cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain

Temporomandibular disorders (TMDs) are one of the most common muco-skeletal disorders, seen in the dental clinics. Many factors work together to initiate or aggravate the condition, so it is a multifactorial disorder. The etiology of TMDs may be a result of parafunctional habits such as clenching and bruxism, acute trauma to the jaw, trauma from hyperextension e.g. after a long dental treatment, joint laxity, psychological distress, occlusal disharmony like presence of high crown or free-end saddle leading to joint instability or systemic diseases such as Rheumatoid arthritis or Osteoarthritis. The aim of this study was to evaluate the effects of naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, and naproxen sodium on pain in patients complaining from temporomandibular pain.


Eligibility Criteria:
Inclusion Criteria:

* Without a systemic disease,
* Not used any medication in the last week
* Have a habit of clenching and / or grinding teeth, individuals with normal preoperative results, suffering with pain and / or limitation of the mouth opening in the temporomandibular region

Exclusion Criteria:

Individuals who smoke

* Have a parafunctional habits (except for squeezing and grinding teeth)
* Pregnant and breastfeeding individuals
* Allergies to study medicines
* Do not use their medications / use different drugs and non-follow-up
Predictive Factors for COVID-19 in Rheumatology

We seek to study the behaviour of Coronavirus infection in patients with rheumatological and/or autoimmune comorbidities, understood as a particular pathophysiological universe with its own risks and eventual benefits, until now fully hypothetical to be confirmed by means of real and recent evidence. On March 12, 2020, an initiative called the Global Alliance for COVID-19 in Rheumatology (The COVID-19 Rheumatology Alliance) arises, as a rapid response of international coordination whose ultimate goal is to serve as help or guideline for all those doctors who seek be faced with receiving, evaluating, understanding and caring for a patient with rheumatological and / or autoimmune diseases in relation to the imminent risk of COVID-19.

Within this context, this study seeks to use the information registered by the Fundación Santa Fe de Bogotá University Hospital as a participating centre. It is intended, under a prospective cohort methodology, to identify, analyze and compare predictive factors of the clinical course of COVID-19 in patients with baseline diagnoses of rheumatological or autoimmune diseases with the intention of establishing well-founded parameters that contribute to the improvement in terms of strategies of prevention, management and prognosis; benefiting both directly treating physicians and patients, as well as indirectly a health system that is predicted to be pushed to the limit as time passes.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years.
* Have a diagnosis of a rheumatological disease and / or an autoimmune disease by meeting its own and standardized classification criteria.
* Confirmed diagnosis of COVID-19 by RT-PCR test
* Being a patient at the Fundación Santa Fe de Bogotá University Hospital.
* Be enroled in the registry of the Global Alliance for COVID-19 in Rheumatology.

Exclusion Criteria:

• Loss of follow-up due to referral to an institution other than the Fundación Santa Fe de Bogotá University Hospital, before documenting the outcome of his clinical picture.
Treatment of Depression in Parkinson's Disease

The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-"Xiaoyao Pill" (Herb extracts)on depression, compared to placebo and "Bupleurum+Ginkgo" in patients with Parkinson's disease.

Depression as the most common non-motor comorbidity of Parkinson's disease (PD), have a negative impact on disability and quality of life.

Traditional Chinese Medicine has shown effects on several depression. It is not known if TCM also is effective for depression in PD. This study is to investigate "Xiaoyao Pill", an antidepressant in TCM, on depression in PD.

A total of 60 patients with depression in PD will be randomized to each of the three arms.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease without dementia
* Depression
* Males or females
* Willing and able to give informed consent

Exclusion Criteria:

* cognitive dysfunction
* other serious diseases
Association Betweenq MAFLD ( Metabolic Associated Fatty Liver Disease) and Chronic Kidney Disease

Assess frequency of renal affection in mafld

Metabolic dysfunction-associated fatty liver disease (MAFLD) is a multisystem disorder, but its relationship with kidney injury remains controversial. This study aimed to evaluate MAFLD effects on the chronic kidney disease (CKD) frequency The association between metabolic dysfunction associated fatty liver disease (MAFlD) and extrahepatic disease is not known .the aim of this cross sectional study is to compare the frequency of CKD in patients with MAFLD and examine association between presence and severity of MAFLD and CKD and abnormal albuminuria.

Non-alcoholic fatty liver disease (NAFLD) is characterized by the accumulation of fat in more than 5% of hepatocytes in the absence of excessive alcohol consumption and other secondary causes of hepatic steatosis. In 2020, the more inclusive term metabolic (dysfunction)-associated fatty liver disease (MAFLD) - defined by broader diagnostic criteria - was proposed to replace the term NAFLD. The new terminology and revised definition better emphasize the pathogenic role of metabolic dysfunction and uses a set of definitive, inclusive criteria for diagnosis. Diagnosis of MAFLD is based on evidence of hepatic steatosis (as assessed by liver biopsy, imaging techniques or blood biomarkers and scores) in persons who are overweight or obese and have type 2 diabetes mellitus or metabolic dysregulation, regardless of the coexistence of other liver diseases or excessive alcohol consumption.

The known association between NAFLD and chronic kidney disease (CKD) and our understanding that CKD can occur as a consequence of metabolic dysfunction suggests that individuals with MAFLD - who by definition have fatty liver and metabolic comorbidities - are at increased risk of CKD.

MAFLD appears to be tightly linked to incident chronic kidney disease (CKD). This association may be attributed to multiple shared risk factors including type 2 diabetes mellitus, arterial hypertension, obesity, dyslipidemia, and insulin resistance Diagnostic criteria of MAFLD are ( steatosis with one of the following

1. BMI \>25
2. type II DM
3. \> 2 metabolic abnormalities \[ 1)waist circumferance \>94 in males or 80 in females 2)bp \>130/85 3) plasma triglycrides \> 150 mg / dl 4) HDL \< 40 5)prediabetes 6) HOMA insulin resistance score \>2.5 7)plasma hs CRP\> 2 mg/dl \]

Eligibility Criteria:
Inclusion Criteria:

1. CKD patients type II . III and type IV not on dialysis
2. Patients with MAFLD
3. patients with type II DM

Exclusion Criteria:

1. Patients with AKI
2. patients with NAFLD
3. patients with alcoholic fatty liver disease
4. patients with type I DM
5. malignancy
6. HBV HCV
7. autoimmune disease
8. liver cirrhosis
Inappropriate Prescribing in the Elderly

The management of pharmacotherapy in elderly patients is an increasingly critical aspect, as polypharmacy, combined with the pharmacokinetic and pharmacodynamic changes typical of aging, makes older adults more sensitive to the development of adverse reactions. This highlights the importance of appropriate use of pharmacotherapy that considers the risks and benefits of individual treatments. The aim of this study is to measure the prevalence of pharmacological appropriateness using the STOPP/START criteria (version 2) at admission and discharge from an acute geriatric ward, thereby evaluating the impact of hospitalization on medication prescribing.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 70 years admitted to a geriatric ward
* Regardless of ethnicity, gender, or type of illness
* Patients transferred from another ward
* Patients admitted to another ward for support

Exclusion Criteria:

• Patients in the terminal phase (\<6 months life expectancy)

Criteria for exit from the study (Dropout):

* Patients transferred to another hospital ward
* Patients who have deceased
PRIME vs Usual Care for Clinical High Risk

The purpose of this study is to determine whether specialty care is superior to usual care in the treatment of patients at clinical high risk for psychosis.

This study is a randomized clinical effectiveness trial for patients at clinical high risk for psychosis that compares two treatments: 1) specialty care delivered in a specialized clinical for patients at clinical high risk for psychosis versus 2) treatment as usual in the community.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following:

  1. Male or female between 12 and 30 years old.
  2. Understand and sign an informed consent (or assent for minors) document in English.
  3. Meet diagnostic criteria for prodromal syndrome as per COPS criteria.

Exclusion Criteria:

* Subjects must not meet any of the following:

  1. Diagnosis of current or lifetime Axis I psychotic disorder, including mood disorder with psychotic symptoms.
  2. Impaired intellectual functioning (full-scale IQ\<70). However, those with an IQ in the 65-69 range will not be excluded if they score \>75 on the WRAT Reading.
  3. Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.
  4. Alcohol or substance dependence in the past 6 months.
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and \< 110 mmHg at Visits 1 and 2
* Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 2
* All patients must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 5 (randomization)

Exclusion Criteria:

* Severe hypertension
* Pregnant or nursing (lactating) women
* Pre-menopausal women not taking accepted form of birth control
* Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
* History of cardiovascular conditions
* Uncontrolled Type 1 or Type 2 diabetes mellitus
* Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures

Other protocol-defined inclusion/exclusion criteria may apply
Kinesiophobia, Pain, Functional Status and Self-Efficacy in Patients With Knee Osteoarthritis

Objective: The aim of this study is to examine the relationship between kinesiophobia, pain, functional status and self efficacy in patients with knee osteoarthritis.

Material and Methods: The study was performed on 72 individuals diagnosed with Stage 2 and Stage 3 knee osteoarthritis according to the Kellgren Lawrence classification. The Tampa Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia, and the Visual Analogue Scale (VAS) was used to assess pain. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to asses the functional status. Self efficacy was assessed using the Arthritis Self Efficacy Scale (ASES).

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 40-85 and diagnosed with stage 2-3 bilateral knee osteoarthritis according to Kellgren Lawrence classification.

Exclusion Criteria:

* With a history of lower extremity surgery and a major trauma, orthopedic knee injuries such as tendinopathy, bursitis, ligament and meniscus injuries, a neurological or cardiopulmonary disease that may affect the evaluations, and any other joint in the lower limb that may cause reflected pain in the knee, individuals who had inflammatory rheumatic disease such as gout, rheumatoid arthritis, have participated in physical therapy and rehabilitation program in the last 6 months and who have been given knee injections
Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689

This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the subject must sign and date the Informed Consent Form.
* Finalised 52 weeks of treatment with insulin detemir in trial NN304-1689.
* Fertile females (girls who have had their first menstrual period) must use adequate contraception (barrier methods, contraceptive pills or intrauterine device (IUD)) if there is any risk of pregnancy in the opinion of the Investigator. For Denmark and France only contraceptive pills or intrauterine device are considered as adequate contraceptive methods.

Exclusion Criteria:

* Significant concomitant disease such as endocrine, hepatic, renal, cardiac, respiratory, neurological, gastrointestinal, malignant or pancreatic diseases as judged by the Investigator.
* Pregnant or the intention of becoming pregnant.
* Previous participation in this trial (defined as enrolment).
Resilience Enhancement Online Training for Nurses (REsOluTioN) Trial

The purpose of the study is to pilot a new training which aims to foster resilience to some of the clinical and workload pressures that nurses encounter on a daily basis.

Background:

Many nurses are exposed to challenges in their clinical setting on a daily basis, which often results in them experiencing stress, burnout and decreased satisfaction with their work; this can have a long term impact on the recruitment and retention rate of these nurses. This stress has intensified over the last year due to the COVID-19 pandemic. The online training being piloted in this trial has been adapted from a recent face-to-face resilience enhancement programme developed for nurses in the UK. By creating an online training, it is hoped that this intervention will be accessible to more nurses, particularly in the context of the COVID-19 pandemic.

Objectives:

The purpose of this trial is to understand whether the online training can improve levels of resilience, psychological, and wellbeing, and whether or not it has changed the way nurses experience in their work environment.

Methods:

All registered nurses working at Oxford Health NHS Foundation Trust during the COVID-19 pandemic will be invited. We intend to recruit 100 nurses who are currently working at Oxford Health NHS Foundation Trust to participate in the pilot study. Recruited nurses will be randomised to the intervention group or the control group. Nurses who are randomised to the intervention group will be invited to do the online training over a four week period. There will be the opportunity to participate in four 2 hour online facilitated sessions during the four-week training period. Nurses will also be asked to complete 30 minutes of independent pre-work ahead of each of the facilitated sessions. The sessions will cover a range of topics and will tackle areas such as building hardiness and maintaining a positive outlook; emotional intelligence and intellectual flexibility; reflective and critical thinking; enabling spirituality and achieving work-life balance. The training also involves twice weekly mentorship sessions ranging between 30 and 60 minutes.

Nurses will be invited to complete two surveys (pre- and post- intervention) which will be used to evaluate the trial outcomes and feedback on training. On completion of the post-intervention survey, nurses will receive a certificate for 10 hours of CPD. Nurses randomised to the control group will only be invited to take part in the pre- and post- intervention surveys, but will not use the online training. However, after completing the survey, nurses will be given the opportunity to complete the pre-work and access the online facilitated sessions so they can receive their CPD certificate.

Implications:

Once the training has been piloted, the effectiveness of the online training will be evaluated at national level.

Eligibility Criteria:
Inclusion Criteria:

* Any registered, non-agency nurses working at Oxford Health NHS Foundation Trust
* Willing to participate and provide signed consent

Exclusion Criteria:

* Not willing to participate and provide signed consent
International Registry on Cardioversion of Atrial Fibrillation (MK-6621-051)

This study will create a prospective registry of consecutive patients with Atrial Fibrillation (Afib) considered for cardioversion treatment to document up-to-date practice of in-hospital treatment, with a focus on the characterization of type of Afib, as well as on treatments applied (drugs, devices, interventions and their combinations), and associated complications within 60 days after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Participant with documented atrial fibrillation (confirmed by electrocardiogram) in the hospital setting at the time of enrollment
* Planned cardioversion (of atrial fibrillation)

Exclusion Criteria:

* Already enrolled in this or any other clinical trial
* Atrial flutter
Clinical Evaluation of a Cochlear Implant Sound Processor

This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit

The overall goal of this clinical study is to demonstrate the safety and efficacy of a cochlear implant sound processor. Hearing outcomes are expected to be similar non-inferior to as compared to the currently approved software and processors. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet and in noise is no worse with the new sound processor than with currently approved software on a Q90 processor.

Eligibility Criteria:
General Inclusion Criteria:

* Ability to provide Informed Consent
* 18 years of age or older
* Unilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D), including bilaterally implanted subjects that only use one implant in their everyday listening modality
* Minimum of 6 months of CI experience
* Having used a Naída CI Q70 or a Naída CI Q90 as their primary processor for a minimum of one month
* Presently using a current steering strategy
* At least moderate open-set speech recognition abilities with implant alone, as defined by achieving a score of ≥ 60% words correct in the AzBio in quiet test using the Naída CI Q90 research processor
* English language proficiency as determined by the investigator
* Willingness to use a BTE processor for the duration of the study

ARH Arm Inclusion Criteria

* Residual low frequency hearing sensitivity (pure tone average of \< 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear
* Willingness to use an in-canal acoustic earhook for the duration of the study

EO Arm Inclusion Criteria

• Severe-to-profound sensorineural hearing loss in the low (pure tone average of ≥ 70 dB HL for 125, 250, and 500 Hz) and high frequencies (pure tone average ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear

Exclusion Criteria:

* Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
* Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator
Effects of Swiss Ball vs Frenkle Exercises on Static and Dynamic Balance in Ataxic CP

Several studies have highlighted the significant impact of cerebral palsy, a prevailing neurological and musculoskeletal developmental disorder among childhood disabilities worldwide. Within the spectrum of cerebral palsy, ataxic CP stands as the least prevalent type, accounting for 5 to 10% of all cases. Individuals diagnosed with ataxic CP encounter difficulties in fine motor skills, precision, and coordination, and exhibit an unsteady gait, some of which are linked to compromised postural control and inadequate core stability. These issues culminate in functional limitations, heightening the risk of falls, and further contributing to the overall disability experienced by the patients. Consequently, there exists a need to prioritize research and develop targeted treatment protocols specifically for ataxic CP. It is crucial to emphasize the enhancement of postural control and coordination, with particular emphasis on improving static and dynamic balance during rehabilitation. Implementing Swiss ball exercises and Frenkel exercises in the rehabilitation protocol for children with ataxic cerebral palsy can significantly diversify treatment strategies. These exercises play a pivotal role in supporting these children to either sustain or regain their ability to function independently, reduce the risk of falls, and notably improve their overall well-being.

A four-week randomized clinical trial will involve 18 participants, divided randomly into two intervention groups, with nine participants in each group. Group A (intervention group 1) will participate in Swiss ball exercises combined with stretching, while Group B (intervention group 2) will partake in Frenkel exercises along with stretching. The sampling method employed will be a non-probability technique. The Pediatric Balance Scale (PBS) will serve as the primary tool for outcome measurement. Randomization will be conducted using computer-generated software. The study design will be single-blinded, ensuring the assessor remains unaware of the groups\&#39; assignments. Initial data collection (pretest) will occur at week 0, followed by post-test data collection at week 4. For intergroup analysis, if the data follows a normal distribution, the parametric Independent t-test will be utilized, enabling the calculation of mean, standard deviation, and p-values. Alternatively, if the data does not display a normal distribution, the non-parametric Mann-Whitney test will be employed, allowing the calculation of median, interquartile ranges, and p-values.

Eligibility Criteria:
Inclusion Criteria:

* Patients with having diagnosis of ataxic cerebral palsy
* Age between 5 to 8 years.
* GMFC level 2.
* Both the genders were included

Exclusion Criteria:

* Visual Impairments and hearing loss
* Mental retardation
* Fixed contractures or deformities of the spine or extremities
* Meningitis