cyrilzakka/clinical-trials huggingface dataset:
Effects of Preoperative Fasting on ECG and Vital Parameters

This study compares differences in hemodynamic ve ECG parameters of patients undergoing urological or orthopedic surgery under spinal anesthesia. First group will comprise of patients undergoing surgery in the morning hours; thus with a standard fasting duration (8 hours), and the second group will comprise of patients undergoing surgery afternoon; thus having a prolonged fasting duration (\>12 hours).

Patients who are scheduled for surgery in surgical wards are routinely fasted after 12am on the day of the surgery regardless of the planned hour of the surgery. This results in a near standard fasting for patients with a planned surgery time in morning hours of the day. However, patients with a planned surgery time in the afternoon hours of the day are fasted more than 12 hours. This situation may not look very important for a healthy young adult but considering that the patient population in a hospital is mostly consisted of sick and elderly people, fasting and associated dehydration may have serious deleterious effects. Our objective is to observe and define these potential deleterious effects with a special focus on cardiovascular system of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 60 years of age
* Patients with an ASA (American Society of Anesthesiologists) physical status score of 1, 2 or 3
* Patients scheduled for elective orthopedic or urological surgery under spinal anesthesia

Exclusion Criteria:

* Patients requiring emergency surgery
* Patients under 60 years of age
* Rejecting to participate in the study
* Contraindications to spinal anesthesia
* Evidence of myocardial ischemia in baseline electrocardiogram prior to surgery
* Conditions mimicking electrocardiographic signs of myocardial ischemia (e.g. electrolyte imbalances such as hypokalemia)
Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique

Cancer and its treatments can be factors that alter the quality of life of patients. The induced alteration of the quality of life can influence compliance and impact survival. Considering the after-effects of the treatment, carrying out such a survey will provide for the first time precise information on the main determinants of the quality of life as well as on the care pathway of patients with invasive breast cancer in the Martinique region.

Breast cancer is the second most common cancer in the West Indies and the leading cancer in women. With 215 new cases in Guadeloupe, 204 in Martinique and 56 in French Guiana each year, it accounts for 37%, 33% and 26% of incident cancer cases in women respectively, but also affects men. Its incidence, lower than in France, is increasing over the period 2008-2014. The diagnostic and therapeutic management of cancer can have an impact on the quality of life of patients, taking into account the adverse effects occurring during and after treatment, both in the short and long term. The European Organisation for Research and Treatment of Cancer (EORTC) has developed a series of questionnaires to assess the quality of life of cancer patients, including a general questionnaire (QLQ-C30) and specific modules for breast cancer (EORTC BREAST (EORTC QLQ-BR23)) with the objective of improving professional practices.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age residing in Martinique with invasive breast cancer diagnosed from 2020 (single tumor at diagnosis)
* Patients who have read the information note and have indicated that they do not wish to participate in the study
* Patient with social security coverage.

Exclusion Criteria:

* Refusal to participate
* Patient with insitu breast cancer
* Patient with a second cancer
* Patient with cancer within 5 years prior to inclusion
* Patient who could not answer quality of life questionnaires
* Patient not fluent in French
* Person under legal protection (safeguard of justice, guardianship, curators , etc.).
Endometrial Cancer, Risk Factors and Prevention Strategies: Perspectives of Patients and At-Risk Women

To learn more about women's attitudes toward and knowledge about endometrial cancer and options that might decrease the risk of developing

To obtain pilot data regarding women's attitudes and perspectives about endometrial cancer and potential endometrial cancer prevention strategies.

Eligibility Criteria:
Inclusion Criteria:

1. Women who present to MD Anderson Cancer Center including MDA Houston Area Locations with a diagnosis of endometrial cancer
2. Women who present to MD Anderson Cancer Center including MDA Houston Area Locations with a diagnosis of abnormal uterine bleeding or endometrial hyperplasia
3. Women without a diagnosis of endometrial cancer or endometrial hyperplasia
4. Women must be at least 18 years or age
5. Women must be able to read, write, and speak English
6. Women must be willing and able to provide written informed consent

Exclusion Criteria:
Differential Effects of Propofol on Scalp and Intracranial EEG

The anesthetic propofol has a dose-depending effect on the EEG, which differs in comparison between scalp and intracerebral electrodes

The electrical activity of the brain (electroencephalogram EEG) is usually assessed from the surface of the head, which is approximately 1-2 cm above the cerebral cortex. Thus, the spatial resolution of the EEG is low, and the electrical activity recorded originates from a multitude of neurons.

Deep brain structures such as the hippocampus also generate electrical activity which cannot be assessed from the surface of the head. However, in some patients electrodes are implanted into the brain to look for the origin of epileptic seizures. Along the way, these intracerebral electrodes enable to record the EEG from intracerebral structures which are generated from few neurons only. Once the origin of epilepsy has been identified, the intracerebral electrodes are removed under general anesthesia.

Anesthetics such as propofol characteristically modify the EEG in a dose-dependant manner. More over, the propofol effect on the EEG recorded from the surface is likely to be different from the intracerebral EEG, however little is known so far. Therefore we aim to investigate the differential effect of propofol on the superficial versus intracerebral recorded EEG.

Eligibility Criteria:
Inclusion Criteria:

* Patients with implanted intracerebral EEG electrodes

Exclusion Criteria:

* Pregnancy
Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa

The primary objective of this study is to assess the efficacy of ALXN1850 versus placebo on functional outcomes in adolescent and adult participants with HPP who have not previously been treated with asfotase alfa.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HPP documented in the medical records
* Must meet 1 of the following criteria:

  1. Documented ALPL gene variant (pathogenic, likely pathogenic, or variant of unknown significance) from a Clinical Laboratory Improvement Amendments (CLIA) or ISO 15189 certified laboratory (Section 8.7 )
  2. Plasma PLP above the upper limit of normal (ULN) during the Screening Period (central or local laboratory results allowed per local regulations)
* Must meet 1 of the following criteria without a probably cause other than HPP:

  1. Serum ALP activity below the age- and sex-adjusted normal range during the screening period as measured by the Central Laboratory
  2. Two documented serum ALP activity results, at least 15 days apart, below the age- and sex-adjusted local laboratory normal range during the 24 months before the Day 1 Visit. Note: Local laboratories need to be CLIA or ISO 15189 certified, or have other local equivalent laboratory certification with Alexion's approval.
* Two separate 6MWTs at below 85% of the predicted distance (for age, sex, weight, and height) during the Screening Period without a probable cause other than HPP

Exclusion Criteria:

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the Investigator
* Diagnosis of primary or secondary hyperparathyroidism
* Hypoparathyroidism, unless secondary to HPP
* Any new fracture within 12 weeks before Day 1 (excluding pseudofractures)
* Planned surgical intervention which may impact the results of study assessments (in the opinion of the Investigator) during the Randomized Evaluation Period
* History of allergy or hypersensitivity to any ingredient contained in ALXN1850 or the placebo comparator (Table 9)
ThermRheum Version 1

Childhood arthritis is a diagnosis made by clinicians based upon their clinical examination, during which patients are assessed for signs of swelling, warmth and restricted movement of the joints using the sensation of touch. Clinicians use investigations such as blood tests and scans which may be costly, associated with waiting times, can cause the patient stress or anxiety. Patients with childhood arthritis can often present with flares of their condition even when on medical treatment, which may require further investigations to determine the nature of the problem. Studies in adult Rheumatology have demonstrated that a thermal imaging camera (which detects heat given off by the body) can be useful in assessing for signs of inflammation in arthritis. The use of this camera could provide an alternative to the tests described; it does not require any contact with the patient, is quick and easy to use, and does not emit any radiation. The investigators hope that this pilot study will demonstrate that thermal imaging can be used to complement the standardised assessments of joint inflammation as done routinely in clinic and may lead to further work comparing thermal imaging with other tests such as MRI scanning and ultra-sound.

The investigators will recruit 20-50 children with arthritis affecting either knee or ankle joints. The investigators will use a highly sensitive thermal imaging camera to take pictures and short video recordings of each ankle and knee joint, recording skin temperature and colour. The investigators will compare this with the clinicians' assessment of whether the knee and ankle joints are inflamed or not. The investigators are interested in finding out whether the information recorded using the camera mirrors the assessment made by the clinician.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of:

* Poly-articular JIA
* Oligo-articular JIA
* Psoriatic JIA
* Enthesitis-related JIA

Exclusion Criteria:

CYP below 4 years of age (pGALS is validated for school-age children and patients will be required to remain still during TI process)

Ongoing active/chronic infection requiring hospitalisation or treatment with intravenous antibiotics within 30 days of recruitment, or oral antibiotics within 14 days of recruitment

History of active tuberculosis of less than 6 months treatment or untreated latent tuberculosis

Soft tissue infection, injury or fracture of the affected joint which could confound the TI signature

Presence of any inflammatory skin condition (including, but not limited to Eczema and Psoriasis) which may be in close proximity to or overlying the joint

Presence of any other diagnosis which could cause arthritis including systemic-JIA (associated systemic inflammation may affect skin temperature independently of arthritis) or undifferentiated-JIA (excluded to ensure homogeneity of the sample investigated)

Non-English speaking patients and/or parent(s)/guardian(s)

Non-consenting CYP, or parent(s)/guardian(s)
Safety and Efficacy of Changing to DuoTrav From Prior Therapy

The purpose of this study to assess the safety and efficacy of changing to DuoTrav® from prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination) pharmacotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
* Must have an IOP of between 19 to 35 millimeters mercury (mmHg) (at any time of the day) in at least one eye (which would be designated as the study eye).
* Must be willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
* Women who are pregnant or lactating.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
* Corneal dystrophies in either eye.
* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
* Bronchial asthma or a history of bronchial asthma, bronchial hyper-reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
* History of severe allergic rhinitis.
* Other protocol-defined exclusion criteria may apply.
Palpation Versus Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx

test persons, anaesthesiologists will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography. The larynx-model is deviated to one of the sides to simulate a patient with neck pathology

test persons, anaesthesiologists will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography. The larynx-model is deviated to one of the sides to simulate a patient with neck pathology.

The test persons are randomised to use other palpation or ultrasonography. Al attempts are video-taped

Eligibility Criteria:
Inclusion Criteria:

* Participants in a course of airway management

Exclusion Criteria: unwillingness to participate

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Hypernatremia in Hydatid Cyst Treatment

Hypertonic saline (HS) is one of the most widely used scolocidal agents in the treatment of hydatid cysts. Hypernatremia is one of the complications associated with the use of HS. It can cause hypernatremia, acid-base disorder, impaired lung, renal, cardiac and neurological functions and even death. Therefore, caution should be exercised in the use of HS, and open technique should be preferred in surgery.


Eligibility Criteria:
Inclusion Criteria: Patients who developed hypernatremia (plasma sodium value above 145 mmol/L) due to HS use in the treatment of hydatid cyst were included to study -

Exclusion Criteria:Patients who developed hypernatremia due to other treatments were excluded from the study.

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A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.

The study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after single administration of CHF 5993 pressurised Metered Dose Inhaler (pMDI) in subjects with different level of renal impairment in comparison with matching healthy volunteers. Moreover, the safety and tolerability of the study drug will be also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers and
* Subjects with mild, moderate and severe renal impairment

Exclusion Criteria:

* pregnant or lactating women
* positive HIV and hepatitis serology
* history of drug abuse
* history of hypersensitivity to the products used in the trial
* smokers
* respiratory disease such as asthma and COPD
* clinically relevant concomitant disease that may introduce a risk for the subjects'safety
* presence of kidney stones
* dialysis
Evaluation of a Carbon Nanotube Enabled Solid-State Head CT

Purpose: The purpose of this study is to evaluate stationary head CT (s-HCT) as a diagnostic tool in patients with known head trauma.

Participants: Participants will be 50 people who have had either a head trauma or a brain bleed and have undergone a head CT in the past 24 hours or who will undergo a CT scan of the head.

Procedures (methods): This investigation will be a single arm, prospective clinical trial. Participants will have one single visit, which will include the s-HCT scan. No follow-up is required. All images will be de-identified before inclusion within a reader study. The investigators will perform a reader study with physician readers comparing the acquired imaging s-HCT images and conventional head CT.

This investigation will be a single arm, prospective clinical trial evaluating stationary head CT (s-HCT) as a diagnostic tool in patients with known head trauma. The investigators hypothesize that a stationary head CT (s-HCT) system based on the carbon nanotube linear array x-ray source can provide diagnostic quality head CT images. Patients included in the study will be 50 people who have had either a head trauma or a brain bleed and have undergone a head CT in the past 24 hours or who will undergo a CT scan of the head.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Medically stable patient with head trauma or known intracranial hemorrhage (subdural or intraparenchymal) or skull fractures
* Patient has undergone conventional head CT imaging at UNC hospitals within the past 24 hours or will undergo a CT scan of the head
* Willing and able to provide written informed consent

Exclusion Criteria:

* Unable to provide consent
* Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours prior to the research scan, or on the basis of patient history, e.g., tubal ligation, hysterectomy or a minimum of 1 year without menses)
* Breastfeeding
Mental Practice and Manipulative Skills Training in Multiple Sclerosis

Introduction: Multiple sclerosis (MS) is a demyelinating disease of the central nervous system which produces both motor and cognitive dysfunctions. MS causes a decline in the performance of activities of daily living (ADL) due to impairments affecting limb function.

Aim: This pilot study sought to determine whether the use of mental practice (MP) or the combined use of MP and the training of manipulative skills would improve the manipulation motor skills and treatment satisfaction among people with MS.

Methods: The study participants were people with MS. Blinded evaluators performed three assessments for each patient (pre-treatment, post-treatment and at a three month follow up). The patients were divided into three groups with alternate allocation: (A) Mental practice, (B) Mental practice + skills training and (C) Control group.

Keywords: activities of daily living; manual dexterity; mental practice, motor image; multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with MS of the RRMS and SPMS subtypes, without the presence of flare-ups during the past three months and aged between 25 and 60 years;
* an Expanded Disability Status Scale (EDSS) score of ≤7,
* not presenting depressive symptoms (measured using the Beck Depression Inventory, BDI),
* not presenting cognitive decline, measured using the Montreal Cognitive Assessment (MoCA) or Minimental Status Examination.
* In addition, they had to be regularly attending physical therapy and/or occupational therapy rehabilitation treatments.
Evaluation of Insecticide Treated Nets and Wall Liners for the Prevention of Malaria

The purpose of this study is to determine whether insecticide treated wall liners, in combination with insecticide treated nets, reduce the incidence of malaria infections compared to insecticide treated nets alone.

Insecticide treated nets (ITNs) have been shown to reduce malaria related morbidity and mortality and are increasingly being scaled up throughout sub-Saharan Africa. However, ITNs alone are unlikely to reduce transmission to zero in most settings and additional vector control tools are necessary. One new promising strategy is the use of insecticide treated wall liners (ITWLs). These are textiles treated with an insecticide that are used to line the inner walls of houses. The wall liners are considered a long-lasting alternative to indoor residual spraying which is also used for malaria vector control but is expensive to implement.

Within 6 pairs of villages, we plan to randomly allocate one village in each pair to receive either ITNs or ITNs plus ITWLs. Households will be randomly selected from each village and all children between the ages of 6 months and 11 years will be enrolled in a cohort study. The children will be cleared of existing infections and then followed monthly until they are found to be infected with malaria. The study will last for 6 months and will demonstrate whether the ITWLs provide additional protection against malaria over that provided by the use of ITNs.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 months up to 11 years
* Living in the study area and remaining in the study area for the duration of the study
* Informed consent provided by parents

Exclusion Criteria:

* No informed consent
* Living outside the study area, or likely to move outside study area
* Severely ill and unlikely to be able to complete study
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant


Eligibility Criteria:
Inclusion Criteria

* Male and female patients of any race between 18 to 65 years old (inclusive)
* Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation
* Patients who gave written informed consent to participate in the study Exclusion Criteria
* Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period
* Graft cold ischemia time greater than 40 hours.
* Patients with pulse rate \< 50 beats per minute (bpm) at screening Other protocol-defined exclusion criteria may apply