cyrilzakka/clinical-trials huggingface dataset:
Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients

The goal of this project is to determine whether the sleep and circadian rhythms of critically ill patients undergoing mechanical ventilation can be improved through practical strategies that can be employed at the bedside.

Nearly 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This project is designed to characterize sleep and circadian rhythmicity in critically ill patients and to explore the efficacy of a non-pharmacological intervention to improve sleep and normalize circadian phase. The study will examine the effect of a protocol employing noise reduction and enforcement of a robust light-dark cycle on sleep quality and circadian rhythmicity. A secondary analysis will examine the relationship between delirium and sleep disruption and loss of circadian rhythmicity. Circadian rhythmicity will be characterized through the measurement of urinary 6-sulfatoxymelatonin levels at frequent intervals, while sleep will be assessed using continuous polysomnography.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Receiving mechanical ventilation and intravenous sedation

Exclusion Criteria:

* Debilitating central nervous system disease or degenerative disorder
* Active seizures
* Persistent coma
* Renal failure requiring dialysis
* Expected to be extubated within 24 hours
* Currently receiving neuromuscular blocker
Cryotherapy VS. Nitric-zinc Complex in the Treatment of Plantar Warts.

Plantar warts are benign skin lesions caused by human papillomavirus (HPV).There are several treatment methods for this illness, but none of them can heal all patients. Cryotherapy using liquid nitrogen is one of the most common local treatments. In this study, we will compare the effectiveness of cryotherapy with liquid nitrogen with the association of organic acids and nitric acid (nitric-zinc complex). In addition, as secondary objectives have been defined: 1) know the number of applications necessary for each treatment to achieve the complete resolution of the plantar wart, in order to compare the healing times between each treatment and establish which treatment is faster, 2) analyze the influence of the HPV biotype, the location of the lesion and the time of evolution in the response to the different treatments, and 3) Compare the ultrasound signs of plantar warts with the ultrasound signs of healthy skin after the resolution of the process.

A randomized controlled clinical trial is proposed. The recruitment of patients will be carried out by including the sample of those patients who have diagnostic confirmation of plantar wart in the Chiropodology and Surgery Service of the University Podiatry Clinic of the Complutense University of Madrid, consecutively, between November 2020 and the date when the estimated sample size is reached.

Participants in the trial will be assigned with equal probability to each treatment arm, based on their consecutive inclusion in the study. Subsequently, the treatment allocation will be determined by a random code generated by the Epidat 4.1 program using random permuted blocks. The treatment used will be evident both for the participant and for the research podiatrist responsible for the intervention. However, the primary result will be confirmed by the microbiological study carried out by the Department of Microbiology of the Complutense University of Madrid, which does not know any data about the patient or the treatment group to which it was initially assigned.

Eligibility Criteria:
Inclusion Criteria:

* Subjects older than 12 years.
* Patients diagnosed with recalcitrant or non-recalcitrant plantar wart.

Exclusion Criteria:

* Diagnosis of Diabetes Mellitus.
* Peripheral vascular disease.
* Patients with an immune system disorder or in immunosuppressants treatment.
* Peripheral or central neuropathy.
* Coagulation disorders.
* Raynaud's disease or some alteration of the perception of cold or heat.
* Alterations in healing for wounds or in the synthesis of collagen.
AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)

Osteoarthritis (OA) is the most prevalent form of arthritis in the elderly. It is estimated that 7% of men and 11% of women over the age of 65 have KOA. The most significant symptoms of the disease are pain and functional disability.

This study has two aims:

1. To characterise the gait patterns and clinical parameters of patients with knee osteoarthritis (KOA) in Singapore at baseline, prior to treatment.
2. To investigate the changes in gait patterns and the clinical benefits of treatment with a new biomechanical device, AposTherapy, for patients with KOA.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from symptomatic bilateral knee osteoarthritis at the medial compartment for at least six months, fulfilling the ACR clinical criteria for OA of the knee, and having radiographically assessed OA of the knee according to the Kellgren and Lawrence scale.
* Patients with an overall WOMAC score of \>2cm (as measured at baseline).
* Males and females between the ages of 50-70.

Exclusion Criteria:

* Patients suffering from acute septic arthritis.
* Patients suffering from inflammatory arthritis.
* Patients who received a corticosteroid injection within 3 months of the study.
* Patients suffering from avascular necrosis of the knee.
* Patients with a history of knee buckling or recent knee injury.
* Patients who have had a joint replacement.
* Patients suffering from neuropathic arthropathy.
* Patients with an increased tendency to fall.
* Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure.
* Patients with a history of pathological osteoporotic fracture.
* Patients suffering from symptomatic degenerative arthritis in lower limb joints other than the knees.
* Patients with referred pain in the knees from back or hip joint symptoms.
Toy Hygiene Education For Hospitalized Mothers

The present study aims to evaluate the effectiveness of toy hygiene education given to mothers of hospitalized children on their knowledge and practices, as well as the cleanliness of toy surfaces.

While studies show that toys contain significant amounts of pathogenic microorganisms and may be effective in the spread of hospital-acquired infections, it appears that the literature and hospital practices on the disinfection of these toys are quite limited. Additionally, there is no routine practice to ensure toy hygiene in most health institutions. Therefore, in order to prevent the transfer of infectious agents through toys, policies and guidelines regarding toy cleaning methods and frequency should be established in hospitals. At the same time, families should be educated about the fact that toys can be a source of infection, and correct behavioral changes regarding toy hygiene should be created. When the literature was examined, it was determined that there were no routine hygiene practices regarding the cleaning of toys in children's clinics in Turkey. For this reason, the study will examine the effect of the toy hygiene education created by the researchers on the knowledge levels and practices of mothers and the surface cleaning of toys. It is thought that the results of the study will be a basis for creating clinical guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Mothers with children in the play (1-3) and preschool (4-6) periods
* Those who keep toys (plastic, metal, wooden, technological) with their children
* Mothers who are always with their children as companions
* Mothers whose children receive inpatient treatment for at least 3 days

Exclusion Criteria:

* Mother has hearing, vision or mental problems
* The mother has been diagnosed with OCD (Obsessive Compulsive Disorder) or has an obsession with cleaning.
* Not being able to speak Turkish
* Being under 18 years of age
* Do not place the child in isolation (contact isolation, droplet isolation, respiratory isolation).
Muscle Energy Technique With Or Without First Rib Mobilization In Adhesive Capsulitis

This study will be a randomized control trial. Study will be conducted in 40 patients in the age range 40-70 years, which will be selected by using non proability convenient sampling technique. Subjects will be divided in 2 groups. Group A will receive first rib mobilization along with METS and conventional treatment, group B will receive METS and conventional physical therapy treatment only. Treatment will be given thrice per week for 3 weeks. Data will be collected pre and post treatment, for data collection numeric pain rating scale, shoulder pain and disability index (SPADI) will be used. Joint range of motion will be measured using goniometer. After collection data from defined study setting, data will be entered and analyzed at Riphah International University, Lahore.

Adhesive capsulitis, also known as "frozen shoulder," is a common condition of the shoulder defined as a pathologic process in which contracture of the gleno-humeral capsule is a hallmark. Clinically, it presents as pain, stiffness, and dysfunction of the affected shoulder. Adhesive capsulitis is thought to afflict between 2 and 5% of the general population, with women affected more frequently than men. Individuals of middle age are most often affected, typically during the 5th to 7th decades of life.

Muscle energy techniques is a manual therapy that uses the gentle muscle contractions to relax and lengthen muscles and normalize joint motion. It is a class of soft tissue osteopathic manipulation consisting of isometric contraction designed to improve musculoskeletal function and reduce pain. The application of MET relaxes and improves biomechanics and result in improving functional ability.

Although conventional physical therapy treatment are used to treat frozen shoulder and effectiveness of muscle energy technique is proven, but the effect of first rib mobilization and MET has not been studied.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40-70 years
* Gender (both male and female)
* Subjects with adhesive capsulitis stage (II and III)

Exclusion Criteria:

* Previous surgery on affected shoulder
* Recent trauma to shoulder
* fracture
Upper Trapezius Myofascial Trigger Point in Overhead Athletes After Upper Trapezius Muscle Fatigue

The healthy overhead athletes with and without upper trapezius myofascial trigger point will be asked to perform a scapular elevation task until the upper trapezius muscle fatigue. The first hypothesis is that the subjects with upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities when compared to subjects without upper trapezius myofascial trigger point. Besides, the investigators suggest that subjects with/without upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities after upper trapezius muscle fatigue, especially in subjects with upper trapezius myofascial trigger point.

The investigators will recruit healthy overhead athletes with and without upper trapezius myofascial trigger point. Participants will be asked to perform a sustained scapular elevation task at their peak force until the force decrease 50 %, which indicates upper trapezius muscle fatigue. There are two purposes in the current study: (1) to compare the differences between overhead athletes with/without upper trapezius myofascial trigger point during arm elevation in scapular kinematics and muscles activities (2) to investigate the effects of upper trapezius muscle fatigue on scapular kinematics and muscles activities in overhead athletes with/without upper trapezius myofascial trigger point. The first hypothesis is that the subjects with upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities when compared to subjects without upper trapezius myofascial trigger point. Besides, the investigators suggest that subjects with/without upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities after upper trapezius muscle fatigue, especially in subjects with upper trapezius myofascial trigger point. The outcome measurements includes scapular kinematics (upward/downward rotation, external/internal rotation, posterior/anterior tilting) and muscles activities (upper trapezius, serratus anterior, lower trapezius).

Eligibility Criteria:
Inclusion Criteria:

* 18-50 years old active overhead athletes
* No symptoms in the shoulder of dominant side in the past 6 months
* Regularly perform overhead sports activity ≥ 3 hr/wk for more than 6 months

Exclusion Criteria:

* History of major shoulder/cervical injury or surgery in the past 6 months
* Experiencing shoulder pain, or participating in rehabilitation for shoulder pain in the past 6 months before the study
Optimised Procedure in Patients With NSTEMI and CKD

Aim of the study is the determination of the ideal timepoint for the treatment of patients with acute Non-ST-segment Elevation Myocardial Infarction (NSTEMI) and an acute or chronic kidney disease (CKD) with a GRACE score \< 140. It should be determine if a prompt coronary angiography or the protection of the kidneys from the used contrast agent is more important for the outcome of the patients. Additionally it will be investigated if the ischemic precondition can help to prevent heart damages.

According to international guidelines a coronary angiography has to be performed within 72h for patients with (NSTEMI).

Patients with a GRACE score \> 140 belong to the high risk group and the coronary angiography has to be performed within 24h.

Until today for patients with a GRACE score \> 140 and an acute or chronic kidney disease (CKD) the best approach is not known even though up to 40% of all NESTMI patients belong to this population. CKD in connection with an NSTEMI is one predictor for short and long term mortality and serious bleeding as a complication of coronary angiography. Additionally patient with CKD are at risk to experience a contrast agent induced aggravation of the CKD right up to a kidney failure. The pre- and post treatment of the kidneys seem to reduce this risk. The irrigation of the kidneys up to 48h prior coronary angiography optimises the kidney function and buffers the aggravation of kidney function caused by fluid loss or abstention at home.

Additionally the influence of ischemic precondition on one arm of the patient will be evaluated in this setting. First studies give a hint that the kidneys may be protected against the contrast agent of the following catheter examination by ischemic precondition.

Eligibility Criteria:
Inclusion Criteria:

* patient with an acute NSTEMI
* patient with a GRACE score \< 140
* patient with an acute or a chronic kidney disease (stage 1 - 5)
* patient who agree with the randomized assignment to one of the study groups in written
* signed Informed content prior to study inclusion
* patient who are legally competent at the time of study inclusion

Exclusion Criteria:

* pregnancy
* nursing women
* patient has been committed to an institution by legal or regulatory order
* Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
* participation in a parallel clinical trial
* subjects who are in any state of dependency to the investigators
Whole Genome Scan of Extended Families With Familial Vocal Cord Paralysis

Vocal cord paralysis is a common cause of congenital stridor and airway obstruction. In this study we plan to identify the genetic locus of the genes in two extended families who suffer of the disease.

In a number of families suffering of familial vocal cord paralysis it has previously been shown that the disease is inherited autosomal dominant. In one of the families the gene coding for the disease was located on chromosome 6q16. We will be analyzing 2 extended families with familial vocal cord paralysis to define their genetic defect leading to the disease. All family members will undergo a laryngoscopy to determine the extent of paralysis. For all family members we will isolate DNA and determine their microsatellite polymorphism on chromosome 6q16. If the results are negative we will continue the study and perform a whole genome scan to localize the gene(s) involved.

Eligibility Criteria:
Inclusion Criteria:

* members of families suffering of familial vocal cord paralysis

Exclusion Criteria:

* none
68Ga-NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-Aca-BBN(7-14) in glioma patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-Aca-BBN(7-14) will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Non-invasive imaging evaluation of GRPR expression would be of great help in drug development, patient stratification and therapeutic response monitoring. Various GRPR targeting imaging probes have been develop to meet the purpose. Bombesin (BBN) is an amphibian homolog of mammalian gastrin-releasing peptide (GRP). BBN(7-14), with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of gastrin-releasing peptide receptor (GRPR), after being labeled with various radionuclides. Multiple preclinical studies have demonstrated receptor-specific accumulation of the tracers in GRPR positive tumors. For interests in clinical translation of 68Ga-NOTA-Aca-BBN(7-14), an open-label dynamic whole-body PET/ CT study was designed to investigate the safety and diagnostic performance of 68Ga-NOTA-Aca-BBN(7-14) in patients with glioma.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to provide a written informed consent
* Clinically based and magnetic resonance imaging (MRI)-based suspected newly diagnosed primary glioma.
* The tumor will be surgically removed and histological diagnosis will be available.

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential；
* Known severe allergy or hypersensitivity to IV radiographic contrast；
* Inability to lie still for the entire imaging time because of cough, pain, etc.
* Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
* Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
Botswana Smoking and Abstinence Reinforcement Trial

Many people living with HIV in southern Africa, specifically Botswana use tobacco products. Using tobacco makes some of the effects of HIV worse and even causes excess deaths. The investigators plan to use an intervention called Screening, Brief Intervention and Referral to Treatment (SBIRT) to help people to quit smoking and also a drug called varenicline. Apart from helping people to stop smoking, the investigators will also test to see how task shifting can be used to help people stop smoking in a sustainable way. Finally, the investigators will estimate the cost of the intervention.

The investigators will utilize a stepped wedge cluster randomized trial to implement BSMART. BSMART will be sequentially rolled out to 15 participating HIV treatment and care facilities assigned in three steps. Each step will provide data for a 12- month control/pre-implementation, a 12-month implementation, and a 12-month maintenance period. The investigators will stratify Botswana's HIV treatment and care facilities into three levels of facilities. The investigative team will randomly assign each of the three levels of facilities to one of three study steps. Each step will comprise (i.e. have representation) from 3 levels of facilities, giving each level of facilities the same probability of beginning the intervention at any step).

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* Self reported current daily smoker
* Age 18 and older
* Engaged in HIV care as defined by being on ART for at least 6 months
* Willing/able to provide informed consent in English or Setswana

Exclusion Criteria:

* Less than 18 years of age
* Pregnant
* Unable or cognitively impaired to provide consent
The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy

Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the risk of contrast induced nephropathy with coronary angiography. The investigators plan to randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary angiography to intravenous isotonic saline or intravenous isotonic sodium bicarbonate beginning one hour before the procedure and for four hours after. The primary endpoint is the development of contrast nephropathy within 48-72 hours after the procedure. Patients with an ejection fraction \<30%, overt CHF, hypokalemia and alkalemia will be excluded.


Eligibility Criteria:
Inclusion Criteria:

* serum creatinine greater then or equal to 1.5

Exclusion Criteria:

* EF\<30
* Overt CHF
* Alkalemia
* Hypokalemia
* GFR\<20 cc/min