amyloidosis

Wild-type transthyretin cardiac amyloidosis (ATTRwt) is a deposition disorder in which one of the proteins of the body misfolds and accumulates at various places in the body, including the heart, leading to both mechanical and cellular damage. The gradual development of the disease will ultimately lead to heart failure and death

The protein which deposits in the heart of patients, damages both the heart mechanically as the myocardium becomes rigid and hypertrophic over time but also at the cellular level. Cell damage can be observed by elevated blood tests for cell damage (Troponin) and during exercise tests that show patients' hearts burning oxygen inefficiently when exposed to physical stress compared with the hearts of healthy individuals . No one has, however, intimately studied this cellular damage.

Vastarel® (Trimetazidine, TMZ) is an already known drug for the treatment of chest pain. The mechanism of action indicates that it may have an effect on patients with cardiac amyloidosis.

The study aims to investigate the effects of TMZ on the mitochondrial function, myocardial performance, and invasive hemodynamics in patients with ATTRwt with a randomized, double-blinded, crossover-trial.


Eligibility Criteria:
Inclusion Criteria:

* Wild-type transthyretin cardiac amyloidosis
* NAC stage I
* NYHA class of I or II
* Informed consent

Exclusion Criteria:

* Other, similar diagnoses
* Hereditary transthyretin cardiac amyloidosis
* Light chain amyloidosis
* Morbus Waldenstrøm
* Myelomatosis
* Medical treatment with loop diuretics in standard doses (40 mgx1 daily)
* Contraindications to trimetazidine
* Significant comorbidity assessed by the investigators
* Unable to provide informed consent
Model for Prognosis of Elderly Gastric Cancer Patients

This study aims to develop and validate a Random Survival Forest (RSF) model for predicting long-term survival in elderly patients following curative resection for gastric cancer. The study is a retrospective multi-center analysis involving patients aged 75 and above who underwent gastric resection from January 2009 to December 2018 at nine top-tier hospitals in China. An online prognostic tool is introduced to assist clinicians in predicting patient prognosis and customizing treatment and follow-up strategies.

This retrospective multi-center study focuses on the development and validation of a predictive model for elderly gastric cancer patients. Data were collected from 16,344 gastric cancer patients, with 1,202 elderly patients ultimately included after applying exclusion criteria. Patients were randomly divided into training and testing cohorts in a 7:3 ratio. The study was approved by the institutional review boards with a waiver of informed consent due to the use of anonymized secondary data.

The analysis employs the Random Survival Forest (RSF) method, incorporating variable importance and minimal depth techniques to select key variables for predicting overall survival (OS) and disease-free survival (DFS). The study also implements rigorous data handling procedures, including multiple imputations for missing data.

The development of an online prognostic tool based on the RSF model is part of the project, designed to provide real-time survival predictions through a user-friendly interface for clinical application.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 75 years or older.
* Histologically confirmed diagnosis of gastric cancer.
* Patients who have undergone curative gastrectomy.

Exclusion Criteria:

* Patients with non-primary gastric malignancies.
* Pathological confirmation of metastatic disease (M1).
* Incomplete follow-up data or loss to follow-up.
Evaluation of Long-term Safety and Performance of PanOptix Intraocular Lens (IOLs)

The purpose of this Post-Market Clinical Follow-up (PMCF) study is to describe the long-term safety and performance of the AcrySof PanOptix Trifocal toric and non-toric IOL models in subjects bilaterally implanted with these IOLs for 3 to 5 years. This study will be conducted in Spain.

Subjects will be recruited from a population that has already undergone lens implantation. Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment. Prospective data will be collected at Visit 1, which will occur Year 3-5 postoperative.

Eligibility Criteria:
Inclusion Criteria:

* Subject or legally authorized representative must be able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form.
* Subject must have had bilateral implantation of AcrySof PanOptix and/or AcrySof PanOptix Toric IOL models for 3 to 5 years prior to enrollment. A subject may have a Toric lens in one eye and a non-Toric in the fellow eye.
* Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.

Exclusion Criteria:

* Subject currently participating in another investigational drug or device study.
* Subject has had corneal refractive surgery after AcrySof PanOptix or AcrySof PanOptix Toric IOL implantation.
* Subject exposed to a study IOL for a minimum of 3 years prior to Visit 1 that have subsequently undergone an IOL exchange and are no longer implanted with a study IOL at the time of enrollment.
* Subject is pregnant or nursing at the time of enrollment.
Paroxetine Safety and Efficacy in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a systemic chronic auto-inflammatory disorder which imposes a remarkable burden of morbidity and mortality on global health. The complex interaction between genetics, environment, and immunological response contribute to RA pathogenesis. Current treatment comprises conventional disease-modifying anti-rheumatic drugs (DMARDs) followed by biological DMARDs, if necessary, to achieve low disease activity or remission. Therapeutics used in RA had limitations in tolerability, access, and response duration and magnitude. Consequently, implementation of safe adjunctive treatment for RA is urgently needed to boost the therapeutic response.


Eligibility Criteria:
Inclusion Criteria:

* Aged 23-57 years fulfilling 2010 American College of Rheumatology - European League against Rheumatism (ACR-EULAR) classification criteria for RA (12) and had active inflammatory RA with no limit in disease duration.
* Patients received MTX, nonsteroidal anti-inflammatory drugs, selective cyclooxygenase-2 inhibitors, acetaminophen, and low dose of oral corticosteroids will be allowed to enroll the trial
* Intravenous, intra-articular or intramuscular corticosteroids; intra-articular hyaluronate sodium; biological DMARDs; and other DMARDs will not be permitted less than 4 weeks before the first dose of paroxetine.

Exclusion Criteria:

* patients refusing to give informed consent, diabetes, congestive heart failure, previous adverse reaction to paroxetine, oral prednisolone greater than 10 mg/day, receiving biological DMARDs, severe anemia, active infection, pregnancy or lactation, and clinically significant renal or hepatic disease.
Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery

1% Lidocaine with 1:100,000 to 1:200,000 of epinephrine is routinely injected into the nasal mucosa during nasal surgery to reduce patient blood loss and improve the surgical field and visibility. Typically 1% lidocaine with 1:100,000 of epinephrine is used in nasal surgery. However, 1 % lidocaine with 1:200,000 (which is a more dilute solution of epinephrine) is also used. This latter dose theoretically should have a lesser effect on cardiac stimulation which increases the heart rate and blood pressure at the time of surgery. The nasal mucosa has excellent absorbing ability which is great for the application of drugs but there is concern for systemic absorption and side effects. Potential serious side effects can occur with local injection such as hypertension, tachycardia, and cardiac arrhythmias. These side effects occur mainly through the absorption of epinephrine. It is the goal of this study to see if a weaker concentration of epinephrine (1:200,000) can maintain a good surgical field with a decrease in hemodynamic side effects.

Objective- To evaluate the effect of 1% lidocaine with 1:200,000 of epinephrine on hemodynamic measures and bleeding in the surgical field in patients undergoing nasal surgery compared to 1% lidocaine with 1:100,000.

Recruitment plan- Patients undergoing general anesthetic for nasal surgery (septoplasty or sinus surgery) will be asked to participate in this study. All patients undergoing nasal surgery are injected with local anesthetic into the nasal mucosa after induction of general anesthetic. Those patients who agree to participate in the study will be randomized into 2 groups (injection either 1 % lidocaine with 1:100,000 or 1:200,000 of epinephrine).

Procedures

1. Patients will be put to sleep following standard general anesthetic protocol
2. Patients will be injected with either 1% lidocaine with 1:100,000 or 1% lidocaine with 1:200,000 into the nasal mucosa
3. After injection the following will be measured every 15 minutes for the first hour to evaluate effectiveness of the local anesthetic.

   1. Heart rate
   2. Blood pressure
   3. Routine ECG monitoring
   4. MAP (mean arterial pressure)
   5. Surgical field, degree of bleeding.

Alternatives- Subjects can refuse to participate in the study. If subjects refuse to participate in the study they will still be injected with 1% lidocaine with 1:200,000 of epinephrine which is standard of care

Data analysis- data will be compiled and statistical analysis will be made using PRISM software.

Eligibility Criteria:
Inclusion Criteria:

* any patient between the ages of 16-75 who is scheduled to undergo routine nasal surgery.

Exclusion Criteria:

* allergy to lidocaine,
* recent MI,
* recent stroke,
* uncontrolled hypertension,
* arrhythmias,
* congestive heart failure.
The Impact of a Novel Infant Formula on Immunity, Gut Health and Growth

The goal of this multicenter, double-blind, randomized, controlled trial is to assess the safety and efficacy of a new infant formula on healthy term infants from enrollment to the age of 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. At enrollment visit, post-natal age ≤ 42 days (date of birth = day 0).
2. Healthy term infant (≥ 37 weeks of gestation).
3. Infants birth weight ≥ 2500 and ≤ 4500 g.
4. For formula fed group: infant is mainly consuming IF (more than 75% of the infant diet) until at least 4 months of age. The parents / LAR(s) have independently decided NOT to breastfeed.
5. For the breastfed reference group: infant has been mainly consuming breastmilk since birth (more than 75% of the infant diet), and the parents / LAR(s) have made the decision to continue breastfeeding until at least 4 months of age.
6. Evidence of personally signed and dated informed consent indicating that the infant's both parents/LAR(s), as per local regulation, have been informed of all pertinent aspects of the study.
7. Parents/LAR(s) of infants demonstrate willingness and capability to adhere to scheduled visits, fulfill the study protocol requirements, and remain accessible by phone throughout the study duration.

Exclusion Criteria:

1. Conditions requiring infant feedings other than those specified in the protocol.
2. Medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:

   1. Evidence of major congenital malformation (e.g., cleft palate, extremity malformation)
   2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)
   3. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigators, would make the infants inappropriate for entry into the study. Of note, infants who are generally healthy but experiencing minor acute illnesses at the time of enrollment, which are common in infancy and do not necessitate any of the exclusionary medications mentioned below, may still be eligible for enrollment.
3. Presently receiving or having received prior to enrolment any medication(s) or supplement(s) which are known or suspected to affect the following:

   1. Fat digestion, absorption, and/or metabolism (e.g. pancreatic enzymes);
   2. Stools characteristics and gut microbiota (e.g., oral, or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose);
   3. Growth (e.g., insulin or growth hormone);
   4. Gastric acid secretion.
4. Currently participating or having participated in another interventional clinical trial since birth.
Study on the Current Situation and Related Factors of Hypertension Management in a Poor County in Shanxi Province

This project aims to understand the current situation of hypertension management in a poor county in Shanxi Province, and explore the factors that affect patients' blood pressure control based on local reality, and provide a basis for further promoting the standardized management of hypertension in poor areas and the comprehensive prevention and control of chronic diseases at the national grassroots level.


Eligibility Criteria:
Inclusion Criteria:

（1）Clinical diagnosis of hypertension (2) Permanent population or floating population who have lived for more than 6 months in the area; (3) In the case of not taking antihypertensive drugs, after 3 different daily blood pressure measurements, the systolic blood pressure ≥140 mmHg and/or the diastolic blood pressure ≥90 mmHg were achieved in all 3 times, and it has been diagnosed by the community and above medical institutions in the past. Residents with high blood pressure; (4) As of October 2020, all research subjects have been included in the national basic public health service projects by medical institutions and have received standardized management of hypertension for one full year.

Exclusion Criteria:

1. Pregnant and lactating women;
2. Those who are critically ill, mentally ill, cognitively impaired, etc.
Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients

The proportion of the elderly population is increasing rapidly. Chronic subdural hematoma has become the most common cause of surgery in neurosurgery for elderly patients. The standard treatment for cSDH is mostly surgery. Clinically, we often encounter elderly patients with certain underlying diseases or organ dysfunction, especially preexisting cardiovascular disease or medication history like anticoagulant or antiplatelet drugs, resulting in poor surgical tolerance, high risk during anesthesia and hematoma recurrence. At present, the mechanism of cSDH is not completely clear. Our previous observational studies had shown significant correlation between cSDH and intracranial hypotension. So we would like to conduct a randomized, controlled, multi-center clinical study to explore the effectiveness and safety of low intracranial pressure treatment strategies for patients with chronic subdural hematoma.


Eligibility Criteria:
Inclusion Criteria:

* patients above 14 yrs with chronic subdural hematoma confirmed by cranial imaging;
* patients with MGS-GCS score ≤1 point, showing no signs of neurological deficits caused by CSDH or characteristics of high intracranial pressure;
* patients with MGS-GCS score ≥1 point, but with medication history of anticoagulant or antiplatelet drugs, coagulation dysfunction so that they are unsuitable or intolerant of surgery although they are in stable condition;
* patients who are unwilling to operate when they have no life-threatening brain herniation or no indications for emergency surgery, which confirmed by two neurosurgeons

Exclusion Criteria:

* women pregnant or in lactation
* those who are allergic to atorvastatin, hypoxamethasone;
* patients with brain herniation or altered mental status;
* patients with primary diseases like tumors, hemorrhagic diseases or some other critically serious conditions( eg.multiple organ failure);
* patients with uncontrollable diabetes and heart failure
* patients with preexisting chronic abdominal diseases (such as inflammatory bowel disease) or lung tumors or digestive system neoplasm
* Patients with abnormal liver function
* patients had taken atorvastatin or dexamethasone, ACEI in the past one week
* other conditions not eligible to enroll the trial confirmed by two individual doctor
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB0942 in Healthy Japanese and Caucasian Subjects

The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of UCB0942 in Japanese and Caucasian subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female and between 20 and 55 years of age (inclusive)
* Subject is in good physical and mental health
* Female subjects will use an efficient form of contraception for the duration of the study (unless menopausal)
* Male subject agrees that, during the study period, when having sexual intercourse with a woman of childbearing potential, he will use an efficient barrier contraceptive AND that the respective partner will use an additional efficient contraceptive method
* For Japanese subjects: Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan)
* For Caucasians: Subject is of Caucasian descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has 4 Caucasian grandparents).

Exclusion Criteria:

At screening:

* Previous study participation with another investigational medicinal product (IMP) within 3 months
* History of alcohol/drug abuse
* History of psychiatric condition and suicide attempt
* Any medical condition unfit for study (including history of cancer)
* History of hypersensitivity for IMP components
* Taking concomitant medications
* Positive for human immunodeficiency virus (HIV)/ hepatitis B virus (HBV)/ hepatitis C virus (HCV)
* Abnormal liver function tests (LFTs), abnormal safety bloods/ vitals/ physical examination and electrocardiogram (ECG) findings
* Positive for pregnancy test
* Other protocol-defined exclusion criteria may apply
Moderate Alcohol Consumption, Glucose Metabolism and Gastric Emptying

Moderate alcohol consumption is associated with a decreased risk of type II diabetes mellitus. In a recent study of Greenfield et al. it was observed that moderate alcohol consumption significantly improved postprandial glucose concentrations. Similar observations were made in our previous study. One of the mechanisms by which this may occur is delayed gastric emptying after alcohol consumption.

Purpose: The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage. Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied. These effects will be studied in apparently healthy, lean or overweight young men.

Design: Randomized, partially diet-controlled, placebo controlled cross-over design.

Subjects: Healthy male lean and obese volunteers aged between 18 and 40 years (n=18).

Intervention: During 2 periods of 21 days either white wine or white grape juice has to be consumed with the evening meal. The last 7 days of each period will be fully dietary controlled.

Treatment A: 375 ml of white wine (35 g alcohol) per day Treatment B: 375 ml of white grape juice per day

Measures:

* Glucose metabolism: glucose uptake and peripheral glucose storage (measurement of isotopic enriched plasma glucose levels.
* Gastric emptying and postprandial wellness.
* Postprandial glycemic response and related factors (glucose, insulin, lactate, FFA, glucagon, ghrelin, CCK, GIP, GLP-1, PYY, triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, paracetamol (absorption test)

Eligibility Criteria:
Inclusion Criteria:

* Healthy as assessed by the:
* physical examination
* results of the pre-study laboratory tests
* Males aged between 18 and 40 years at Day 01 of the study (including 18 and 40)
* Lean subjects and overweight/obese subjects: BMI 18.5-35 kg/m2
* Alcohol consumption between 7 and 28 units/week (including 7 and 28)
* Non restrained eater, defined as a score ≤ 2.5 on the Dutch Restrained Eating Questionnaire

Exclusion Criteria:

* Smoking
* Not willing or able to change habitual alcohol consumption during the study according to protocol
* Having an allergy for paracetamol