cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess Administration of an Oral Anti-thrombotic With Antiplatelet Therapy in Healthy Subjects

This study will investigate the safety and interaction of BMS-986177 in healthy volunteers, when administered with Aspirin and/or Clopidogrel


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Must have a Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
* Must have a normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) of \> 80 mL/min/1.73 m2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula and the absence of protein in the urine

For Parts 1 and 2:

• Must be a clopidogrel responder (eg, a decrease in platelet aggregation of at least 30% after a single 600-mg dose of clopidogrel compared with baseline).

Exclusion Criteria:

* Any significant acute or chronic medical illness, including tinnitus or any other condition listed as a contraindication in the aspirin package insert.
* History of dizziness and/or recurrent headaches (i.e. daily headaches lasting for 1 week's duration in the last month prior to study treatment administration).
* History of head injury in the last 2 years, including participants with base skull fractures, intracranial tumor, or aneurysm.
* History of gastroesophageal reflux disease, dyspepsia (indigestion), protracted nausea, or chronic diarrhea (defined as 3 or 4 loose stools per day that last for ≥ 4 weeks) within the past 6 months.

Other protocol-defined inclusion/exclusion criteria apply.
Non-invasive Identification of Preoperative Anaemia

Approximately 20% of patients undergoing elective orthopaedic surgery are anaemic. When not identified and treated before surgery, this can lead to requiring blood transfusions, which brings additional expenses, time and inconvenience to the patient.It is recommended that preoperative assessment involves investigation and where possible, treatment of anaemia.

The timescale between assessment and surgery makes it difficult to comply with guidelines without postponing surgery.

This study will investigate adult patients scheduled for elective orthopaedic surgery, where a full blood count is to be taken as part of routine care. A paired non-invasive reading of their blood will be taken. It will be conducted at The Royal Infirmary, Edinburgh. This device is not in use within the department currently but has been given free of charge for the study. There are no restrictions placed on the device except that it is not accurate for measuring haemoglobin \<8g.dL. Participant care will only be determined by results from the laboratory assay as per routine care, not the noninvasive device.

The device is CE marked for haemoglobin determination. Masimo (manufacturer) have released results in the accuracy of their monitor but with very little other information, for example, study population or precision. This study aims to answer how accurate and precise non-invasive measurements are in patients scheduled for orthopaedic surgery (there are no studies with these results) and whether anaemia can be identified earlier in the patient pathway i.e. an anaemia screen at time of surgical listing, therefore leaving ample time for treatment and optimisation of care.

The data from the study will not be shared with Masimo. There is ongoing work towards introducing and piloting a new pre-operative triage system where optimisable conditions e.g. anaemia are identified at the time of listing. This study would aid this work.


Eligibility Criteria:
Inclusion Criteria:

* able to provide informed consent
* aged between 16-80 years old
* scheduled for elective orthopaedic surgery
* a full blood count (FBC) is to be taken as part of routine care

Inclusion Criteria for healthy volunteers cohort:

* able to provide informed consent
* aged between 16-80 years old

Exclusion Criteria:

* Patients with haemoglobin disorders
* Raynaud's disease (or any other condition affecting the blood supply to the digits).

Exclusion Criteria for healthy volunteers cohort:

* Patients with haemoglobin disorders
* Raynaud's disease (or any other condition affecting the blood supply to the digits).
Study to Assess the Efficacy and Safety of CLBS12 in Patients with Critical Limb Ischemia (CLI)

A prospective, open label, controlled, randomized, double arm, multi-center study to assess the efficacy and safety of CLBS12 in patients with critical limb ischemia (CLI) due to arteriosclerosis obliterans (ASO) with a single arm sub-study to assess the safety and potential efficacy of CLBS12 in patients with CLI due to Buerger's Disease (BD).

Main ASO Study: This study will compare safety and efficacy of intramuscular transplantation of autologous CD34+ cells (CLBS12) plus standard of care (SOC) pharmacotherapy (cell treatment arm) versus SOC pharmacotherapy alone (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids) (control arm) in subjects with CLI categorized as Rutherford score 4 or 5 due to ASO aged 20 to 85 years and with no endovascular or surgical revascularization options. Subjects assigned to the cell treatment arm will continue SOC pharmacotherapy and will also receive subcutaneous injections of GRAN® 5 ug/kg/day for 5 days and undergo apheresis on the last day of GRAN® administration. Then each subject in the cell treatment arm will receive intramuscular injections of autologous CD34+ cells. Subjects assigned to the control arm will continue to receive SOC pharmacotherapy alone with the possibility of receiving cell treatment via the rescue option.

BD Substudy: A single arm substudy is included to assess the safety and efficacy of intramuscular transplantation of CLBS12 in patients (N=\~5) with CLI categorized as 4 or 5 Rutherford score due to BD aged 20 to 85 years. Subjects who give informed consent will be screened for eligibility within 28 days before registration. Subjects will continue SOC pharmacotherapy and will also receive subcutaneous injections of GRAN® 5 µg/kg/day for 5 days (Pretreatment Days 1 5) to mobilize CD34+ cells into the peripheral blood and undergo apheresis on pretreatment Day 5 to collect CD34+ cells. The choice of pharmacotherapy will be made by the investigators.

Each subject in a cell treatment arm will receive intramuscular injections of up to 1 × 10\^6 autologous CD34+ cells/kg/limb. All subjects will be evaluated for efficacy and safety assessments during approximately 12 months.

Efficacy assessments include CLI free status, AFS, PFS, ABI, TBI, SPP, TcPO2, ICD, VAS, and AQA.

Eligibility Criteria:
Inclusion Criteria:

* subject has CLI caused by ASO or BD

Exclusion Criteria:

* \< 20 years old
Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes

Twenty-one patients with insulin-treated type 2 diabetes with diabetic complications will be recruited to Part 1 of the study, a three-hour combined hyper- and hypoglycaemic clamp, along with a control group of twenty-one individuals with normal glucose tolerance matched for age, gender, and body mass index. Patients with type 2 diabetes will be scheduled for a three-week run-in period with LR and CGM prior to participation in Part 1. Only patients with a well-functioning loop-recorder and who can comply with CGM will be included. Patients with type 2 diabetes will continue in part 2 of the study, a one year observational study employing CGM and LR and clinical examination after 1, 3, 6, 9, and 12 months and an extended observation period of 2 years employing LR and clinical examination.


Eligibility Criteria:
Inclusion Criteria:

Patients with type 2 diabetes

* Informed and written consent
* Type 2 diabetes diagnosed according to the criteria of the World Health Organization (WHO)
* Treatment with insulin
* Glycated haemoglobin A1c (HbA1c) ≤58 mmol/mol
* One or more clinical relevant complications to diabetes defined as: peripheral neuropathy with vibration perception threshold of \> 25 volt determined by biothesiometry, moderate to severe retinopathy, nephropathy (creatinine \>130 μmol/l and/or albuminuria), and/or macrovascular disease. Macrovascular disease is defined as coronary disease (stable angina pectoris or previous unstable angina pectoris or myocardial infarct), cerebrovascular disease (previous stroke or transitional cerebral ischaemia), and peripheral vascular disease (previous intermittent claudication or prior acute ischemia)
* Well-functioning LR during run-in period (acceptable readings judged by an arrhythmologist)
* Participation in the extended study

Healthy individuals

* HbA1c ≤42 mmol/mol
* Fasting plasma glucose ≤6.1 mmol/l

Exclusion Criteria:

Patients with type 2 diabetes

* Arrhythmia diagnosed prior to or at the time of inclusion
* Implantable cardioverter defibrillator (ICD) or pacemaker at the time of inclusion
* Severe heart failure (left ventricular ejection fraction \<25%)
* Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
* Insulin naïve patients with type 2 diabetes
* Thyroid dysfunction (except for well-regulated eltroxine substituted myxoedema)
* Unable to comply with daily CGM during run-in period
* Anemia (male: hemoglobin \< 8.0; female: hemoglobin \< 7.0 mmol/l)

Healthy individuals

* Type 1 or type 2 diabetes
* Prediabetes (HbA1c \>42 mmol/l and/or fasting plasma glucose \>6.1 mmol/l)
* Family history of diabetes (type 1 og type 2 diabetes)
* Arrhythmia diagnosed prior to or at the time of inclusion
* ICD or pacemaker at the time of inclusion
* Severe heart failure (left ventricular ejection fraction \<25%)
* Structural heart disease (Wolf-Parkinson-White syndrome, congenital heart disease, severe valve disease)
* Thyroid dysfunction (except for well-regulated eltroxine substituted myxoedema)
* Anemia (male: hemoglobin \< 8.0; female: hemoglobin \< 7.0 mmol/l)
The Construction and Application of a Mobile Health Management Program for Elderly Depression Based on the Patterns of Cognitive Function Changes

Based on the changing law of cognitive function, combined with the behavior change wheel theory and the health behavior process orientation model, we constructed a mobile health management program for geriatric depression. The aim is to explore the effect of this intervention program on the health behavior of elderly patients with depression; and to verify the effect of the intervention program on improving the primary outcome and other secondary outcomes of elderly patients with depression, with a view to providing a scientific basis for the management of depression in the elderly and promoting the optimization of personalized intervention strategies.

Based on the changing law of cognitive function, combined with the behavior change wheel theory and the health behavior process orientation model, we constructed a mobile health management program for geriatric depression. The aim is to explore the effect of this intervention program on the health behavior of elderly patients with depression; and to verify the effect of the intervention program on improving the primary outcome and other secondary outcomes of elderly patients with depression, with a view to providing a scientific basis for the management of depression in the elderly and promoting the optimization of personalized intervention strategies.

Eligibility Criteria:
Inclusion Criteria:

* ① Meet the clinical diagnosis of geriatric depression and DSM-5 diagnostic criteria; ② Age ≥ 60 years old, clear consciousness; ③ Be able to communicate in Mandarin, with a certain degree of comprehension and expression; ④ Possess a smart phone and have the ability to operate it in a basic way; ⑤ Voluntarily participate in this study and sign an informed consent form

Exclusion Criteria:

* ①previous or current cognitive impairment and other severe mental illnesses that prevent cooperation with the study;②comorbidities such as severe cardiac, hepatic, or renal impairment
A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.


Eligibility Criteria:
Inclusion Criteria:

* Is Healthy, based on clinical judgment of the investigator
* Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

Exclusion Criteria:

* Has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease
* Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine
* Has any contraindication to the concomitant study vaccines being administered in the study
* Has a known or suspected impairment of immunological function
* Has a history of congenital or acquired immunodeficiency
* Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
* Has or his/her mother has a documented hepatitis B surface antigen - positive test
* Has known or history of functional or anatomic asplenia
* Has failure to thrive based on the clinical judgment of the investigator
* Has a known coagulation disorder contraindicating intramuscular vaccination
* Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders)
* Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
* Has received a dose of any pneumococcal vaccine prior to study entry
* Has received \>1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
* Has received a dose of rotavirus vaccine prior to study entry
* Has received a blood transfusion or blood products, including immunoglobulins
* Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study
* Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study
* Has an immediate family member (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.
Relationship Between FGF19 Overexpression and Disease Prognosis

A real-world study of FGF19 overexpression status and treatment outcome and prognosis in advanced hepatocellular carcinoma

This is a real-world, single-arm, observational study to collect information on the diagnosis and prognosis of hepatocellular carcinoma patients with previous tissue samples in routine clinical practice, and to detect the expression of FGF19 expression in tissue samples, with a view to discovering prognostic and predictive markers for advanced hepatocellular carcinoma The treatment protocol of this study follows the clinical practice and does not set any limitations on the interventions for patients.

In this study, real-world liver tissue samples will be collected from patients with hepatocellular liver cancer after surgical resection, and the samples will be sent to a third-party pathology slice reviewer for review, and a report on the FGF19 expression results will be returned to the project team. Simultaneously collect clinical data of the patient.

According to the principle of clinical routine diagnosis and treatment, the patient's imaging data were collected, and the imaging of the 2-month period was evaluated, and whether the disease progressed was judged according to the RESCIST v1.1 standard. Every two months will be an observation cycle. Each subject will be followed from the first treatment until disease progression or change of drug regimen.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years on the day of signing the informed consent form
* Histologically or clinically confirmed diagnosis of intermediate to advanced HCC
* Adequate tissue samples of previous liver cancer
* Expected survival of more than 3 months

Exclusion Criteria:

* Fibrous laminae or sarcomatoid HCC or mixed HCC-ICC, or other rare non-HCC pathologic subtypes
* Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate
A Controlled-Study of Fenofibrate 145 mg and Ezetimibe 10 mg in Type IIb Dyslipidemic Patients With Features of the Metabolic Syndrome

Type IIb dyslipidemia is characterized by elevated triglycerides (TG ³ 150 mg/dL), and elevated LDL-C levels (³160 mg/dL). When in addition, HDL-C is low, the presence of the lipid triad, elevated TG and LDL-C and low levels of HDL-C, seems to confer additional CHD risk in this type of patient, compared to elevated LDL-C alone.Coadministration of fenofibrate and ezetimibe could provide a complementary efficacy therapy and improve the atherogenic profile of this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Type IIb dyslipidemia.

Exclusion Criteria:

* Known hypersensitivity to fibrates or ezetimibe. Pregnant or lactating women. Contra-indication to fenofibrate or ezetimibe.
Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

In this study the investigators propose to monitor subjects who have received Triathlon total knee components inserted with HV cement. The primary outcome will be fixation of the tibial implant component as assessed with RSA and to determine the functionality of patients after surgery using self-reported questionnaires. This is a historical control study, comparing the study cohort to a previous group with Triathlon implants and the long-standing Simplex T cement. The secondary outcomes are inducible displacements of the implants as well as a qualitative evaluation of the cement handling characteristics performed by the operating room staff.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic arthritis of the knee indicating primary total knee arthroplasty
* Between the ages of 21 and 80 inclusive
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent

Exclusion Criteria:

* Active or prior infection
* Medical condition precluding major surgery
* Severe osteoporosis or osteopenia
* Neuromuscular impairment
* Significant co-morbidity affecting ability to ambulate
Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis

The purpose of this study was to compare the pharmacodynamics of intravenous (IV) lansoprazole to oral lansoprazole capsules, once daily (QD), in participants with erosive esophagitis.

Phase 2, open label, multi-center, 2-period study to compare the pharmacodynamics of IV lansoprazole 30 mg to oral lansoprazole 30 mg in subjects with erosive esophagitis (grade \>or= 2)diagnosed by endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects were required to have Grade 2, 3 or 4 esophageal findings according to the TAP Grading Scale during the pretreatment endoscopy.
* Subjects must discontinue histamine H2-receptor antagonists, proton pump ® inhibitors, prokinetic agents, antacids and Carafate before the first dose of drug and during the study.

Exclusion Criteria:

* Gastric or duodenal ulcer (a lesion with appreciable depth ≥3 mm) or a hiatal hernia \>5 cm.
* Subjects could not have a diagnosis of Barrett's esophagus (with or without dysplastic changes).
* Co-existing systemic disease affecting the esophagus, (ie, scleroderma, viral or fungal infection), radiation therapy to the region of the esophagus, or caustic or physiochemical trauma to the esophagus.
* Current esophageal stricture requiring dilatation. The endoscope had to pass freely into the stomach during endoscopy. Any strictures could not have been dilated within 12 weeks before beginning the Pretreatment Period.
* Positive H pylori by rapid urease test (CLO® test Kimberly-Clark Corporation).
* Uncontrolled, clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, gastrointestinal, neurological or endocrine disease or other abnormality (other than the erosive esophagitis disease being studied).
* Diagnosis of Zollinger-Ellison syndrome, esophageal varices, symptomatic pancreaticobiliary tract disease, cholecystitis, rheumatoid arthritis, lupus, or malignancy (except basal cell carcinoma).
Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation

The purpose is threefold: Assess the anxiety reduction, the mood positive effect and the rise of quality of life when using methods of relaxation combined with virtual reality with patients suffering from generalized anxiety disorder in comparison of the effect of traditional relaxation therapy. Observe and evaluate the effect of perceived presence in synthetic environments in the virtual experience of relaxation. Evaluate the therapeutic efficacy of stereoscopy during exposure to relaxing virtual environments for the treatment of generalized anxiety disorder.

It is a comparative, randomized, two groups study (29 in each group):

* Relaxation optimized virtual reality
* Classical relaxation (without Virtual Reality). The protocol comprised for each groups 7 relaxing sessions (with or without virtual reality epending on the group). Each session lasted for approximately 30 to 35 minutes, including a 5-minute pause between immersive trials, in order to avoid cyber sickness in the virtual reality group.

Expected results: a measurable therapeutic improvement produced by the combination of relaxation and virtual and its additional effect when compared to the traditional treatment.

Measurements of variables and therapeutic effects will be carried out with psychometric measures.

The creation process of the relaxing virtual environments has already been completed. The virtual environments are ready for use.

The apparatus needed and in our possession include:

* A laptop for generating virtual environments
* A stereoscopic display
* Apparatus for physiological measurements


Eligibility Criteria:
Inclusion Criteria:

* Male or Female.
* Age 18-65 years inclusive.
* Generalized Anxiety Disorders primary diagnosis in patients according with major depressive episode V (DSM-V) criteria.
* Topic speaking English or French language
* Subject who have signed a written informed consent and undertaking to comply with the instructions of the protocol.

Exclusion Criteria:

* Subject not having at least one inclusion criterion;
* Minor Subject, pregnant or nursing women, about not being affiliated to the social security scheme, or deprived of liberty subject;
* Age greater than 18 and less than 65 years.
* Subject Trust;
* Subject indication against having a virtual reality: epilepsy, major organ failure, severe myopia, acute psychiatric disorder (such as schizophrenia in acute period, paranoia, manic, or melancholic major depression).
* Subject did not sign the informed consent, or topic for which the legal representative has not signed this consent in cases where the subject is under curatorship.
* Subject wishing to interrupt his participation in the study before the end;
* Subject for which the occurrence of an event makes it necessary to interrupt the therapy program before the end
* History of neurological disease, head injury or mental retardation.
* Presence of a psychotic disorder decompensated
* Presence of addictologique comorbidity.