cyrilzakka/clinical-trials huggingface dataset:
Assessment of Voluntary and Reflex Cough in Patients With ALS

This study aims to assess the presence and the intensity of voluntary and cough reflex in patients with amyotrophic lateral sclerosis (ALS), comparing the results with the healthy control group. The assessment of the cough is fundamental to verify the mechanism of airways protection which is particularly compromised in ALS patients.

Objective parameters of voluntary and reflex cough would be measured by the spirometer. The reflex of cough would be elicited by a solution of citric acid through an ultrasonic nebulizer.

Protocol:

1. Volitional Cough assessment by spirometer (Pony FX- Cosmed): a) Forced vital capacity (FVC); b) Volume Tidal; c) Maximum Espiratory Pressure (MEP); d) Maximum Inspiratory Pressure (MIP); e) Peak of Cough Expiratory Flow.
2. Cough Reflex would be trigged by the inhalation of 0.4M of citric acid solution using the ultrasonic nebulizer (MO-03 Norditalia Elettromedicali) connected with the spirometer and the nebulizer via a bidirectional valve. It would be measured the Peak of Cough Expiratory Flow.

Participants:

It would be recruited 60 subjects at the IRCCS Ospedale San Camillo Venezia (Italy). All participants have to provide informed consent independently. The study group is composed by thirty participants with diagnosis of ALS and the severity score of Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS). The control group consist of thirty healthy subjects matched by aged and sex with the study group.

Statistical consideration:

The variables measured will be summarized by means and standard deviations or by proportions. Numeric variables MIP-MEP-FVC-Vt-PCEF will be analyzed using the Shapiro-Wilk test to verify the normality of distribution. Depending on the outcome, for the comparison between groups will be used or the t-test (parametric) or the test of Mann Whitney (non-parametric) for independent samples.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ALS
* Consensus

Exclusion Criteria:

* Smokers
* Oxygen Therapy
* Invasive Ventilation
* Allergy of citrus
* Asthma
Ileal Pouch-Anal Anastomosis Registry

Little is known about the factors that predispose patients to complications after an ileal pouch-anal anastomosis procedure (IPAA). Our goal is to establish a registry that prospectively captures pre- and post-surgical data from participants. Retrospective studies concerning IPAA outcomes and will be conducted using these data.

In order to better understand the long-term outcomes following IPAA, a registry that collects pertinent information about the underlying disease and its treatments and complications in an organized manner must be established. Establishing this Registry will allow us to follow patients who have an IPAA and organize retrospective medical information into a meaningful system.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with one of the following: Ulcerative colitis, Crohn's disease, Indeterminate colitis, Familial adenomatous polyposis, Hereditary nonpolyposis colorectal cancer, Lynch syndrome I or II, or Gardners' syndrome
* Treated by a Center for Digestive Disorders physician
* Scheduled for, or has undergone, ileal pouch-anal anastomosis procedure

Exclusion Criteria:

* Patients who do not speak a language for which the IRB has approved an Informed Consent Form or Short Form
* Patients who are currently incarcerated
Muscle Architecture of Lower Extremity In Multiple Sclerosis

The aim of this study was to determine the muscle architecture of the lower extremity muscles (pennation angle, muscle fiber length and muscle thickness) in patients with multiple sclerosis. Lower extremity muscles of patients with multiple sclerosis and healthy individuals; rectus femoris, biceps femoris, tibialis anterior, gastrosoleus and gastrocnemius muscles will be examined by ultrasound method.

Multiple sclerosis (MS) is characterised by complex and heterogeneous symptoms, often leading to reduced quality of life and impaired functional capacity. The latter is related to reduced muscle strength of predominately the lower limbs . The mechanisms underlying the observed strength deficits are of muscular as well as neural origin . At the whole muscle level, a number of studies have examined skeletal muscle characteristics of MS patients, with some studies but not all, reporting loss of muscle mass and decreased or comparable maximal muscle strength.

However, there is no study describing the features of lower extremity muscle architecture in multiple sclerosis. Muscle architecture is defined as the alignment of muscle fibers with respect to the axis of force. Although the diameters of the muscles of different sizes are quite similar to the diameters of the fibers, the sequences of these fibers contain several differences. The alignment of the muscle forming fibers has a significant effect on the force of muscle formation. The parameters that determine muscle architecture characteristics are the muscle fiber length, pennation angle, the physiological cross-sectional area. For each muscle these parameters may differ from each other. Any type of load in the case is the result of an adaptation process that results in muscle development. Muscle architecture allows the macroscopic understanding and interpretation of this adaptation process.

Determining the muscle architecture of multiple sclerosis patients by ultrasound will guide the rehabilitation process.

Eligibility Criteria:
Inclusion Criteria:

* 18-50 years old
* Individuals who agree to be voluntary,
* With the EDSS 4 and below
* Without pregnancy
* Do not receive corticosteroid treatment in the last month
* Do not take any medicine that will affect walking in the last 1 month

Exclusion Criteria:

* Those who refuse to volunteer,
* EDSS over 4
* Pregnancy
* Corticosteroid therapy within 1 month
* Any medication that will affect walking in the last 1 month
Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx

This is a pilot study to examine the diagnostic utility of a novel transmembrane surface sensor, and compare signals obtained with the transmembrane sensor to conventional needle EMG signals from healthy volunteers to those with documented neurologic pharyngeal muscle dysfunction (ALS and muscular dystrophy) and to those with severe OSA.

Transmembrane electromyography (TM-EMG) may be a feasible and valid non-invasive EMG technique for detecting neuromuscular (NM) impairment. This study will assess whether, in healthy volunteers and participants with known obstructive sleep apnea (OSA) and other NM diseases involving the oropharynx, the same characteristic motor unit potentials obtained on conventional needle EMG (NEMG) can be obtained using a TM-EMG sensor. The purpose of this study is to demonstrate whether the TM-EMG sensor can provide the same diagnostic accuracy as the concentric needle electrode for the diagnosis of NM diseases. Having demonstrated diagnostic similarity of TM-EMG to NEMG, the secondary aim of this study is to confirm that NM disturbance of oropharyngeal striated muscles in participants with OSA can be elicited with the TM-EMG sensor.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70
* Must be able to pause use of anticoagulation, NSAID and multi-vitamins for appropriate period prior to study test.
* Must be willing to stop any type of smoking or vaping 10 days prior to testing

A cohort of participants with documented neurological disorders involving upper airway striated muscles including ALS and muscular dystrophy with the presence of bulbar symptoms.

A cohort of participants diagnosed with moderate to severe OSA proven by an in-lab PSG, including the following criteria:

* AHI \> 25
* Nadir SaO2 \< 85%
* not currently using CPAP

A cohort of healthy participants that meet the following criteria:

* Normal craniofacial anatomy
* BMI \< 30

Exclusion Criteria:

* Allergy to topical anesthetic
* 4 or more alcoholic drinks on the same occasion on 5 or more days in the past month
* Prior cancer, or radiation to the head or neck
* Craniofacial anatomical disorders
* Presence of any underlying medical, surgical or psychiatric disorder that would preclude participation as determined by the principal investigator
Efficacy of PRF and MTA as Compared to Calcium Hydroxide for Pulpotomy in Human Irreversibly Inflamed Permanent Teeth

Of all the various pulpotomy medicaments that have been studied till to date, three agents have been selected for this study to compare their efficacy. CH being the control, MTA being one of the most recommended biomaterial and PRF that in addition to being a biomaterial is an autologous agent. Uptil now there have been no prospective trials using these three pulpotomy agents in mature permanent teeth with irreversible pulpitis in our part of the world and even the international studies that have been done utilized different methodologies with no unanimous conclusion. This is the reason that at present this treatment regime (pulpotomy) showing better perspectives cannot be presented with confidence as a predictable treatment option to the patients with irreversible pulpitis. By virtue of this study this challenge is being undertaken.

Hypothesis:

ALTERNATE HYPOTHESIS There is a difference between the efficacy of the PRF, MTA and CH when used as pulpotomy medicaments in mature permanent teeth with irreversible pulpitis NULL HPOTHESIS There is no difference in efficacy of the PRF, MTA and CH when used as pulpotomy medicaments in mature permanent teeth with irreversible pulpitis


Eligibility Criteria:
Inclusion Criteria:

* Patients with permanent teeth with completely formed roots diagnosed with irreversible pulpitis i.e. showing signs and symptoms as spontaneous, lingering pain initiated by hot and cold stimulus and /or radiating. Pulp being exposed or near to exposure by caries or alternatively by trauma.

Exclusion Criteria:

* CLINICALLY Teeth with

  * Necrotic pulp
  * History of swelling, abscess , fistula and/ or sinus tract
  * Doubtful restorability as indicated by over all Dental Practicality Index- (DPI) \> 2 (Dawood and Patel 2017) will be excluded
  * Periodontal disease
  * Uncontrolled bleeding (more that 10 mins.) of pulp after removal of inflamed part.
  * No bleeding of pulp at all after access into pulp RADIOGRAPHICALLY (with the use of periapical radiographs) Teeth with
  * Internal/ external pathologic root resorption
  * Pulp canal obliteration
  * Periapical / furcal radiolucency
  * Resorbed roots.
  * Crestal bone loss Generally patients
  * With systemic diseases, bleeding disorders, physical or mental disability, pregnant or nursing.
  * On opioid or steroid therapy or anticoagulants and/or on any kind of antibiotics.
  * Who have gone through some previous treatment for the same tooth other than filling.
Bedside Assessment of Immune Function in Patients With Covid-19

Covid-19 is a global pandemic causing unprecedented morbidity and mortality in the general population. It appears to have a greater effect on the elderly or those with underlying health problems but is not exclusively confined to these groups. As people age, particularly toward the end of their lives, the response of the immune system begins to drop away, an occurrence known as immunosenescence. It is known that there exist a group of people that do not respond to immune stimulation in a normal way but who may to observers be considered fit and healthy. The leukocyte immune test (LIT) relies upon the supramaximal stimulation of white cells outside of the body to determine their reactiveness when stimulated. It is intended to study patients admitted to Barts Health with diagnosed Covid-19. 4 ml blood will be taken of which 10microlitres will be used for the LIT. The remainder will be used for measurement of antibody levels previously associated with poor outcome following cardiac surgery. The patients will be followed up to see the proportion that progress to requirement for critical care, advanced ventilatory support, renal failure and in-hospital mortality. If a link can be established between a poor outcome following admission to hospital with Covid-19 and the immune response on admission, as predicted by means of the LIT, then it may enable better formulation of potential treatment strategies. Being able to measure at point of admission the responsiveness of someone's immune system may mean that treatment strategies such as the administration of passive immunization either via convalescent plasma or gammaglobulin will be better guided. If the LIT proves able to identify those people at risk of severe disease it may be able to identify individuals amongst healthcare workers that may benefit from passive immunisation or avoidance of high-risk exposure to Covid-19.


Eligibility Criteria:
Inclusion Criteria:

* Over 18y age Suspected diagnosis of Covid-19 Able to give written informed consent

Exclusion Criteria:

* Unwilling or unable to give consent Under 18years of age Suffering from other acute septic/infective illness other than Covid-19
Comparison of Blogshot Formats With Standard Cochrane Plain Language Formats

Participants will receive in random order on format of brief description of systematic review summary on health intervention. One group will receive standard plain language summary, while another will receive Cochrane blog shot, containing only few information about the efficacy of the intervention. After reading, their task will be to answer several questions about the material they have read.


Eligibility Criteria:
Inclusion Criteria:

* Patients visiting their family doctor, students of biomedical studies.

Exclusion Criteria:

* None
WHIRLPOOL FOR OSTEOARHRITIS

Both neuropathic and nociceptive mechanisms may contribute to the OA pain experience. Aims: The aim of this study was to determine the efficacy of warm whirlpool on pain, disability, quality of life (QoL) and sleep for patients with neuropathic pain.

Whirlpool treatment method is used for medical and surgical conditions. In literature there are studies which recommend whirlpool therapy as a treatment for reducing pain in patients with osteoarthritis. The aim of this study was to determine the efficacy of warm whirlpool on pain, disability, quality of life (QoL) and sleep for patients with neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* suffering from knee pain at least 3 months
* radiological manifestations considering were consistent with grade 3 and 4 knee OA due to Kellgren and Lawrence criteria had DN4 scores ≥4.

Exclusion Criteria:

* lower extremity surgery history, knee infection inflammatory disease like rheumatoid arthritis back or pelvic pain related with knee pain another cause of polyneuropathy (diabetes mellitus, vitamin B 12 deficiency, toxic or neurological disease like stroke, spinal cord injury) lumbar disc herniation malignancy or active systemic disease.
Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06

The purpose of this study is to evaluate the potential of DFD-06 to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days.

This is a 15-day, single arm, multicenter, multi-dose, open-label, two stage, sequential study. In the first stage, subjects who are at least 12 years of age and not more than 16.9 years (16 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). In the second stage subjects who are at least 6 years of age and not more than 11.9 years (11 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). An attempt will be made to enroll subjects throughout the age range of each cohort including the lower age range. DFD-06 will be applied twice daily to all affected areas on the body excluding face, scalp, groin, axillae and other intertriginous areas. Subjects must have ≥10% Body Surface Area (BSA) treated to achieve maximal use exposure.

Eligibility Criteria:
Inclusion Criteria:

* Subjects and the parent or legal guardian understand the study procedures and agree to participate by giving assent and written informed consent, respectively. Subject's parent or legal guardian must be willing to authorize use and disclosure of protected health information collected for the study.
* Subjects must be at least 6 years and not more than 16.9 years of age, with body weight greater than or equal to 45 pounds at Screening.
* Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
* Subjects with psoriasis involving ≥10% Body Surface Area (BSA), not including the face, scalp, groin, axillae and other intertriginous areas at the Baseline Visit.
* Subjects must have an Investigator Global Assessment (IGA) grade of at least 3 (moderate) at the Baseline Visit.

Exclusion Criteria:

* Subject has a current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
* Subject has a history of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
* Subject has received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.
* Subject has a history or presence of intracranial hypertension.
* Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the investigator to likely modify the subject's disease
Self Reported Oral Health, Awareness and Attitude Towards Dental Care Among Pregnant Women

Purpose/Objective of the study:

The main objective of the study is to investigate oral health awareness and attitudes towards oral health among Norwegian pregnant women and assess the impact of information about oral hygiene on the risk of dental caries during pregnancy.

The hypothesis of the study are:

1. The state of oral health during pregnancy depends on pregnant woman's preventive oral hygiene behaviour and practice.
2. Pregnant women with high level of oral health awareness and positive attitude towards oral health are more likely to visit their dentists regularly and have better oral hygiene compared to those with less awareness.
3. Proper information and guidance on oral hygiene care provided during pregnancy can help to improve oral bacteriological milieu and reduce the dental caries risk among pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Women with viable pregnancy ≥ 17 weeks gestation

Exclusion Criteria:

* Those not willing to participate in the study.
* Women who are unable to communicate well in Norwegian.
* Women who have been diagnosed to have a fetus with a chromosomal or structural fetal anomaly and do not plan to continue their pregnancy
Sugammadex vs Placebo to Prevent Residual Neuromuscular Block

The study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery with general anesthesia
* Patients weighing \> or = 80 pounds
* Patients not intubated prior to surgery
* Patients who are able to give informed consent

Exclusion Criteria:

* Patients unable to give informed consent.
* Patients whose condition will not allow for placement of the electrode PadSet of ExSpiron
* Patients who are anticipated to remain intubated in recovery period.
Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol

PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults.

Eligible subjects must have a primary diagnosis of MDD without psychotic features based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1 ratio to receive either solriamfetol (300 mg) or placebo for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Currently meets the DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT
* Current major depressive episode
* Male or female, aged 18 to 65 inclusive

Exclusion Criteria:

* Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription
* Unable to comply with study procedures
* Medically inappropriate for study participation in the opinion of the investigator
FlexStone Enabled Kidney Stone Retrieval

This study investigates if additional basket control in helpful during retrieval of kidney stones especially those that are difficult to reach for standard baskets.

The clinical practice at Vanderbilt University Medical Center will perform standard flexible ureteroscopy (fURS) procedures using conventional stone retrieval baskets, the EndoTheia FlexStone basket, laser fibers for intracorporeal lithotripsy , and any other fURS accessory devices as determined by the surgeon. If renal calculi are present which the physician deems retrieval of would benefit from the added aimability of the EndoTheia FlexStone basket will be used.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 80 years of age
* Able to provide written informed consent
* Have renal stones present and are appropriate candidates for fURS

Exclusion Criteria:

* Females who are pregnant. As part of routine pre-operative care, all females of childbearing potential will undergo either urine or blood pregnancy testing.
* Cancer positive subjects or any patients currently undergoing any treatment or therapy to treat, cure, or mitigate cancer.
* Patients with active urinary tract infection or anatomy that complicates retrograde access to the ureter and kidney
* Patients who do not meet inclusion criteria
* Patients who are unable or unwilling to provide informed consent