cyrilzakka/clinical-trials huggingface dataset:
The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

The study investigates the association between normalization of serum sodium levels and bone markers in patients with epilepsy and chronic hyponatremia.

The study is a randomized, single blinded, placebo controlled study where participants will be randomized to either treatment with salt tablets or placebo tablets through 4 months. At the beginning and end of the 4 months bone markers will be measured.

The investigators null-hypothesis is that there will be no difference in bone markers before or after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Epilepsy requiring treatment for at least 2 years
* Known hyponatremia (2 subsequent s-sodium values \< 136 mmol/l)
* Age 18-80 years
* Danish speaking
* Signed form of prior consent

Exclusion Criteria:

* Pregnancy and breastfeeding
* Known osteoporosis. DXA scan \< -2.5 T-score. Z-score is used for patients 50 years or younger.
* Undergoing treatment for osteoporosis
* Undergoing treatment with salt tablets
* Known SIADH
* Severe concomitant disease such as cancer or ischemic heart disease
* Alcohol, drug or substance abuse
Arterial Endothelial Function--An Epidemiologic Study

To determine if risk factors measured in childhood can predict the development of atherosclerotic coronary and carotid artery disease in adulthood.

BACKGROUND:

Many young adult subjects have some degree of atherosclerotic coronary and carotid artery disease and experience no symptoms. As time passes, many die suddenly and unexpectedly and only limited therapeutic process begins in youth, a measure of the early manifestations of atherosclerosis may have the potential of identifying subjects at risk for premature coronary and carotid occlusive vascular disease when therapeutic options can be administered. Impaired brachial artery flow mediated dilatory (FMD) capacities have been shown to exist in children and young adults with hypercholesterolemia, hyperhomocysteinemia, diabetes and in those who smoke. Impaired brachial artery FMD has been shown to related to impaired endothelial function, which is an early manifestation of the atherosclerotic process. If impaired brachial artery FMD is a predictor of the process, then it may be used to non-invasively assess atherosclerosis early in its development and to evaluate the effect of therapeutic interventions.

DESIGN NARRATIVE:

In this longitudinal study using previously studied members of the Muscatine study, measurements are made of contemporaneous risk factors, and brachial artery FMD, along with coronary artery calcification (CAC) and carotid artery intimal-medial thickness (IMT) (the latter two established measures of early atherosclerosis) and again three years later. The effort is designed to examine the following hypotheses: 1) Established risk factor levels measured in childhood, adulthood and across the years form childhood through adulthood are predictive of brachial artery flow mediated dilatory (FMD) capacities; 2) Putative risk factor levels measured in adulthood are related to the degree of brachial artery FMD, CAC and carotid artery IMT; 3) Brachial artery FMD, CAC and carotid artery IMTare related in adults; and 4) Brachial artery FMD is predictive of increased carotid artery IMT.

Eligibility Criteria:
Participated in at least on school survey examination, at least one young-adult follow-up survey examination and the first Longitudinal Adult Cohort examination
Methylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder

Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. To test the hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic strategy to improve outcome in OCD.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Met DSM-V criteria
* Y-BOCS ≥ 16
* Course of illness ≥ 1year
* Age range between 18\~40 years old
* Junior high school education level above

Exclusion Criteria:

* Any other psychiatric axis-I or axis-II disorders
* History of epileptic seizures or any other neurological disorder
* Any other clinically relevant abnormalities in their medical history or laboratory examinations; alcohol or drug abuser
Does Bladder Training Improve the Efficacy of Nerve Stimulation in Women With Refractory Overactive Bladders

Overactive Bladder (OAB) is a chronic condition defined as urgency with or without incontinence usually associated with frequency and nocturia. It is a common condition affecting 15-45% of adults and constitutes a significant proportion of patients attending urogynaecology clinics. OAB is known to have a significant impact on the physical, social and emotional quality of life and sexual function in women. The treatment of OAB is initially conservative with bladder training followed by pharmacotherapy.

Evidence from a recent Cochrane review on treatment of OAB suggests that the efficacy of anticholinergics in treatment of OAB is enhanced when combined with BT. Women who fail to improve with these initial measures are offered Intravesical Botox or neuromodulation in the form of Percutaneous Tibial Nerve Stimulation (PTNS) or Sacral Nerve Stimulation (SNS).

PTNS has also been shown to more effective than pharmacotherapy with anticholinergics. In 2010 National Institute of Clinical Excellences (NICE) issued guidance stating '"PTNS for OAB demonstrates effectiveness without major safety concerns"

We hypothesise that the outcome of PTNS will improve if the PTNS sessions are combined with bladder training (BT).


Eligibility Criteria:
Inclusion Criteria:

* All women with refractory OAB who are offered PTNS as a treatment option

Exclusion Criteria:

* Who cannot give informed consent.
* Women in whom PTNS is contraindicated. This includes women who have:

Gross leg oedema A pacemaker
Capturing MultiORgan Effects of COVID-19

The C-MORE study is prospective observational holistic longitudinal study which will characterise the prevalence of multi-organ injury among COVID-19 survivors post hospital discharge and assess its effects on quality of life, exercise tolerance and mental health.

Since the outbreak of Coronavirus disease (COVID-19), hundreds of thousands of lives have been lost and millions significantly affected. Although primarily a respiratory viral illness, emerging data suggests that multiorgan involvement is common in those with moderate-severe infections. Whether or not persistent multiorgan damage will be seen in COVID-19 survivors is unknown.

C-MORE is an observational study that aims to investigate the long-term effects of COVID-19 on the lungs, heart, brain, liver and kidneys using advanced state-of-the art magnetic resonance imaging (MRI) technology. The study will assess 616 patients with laboratory-confirmed COVID-19 from leading UK centres and undertake multi-organ magnetic resonance imaging at 3, 6, and 12 months following the onset of COVID-19 symptoms. In addition, assessments of breathing, exercise capacity, cognition and mental health will be carried out.

The study will describe the prevalence of persistent multi-organ injury in COVID-19 patients and assess how this relates to comorbid conditions, severity of acute respiratory illness, immunological response, genetic factors, quality of life and mental health.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Diagnosis of COVID-19 infection confirmed by detection of viral nucleic acid on reverse-transcription Polymerase Chain Reaction (RT-PCR).
* Infection should be of moderate to severe intensity (i.e, patients with clinical signs of pneumonia such as respiratory rate \> 30 breaths/min; or severe respiratory distress; or SpO2 \< 90% (on room air) and admission for \>48 hours.
* Controls: Participants with no serological evidence of previous infection, or active/previous symptoms suggestive of COVID-19, and who may or may not have comorbidities.

Exclusion Criteria:

* Contraindication to MRI e.g. pregnancy, pacemaker, ferromagnetic implant, shrapnel injury, severe claustrophobia, inability to lie flat.
* Any other significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study.
* Any signs of active COVID-19 infection on day of visit.
* Significantly impaired renal function (eGFR\<30 ml/min)
Preventing Injury in Elite Orienteerers

The aim of this study is to investigate the effect a specific exercise program on the incidence of injuries in the lower extremity. 72 elite orienteerers, aged 18-40 years, are allocated to an intervention or control group. The intervention group performs four specific exercises, four times a week (10 minutes per session) in conjunction with normal training. Injury data are collected every second week using valid injury questionnaire distributed by text messages over 14 weeks. Primary outcome is number of substantial injuries in the lower extremity. Secondary outcomes are incidence of ankle sprains and the average substantial injury prevalence across the 10 weeks.

The high physical load associated with running through uneven terrain contributes to that orienteerers are exposed to high injury risk, where the majority of injuries located in the lower extremities. Specific training programmes have been effective at reducing injury risk in sports. Yet, not trial has been conducted in elite orienteering. The aim of this study is to investigate the effect a specific exercise program on the incidence of injuries in the lower extremity. 72 elite orienteerers, aged 18-40 years, are allocated to an intervention or control group. The intervention group performs four specific exercises, with three difficult levels intensified every second week over the first four weeks, targeting strength, flexibility and coordination of the lower extremity. The exercises are completed four times a week (10 minutes per session) in conjunction with normal training. Injury data are collected every second week using valid injury questionnaire distributed by text messages over 14 weeks. Primary outcome is number of substantial injuries in the lower extremity. Secondary outcomes are incidence of ankle sprains and the average substantial injury prevalence across the 10 weeks. Participants will be recruited in January-February 2018. The intervention starts in February 2018 and data collection will be completed in June 2018. Data analyses are expected to be completed in October-November 2018.

Due to high injury risk and lack of injury prevention trials in orienteering, a RCT investigating the effect of a specific exercise program on the incidence of injuries in the lower extremity, is warranted. The results of this trial will be beneficial to orienteerers, clubs, federations and increase our understanding on how lower extremity injuries can be prevented in a physically challenging sport.

Eligibility Criteria:
Inclusion Criteria:

Adult elite orienteerers Aged 18-40 years Participating in the highest national orienteering league (Swedish League) Participant inclusion criteria - Age group: Adult Participant inclusion criteria - Gender: Both

Exclusion Criteria:

Injured adult elite orienteerers not able to perform baseline tests
Lipid Kinetics of Patients With Pneumonia

Nonfermenting Gram-Negative Bacilli (NFGNB) are aerobic, non-motile, non-lactose fermenting, oxidase-negative, catalase-positive coccobacilli that pose a serious threat to critically ill patients. Primarily Pseudomonas aeruginosa (PA) and Acinetobacter baumannii (AB), are NFGNB which are potential multi-drug resistant (MDR) pathogens that are related to ventilator-associated pneumonia (VAP). In Nonfermenting Gram-Negative Bacilli (NFGNB) infections, which are potential multi-drug resistant (MDR) pathogens, pathogenesis is determined not only by bacterial virulence factors but more importantly by the interaction between bacteria and the host immune system. Thanks to their direct immunomodulatory properties, lipoproteins and lipids bind and neutralise toxic bacterial substances. During the acute phase response and inflammation, HDL presents significant structural and functional changes. This study was planned to evaluate the relationship between the changes of the serum lipid metabolism and other inflammation markers with the antimicrobial resistance status and the results in NFGNB VAP patients. Also, we aimed to investigate whether there is a difference in the clinical characteristics of the patients depending on the resistance profile of NFGNB.

This prospective study was performed in adult intensive care unit (ICU) patients. They were intubated endotracheally and received mechanical ventilation (MV) treatment for at least 48 hours in Konya Numune Hospital ICU, which has 42 surgery and medicine beds. The study was conducted between May 2019 and December 2020 and approved by the Ethics Committee of Necmettin Erbakan University Medical School. Informed consents were obtained from the patients who participated in the study or from their relatives. The characteristics of the patients and the sequential changes of the inflammatory response including the lipid profile were recorded.

Eligibility Criteria:
Inclusion Criteria:

* ICU Patients of 18 years of age and above, with clinical suspicion of VAP as defined in the American Thoracic Society (ATS) guidelines and a simplified version of Clinical Pulmonary Infection Score (CPIS)\> 6, with significant NFGNB growth in respiratory cultures and with no signs and symptoms of infection at the time of admission, were included in the study.

Exclusion Criteria:

* Patients with chronic inflammatory disease, hepatic dysfunction, active tuberculosis, malignancy, malnutrition, severe immunosuppression (i.e., neutropenia, HIV positive, organ transplant, having received immunosuppressants or used ≥ 20 mg/day prednisone for two or more weeks in the preceding three months), those that within 72 hours since being included in the study had any extrapulmonary infection other than VAP, as well as those whose respiratory cultures presented bacterial agents other than NFGNB and fungal agents were not included in the study.
Sharing HaRT in New Expanses

The goal of this parallel cluster randomized control (CRT) trial is to evaluate a group-based mind-body intervention (Move with HaRT) in survivors of human trafficking. The main study aims are:

1. Determine effectiveness of the Move with HaRT intervention on PTSD, depression, and anxiety symptoms among survivors of human trafficking in Uganda
2. Explore participant characteristics (e.g., age, trafficking history, food security) that may moderate the intervention effectiveness.
3. Understand potential barriers and facilitators to future implementation and scale-up.

Participants will complete:

* Complete three surveys (baseline, endline, and 3 month follow-up)
* Participate in either Services as Usual or Move with HaRT groups
* Qualitative in-depth interviews

Researchers will compare Move with HaRT with Services as Usual to see effects on mental health symptoms.

Despite significant mental health challenges experienced by human trafficking survivors, a lack of research on effective interventions exists. The proposed parallel cluster randomized control trial aims to evaluate the mental health impact of Move with HaRT with human trafficking survivors in Uganda. Move with HaRT is a group-based intervention facilitated by paraprofessionals that includes breathwork, yoga poses, meditation, and discussions. The proposed study will use a parallel cluster randomized control (CRT) trial with 302 survivors randomized in groups to either Move with HaRT or Services as Usual. The main study aims are: 1) Determine effectiveness of the Move with HaRT intervention on PTSD, depression, and anxiety symptoms among survivors of human trafficking in Uganda; 2) Explore participant characteristics (e.g., age, trafficking history, food security) that may moderate the intervention effectiveness; 3) Understand potential barriers and facilitators to future implementation and scale-up. Surveys at baseline, endline, and 3-month follow-up assess mental health outcomes, as well as secondary outcomes on physical and social wellbeing. Qualitative research will inform barriers and facilitators to future implementation and scale-up. Results of this study have the potential to inform protection services in Uganda and beyond.

Eligibility Criteria:
Inclusion Criteria:

* identify as female;
* history of forced labor or sex trafficking;
* aged 14 and above;

Exclusion Criteria:

* physically unable to perform basic day-to-day activities without assistance
* does not provide consent (or assent if a minor)
Personal Activity Intelligence (PAI) Pilot

Pilot study to evaluate the use of the Personal Activity Intelligence (PAI) score in a clinical setting.

This is a pilot project to evaluate the feasibility of a larger study to evaluate the effectiveness of Personal Activity Intelligence (PAI) score in patients with chronic disease, as an adjunct to lifestyle medical therapy.

The PAI score is a proprietary formula developed by PAI Health (PH) to aid physical fitness. A PAI score calculation uses biometrics obtained via a device that measures heart rate and steps. For this study, Mio Slice, a commercial wrist worn device will be utilized to obtain data which will be linked to a smart phone. Data from the smart phone app will be accessed by PAI Health. Feedback information will be given to the participants to encourage increased physical activity.

The short-term aim of this study is to evaluate the logistics of utilizing PAI in the patient setting.

The data obtained from this study will be utilized to devise a larger study to evaluate the utility of PAI in patients with chronic disease who are receiving lifestyle medical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who are seen by the PI in his lifestyle medicine practice at Muntean Health Care.
* Participants must own a smart phone and feel comfortable managing apps on their smart phone.
* Participants must be willing and able to register online with PAI Health (PH)
* Participants must be willing to wear a wrist device around the clock, except when charging or bathing for 12 weeks.
* Participants must have at least one of the following diagnoses:
* overweight / obesity
* diabetes or prediabetes
* hypertension or pre-hypertension
* abnormal lipids
* cardiovascular disease

Exclusion Criteria:

* Patients with angina or poor exercise tolerance, based on the evaluation by the PI, will be excluded from the study.
Operative Plate Fixation Versus Conservative Treatment for Acute, Displaced Fractures of Humeral Shaft

Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

From Jane 2015 to October 2016, patients with displaced humeral shaft fractures are retrospectively included in this study, they were treated with either operative plate or conservative treatment. All the patients are regularly followed up in clinic. Then we will compare the union rate and clinical functional outcome(DASH score) between the 2 groups at 1 year after surgery.

Eligibility Criteria:
Inclusion Criteria:

Men or women aged 18 to 65 years of age Completely displaced ,closed fracture of humeral shaft confirmed by radiograph Fractures within 1 month post injury Provision of informed consent

Exclusion Criteria:

Pathological fractures Non-displaced (cortical contact) fractures Open fractures Presence of vascular or nerve injury Fractures more than 1 month post-injury Limited life expectancy due to significant medical co-morbidity Medical contraindication to surgery Inability to comply with rehabilitation or form completion Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors

The aim of this study is to investigate the feasibility (safety, adherence) and initial efficacy (physical function and patient reported outcomes) of a multicomponent tele-rehabilitation program during COVID-19 recovery of patients who have been hospitalized due to COVID-19.

The aim of this study is to investigate the feasibility and initial efficacy of a multicomponent tele-rehabilitation program during COVID-19 recovery. The tele-rehabilitation program will include biobehavioral training and high intensity exercise facilitated through an online application ('Platform'). Initial efficacy will be assessed primarily by performance on the 30" Chair Stand Test and secondarily through other physical function tests and patient reported outcome measures.

This study will advance the feasibility of tele-rehabilitation as a more generally useful intervention in patients lacking access (distance, availability, mobility) to standard rehabilitative services and could transform the way in which acute rehabilitation and post-hospital care is delivered for all patients.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed COVID-19, per diagnostic criteria (PCR testing)
2. Hospitalized for at least 24 hours
3. Able to provide informed consent
4. Internet capability to access the platform
5. Community-dwelling prior to hospitalization

Exclusion Criteria:

1. Unstable medical comorbidities that would preclude participation in exercise
2. Receipt of \>1 session of outpatient physical therapy
3. Known pregnancy, as the impact on physical function, pulmonary function, and other outcomes will vary well beyond any expected effects of COVID-19
4. Anticipating concurrent additional physical therapy services during study intervention period (12 weeks)
Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents

Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents

Medical management of incipient lesions by application of remineralizing agents like fluoride therapy, amorphous calcium phosphate (ACP), and Casin phosphopeptide amorphous calcium phosphate (CPP-ACP) has proved to be effective in reversing such lesions.

Fluoride was considered the "gold standard" remineralizing agent , However several recent researchers found that; the ideal remineralizing agents should diffuse or deliver calcium and phosphate ions into early enamel lesion.

Calcium-silicate based material such as β-CaSiO3 and β-Ca2SiO4 play an important role in hard tissue regeneration, showing good bioactivity and biocompatibility and can induce bone like apetite formation in stimulated body fluids. when β-CaSiO3 and β-Ca2SiO4 come in contact with saliva it will be dissolve forming silanol group (Si-O ) on the enamel surface which can bind to Ca ions and inducing the precipitation of hydroxyapatite.

In the light of this, this study was designed to compare the remineralization potential of silver diamine flouride/ potassium iodide, casin phosphopeptide amorphous calcium phosphate and experimental tricalcium silicate on early enamel lesions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with early enamel lesions (ICDAS score 1 and 2).
* Patients with normal occlusion .
* Patients must have a good oral hygiene
* patients free from any systemic diseases and don't receive any medication

Exclusion Criteria:

* smoker patients
* pregnant females
* patients with bad oral hygiene
* patients with enamel defects ( Amelogenesis Imperfecta, fluorosis, cracks or any developmental defects)