cyrilzakka/clinical-trials huggingface dataset:
A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese

The study is investigating new medicines for weight control in people with high body weight. The study looks at how the study medicines work in the body. Participants will get semaglutide and either NNC0165-1562 or "dummy" medicine -which treatment participants get is decided by chance. Participants will get 2 injections per week for 5 months. A study nurse at the clinic will inject the medicine with a thin needle in a skin fold in the stomach. The study will last for about 7 months. Participants will have 27 visits to the clinic.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 19-55 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria:

* Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and are not using highly effective contraceptive methods (Pearl Index less than 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), or are pregnant, breast-feeding or intend to become pregnant.
* Male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s), who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index less than 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.
Validation of a Boindicator as Monitoring Tool for Oyster Norovirus Outbreak

Noroviruses are responsible for 700M of annual cases of gastroenteritis, of which 15M are directly related to the consumption of contaminated food, including oysters. Current regulations do not require control of human noroviruses in shellfish. However, an ISO standard recommended to detect their genome in high-risk foodstuffs. However, presence of viral genome doesn't testify to the presence of infectious particles. Routine application of this standard would therefore wrongly lead to the withdrawal of shellfish from market, since norovirus genomes are widely found in the environment and in food without indicating a viral risk. Given the difficulty of cultivating human noroviruses in vitro and thus of discriminating infectious particles from non-infectious particles only based on genome detection, it is necessary to identify an indicator of the infectious nature of these pathogenic viruses. To be suitable, the indicator must first be associated with the presence of norovirus genome in the environment. This is the case of fecal bacteriophage F-specific RNA. Since bacteriophages are cultivable in the laboratory, it is easy to estimate the proportion of genomes of these bacteriophages corresponding to infectious particles. To confirm this indicator, it is necessary to demonstrate a relationship between the presence of infectious bacteriophages with that of infectious norovirus. This is only estimable by the occurrence of a gastroenteritis after consumption of a contaminated food by humans. We propose this randomized controlled clinical trial to evaluate the incidence of norovirus infection after consumption of oysters free from or containing infectious F-specific RNA bacteriophages.

The purpose of this study is to evaluate if norovirus infections incidence is significantly weak after the consumption of oysters free of F-specific infectious RNA bacteriophages, compared to the consumption of oysters containing these same infectious bacteriophages.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed
* Health status
* No seafood allergy
* Nancy city residents

Exclusion Criteria:

* Recent gastroenteritis (\<6 months)
* Fragile health person proximity
* Oysters consumption during the study
* Pregnancy or breastfeeding
* "nonsecretor" phenotype
Prosthetic Arthroplasties in Weight-bearing Shoulders

Repeated transfers and wheelchair propulsion in patients with neurological deficit of the lower limbs leads to a major mechanical overload of the upper limbs, especially on shoulders, the "weight-bearing" shoulder. Under these conditions, arthroplasty is subject to significant constraints; such an indication in this condition is always discussed. The objective of this study was to evaluate the medium-term clinical and functional outcomes of anatomical and reverse arthroplasty on the weight-bearing shoulder in individuals with long-term wheelchair use.


Eligibility Criteria:
Inclusion criteria:

* patients not walking or rarely walking, long-term users of a wheelchair before the intervention, and surgery on at least one shoulder by anatomical or reverse prosthesis

Exclusion criteria:

* Patient walking without aid
* Shoulder surgery other than arthroplasty
Effect of the Transmuscular Quadratus Lumborum Block on Duration of Stay in Recovery

The study will review data collected in 5 previously completed randomised controlled trials with a new primary outcome: to assess whether administration of the transmuscular quadratus lumborum block has an impact on the time an individual patient stays in the postanaesthesia care unit and how much opioid is consumed during this specified time.


Eligibility Criteria:
Inclusion Criteria:

- Elective Surgery

Exclusion Criteria:

* Inability to cooperate
* Allergy to local anaesthetics or opioids
* Inability to understand Danish
* Regular intake of opioids
* Local infection at site of injection
Rationalisation of Polypharmacy in the Elderly by the RASP Instrument

The aim of this study is to determine whether a clinical pharmacist using the RASP list (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions) can optimise the drug use in elderly inpatients.

Older persons take on average multiple drugs. As people age, there is an apparent increase in pharmacodynamic sensitivity to different making the patient more prone to experience side effects. Alterations in body composition and concomitant changes in pharmacokinetic parameters can also result in a higher risk for adverse drug events. All these factors make the older person, notwithstanding the heterogeneity of this population, more vulnerable for the negative consequences of polypharmacy.

Polypharmacy is a cause of negative clinical outcomes but it still remains unclear which intervention or set of interventions should be used to optimize the prescription of pharmacotherapy in the elderly patient. Therefore, the investigators developed the RASP (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions), a list as tool to reduce polypharmacy adapted to Belgian national prescribing tendencies within geriatric wards. Content and reliability of the RASP have been validated and the investigators aim to further study the impact of the systematic implementation of this RASP on geriatric wards in a prospective cluster randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent by the patient or a caregiver if the patient is incompetent to sign
* Consecutive inclusion of all newly admitted patients to the wards coming from home or the emergency room department

Exclusion Criteria:

* Patients not admitted to the hospital from home or a nursing home
* Patients unable to communicate in Dutch
* Patients admitted for palliative care
* Patients who do not take any drugs at admission
The Role of a Mycobacterium Growth Inhibition Assay to Quantify Host Immune Control of M. Tuberculosis

The goal of this observational study is to learn about how the blood leucocytes from patients with and without exposure or disease from tuberculosis (TB) are able to kill live mycobacteria (M. tuberculosis). The main question it aims to answer is:

Is intracellular growth suppression of M. tuberculosis in peripheral blood mononuclear cells variable among healthy blood donors and higher than in patients with latent TB compared to active TB?

Background: The host immune response is crucial in determining the outcome after exposure to Mtb. A substantial proportion of exposed individuals (40-70%) never develop infection indicating an efficient cell mediated immune response against Mtb and early clearance by the host immune defense (Verall et al, Immunology 2014). Thus, the outcome of exposure is highly dependent on host immunity. In this study, our aim was to investigate whether the previously developed mycobacterium groth inhibition assay (MGIA) method (Andersson et al, Tuberculosis 2020) could be used to quantify the host immune response to Mtb.

Study design: In this study we will include healthy donors (n=80), patient with active TB (n=40), subjects recently exposed to active TB (n=80) and patients with latent TB (LTBI) (n=80). Exclusion criteria for all groups are known HIV infection or other immunosuppression from treatment or disease. Patients and healthy blood donors will be recruited at the departments of infectious diseases in Region Kalmar and Region Östergötland. From patients giving oral and written consent, 40 ml of blood will be collected for MGIA analysis.

Primary aim: To determine the difference in MGIA between healthy blood donors and patients with latent and active TB as well as the variation in host control of Mtb within each group.

Method: The Mycobacterial growth inhibition assay (MGIA) using human PBMCs isolated by density gradient by Lymhoprep (Axis-Shield) and SepMate tubes (StemCell Technologies) will be performed as described in study I with minor modifications. The PBMCs are infected with GFP expressing M. tuberculosis H37Rv and intracellular growth of Mtb and viability of PBMCs are assessed by live-cell imaging (Incucyte©) and measured as relative fluorescence units (RFU) during 5 days with and without stimulation with the purified protein derivate (PPD) is included. The cytokine response following exposure to gamma-irradiated H37Rv will be quantified by Olink proteomics.

Eligibility Criteria:
Inclusion Criteria: Healthy blood donors or subjects who will get vaccinated.

Exclusion Criteria:Known HIV infection, not Swedish citizen, chronic liver och kidney disease,immunosuppression from treatment or disease.
Hemodynamic Effects of Aliskiren Compared to Captopril on the Kidney in Healthy Volunteers on a Low- and High- Sodium Diet

This study will measure the effects of different doses of aliskiren on kidney blood flow and function in healthy adults and determine how salt intake affects the response to aliskiren.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects age 18 to 75 years of age included
* Strictly adhere to provided diet.

Exclusion Criteria:

* Symptomatic low blood pressure
* Prescription medications, including those for blood pressure control, birth control pills, and any other medication that could affect kidney function
* Over-the-counter medication 2 weeks before study start
* Clinically significant heart abnormalities.
* Previous history of allergy to the study drug or drugs similar to the study drug.
* Any surgical or medical condition which might significantly alter the action of a drug (for example, absorption, distribution, metabolism or excretion) or which may jeopardize the subject in case of participation in the study.

Other protocol-defined inclusion/exclusion criteria apply
Prediction of Late Fetal Growth Restriction Using Cerebroplacental Ratio

To investigate the screening performance of CPR and biophysical profile score for the prediction of composite of adverse neonatal morbidity and mortality and operative delivery (CS or instrumental) for intrapartum fetal distress in low-risk pregnancies

Fetal growth is a dynamic process and its assessment requires multiple observations over time. In most women, placental function is sufficient to allow appropriate fetal growth throughout pregnancy, however in some, it may be not near term or during labor leading to intrapartum compromise Small for gestational age (SGA) is estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile of given reference ranges Fetal growth restriction (FGR) is fetus that has not achieved its growth potential. There are early-onset (\< 32 weeks) and late-onset (≥ 32 weeks) types. Late FGR is defined as

- AC/EFW \< 3rd centile Or at least two out of three of:

1. AC/EFW \< 10th centile
2. AC/EFW crossing centiles \>2 quartiles
3. Cerebroplacental ratio (CPR) \<5th centile or Umbilical artery Pusitility Index(UAPI )\>95th centile FGR fetuses will not necessarily be SGA at delivery and vice versa. In fact, most SGA are likely to be 'constitutionally' small CPR is the ratio of the Middle cerebral artery Pulsatility Index (MCAPI) to (UAPI). The CPR gradually rises until around the 34th week and subsequently slowly declines until term. Its use has been echoed recently because of association of an abnormal ratio with fetal distress in labor requiring emergency cesarean section , a lower cord pH, admission to the intensive care unit and poor neurological outcomes The biophysical profile (BPP) abnormalities that characterize late FGR include alteration of fetal breathing, oligohydramnios and loss of fetal heart rate reactivity on conventional cardiotocography ( CTG). It seems that BPP becomes abnormal only shortly before stillbirth .

Eligibility Criteria:
Inclusion Criteria:

* •Women with uncomplicated singleton pregnancy who are planning a vaginal delivery

  * Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)
  * Cephalic presentation

Exclusion Criteria:

* •Multiple pregnancy

  * known SGA fetus.
  * Medical disorders with pregnancy: diabetes mellitus, hypertension, pre-eclampsia
  * Known fetal anomaly or aneuploidy or stillbirth.
  * Any contraindication of vaginal delivery eg. placenta previa.
the Effect of Erector Spinae Plane Block on Fentanyl Consumption During Abdominal Hysterectomy

This study aims to evaluate the effects of erector spinae plane block on intraoperative fentanyl consumption in patients undergoing abdominal hysterectomy under general anesthesia.

To our knowledge, no study in the literature demonstrates this effect.

This study will be performed in Fayoum University hospital after approval of the institutional ethics committee and written informed consent. This study will be conducted as a prospective, randomized, double-blind, parallel-group clinical trial.

Inclusion criteria:

* American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective abdominal hysterectomy.
* Age range above 18.

Exclusion criteria:

* Patient refusal.
* Significant renal, hepatic and cardiovascular diseases.
* History of allergy to one of the study drugs.
* Any contraindication to regional anesthesia such as local infection or bleeding disorders.
* Chronic opioid use, history of chronic pain and cognitive disorders.

The patients will be randomized into two groups: ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side and Control group who will undergo the same procedure but with an injection of 20 ml of saline on a 1:1 ratio using a computer-generated random table. The patient's assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the ESP block and will not be involved in further data collection or patient care. The patients and both the surgical and anesthesia teams, who are responsible for patient care and data collection are blinded from the group assignments.

Eligibility Criteria:
Inclusion Criteria:

-

Inclusion criteria:

* American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective abdominal hysterectomy.
* Age range 18-70 years

Exclusion Criteria:

* Patient refusal.

  * Significant renal, hepatic, and cardiovascular diseases.
  * History of allergy to one of the study drugs.
  * Any contraindication to regional anesthesia such as local infection or bleeding disorders.
  * Chronic opioid use, history of chronic pain and cognitive disorders.
REpetitive Assessement of SCOREs in Patients on Dual Antiplatelet Therapy

Patients treated with percutaneous coronary intervention (PCI) require dual antiplatelet therapy (DAPT). Preliminary assessment of the PRECISE-DAPT score is mandatory in order to assess the risk of bleeding while on DAPT. The score takes into consideration age, creatinine clearance, haemoglobin, white-blood-cell count and previous spontaneous bleeding. One should consider, however, that some of the variables included in the PRECISE-DAPT score might change with time. As a consequence, the PRECISE-DAPT score should not be considered a static score as it might vary after the initial computation. It remains unknown, however, if the delta PRECISE-SCORE, reflecting the change in score between baseline and follow-up, might predict more reliably the long-term bleeding risk of PCI patients.

The RE-SCORE registry is a multicenter study aimed at comparing the predictive value of the PRECISE-DAPT score assessed at time of discharge vs. the Delta PRECISE-DAPT score, as assessed every 3 months in PCI patients receiving DAPT.

The primary end-point of the study is the occurrence of bleeding, as defined according to the criteria of the Bleeding Academic Research Consortium (BARC), either in the whole study population or in men vs women.

Eligibility Criteria:
Inclusion Criteria: All patients undergoing percutaneous coronary intervention and treated with dual antiplatelet therapy for at least 3 months

Exclusion Criteria: Contraindications to dual antiplatelet therapy lasting more than 3 months
Reference Values for Non-invasive Hydration Status Markers H10-14

The objective of this study is to establish reference values for non-invasive hydration status markers. Although there are no hypotheses associated with this study, the outcome will help advance the development of non-invasive hydration status monitors (described above and in H08-12; A-15208) capable of detecting dehydration from a single, static measure. The outcome that this research effort supports what is recognized by the military community as a high priority medical technology gap (MOM ICD v1.3, 2008).

Disorders of fluid and electrolyte balance in the U.S. military result in at least 125 hospitalizations, two lost duty days per event, and 9,300 ambulatory hospital visits per year (60% hyponatremia, 40% dehydration) (Carter et al., 2005; DoD, 2008). Diarrhea is a major infectious disease threat which requires aggressive i.v. fluid replacement in 30% of U.S. troops deployed to Iraq or Afghanistan (Brown et al., 2009). It is also important to recognize that the management and outcome of the 662 severe or penetrating traumatic brain injuries (TBI) reported for the military in 2009 (DoD, 2010) may be hindered by dehydration (Clifton et al., 2002). Fluid and electrolyte imbalances also contribute to heat illness (Carter et al., 2005) and can substantially impair combat fighting effectiveness (Dupont, 2003).

The importance of developing a valid assessment measure of human hydration status for clinical and field use is recognized by the military community as a high priority medical technology gap (MOM ICD v1.3, 2008). In far forward locations (levels I-II), orthostatic testing or gross symptoms are most commonly used to estimate hydration status (Manning et al., 2007). However, level I-II methods share symptoms with numerous other maladies and are insensitive until dehydration is severe or becomes debilitating (Levitt et al., 1992; McGee, 1999). Definitive hydration assessment in rear roles of medical care (levels III-V) requires invasive serial blood and/or urine measurements (Feig, 1977; Mange, 1997). Thus, a field-expedient technology that provides an accurate, non-invasive assessment of hydration status would improve medical triage by allowing better fluid-electrolyte management by medics in theatre (point of care), and by medical personnel in the rear levels of care (treatment and return to duty).

Eligibility Criteria:
Inclusion Criteria:

* male or female subject over the age of 18 years
* subject in good general health
* written informed consent for participation in the study
* report any adverse events?
* if female of child bearing potential, has the subject confirmed that she is not pregnant
* if the subject wears contact lenses, is he/she willing to remove them

Exclusion Criteria:

* Presence of a significant medical condition, which in the opinion of the investigator precludes participation in the study
* Use of ANY medication other than oral contraceptives
Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in the Reversal of Profound Neuromuscular Blockade (P05767)

The current trial was designed to demonstrate faster recovery in participants undergoing elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a fourth twitch/first twitch (T4/T1) ratio of 0.9, after reversal of a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 Sugammadex compared to Placebo, to evaluate the safety of 4.0 mg.kg-1 Sugammadex and to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay for these participants.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants
* American Society of Anesthesiologists (ASA) class 1, 2 or 3
* Age \>=18 years
* Scheduled to undergo a surgery requiring profound NMB such as cardiovascular, gynaecologic, neurologic and thoracic surgical procedures under general anesthesia requiring neuromuscular relaxation with rocuronium for endotracheal intubation and if applicable maintenance of NMB in a position allowing neuromuscular monitoring
* Given written informed consent

Exclusion Criteria:

* Participants known or suspected to have neuromuscular disorders affecting NMB