cyrilzakka/clinical-trials huggingface dataset:
A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip Replacement

The purpose of this study is to monitor the performance of the Summit™ hip in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility Criteria:
Inclusion Criteria:

i) Male or female subjects, aged between 18 and 70 years (inclusive).

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects who require primary total hip replacement and are considered suitable for a cementless femoral stem.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Subjects who have previously undergone a hemi-arthroplasty or total hip arthroplasty.

iii) Women who are pregnant.

iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.

vi) Subjects who are currently involved in any injury litigation claims.
MMR at 6 Months Trial

Randomised, double-blind clinical trial to test humoral and cellular immunogenicity, and potential in-direct beneficial effect of the MMRvaxpro-vaccine administered at 6 months of age


Eligibility Criteria:
Inclusion Criteria:

* Gestational age of 32+ weeks.
* Birth weight of 1000+ grams.
* Signed informed consent from the parents.

Exclusion Criteria:

* Immune-deficiency (primary or acquired) or -suppression.
* Intake of immune modulating medicine (including high doses of corticosteroids) (M-M-RVAXPRO is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids, e.g. for asthma prophylaxis or replacement therapy).
* Signs of severe illness or major malformation.
* No Danish-speaking parent.
* Children with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion are excluded.
* Children with known fructose intolerance, thrombocytopenia or any coagulation disorder will be excluded.
* Children who received blood or plasma transfusions, or administration of human immune serum globulin within the last 3 months will be excluded.
* Further, children are excluded from the trial if any contraindication is suspected: history of hypersensitivity to any measles, mumps, or rubella vaccine, or to any of the excipients, including neomycin.
* Children with active untreated tuberculosis, blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems will be excluded.
Single Ascending Dose Study of TD-0714 in Healthy Subjects

Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) 18 to 32 kg/m2 inclusive
* Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control
* Women of non-childbearing potential are at least 2 years postmenopausal or are surgically sterile
* Males must abstain from sex or use highly effective methods of birth control
* Negative for HIV, and Hepatitis A, B, and C

Exclusion Criteria:

* Female subjects who are pregnant, lactating, breastfeeding or planning to become pregnant during the study.
* Subjects with a history of angioedema.
* Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
* Subject has acute illness (gastrointestinal, infection \[e.g., influenza\] or known inflammatory process)
* Subject bradycardia
* Subject has hypertension
* Subjects has orthostatic hypotension
* Subjects has orthostatic tachycardia
* Subject has a known personal or family history of congenital long QT syndrome or known family history of sudden death.
* Subject has donated blood or blood components or has had blood loss exceeding 400 mL within the 90 days prior to Screening.
* Additional exclusion criteria apply
Clinical Trial on Treatment of Intraventricular Hemorrhage

The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.

The purpose of this trial is to determine the efficacy and pharmacokinetics of intraventricular injections of multiple low doses of rt-PA. Sixteen subjects were already randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to 8 doses. Results of this stage (n=16) were then analyzed and the most effective dose of 1.0 mg was chosen to be used in the second stage (n=36) to determine the optimal frequency of dosing. We propose to test if this intervention facilitates more rapid clot resolution, complete recovery function and decreased mortality from this condition.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75
2. IVC placed as standard of care using less than or equal to 2 complete passes.
3. Spontaneous ICH less than or equal to 30 cc.
4. Able to receive first dose within 48 hours of CT scan diagnosing IVH (providing the time of symptom onset to diagnostic CT does not exceed 12 hours).
5. Clot size measured on CT scan done 6 hours after IVC placement must be equal to the presentation clot size plus or minus 5 cc (as determined by the AxBxC)/2 method).
6. ON stability CT scan either the 3rd or 4th ventricles are occluded with blood (no evidence of CSF flow on CT).
7. SBP \< 200 mmHg sustained for 6 hours.
8. Historical Rankin of 0 or 1.

Exclusion Criteria:

1. Suspected or untreated aneurysm or AVM (unless ruled out by angiogram or MRA/MRI).
2. Clotting disorders.
3. Patients with platelet count \< 100,000, INR \> 1.7, PT \> 15s, or an elevated APTT.
4. Pregnancy (positive pregnancy test).
5. Infratentorial hemorrhage (i.e., parenchymal/posterior fossa hematoma; all cerebellar hematomas excluded).
6. SAH (An angiogram should be obtained when the diagnostic CT scan demonstrates subarachnoid hemorrhage or any hematoma location or appearance not strongly associated with hypertension. If the angiogram does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study).
7. ICH enlargement during the 6-hour stabilization period (6 hour after IVC placement).
8. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.
9. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention.
10. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis.
11. Prior enrollment in the study.
12. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
13. Participation in another simultaneous medical investigation or trial.
Short-course Antimicrobial Therapy for Paediatric Respiratory Infections

Randomized controlled double-blind non-inferiority clinical trial to determine whether five days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with 10 days of high-dose amoxicillin for previously healthy children with mild community-acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

Children aged 6 months to 10 years presenting with CAP will be eligible. CAP will be defined if all of the four following numeric criteria are met:

1. fever (\>37.5 C axillary, \> 37.7 C oral, or \>38 C rectal) recorded in the ED or at home in the 48h prior to presentation;
2. any one of:

   1. tachypnoea on exam (\>60 bpm for age \<1 y, \>50 bpm for 1-2 y of age, \>40 bpm for 2-4 y of age, and \>30 bpm for \>4 y of age);
   2. cough on exam or by history;
   3. increased work of breathing on exam; or
   4. auscultatory findings (focal crackles, bronchial breathing, etc.) consistent with pneumonia;
3. infiltrates on chest radiograph consistent with bacterial CAP as judged by the ED physician; and
4. the attending ED physician diagnoses the child with primary CAP. (Children treated with systemic steroids in the ED will be presumed to have primary asthma exacerbation with possible infection and therefore will not meet inclusion criteria.)

Participants must be well enough to be treated as outpatients (discharged home by the ED physician, adequate volume status, able to tolerate oral medication, oxygen saturation \> 90%, no evidence of impending respiratory failure), and have no evidence of empyaema or necrotizing pneumonia on chest radiograph.

Exclusion Criteria:

Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease, history of repeated aspiration or velopharyngeal incompetence, malignancy, conditions requiring treatment with immune suppressants, primary immunodeficiency, advanced HIV infection, prolonged admissions (\>48 h) to hospital within the past 2 months, pneumonia previously diagnosed within the past month, lung abscess diagnosed within the past six months, receipt of \> 24 hours of beta-lactam antibiotic therapy already received at presentation to the ED, receipt of at least a 5 day course of amoxicillin \< 72h prior to presenting to the ED, receipt of an intravenous cephalosporin or azithromycin in the ED, or suspected allergy to penicillin. Children will not be eligible to participate more than once.
Clinical and Genetic Examination of Usher Syndrome Patients' Cohort in Europe

This study aims to characterize Usher patients in order to correlate this data with genetic information.

Tasks:

* Standardization and improvement of Usher syndrome diagnosis: refine and elaborate special tests of visual and otological function in association with genotype that enable to determine the most significant markers for Usher disease progression and therapeutic effect.
* Perform genotype and phenotype correlations in Usher syndrome patients
* Develop and maintain database for phenotypically and genotypically well-characterized patient cohorts, suitable for future therapeutic trials


Eligibility Criteria:
Inclusion criteria :

* Clinical characteristics for USH1, USH2 and USH3 as defined by the Usher syndrome consortium;
* Informed consent and agreement to participate in the study;
* Distance best corrected visual acuity ≥ 0.1.

Exclusion criteria:

* Systemic pathologies or severe ocular pathologies, systemic or topical medication usage, and/or other otolaryngology pathologies which could contaminate the results;
* Unwillingness to provide a blood sample ;
* Unwilling and/or unable to undergo the study procedures.
Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma

This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).


Eligibility Criteria:
Key Inclusion Criteria:

1. Age 18 years or older
2. Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes
3. Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least partial response or documented progressive disease (PD) after, the most recent systemic treatment
4. Current need for systemic therapy for MZL
5. Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
6. Eastern Cooperative Oncology Group (ECOG) of 0-2
7. Life expectancy ≥ 6 months
8. Adequate bone marrow function
9. Adequate organ function
10. Male and female participants must use highly effective methods of contraception

Key Exclusion Criteria:

1. Known transformation to aggressive lymphoma, eg, large cell lymphoma
2. Clinically significant cardiovascular disease
3. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer
4. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
5. History of stroke or intracranial hemorrhage
6. Severe or debilitating pulmonary disease
7. Active fungal, bacterial and/or viral infection requiring systemic therapy
8. Known central nervous system involvement by lymphoma
9. Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection
10. Major surgery within 4 weeks of the first dose of study drug
11. Prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
12. Pregnant or lactating women
13. Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or inducer
14. Concurrent participation in another therapeutic clinical trial

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155

This protocol is open to subjects previously enrolled in and who had completed a Phase I or Phase II study administering YM155. Subjects who are receiving benefit from treatment with YM155 are eligible after completing the previous study.

The main objective of the study is to continue to evaluate the safety and efficacy of YM155.

Each subject will be treated at the dose he/she was receiving at the completion of his/her previous phase I or phase II YM155 study.

Eligibility Criteria:
Inclusion Criteria:

* Completed a Phase I or II YM155 study with at least stable disease and continues to meet the criteria as stated in the previous YM155 study that allows for additional treatment with YM155
* Lack of progression based on the most recent radiological imaging, biochemical assessments and/or physical examination
* Negative pregnancy test result (females of child-bearing potential)

Exclusion Criteria:

* More than 21 days (or 14 days depending on the study of origin) between the time the last infusion of YM155 was stopped in the previous study and the proposed start of the first infusion in this study
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form 18 years of age or older
* Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to screening
* Moderately to severely active UC as per the modified Mayo score
* Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol

Exclusion Criteria:

* Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
* UC limited to rectum only or to less than (\<) 15 centimeters (cm) of colon
* Presence of a stoma
* Presence or history of fistula
* History of extensive colonic resection (example, \<30 cm of colon remaining)
* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease
Combined Determination of sTREM-1, PCT and CD64 in Diagnosing Sepsis

The purpose of this study is to determine wether the combined measurement of the soluble form of TREM-1, PCT and the determination of neutrophils CD64 expression could diagnose sepsis in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients admitted into the ICU

Exclusion Criteria:

* absence of social protection
Prevalence of Digestive Carriage of Integrons

Bacterial resistance to antimicrobials is an increasing problem. Doctors occasionally face genuine therapeutic dead-ends, when attempting to cure nosocomial infections and, more and more frequently, community-acquired infections. Mastering antimicrobial resistance diffusion is nowadays a major Public Health issue.

Struggling against bacterial resistance to antimicrobials lays on three main measures:

* individual and collective hygiene.
* proper antibiotics practices, which could help reduce antibiotic selective pressure.
* better understanding of bacterial resistance mechanisms and resistance gene transfer between bacteria.

Integrons, gene capture and expression systems, are recognised as major players in resistance gene transfer, which accounts for the greater part of resistance emergence and dissemination. Integrons are typically described in Gram negative bacteria, isolated in man, environmental settings and animals. They encode resistances to nearly every class of antimicrobials. A strong link between integrons and resistance to multiple antibiotic compounds has been described and integron detection is a relevant indicator of resistance to multiple antibiotics.

The investigators project offers to study the impact of antibiotics on the frequency of integron intestinal carriage in the Limousin region and the genetic communities between the two groups.

This study will use an innovative real-time PCR technique to detect integrons directly in the sample without using traditional culture-based techniques. The investigators hope to detect new integron-carriers, notably patients for whom integrons are borne by non or poorly cultivable bacteria. Stool samples will be taken from two groups of subjects : 246 intensive-care unit patients under high antibiotic selective pressure, compared with 246 healthy individuals representative of the community, under a more usual selective pressure. In both groups, antibiotic consumption will be fully documented.

Eligibility Criteria:
Inclusion Criteria:

* adults \> 18 years
* patients Hospitalized in intensive care unit for at least 48 hours, including one antibiotic was found at least in the background (\<3 months).
* patients followed by the Department for Work and Health for bacteriological examination of stool
* possible information about antibiotic therapy provided
GW273225 Therapy Added To Current Seizure Treatments In Patients With Partial Seizures

Study to determine drug interactions between GW273225 and the anticonvulsants valproate, carbamazepine or phenytoin


Eligibility Criteria:
Inclusion criteria:

* Confident diagnosis of epilepsy
* Currently on VPA, CBZ or PHT
* \>or= 4 seizures/4 weeks prior to screen

Exclusion criteria:

* Prior lamotrigine use (excluded if treatment discontinued for clinically significant safety reasons (i.e., rash, hypersensitivity)).
* Females of childbearing potential on hormonal contraceptives or hormone replacement therapy.
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke

To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.

Young patients with a cryptogenic ischemic event undergoing transcatheter PFO closure exhibit a low but clinically relevant risk of bleeding (overall and major bleeding) at long-term follow-up, eventually exceeding the risk of ischemic events.

Importantly, the vast majority of major bleeding events seem to occur in patients receiving antiplatelet therapy. Preliminary data suggest that antiplatelet therapy discontinuation is not associated with any increase in ischemic events, and could potentially translate into a lower rate of major bleeding events at longer term follow-up. We therefore hypothesize that in young patients without any other comorbidities increasing the risk of stroke, shorter-term (≤1 year instead of lifelong) antiplatelet treatment could be a safe option following PFO closure.

Eligibility Criteria:
Inclusion Criteria:

* Successful transcatheter PFO closure with any approved device
* Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure

Exclusion Criteria:

-\>60 year-old

* RoPE score \<6
* Residual shunt ≥moderate following PFO closure
* Atrial fibrillation following PFO closure
* Presence of ≥2 cardiovascular risk factors (smoking, hypertension, dyslipidemia)
* Diabetes mellitus
* Thrombophilia (factor V Leiden, factor II mutation, anticardiolipin antibodies, lupus anticoagulant, anti-b2 glycoprotein-I antibodies, protein C deficiency, protein S deficiency)
* Recurrent cerebrovascular event (stroke, TIA) within the year following PFO closure
* Failure to provide signed informed consent
* Absolute contraindications for an MRI study
Turkish Validity and Reliability of the Haptotherapeutic Well-Being Scale

Objectives: Haptotherapy fosters a sense of unity between the body, mind, and emotions. In addition, it contributes to expanding the woman's perception of her pregnancy and developing a more positive attitude towards pregnancy and childbirth. The study aims to examine the Turkish validity and reliability of the Haptotherapeutic Well-Being Scale, which will be used to evaluate the well-being levels of haptonomy and haptotherapy practices in women.

Design: The study was methodological type. Methods: The study conducted between October 20 and December 20, 2023, with 242 women who volunteered to participate by sharing forum pages on social media (Facebook, Instagram) via the web. Data were collected using a personal information form, including sociodemographic and obstetric characteristics and the Haptotherapeutic Well-Being Scale.


Eligibility Criteria:
Inclusion Criteria:

* Women over 18 age, living in Turkiye, using social media (Facebook, Instagram), and agreeing to participate in the study.

Exclusion Criteria:

* Women who were illiterate in Turkish, had hearing-vision problems or mental disabilities, did not have social media (Facebook, Instagram), and did not volunteer to participate.