cyrilzakka/clinical-trials huggingface dataset:
Ferrous Sulphate Supplement (V0355) in Women With Iron Deficiency Anaemia

The purpose of this study is to investigate the pharmacokinetics of serum iron after a single oral administration of 160 mg (2 tablets of 80 mg) V0355 in women with iron deficiency anaemia.


Eligibility Criteria:
Inclusion Criteria:

* Women 18-45 years inclusive with iron deficiency anaemia
* haemoglobin level between 85 g/L and 105 g/L
* serum ferritin level \< 15 µg/L
* D14 +/- 7 days of the menstruation cycle on the day of pharmacokinetic evaluation

Exclusion Criteria:

* Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,
* Haemochromatosis or iron overload of secondary origin (blood transfusion),
* Long term treatment known to modify iron absorption,
* Gastro duodenal ulcer,
* Inflammatory bowel disease or any digestive disease which could modify iron absorption,
* Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders),
* Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.
A Phase 1/2, Dose-Exploration Study to Evaluate the Safety and Efficacy of BEAM-301 in Patients With Glycogen Storage Disease Type Ia (GSDIa)

This is a Phase 1/2, multicenter, open-label, single-ascending-dose study to evaluate the safety, tolerability, and efficacy of BEAM-301 in adult patients with GSDIa homozygous or compound heterozygous for the G6PC1 c.247C\>T (p.R83C) variant and to determine the optimal biological dose.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females age ≥18 years of age at the time of consent.
2. Diagnosis of GSDIa and homozygous or compound heterozygous for the G6PC1 c.247C\>T (p.R83C) variant (confirmed by genetic testing).
3. History of at least 1 episode of hypoglycemia \<60 mg/dL within the 2 years prior to signing the ICF.

Exclusion Criteria:

1. Liver transplant recipient/on waiting list for liver transplant or known history of liver cirrhosis.
2. Presence of liver adenoma \>5 cm in size based on liver MRI or liver ultrasound performed at screening or within 6 months prior to screening.
3. Presence of liver adenoma \>3 cm and ≤5 cm with a documented annual growth rate of ≥0.5 cm per year.
4. Have aspartate transaminase or alanine transaminase \>upper limit of normal (ULN).
5. Total bilirubin levels \>ULN; if documented Gilbert's Syndrome, total bilirubin \>2 × ULN.
6. Previous treatment with any cell-, gene-, or viral vector-derived therapy Hospitalization for management of hypoglycemia within 4 weeks prior to signing the ICF.
7. Have triglycerides \>1000 mg/dL or a history of pancreatitis or a history of acute pancreatitis within 5 years that does not have a known and corrected etiology (eg, cholecystectomy for gallstone pancreatitis).
A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism

The goal of the study was to evaluate the efficacy and safety of crizanlizumab in sickle cell disease (SCD) patients with priapism.

Before participating in this study, information to determine key eligibility criteria was collected as a part of a 14-week Pre-Screening period. The study included a 12-week Screening period and a 52-week (1 year) Treatment period. Eligible participants received crizanlizumab 5 mg/kg by intravenous infusion (IV). Study treatment was received at clinic visits on Week 1 Day 1, Week 3 Day 1, and then on Day 1 of every 4-week cycle. Efficacy assessments included evaluation of priapic and vaso-occlusive (VOC) events. Safety assessments included laboratory tests, electrocardiograms (ECGs), vital signs and physical examinations. Participants had a safety follow-up for up to 15 weeks after the last dose.

Eligibility Criteria:
Inclusion criteria

* Male patients aged 12 years and above
* Confirmed diagnosis of SCD by hemoglobin electrophoresis or high-performance liquid chromatography. All SCD genotypes were eligible (HbSS, HbSβ0, HbSC, HbSβ+, and others)
* Experienced 4 or more priapic events (unwanted erection lasting at least 60 minutes) over the 14 weeks preceding study participation
* Experienced at least 3 priapic events (unwanted erection lasting at least 60 minutes) during the 12-week Screening period with at least 1 event occurring within 4 weeks prior to the first treatment
* If receiving hydroxyurea/hydroxycarbamide or L-glutamine or erythropoietin stimulating agent or voxelotor, must have been receiving the drug for at least 14 weeks prior to screening and planned to continue taking the drug at the same dose and schedule during the trial
* If receiving prophylactic treatment for priapism, must have been receiving the drug for at least 14 weeks prior to screening and planned to continue taking the drug at the same dose and schedule during the trial
* Written informed consent (or assent/parental consent for minor participants) prior to any screening procedures

Exclusion criteria:

* Had penile prosthetic implants or shunts or any other surgical procedure on the penis performed within 12 months prior to consenting was not allowed
* Took drugs/medications that may induce priapism over the 14 weeks preceding study entry
* Received leuprolide acetate (Lupron) or any other gonadotropin releasing hormone receptor agonist agent within 3 months before pre-screening
* Had an erection lasting more than 12 hours over the 14 weeks preceding study entry
* Had an erection lasting more than 12 hours during the 12 weeks of the Screening period
Outcome After Selective Dorsal Rhizothomy Concerning Life Quality, Cerebral Imaging and Cognition

Selektive dorsal rhizotomy (SDR) has been used as treatment option in children suffering from cerebral palsy (CP) for several decades and multiple studies demonstrated its benefits. Nevertheless, there are still no proven strategies for patient selection, optimal point of time for the operation or pre- and postoperative therapies. The evaluation of the impact of selective motor control, cognition and cerebral imaging findings on the motor outcome and life quality in children with CP who underwent SDR at the Charité University clinics will clarify these critical points in daily care for patients with CP.

SDR at the Charité University clinics. Two study visits before surgery and during the follow-up 3 months, 6 months, 12 months, 24 months and 5 years post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of cerebral palsy
* able to perform most tasks according to study protocols
* parents and physician decided to perform SDR

Exclusion Criteria:

* not able to perform any tasks according to study protocols
* no candidate for SDR
Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect

MNPLs effects on human health are still preliminary. Workers exposed to plastic residues are exposed constantly to MNPLs. One of these jobs corresponds to greenhouse workers, that could be considered as a population highly exposed to plastics. The objective of the research is to be able to detect MNPLs on body fluids as well as their potential genotoxic and immunological damage.

The exponential increase in the production/use of plastic translates into a parallel increase of environmental plastic waste that is continuously degraded into MNPLs. Information on the MNPLs' effects on human health is still preliminary and, furthermore, the limitations in current methodologies prevent accurate exposure/risk assessment.

This observational study will obtain body samples of greenhouse workers and from a control group. That would allow optimizing specific biomarkers of human MNPLs exposure and the characterization of biomarkers of early effect that allows an association among the exposure to MNPLs and effects on human health.

Eligibility Criteria:
Inclusion Criteria of workers exposed to plastic residues:

* Working in an operating greenhouse for a period of 1 month or more
* Age over 18 years old
* Absence of chronic pathology including neoplasia
* Absence of infectious disease at the date of sample collection and for a period of more than 2 weeks
* Spanish residence

Inclusion Criteria of controls :

* Age over 18 years old. Matched by age, gender, and lifestyle to the exposed group.
* Absence of chronic pathology including neoplasia
* Absence of infectious disease at the date of sample collection and for a period of more than 2 weeks
* Spanish residence

Exclusion Criteria of workers exposed to plastic residues:

* Participation in another clinical study
* Pregnancy
* Unsigned informed consent

Exclusion Criteria of controls:

* Participation in another clinical study
* Pregnancy
* Unsigned informed consent
Effect of Hepatic Impairment on LDK378 Pharmacokinetics

Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired hepatic function and healthy subjects with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria (all groups):

* Male Subjects between 18-70 years of age
* Female subjects between 18-70 years of age who are postmenopausal or sterile
* Body Mass Index (BMI) of 18.0- 36.0 kg/m2, with body weight ≥ 50 kg.

Inclusion (group mild, moderate and severe hepatic impairment):

- Subjects with confirmed cirrhosis

Exclusion Criteria (all groups):

* impaired cardiac function
* concurrent severe and/or uncontrolled medical conditions

Exclusion Criteria (moderate, mild and severe groups):

* Clinical evidence of severe ascites
* Use of PPIs within 10 days prior to 2 days after LDK378 dosing
Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)

The primary purpose of this study was to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in participants with highly-active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568_0022 (NCT03364036).


Eligibility Criteria:
Inclusion Criteria:

* Participants of the MAGNIFY Multiple Sclerosis (MS) trial who received at least a single dose of cladribine tablets during the MAGNIFY MS trial and data on Magnetic resonance imaging (MRI) is available/acquired from at least parent study Month 18 or Month 24 visit and Expanded Disability Status Scale (EDSS) and relapse from parent study Month 24 visit
* Capable of giving signed informed consent

Exclusion Criteria:

* Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
* Participation in other studies/trials
Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult Volunteers

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 19 - 55 years
* A body mass index in the range 19 - 27 kg/m2
* Willingness to participate during the entire study period
* Written informed consent after being fully informed about the study procedures

Exclusion Criteria:

* Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
* History of clinically significant drug hypersensitivity
* Use of medication within 7 days before the first dose
* Heavy drinker (\>140 g/week)
* Whole blood donation during 60 days before the study
* Judged not eligible for study participation by investigator
Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence

The primary objective is to develop a rapid in vitro screening assay for detection of pancreatic cancer biomarkers in blood of patients with pancreatic cancer.

The goal of the project is to develop a rapid in vitro screening assay for detection of cancer biomarkers in blood. The aim is testing and optimization of nanoparticle sensors, based on cyanine dyes that are chemically linked to Fe/Fe3O4 nanoparticles via protease-selective consensus (cleavage) sequences. The focus is on the quantitative determination of active cancer-specific proteases in blood via simple fluorescence measurements. The matrix metalloproteinases, urokinase-type plasminogen activator, and cathepsins, are up-regulated in the vast majority of progressing cancers and can, therefore, serve as markers for cell survival/tumor progression, angiogenesis, and tissue remodeling/invasion

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for Pancreatic Cancer Patients:

* Patients will either have a histologic diagnosis of pancreatic carcinoma or a clinical picture consistent with pancreatic cancer and will be undergoing surgery or a diagnostic procedure to confirm the diagnosis.
* Patients will have had no prior treatment or surgery

Inclusion Criteria for Healthy Subjects:

* Subjects will have no prior history of any cancer

Exclusion Criteria:

Exclusion Criteria for Pancreatic Cancer Patients

* Any prior treatment for pancreatic cancer
* Poorly controlled diabetes

Exclusion Criteria for Healthy Subjects

* Poorly controlled diabetes
Intubating Conditions of Neuromuscular Blockade

The purpose of this research is to learn about the difference in the endotracheal intubation condition (ease of using a device to view vocal cords, position of vocal cords, and patient's reaction to endotracheal tube insertion) and determining the appropriate time to perform the intubation.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to participate and provide an informed consent.
* Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) administered intraoperatively.

Exclusion Criteria:

* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis.
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents; i.e., severe renal impairment or end-stage liver disease.
* Patients having surgery that would involve prepping the arm into the sterile field.
* Patients receiving a rapid sequence induction.
Triangular Exclusion Technique in Isolated Posterior Mitral Valve Leaflet Prolapse for Mitral Valve Repair

The goal of this clinical trial is to learn if surgical method done to repair one of the heart valve called mitral valve disease during open heart surgery

The main questions aims to answer is:

Does this method is safe and effective for long time and can be used in special cases of mitral valve surgery ? participants come to clinic to be checked clinically and radiologcally every month by the surgeon till 12 month

the surgical method isThe prolapsed part of the posterior leaflet of the mitral valve is inverted and excluded, toward the left ventricle but not cutted echocardiography done before participants leave hospital after sugery, after 6 month and after 12 months to confirm that this method of repair is safe and effective for participants life long

Eligibility Criteria:
Inclusion Criteria:

* varying degrees of degenerative MV regurgitation, ranging from moderate to severe or severe caused by isolated prolapse of the posterior MV leaflet
* concomitant tricuspid annuloplasty

Exclusion Criteria:

* with Mitral Valve stenosis or any other manifestation of mitral regurgitation pathology.
* individuals requiring surgical intervention for the aortic or pulmonary valves
Clinical Correlation Evaluation of the LIVERFASt Test for Diagnosing Important Liver Lesions of Fibrosis and Steatosis Against Magnetic Resonance Elastography (MRE) for Liver Fibrosis and MR-based Assessment of Steatosis, in Adult US Population.

This is a retrospective cross-sectional research intended to explore the utility of LIVERFASt in the clinical pathways for the detection of liver fibrosis and steatosis in comparison with the Magnetic Resonance Elastography (MRE) and MRct1 fibrosis classification (historical records) and to assess LIVERFASt performance for MR steatosis assessment in an United States adult miscellaneous population with available (historical) MR intracellular fat fraction assessment (ICFF) from a single tertiary US clinic.

1. To assess the correlation and the strength of concordance of LIVERFASt for staging important liver lesions of fibrosis and steatosis against MR liver assessment of clinically significant (≥F2 stage), advanced fibrosis (≥F3 stage) and cirrhosis (F4 stage) (MRE, ct1) and steatosis (MR) in a SLD (MASLD, MetALD) adult US population.
2. To assess the diagnostic performance \[AUROC (95%CI)\] of LIVERFASt for diagnosing important liver lesions of fibrosis, steatosis taking MR-based methods as surrogate gold-standard (MRE for fibrosis assessment and MR for steatosis quantification).

Eligibility Criteria:
Inclusion Criteria:

* SLD with MASLD or MetALD Adult patients with:

  * available historical report of MRE and LIVERFASt test
  * at least fibrosis scoring available (steatosis and necro-inflammation imaging reports are requested equally when available).
* Other imaging modality reports ie. MRI, ARFI, ct1, SWE and Fibroscan can be included when available

Exclusion Criteria:

* Participants identified as having risk factors for false positive/negative results for Liverfast (severe intravascular hemolysis-if condition is known-, acute hepatitis or severe cytolysis with ≥ 600 ALT values)
* Other comorbidities not compatible with the diagnosis of MASLD or MetALD
Attention Training and Its Effects on Body Image Disturbance

Research has consistently found attentional biases towards negative weight-related stimuli in individuals with eating disorders. It has been suggested that these biases may act as a vulnerability factor for the development and maintenance of body dissatisfaction and may therefore be an important target for intervention. Previous studies have demonstrated the capacity to modify the patterns of attention allocation to threatening stimuli in a variety of anxiety disorders, with a subsequent and sustained reduction in anxiety symptoms. Thus, the present study aimed at testing the efficacy of attention training in reducing attentional biases and eating disorder symptoms in individuals with elevated levels of body image disturbance and eating disorder symptomatology of clinical severity. Thirty-two participants were randomly allocated to receive eight sessions of a 10-minute computer task aimed at training their attention away from weight-related stimuli or a control placebo training condition. Results showed that participants in the attention training group had a significantly greater reduction in their attentional bias and body dissatisfaction from pre- to post-training relative to the placebo condition. At follow-up, both groups showed a significant decrease in body dissatisfaction from their pre-training levels. The only significant difference between groups in eating disorder symptoms at follow-up was in terms of the attention training group experiencing a greater reduction in weight and shape concerns.


Eligibility Criteria:
Inclusion Criteria:

* If they have a score on the Body Shape Questionnaire of 113 or more AND a score in the EDE-Q of 4 or more in any subscale.

Exclusion Criteria:

* attention bias score of \<-10
Feasibility Testing of Plant-Based Meal Replacement Products Made with Manitoba Crop Ingredients for Weight Loss and Diabetes Remission

The goal of this clinical trial is to advance the development of the WI meal replacements by evaluating the acceptance and feasibility of the meal replacements within the Wellness Institute's Weight Loss Clinic program (WLC). The main questions it aims to answer are:

* To determine whether the incorporation of WI meal replacements into their weight loss clinic design is feasible.
* To determine whether weight loss is supported by a plant-based meal replacement.
* To assess efficacy of the meal replacements by measuring changes in lifestyle behaviours and risk factors for chronic disease compared to non-meal replacement weight loss program members.
* To assess remission of diabetes and pre-diabetes.

Researchers will compare the WLC program plus meal replacements to the WLC program without the meal replacements to evaluate the implementation of the meal replacements into the WLC.

Participants will follow their WLC program for 16 weeks, and those in the intervention group will begin their meal replacements. Participants will have a choice on what type of meal replacement they will consume each day (either a bar or a shake) and will record this in the product consumption log.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 years or above
* Live within the province of MB
* Ability to give written informed consent in English.
* Enrolled in the Wellness Institute Weight Loss Clinic

Exclusion Criteria:

* Female participant who is pregnant, lactating or planning pregnancy during the course of the program.
* Participants with known allergies to the meal replacement ingredients
* Has an active eating disorder
A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma

The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).

In addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic progression (TTSP), response rate (RR) and overall survival between the 2 study populations.

The possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints.

The safety and tolerability will be assessed in the adverse event section. Doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity).

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a life expectancy of at least 12 weeks
* Patients with advanced HCC (unresectable, and/or metastatic) which has been histologically or cytologically documented
* Patients must have at least one tumor lesion that meets both of the following criteria:

  * can be accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST)
  * has not been previously treated with local therapy
* Patients who have received local therapy except chemoembolization, such as surgery, radiation therapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of 25% in the size. Local therapy must be completed at least 4 weeks prior to the baseline scan
* Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria:

* Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to entry is permitted
* History of cardiac disease
* Serious myocardial dysfunction
* Active, clinically serious infections
* Known history of Human Immunodeficiency Virus (HIV) infection
* Known Central Nervous System (CNS) tumors including metastatic brain disease
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry