cyrilzakka/clinical-trials huggingface dataset:
Study of Radiolabeled ALXN2050 in Healthy Adult Males

This is an open-label study to assess the absorption, metabolism, excretion, and mass balance of a single oral dose of carbon-14 (\[14C\])-ALXN2050 in healthy adult males.


Eligibility Criteria:
Inclusion Criteria:

1. No clinically significant medical history, physical or neurological examination findings, screening clinical laboratory profiles, or electrocardiogram findings.
2. Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening.
3. Non-sterile participants must agree to abstinence or use a highly effective method of contraception.

Exclusion Criteria:

1. History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
2. History or presence of drug or alcohol abuse within previous 2 years, current user of tobacco/any nicotine-containing product, or positive drugs-of-abuse screen or alcohol screen at screening or Day -1 of Period 1.
3. History or presence of seizures, head injury, or head trauma.
4. History of procedures that could alter absorption or excretion of orally administered drugs.
5. History of meningococcal infection, or has a first-degree relative with a history of meningococcal infection.
6. Body temperature ≥ 38.0°Celcius at screening or check-in.
7. Donation of whole blood from 3 months prior to first dosing or of plasma from 30 days before first dosing, or receipt of blood products within 6 months prior to first dosing.
8. Has less than 1 bowel movement every 2 days or has a recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks prior to dosing.
9. Has received radiolabeled substances or has been exposed to radiation sources within 12 months of dosing or is likely to receive radiation exposure or radioisotopes within 12 months of dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe.
10. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days prior to dosing, whichever is longer.
Comprehensive Cardiac CT Versus Exercise Testing in Suspected Coronary Artery Disease (2)

Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with standard stress testing in patients with stable chest pain complaints.

Rationale: CT calcium and coronary lumen imaging allow efficient exclusion of coronary artery disease (CAD), but cannot assess the hemodynamic significance of obstructive findings. Addition of stress myocardial perfusion imaging, which assesses the functional relevance of coronary narrowing, completes the non-invasive cardiac evaluation.

Hypothesis: A comprehensive cardiac CT examination will allow fast, accurate and complete evaluation of suspected CAD.

Objective: evaluate the effectiveness and efficiency of comprehensive cardiac CT workup of suspected CAD.

Study design: Open-labelled, randomized-controlled, clinical efficiency trial, with an intention-to-diagnose approach, between CT-guided management and the current standard of care (based on functional testing of provocable myocardial ischemia) in patients with suspected CAD.

Study population: 250 patients (\>18 yrs) with stable chest complaints, a \>10% pre-test probability of CAD, and referred for evaluation of possible CAD.

Intervention: Instead of the usual diagnostic approach, patients in the intervention group will undergo in sequence the following CT examinations: coronary calcium scan, coronary CT angiography and CT myocardial perfusion imaging, with completion dependent on results. Findings on CT will direct further management.

Main study parameters/endpoints:

Primary: Rate of negative invasive angiograms (as percentage of total population) Secondary: Diagnostic yield, chest complaints, quality of life, diagnostic and therapeutic procedures, overall costs and adverse events at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged \>18 years.
* Chest pain symptoms suspicious of coronary heart disease.
* Pre-test probability of coronary artery disease \>10%

Exclusion Criteria:

* History of CAD: prior myocardial infarction or revascularization procedure
* Contra-indication to radiation exposure (CT/SPECT): pregnancy
* Contra-indication to iodine contrast media: renal failure, iodine allergy
* Contra-indications to adenosine
* Inability or unwillingness to provide informed consent.
N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial

Contrast induced nephropathy has an incidence of 7-11 % in patients undergoing Contrast imaging for various conditions. The risk associated with the development of CIN are still under evaluation. Even with patients having normal kidney functions there is a risk of contrast induced nephropathy hence the need for markers which could predict injury. Cirrhosis of liver predisposes patient to Kidney abnormalities as these patients lower renal reserve and can have various conditions like Hepatorenal syndrome, Sepsis, ATN. Contrast imaging is vital for ruling out conditions like Hepatocellular Carcinoma in patients of cirrhosis of liver. Presently there is no study in cirrhosis of liver which studies the Effect of N-acetyl cysteine before and after contrast imaging in the prevention Of CIN. The incidence of CNI is cirrhosis is also an avenue which requires more studies and also there is a need for formulation of a Score to predict this CIN. Hence this study is being done to assess the incidence of CNI and the role of N-Acetyl cysteine in Preventing CNI.


Eligibility Criteria:
Inclusion Criteria:

* Age-18-70 years
* Normal kidney parameters (Creatinine below \<1 ,Creatinine clearance \>60)
* Cirrhosis of liver
* eGFR\>60ml/min

Exclusion Criteria:

* Chronic kidney disease
* H/o anaphylaxis to contrast
* Prior h/o AKI
* GFR\<60 ML/MIN
* Prior H/o TACE/HVPG /Contrast ECHO in the last 4 weeks
Application of 3D Printing Technique in Small Pulmonary Nodule Localization

The trial is to evaluate the efficacy and safety of three-dimensional printed navigational template in the clinical application of small peripheral lung nodule localization.

Localization of small lung nodule is challenging due to the difficulty of nodule recognition during VATS. A three-dimensional printed navigational template was designed to aid percutaneous lung nodule localization, and its feasibility has been confirmed in previous study. The trial was conducted to confirm the non-inferiority of template-guided method to conventional CT-guided method in terms of localization accuracy.

Eligibility Criteria:
Inclusion Criteria:

1. Aged from 19 to 80 years
2. lesions located in peripheral lung tissue which can be removed by wedge resection
3. The maximum diameter of the lesion is no more than 20 mm.
4. Research assistant consulted with the patient's surgeon to confirm the necessity of lung nodule localization
5. Informed consent was signed voluntarily.

Exclusion Criteria:

1. nodule located in the scapula region.
2. there were two or more lung nodules needed to be localized.
Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliative Care Unit

Even if most patients in palliative care units presented with well-recognized risks factors of venous thromboembolism (VTE) (eg: active cancer, bed rest, previous history of venous thrombosis), the incidence of VTE in palliative setting is unknown. By consequence, the efficacy and safety of antithrombotic prophylaxis in such a population is not established. Indeed, patients admitted in palliative care units were not included in trials evaluating the potential effect of antithrombotic drugs in regard to their poor prognosis at short term. In addition, the main role of prophylaxis is to prevent sudden death from pulmonary emboli and is thus a life prolonging therapy which is viewed as counterintuitive to palliative care philosophy and inappropriate on grounds of futility. Nevertheless, the current use of Low Molecular Weight Heparin in palliative care units seems to increase particularly in patients with advanced malignancy. The identification of high hemorrhagic risks in palliative care patients could help the decision of antithrombotic prophylaxis initiation. For this, the investigators conducted a multicenter prospective longitudinal study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years
* admitted in a palliative care unit for a cancer, a pulmonary, a cardiac or a neurologic advanced disease

Exclusion Criteria:

* life prognosis less than 48 hours
* patients treated with curative doses of antithrombotic therapy
* patients with follow up of 3 months is not possible
Liquid Biopsy to Enable Diagnostics and Monitoring for Immune-mediated Lymphoproliferative Disorders

Immune-mediated lymphoproliferative disorders (ILD), as per World Health Organization (WHO HAEM 5) classification, are rare conditions associated with a poor outcome. Current management of ILD is focusing on prevention (e.g.) early detection of ILD with preemptive Epstein Barr virus (EBV) Deoxyribonucleic acid (DNA) levels monitoring, however, this approach is useless for the early detection of EBV-negative ILD. Therapeutic management consists of a reduction in immunosuppressive therapy (RIS), allowing mostly partial and transient responses. Rituximab, an anti-CD20 (cluster differentiation 20) antibody, provides roughly 20-25% of complete and durable responses, thus the majority of ILD patients will require immunochemotherapy, burden with significant toxicity in this challenging population. Implementation of liquid biopsy, also called circulating tumor DNA (ctDNA) in plasma or serum is an area of investigation that is becoming increasingly relevant for clinical practice, allowing for non-invasive monitoring of disease status.

Early detection and monitoring of ILD using ctDNA may allow for preemptive therapy, improved risk-stratification and ultimately, lead to outcome improvement. This multicenter Swiss project will allow a better understanding of ILD mutational landscape and pathogenesis, which could lead to the development of new screening and monitoring approaches for patients suffering from ILD.

In this observational prospective study, the investigators will collect clinical data from subjects' charts through a dedicated multicenter electronic case report form (eCRF).

Whenever available, PET-CT will be transferred through a Web-based Imaging and Diagnosis Exchange Network (WIDEN) to perform a blinded independent review of staging and response.

Biological samples included 20 ml of blood collected at each of the following planned clinical points in time: i) at ILD diagnosis, ii) after first cycle of therapy, iii) at interim response assessment, iv) at the end-of-treatment, v) at 3 months follow-up, vi) at 12 months follow-up, vii) at disease progression, if applicable. Additional samples could be collected if clinically relevant.

Additionally, the investigators will request formalin-fixed and paraffin-embedded tissue (FFPET) or fresh-frozen (FF) tissue slices/blocks at ILD diagnosis from Pathology Departments of participating Centers for retrospective ILD subjects.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with a diagnosis of ILD defined by the World Health Organization (WHO HAEM 5)(e.g. post-transplant setting, X-link, concomitant auto-immune disorders)

Exclusion Criteria:

* Lymphoproliferative disorders non immune-mediated
* Lymphoproliferative disorders occurring in the context of a concomitant human immunodeficiency virus (HIV) infection
Screening Protocol for a Gene Therapy Trial in Subjects With Homozygous Familial Hypercholesterolemia

The purpose of this protocol is to identify and screen potential candidates for future enrollment in a gene therapy clinical trial for HoFH.

Homozygous Familial Hypercholesterolemia (HoFH) is a rare genetic metabolic disorder characterized by markedly elevated LDL-cholesterol (LDL-C) levels, resulting in severe atherosclerosis often leading to early onset of cardiovascular disease. The most frequent cause is mutation in the LDL receptor gene (LDLR). LDL-C levels remain frequently above acceptable levels despite treatment with multiple existing lipid lowering drugs and/or LDL apheresis. Thus, the functional replacement of the defective LDLR via AAV-based liver-directed gene therapy may be a viable approach to treat this disease and improve response to current lipid-lowering treatments. The purpose of this protocol is to identify and screen potential candidates for future enrollment in a gene therapy clinical trial. No study drug will be administered in this screening study.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of age
* Clinical presentation consistent with homozygous FH
* Subjects must be able to comprehend and willing to provide a signed IRB approved Informed Consent Form

Exclusion Criteria:

* Known to carry confirmed mutations in genes affecting LDL receptor functionality other than the LDLR gene
* History of cirrhosis based on documented histological evaluation or non-invasive imaging
* Documented diagnosis of any of the following liver diseases: Hepatitis B or C; Biopsy-proven nonalcoholic steatohepatitis; Biopsy-proven alcoholic liver disease; Autoimmune hepatitis; Primary biliary cirrhosis; Primary sclerosing cholangitis; Wilson's disease; Hemochromatosis; alpha1 anti-trypsin deficiency
* History of immunodeficiency diseases, including a positive HIV test result
* Previous organ transplantation
* Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
* Inability to participate
Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products

To assess Hibiscus sabdariffa extract and collagen products on skin condition improvement


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure (\> 3 hr/week) in the past 4 weeks.
* Constant drug use
* Students who are currently taking courses taught by the principal investigator of this trial.
Perfusion Parameters and Outcome During a Standardized Deresuscitation Strategy with Net Ultrafiltration: a Retrospective Cohort Study.

Hemodynamic tolerance of fluid removal during deresuscitation is a cornerstone of the impact on outcome of such a strategy. However, how to define and to predict hemodynamic tolerance to fluid removal remains controversial. The investigators routinely use a standardized deresuscitation protocol in patients with fluid overload and continuous renal replacement therapy combined with monitoring of clinical and biological perfusion parameters.

The aim of the study was to describe perfusion during deresuscitation, and to determine whether it is associated with major adverse kidney events at day 30.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Acute kidney injury requiring continuous renal replacement therapy
* Standardized deresuscitation following a routine care protocol

Exclusion Criteria:

* Chronic hemodialysis
* Advanced directives to withhold or withdraw life-sustaining treatment,
* Patient's opposition to the use of his/her personal health data
Progressive Muscle Relaxation Exercises on Sleep, Fatigue and Pain in Pancreatic and Colon Cancer Patients

With regular practice, relaxation has been found to have many benefits such as reducing sensitivity to pain and fatigue, facilitating the transition to sleep, and improving quality of life. Therefore, this study was planned to examine the effects of progressive muscle relaxation exercises applied to pancreatic and colon cancer patients receiving chemotherapy on sleep, fatigue, and pain.

A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age
* Being able to communicate adequately
* Not having a psychiatric problem
* Those who are determined by a physician to have no physical obstacle to exercise
* Individuals who can use technological devices
* Patients who have had at least 3 cycles

Exclusion Criteria:

* Those with communication problems
* Those with psychiatric problems
* Patients doing any exercise
* Individuals with phones that do not have a voice recording feature
* Individuals with phones that do not have a WhatsApp feature
Vestibular Infant Screening - Rehabilitation

The goal of this clinical trial is to investigate the short-term effect of a structured, combined postural control and gaze stabilisation protocol (VIS-REHAB protocol) in a group of vestibular-impaired children of different age categories (3-17 years). The main questions it aims to answer are:

* What is the short-term effect of the VIS-REHAB protocol?
* What are the most important factors that may influence the effect of and outcome after application of the VIS-REHAB protocol?

The participant will undergo both an active rehabilitation program (VIS-REHAB protocol) and a period during which physical therapy is discontinued (CTRL protocol).:

- VIS-REHAB protocol: Postural control (static and dynamic postural stability exercises), gaze stability exercises (oculomotor function and VOR-exercises) \& general gross motor training with focus on gaze stability and postural control.

Researchers will compare the VIS-REHAB protocol with receiving no therapy (CTRL protocol) to evaluate potential enhancements in postural stability, gaze stability, motor performance and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with identified vestibular dysfunction
* With or without concomitant hearing loss and/or cochlear implant (CI)

Exclusion Criteria:

* Children incapable to understand simple instructions (due to severe cognitive disorders, impaired language comprehension, etc.)
* Severe disorders of other primary sensory input systems for balance function
* Severe neuromotor disorders (incapable of independent standing and walking)
* Severe muscle tone disorders (e.g. cerebral palsy)
* Severe orthopaedic dysfunctions
* Patients with vision problems that cannot be corrected for
* Children with planned CI-surgery within 5 months before or during the study period
Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model

The clinical study aims to assess the osteogenic effects of Galibone+ in bone regeneration post-extraction of impacted mandibular third molars.

With a focus on both clinical and radiological outcomes, the study seeks to compare the efficacy of Galibone+ against a standard material (Bio-Oss) through a double-blind, randomized split-mouth trial involving 30 patients. Variables including pain, inflammation, and post-surgical complications will be monitored during the initial seven-day follow-up, while bone volume reduction and mineral density will be evaluated radiographically over a six-month period. The study's findings promise to shed light on the potential of Galibone+ as a promising adjunct in enhancing bone regeneration following dental extractions, thereby advancing oral surgical practices and patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be of legal age.
* Participants must provide informed consent for participation in the study.
* Participants must require extraction of both impacted mandibular third molars.
* Both impacted molars must exhibit a similar level of complexity for extraction.
* Participants must have no history of infection in the impacted molars prior to extraction.
* Participants must not have any contraindications to undergoing oral surgical procedures (ASA I/II classification).

Exclusion Criteria:

* Participants with severe mental disorders that may impair their ability to provide informed consent or follow study instructions.
* Participants currently receiving medications contraindicated for dental extractions.
* Participants under the age of legal consent.
* Participants who have undergone head and neck radiotherapy within the past 18 months.
Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients

Lung transplant recipients undergo bronchoscopy with biopsies for clinical indications and for surveillance in the diagnosis of acute rejection using standard transbronchial forceps. It is recognized that standard forceps biopsies underestimate the presence or degree of airway rejection due to crush artifact and sample size. Transbronchial cryobiopsies have been shown in the literature to provide larger samples without crush artifact in a safe fashion in lung cancer patients. The aim of this study is to determine if transbronchial cryobiopsy is superior to standard transbronchial forceps biopsies in regards to sample size, architecture and the diagnosis of early rejection in lung transplant recipients which if discovered earlier may improve survival.


Eligibility Criteria:
Inclusion Criteria:

* Individuals referred for either clinically indicated or surveillance flexible bronchoscopy will be included in the study population
* Age greater than 18 years and having undergone bilateral orthotopic lung transplantation

Exclusion Criteria:

* Coagulopathy: plts \< 50,000 international normalized ratio (INR) \> 1.5
* Forced expiratory volume at one second (FEV1) \< 0.8
* Diffuse bullous disease
* Hemodynamic instability
* Severe hypoxemia
Comparative Effects of UE Aerobic and Resistance Training on Cardiorespiratory Fitness in Hypertensive Patients

simple random sampling into group A \& group B to collect data. Group A will be given upper extremity aerobic training and group B will be given upper extremity resistance training. The study will be completed within the time duration of ten months. Primary Outcome measures of the research will be pain, range of motion, and quality of life.

A randomized clinical trial will be conducted at Multan institute of cardiology, Multan. Non probability convenient sampling technique will be applied on--patients who will be allocated through simple random sampling into group A \& group B to collect data. Group A will be given upper extremity aerobic training and group B will be given upper extremity resistance training. The study will be completed within the time duration of ten months. Primary Outcome measures of the research will be pain, range of motion, and quality of life. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age group of 35-65years
* Both male and females
* Patients with blood pressure \>140/90mm Hg

Exclusion Criteria:

* Regular engagement in physical exercise training in past 4 weeks
* Patients with secondary hypertension
* Patients using more than one hypertensive drugs
* Recent myocardial infarction
* Congestive heart failure
* Uncontrolled cardiac arrythmia