cyrilzakka/clinical-trials huggingface dataset:
A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease

The purpose of this study is to assess the effect of JNJ-64042056 on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Elevated brain tau pathology defined as Braak 3 region of interest standardized uptake value ratio (ROI SUVR) greater than (\>) 1.1 on a screening tau PET scan, reviewed centrally by a qualified reader
* Clinical Dementia Rating (CDR) global score of 0 at screening and baseline
* Mini Mental State Examination (MMSE) greater than or equal to (\>=) 27 (with educational adjustment)
* Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening
* A participant must be of non-childbearing potential

Exclusion Criteria:

* History consistent with or known autosomal dominant AD (mutation identified in the family and/or participant)
* Fulfills diagnostic criteria for Alzheimer's Dementia or non-Alzheimer's Dementia, including, but not limited to Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), Vascular Dementia (VAD), alcoholic dementia, Parkinson's dementia, Korsakov, Creutzfeldt-Jakob or other prion diseases, Posterior Cortical Atrophy
* Diagnosis of Mild Cognitive Impairment (MCI)
* Vitamin B12 or folate levels below the central laboratory lower limit of normal, unless in the opinion of the investigator it does not require treatment
* History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult
A Study of ARGX-110 in Combination With Azacytidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS)

The purpose of this study is to determine the maximum tolerated dose (MTD) of ARGX-110 and/or the recommended Phase II dose (RP2D) in combination with a standard dose of azacytidine (AZA) in Phase 1; and to evaluate efficacy of ARGX-110 when administered at a RP2D level established in Phase I in combination with a standard dose of AZA (proof-of concept) by evaluating overall response rate (ORR) in Phase 2.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form (ICF) indicating an understanding of the purposes, risks, and procedures required for the study and willingness and ability to participate in the study
* Acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS) (according to 2016 World Health Organization \[WHO\] classification definition of greater than or equal to \[\>=\] 20 percent \[%\] blasts) (bone marrow) unsuitable for intensive treatment (including stem cell transplantation) with a curative intent, but eligible to receive azacytidine (AZA) treatment
* Expected life expectancy \>= 3 months, at the discretion of the investigator
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Women of childbearing potential having a negative serum pregnancy test at screening and within 48 hours before infusion of ARGX-110 on Day -14, and willing to use an effective contraceptive method (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) during the study and for at least 3 months after the last study drug administration

Exclusion Criteria:

* Prior or concurrent malignancy, except for the following: (1) adequately treated basal cell or squamous cell skin cancer; (2) carcinoma in situ of the cervix; (3) carcinoma in situ of the breast; (4) incidental histological finding of Prostate cancer (Tumour, Node, Metastasis \[TNM\] stage T1a or T1b), or; (5) Any other cancer from which the subject has been disease-free for more than 2 years
* Any previous AML or MDS chemo- or radiotherapy (with the exception of hydroxyurea/Litalir for leukocyte control which should be discontinued by the first day of AZA, local radiation therapy, therapy for basal or squamous cell carcinoma of the skin)
* Treatment with any investigational product within 4 weeks before the first administration of ARGX-110
* Any known active or chronic infection, including human immunodeficiency virus (HIV) and hepatitis B or C virus infection
* Any other concurrent disease or medical condition that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study
The Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students

The anti-HBs produced after hepatitis B vaccination will decrease over time. College students are vaccinated with hepatitis B vaccine at birth, and their antibodies may have decreased significantly. In addition, college students are sexually active population, which has a high risk of HBV infection. It is necessary to study the anti-HBs level of college students, and analyze the strengthening immunization for this special group.

This study will analyze the immunogenicity, immune persistence, and safety of booster dose of intramuscular 20 µg recombinant hepatitis B vaccines. Different booster vaccination including one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) was given according to the antibody production level after booster vaccination among college students.

Participants are given booster dose of one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) 20 µg recombinant hepatitis B vaccine according to the antibody production level. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Aged of 18 years or above
* Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) at enrollment
* Sign informed consent, willing to participate in this study

Exclusion Criteria:

* Being pregnant
* Intolerance or allergy to any component of the vaccine
* Participants with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
The Impact of Renal Impairment on the Pharmacokinetic and Pharmacodynamic of LEO 27847

The study will investigate the impact of reduced renal function on the pharmacokinetic and pharmacodynamic profile of LEO 27847. Volunteers with different degrees of renal impairment will be administered one dose of the investigational drug and then followed until investigational drug is eliminated from the body.


Eligibility Criteria:
Main Inclusion Criteria:

* Male and/or non-childbearing potential female, 18 years of age and older, healthy or with stable renal impairment (deemed stable by the referring physician for at least the last 4 weeks and not expected to change significantly during the next 3 months)
* BMI ≥18.0 and ≤ 42 kg/m2
* Patients with stable concomitant medical conditions
* Healthy subjects or patients with a creatinine clearance (at the time of screening) estimated using the formula of Cockcroft and Gault within the range of:

  * ≥ 50 to ≤ 80 mL/min (Mild Group: 8 subjects),
  * ≥ 30 to \< 50 mL/min (Moderate Group: 8 subjects),
  * \< 30 mL/min (Severe Group: 8 subjects).

Main Exclusion Criteria:

* Patients with renal transplants or currently on haemodialysis or peritoneal dialysis
* Clinically significant illness or surgery within 4 weeks prior to dosing
* Clinically significant ECG abnormalities or vital sign abnormalities at screening
* History of stroke, cerebrovascular disorder, coronary angioplasty and coronary bypass graft
* Clinically significant history or presence of any gastrointestinal pathology
* Use of medications other than their stable medications within 14 days prior to administration of investigational product or over-the-counter products within 7 days prior to administration of investigational product, except for:

  * multivitamins or vitamin D taken on a regular basis
  * topical products without systemic absorption
* Hemoglobin ≤ 90 g/L
* Serum total calcium (adjusted for albumin) level \< 2.25 mmol/L
* Clinically significant history of congestive heart failure, cardiac dysfunction or liver disease
Effect of Sciatic Nerve Slider Technique in Different Positions in Low Back Pain Patients

Neural mobilization is a technique that plays an important role in repairing the neural tissue's ability to respond to stress or tension by triggering the reconstruction of normal physiological functioning, pain reduction, and functional improvement. The study aims to examine the effect of the sciatic nerve slider technique in different positions and which of the most common positions is more effective in the application of neural mobilization in low back pain with sciatica.

Low back pain (LBP) is one of the most common musculoskeletal disorders, accounting for a significant portion of disability. It's a severe healthcare burden that has large societal costs, according to estimates, LBP can affect anywhere between 22% and 65% of people within a year. Additionally, back pain-related absences from work result in prolonged periods of sick leave, which has an adverse effect on workplace productivity.

Sciatica is the name given to a collection of symptoms caused by compression and irritation of the sciatic nerve, including pain, numbness, muscular weakness, and difficulty moving or controlling the legs. The lower back, buttocks, and multiple dermatomes of the leg and foot are typically where symptoms appear. Sciatica can be caused by a disc bulge or herniation, lumbar canal stenosis, spondylolisthesis, trauma, piriformis syndrome, or spinal tumors. It affects women more than men and people who lead sedentary lifestyles more than active ones. It might arise quickly or gradually with physical activity, and it is usually unilateral.

The slider and tensioner are two distinct types of neural mobilization procedures. There are clinical improvements and positive therapeutic benefits after treatment with different neural mobilization techniques, but the slider technique is safer, involves less stretching and strain of the nerves, and has a more significant effect than the tensioner technique.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 40 - 65 years,
* Both genders,
* Diagnosed by magnetic resonance imaging to confirm disc lesion,
* LBP with radicular pain for more than 12 weeks up to 1 year with no acute episodes in the last 4 weeks, and a numeric pain rating score (NPRS) greater than 4/10.
* Positive SLR test with reproduction of neurological symptoms.

Exclusion Criteria:

* Sciatica due to other pathologies (e.g. lumbar canal stenosis or piriformis syndrome),
* Having any physiotherapy before 6 months.
* History of spinal surgery
* Vertebral fracture or trauma,
* Negative SLR test,
* pregnant.
Laser Acupuncture Versus Tap Water Iontophoresis on Hyperhidrosis

the purpose of the present study is to assess the effect of laser acupoints on subjects with hyperhidrosis in comparison to tap water iontophoresis

The study will be randomized control trial pre and post-experimental design. Anonymity and confidentiality of all procedures will be assured in compliance with relevant laws and institutional guidelines. All patients will sign two copies of a consent form before the beginning of data collection. Subjects will be recruited using publicly distributed posters and by online social media, subjects their hyperhidrosis examined by Hyperhidrosis Disease Severity Scale, Perceived Stress Scale. Recruited subjects will be randomly assigned to Laser Acupoint or Tap water iontophoresis groups. The participants and assessor will be blinded for the study hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* volunteer subjects from MIT physical therapy students complained from hyperhidrosis examined by Hyperhidrosis Disease Severity Scale, Perceived Stress Scale.

Exclusion Criteria:

* Subjects will be excluded if they had musculoskeletal diseases and visceral disorders or had any operations or recent injury
Study of LUNG Stereotactic Adaptive Ablative Radiotherapy

The proposed study expands on the principles of SBRT (Stereotactic Body Radiation Therapy) and SABR (Stereotactic Ablative Radiotherapy) for centrally located NSCLC (Non-Small Cell Lung Cancer) to further optimize outcomes in this patient population with utilization of the adaptive workflow to maintain tumor control rates but decrease the incidence and grade of treatment-related toxicities.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* Clinical diagnosis of NSCLC
* Stage T1-2b (≤ 5 cm)

Exclusion Criteria:

* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year (i.e., carcinomas in situ of the breast, oral cavity, or cervix are permissible); previous lung cancer, if the patient is disease-free for a minimum of 1 year is permitted;
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Prior chemotherapy for the study cancer
* Plans for the patient to receive other local therapy (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression
* Plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression
Dezocine for Prevention of Catheter-related Bladder Discomfort

This study evaluates the efficacy of dezocine in preventing the catheter-related bladder discomfort (CRBD) in a postanesthesia care unit (PACU).

Thirty min before the end of the surgery, patients were randomly assigned to one of the two group to receive intravenous dezocine 0.1 mg/kg (Group D, n=48) or flurbiprofen axetil 1 mg/kg (Group F, n=48) . The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (\>/=18)
2. Male or female
3. Patients scheduled for abdominal surgery
4. Undergoing catheterization
5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2

Exclusion Criteria:

1. Patient with bladder outflow obstruction
2. Patient with overactive bladder (frequency greater than three times per night or more than eight times per 24 h)
3. Patient with multisystemic diseases (central nervous system, cardiovascular system hepatic, psychiatric, and end-stage renal diseases)
4. Patient with chemical substance abuse
5. Patient with chronic pain
6. Patient with morbid obesity
7. Patient needs for urgent intervention
Atorvastatin for Prevention of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery

The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.

Atrial fibrillation after cardiac surgery is the most common arrhythmic complication that may increase incidence of congestive heart failure, renal insufficiency, and stroke, which increase the length of hospital stay, the rates of re-hospitalization, and cost of care. Its pathogenesis is multifactorial, and its prevention and management remain suboptimal. Recently, observational evidence has suggested that patients who have undergone previous statin therapy have a lower incidence of postoperative atrial fibrillation.

The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.

Eligibility Criteria:
Inclusion Criteria:

* consecutive patients scheduled for the elective off-pump CABG surgery

Exclusion Criteria:

* prior statin use
* previous episodes of atrial fibrillation
* impaired renal function with serum creatinine \>2mg/dL
* serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
* a malignancy or inflammatory disease
Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation

The objective of the clinical investigation presented is to guarantee the safety and usability of the RESPIRA ADVANCED medical device in patients undergoing mechanical ventilation in the ICU, both stable patients and in the weaning phase. Through the clinical investigation, the reliability and durability of the device, the adequacy of the ventilatory parameters and their consistency over time, and the response of the patients wills be checked. During the entire course of the patient's participation in the study, the patient will be closely monitored following the protocol specifications, to guarantee safety and evaluate the effectiveness of the device.


Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years
* Availability of a family member or legal representative capable of understanding and signing the informed consent
* Patient admitted to the intensive care unit requiring invasive mechanical ventilation, who shows:
* Hemodynamic stability: MAP ≥ 65 mmHg and norepinephrine requirements ≤ 0.5 µg / kg / min, and
* Respiratory stability: PaO2 / Fraction of Inspired Oxygen (FiO2)\> 100 and stable oxygen requirements in the previous 6 hours.
* In case is considered to start phase of "weaning" or awakening, the level of sedation should allow adequate triggering of the inspiratory trigger, in a patient with improvement of respiratory failure and / or radiological image.

Exclusion Criteria:

* Age under 18 years
* Weight less than 50 kg
* Body weight greater than 120 kg
* Height greater than 1,90 m
* Presence of barotrauma (pneumothorax) or pleural fistula
* Hemodynamic instability (MAP \< 65 mmHg or norepinephrine requirements \> 0,5 µg /kg / min)
* Neurocritical patient
* Obstetric patient
Evaluating the Effect of Tooth Cleaning Devices on Oral Health

This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.


Eligibility Criteria:
Inclusion Criteria:

* are in good/excellent health;
* are 18 - 70 years old;
* have a minimum of 20 natural teeth (excluding 3rd molars);
* have sufficient test sites;
* have ≥ 20 bleeding sites;
* are willing to participate and available for participation.

Exclusion Criteria:

* have systemic diseases such as Down's syndrome, or known AIDS/HIV;
* have insulin dependant Diabetes;
* are pregnant or nursing by subject report;
* have a cardiac pacemaker
* are undergoing or require extensive dental or orthodontic treatment;
* require antibiotic treatment for dental appointments;
* have heavy deposits of calculus;
* have severe gingivitis or periodontitis;
* have extensive crown or bridge work and/or rampant decay;
* currently use bleaching trays;
* have any oral or extraoral piercing on lips or in mouth;
* have a professional prophylaxis within 4 weeks of study;
* participation in a prior study ≤ 20 days;
* employed by a oral healthcare products company or research institution.
Novel Medications for Opiate Detoxification - 4

The purpose of this study is to evaluate novel medications for opiate detoxification.


Eligibility Criteria:
Please contact site for information.
REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest (RELIEPH-study)

Background: For patients with out-of-hospital cardiac arrest (OHCA) at the intensive care unit (ICU), oxygen therapy plays an important role in post resuscitation care. During hospitalisation, a lot of these patients occur with pulmonary arterial hypertension (PAH). Currently a wide oxygen target is recommended but no evidence regarding optimal treatment targets to minimise the prevalence of PAH exists.

Methods: The RELIEPH trial is a substudy within the BOX (Blood pressure and OXygenation targets in post resuscitation care) trial. It is a single-center, parallel-group randomised controlled clinical trial. 300 patients with OHCA hospitalised at the ICU are allocated to one of the two oxygenation interventions, either a restrictive- (9-10 kPa) or liberal (13-14 kPa) oxygen target both within the recommended range. The primary outcome is the fraction of time with pulmonary hypertension (mPAP \>25 mmHg) out of total time with mechanical ventilation. Secondary outcomes are: length of ICU stay among survivors, lactate clearance, right ventricular failure, 30 days mortality and plasma brain natriuretic peptide (BNP) level 48 hours from randomisation.

Discussion: This study hypothesises that a liberal target of oxygen reduces the time with PAH during mechanical ventilation compared to a restrictive oxygen target in patients with OHCA at the ICU. When completed, this study hopes to provide new knowledge regarding which oxygen target is beneficial for this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* OHCA of presumed cardiac cause
* Sustained ROSC
* Unconsciousness (Glasgow coma scale \<8) after sustained ROSC

Exclusion Criteria:

* Conscious patients (obeying verbal commands)
* Females of childbearing potential (unless a negative HCG test can rule out pregnancy within the inclusion window)
* In-hospital cardiac arrest
* OHCA of presumed non-cardiac cause e.g. after trauma or dissection/rupture of major artery or cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging).
* Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient)
* Suspected or confirmed acute intracranial bleeding
* Suspected or confirmed acute stroke
* Unwitnessed asystole
* Known limitations in therapy and Do Not Resuscitate-order
* Known disease making 180 days survival unlikely
* Known pre-arrest cerebral performance category 3 or 4
* \>4 hours (240 minutes) from ROSC to screening
* Systolic blood pressure \<80 mmHg in spite of fluid loading/vasopressor and/or inotropic medication/intra-aortic balloon pump/axial flow device
* Temperature on admission \<30°C
Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children

Prospective, monocentric, observationnal study. The primary objective of this study is to identify if presurgical child or/and parental anxiety is predictive of chronic postsurgical pain in abdominal or urologic ambulatory surgery.

The post surgical pain guidelines recommend to identify predictive factors, especially for vulnerable subjects.

For children, there is few data about predictive factors of postoperative pain after ambulatory surgery.

The objective of this study is to collect preoperative data (preoperative children's anxiety and parental anxiety) and postoperative data (postoperative pain measure: the day of surgery and 3 months after surgery) for children undergoing abdominal ou urologic ambulatory surgery, and to determine if there is a relationship between these data (Odds Ratio)

Eligibility Criteria:
Inclusion Criteria:

* child from 3 to 18 years old
* undergoing scheduled urology or abdominal ambulatory surgery
* child and parents speaking French
* affiliation to national health insurance

Exclusion Criteria:

* emergency surgery
* lack of parents consent
* no parental support on surgery day