cyrilzakka/clinical-trials huggingface dataset:
The Effect of Bike Exercise on Joint and Muscles

The design of our study is a prospective. It is planned to be completed in twenty-four weeks with 34 participants. The main purpose of this study is to examine and compare the effects of two different bike exercises on knee joint and lower extremity muscles by ultrasonographic method.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-35
* Not exercising regularly
* BMI between 18.9-24.9 kg/m2
* Volunteering to participate in the study
* Absence of chronic rheumatic, cardiovascular, neurological, pulmonary or other system diseases that may prevent participation in the exercise program.
* Those who do not have a history of pregnancy, malignant hematological and oncological diseases
* Not smoking
* No musculoskeletal problems of the lower extremity in the last 6 months
* No previous history of lower extremity surgery in the last 1 year

Exclusion Criteria:

* Being outside the age range of 18-35
* Exercising regularly
* Being outside of the BMI 18.9-24.9 kg/m2 range
* Having chronic rheumatic, cardiovascular, neurological, pulmonary or other system diseases that may prevent participation in the exercise program
* Those with a history of pregnancy, malignant hematological and oncological diseases
* Individuals who smoke
* Any musculoskeletal problem of the lower extremity in the last 6 months
* Having a history of lower extremity surgery in the last 1 year
Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults

The goal of this observational study is to characterize the standardized stimulation parameter for noninvasive, transcutaneous, repetitive phrenic nerve electrical stimulation.

The main questions it aims to answer are:

* Is the phrenic nerve repetitive electrical stimulation test feasible for use as non-invasive transcutaneous electrical stimulation?
* What is the most optimal stimulation parameters for repetitive phrenic nerve electrical stimulation in healthy adult populations in terms of effective and safe activation of diaphragm?


Eligibility Criteria:
Inclusion Criteria:

* Koreans who speak Korean as their mother tongue, aged 19 or older and younger than 40.
* Those who understood the purpose and procedure of this study and voluntarily participated with consent.

Exclusion Criteria:

1. - Those who have any neuromuscular disease.

   - Those whom abnormal findings are observed on a neurological examination. e.g.) Cases with abnormal findings in peripheral motor nerve (median nerve) and sensory nerve (sural nerve) conduction studies performed in screening.

   e.g.) People who have been diagnosed with a neuromuscular junctional diseases such as myasthenia gravis or receiving related treatment.
2. In the case of implantable electronic medical devices such as pacemakers, implantable cardioverter defibrillators (ICDs), and spinal cord stimulation devices.
3. Those who have any history of radiation therapy or chemotherapy for cancer within a year.
4. People who have a history of cardiovascular or cerebrovascular disease or lung disease within 6 months.
5. Those who have been diagnosed with a psychiatric/neurological problem or taking related medications that may affect electrophysiological study.
6. Those who are pregnant or may be pregnant.
7. Those who are judged to lack the cognitive ability to understand the explanation of the purpose and procedure of this study.
8. Those whom the researchers judge for other reasons to be inappropriate to participate in this study.
Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence

This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 lasers for improvement of symptoms of urinary incontinence.

Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue exhibit similarities that suggest the clinical results seen with skin resurfacing may be translated to the vaginal tissue. Improved vaginal tissue tone and increased collagen formation in the lamina propria beneath the urethra may lead to improved urinary control. This multi-centered, 18-month prospective clinical trial will determine the safety and long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (Hybrid Fractional Laser) as an alternative non-surgical, non-hormonal treatment for improvement of symptoms of urinary incontinence.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy biological female aged between 30 to 75 years
2. Is experiencing at least one or a combination of the following symptoms of urinary incontinence (UI)

   1. involuntary urine leakage on effort, exertion, sneezing, coughing
   2. sudden intense urge to urinate followed by involuntary loss of urine
3. Has been experiencing symptoms of UI for greater than 3 months
4. Normal urinalysis
5. Has indicated willingness to participate in the study by signing an informed consent form
6. Can read, understand and sign informed consent form
7. Agree to adhere to the treatment and follow-up schedule and post treatment care instructions

Exclusion Criteria:

1. Undiagnosed abnormal genital bleeding
2. Has history of pelvic surgery or other energy-based vaginal therapy within 6 months prior to enrollment
3. Is pregnant or planning to get pregnant within the study period
4. Is currently breastfeeding
5. Has an active sexually transmitted infection (STI)
6. Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q test)
7. Has signs or symptoms of vaginitis/vulvitis
8. Has signs or symptoms of acute urinary tract infection (UTI)
9. Has voiding dysfunction or urinary retention
10. Has predominantly overactive bladder (OAB) as proven by urodynamics
11. Is currently taking medication for treating urinary incontinence
12. Has a known history of neurologic disease
13. Has history of heart failure
14. Any medical conditions that might interfere with wound healing
15. Has history of abnormal wound healing
16. Has participated in any clinical trial involving an investigational drug or procedure within past 30 days
17. The investigator feels that for any reason the subject is not eligible to participate in the study.
Benefit of the Digital Workflow for Screw-retained Single Implant Restorations

The aim of this research project is emphasize the benefit of the digital workflow compared to conventional impressions and crown processing with standard la procedures. The objectives of the present study are to measure and compare the global cost, the time spent in the dental chair and in the lab and the fit of both digital and conventional workflow. Additionally, patient centered outcomes will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have voluntarily signed the informed consent form before any study related action
* Age: 18 with one or more missing teeth in the maxillary area, seeking for implant therapy.
* Men/Women
* In good systemic health (ASA I/ II)
* Present with no contra indication against oral surgical interventions
* Patients required replacement of a single missing tooth. The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation.
* At least 10 mm of bone in the vertical dimension
* At least 6 mm of bone in the bucco-lingual dimension.
* No need for bone augmentation procedure in any of the dimensions
* Full mouth plaque score (FMPI) lower or equal than 25%

Exclusion Criteria:

* Autoimmune disease require medical treatment
* Medical conditions requiring prolonged use of steroids
* Use of Bisphosphonate intravenously or more then
* Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
* Current pregnancy or breastfeeding women
* Alcoholism or chronically drug abuse
* Immunocompromised patients
* Uncontrolled Diabetes
* Smokers
* Prisoners
Study of HQK-1004 and Valganciclovir to Treat Epstein-Barr Virus (EBV) - Positive Lymphoid Malignancies or Lymphoproliferative Disorders

The purpose of this study is to determine if treatment with HQK-1004 and valganciclovir will result in complete or partial responses in patients with EBV-positive lymphoid malignancies or lymphoproliferative disorders.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed lymphoid malignancy or lymphoproliferative disorder with EBV detected by either immunohistochemistry or in situ hybridization. Pathology can be assessed on either a current or previous biopsy. All disease stages are eligible
* Disease that is refractory or relapsed after at least one prior standard therapeutic regimen, which includes biologic agents (e.g., monoclonal antibodies), chemotherapy or chemoradiotherapy regimens. Prior therapy may include high dose chemotherapy and stem cell rescue or bone marrow transplantation
* Bidimensionally measurable disease by computerized tomography (CT) or magnetic resonance imaging (MRI; patients with sensitivity to contrast or for tumor types that are less accurately measured by CT) scan or physical measurement (cutaneous lesions only) with at least 1 lesion ≥ 10 mm in the greatest diameter. PET-CT should be used at baseline for patients with Hodgkin's Disease (HD) or diffuse large B-cell lymphoma (DLBCL).
* Absolute neutrophil count ≥ 500/mm3 and platelet count ≥ 50,000/mm3
* Bilirubin ≤ 2.0 times upper limit of normal (ULN) with the exception of patients with Gilbert's syndrome (bilirubin ≤ 3.5 times ULN allowed), and both AST and ALT ≤ 3 times ULN
* Serum creatinine ≤ 2.0 mg/dL

Exclusion Criteria:

* Patients who have not recovered from previous treatment with chemotherapy
* Patients who have been treated with biologic agents within two weeks prior to first dose of HQK-1004
* Uncontrolled ischemic heart disease or uncontrolled congestive heart failure, or myocardial infarction within the past 3 months
Observational Study to Evaluate LDL-C Lowering Effect of Ezetimibe (0653-070)

To evaluate the LDL-C lowering in south african patients with primary hypercholesterolaemia after the addition of ezetimibe 10mg /day to ongoing therapy with a statin.


Eligibility Criteria:
Inclusion Criteria:

* Men or women \>18 and \<80 years of age
* Patients receiving statin therapy for a minimum period of 6 weeks prior to visit 1
* Female patients receiving hormone therapy (including hormone replacement therapy, any estrogen antagonist/agonist, or oral contraceptives) if maintained on a stable dose and regimen for at least 8 weeks prior to visit 1 and if willing to continue the same regimen throughout the study
* Liver enzyme levels less than or equal to 1.5 times the upper limit of normal with no active liver disease and CPK less than or equal to 1.5 times upper limit of normal at visit 1

Exclusion Criteria:

* Cardiovascular medications, such as beta-blockers, calcium-channel blockers,

angiotensin ii receptor antagonists or anticoagulants (i.e., warfarin) unless

treated with a stable regimen for at least 6 weeks prior to randomization and

patient agrees to remain on constant regimen for the duration of the study

* Patients on amiodarone hydrochloride will also be excluded
* General weight less than 50% of ideal body weight according to the 1983 metropolitan height and weight tables or weighing less than 100 lbs (45 kg)
* Hypersensitivity to HMG-COA reductase inhibitors
* Patient has congestive heart failure defined by nyha class III or IV, uncontrolled cardiac arrhythmias, unstable angina pectoris, or myocardial infarction; coronary artery bypass surgery, or angioplasty within 3 months of visit 1
* Taking lipid-lowering agents including fish oils, cholestin, bile-acid sequestrants

and niacin (grater than 200 mg/day) taken within 6 weeks and fibrates taken within 8 weeks prior to visit 1

* Taking medications that are potent inhibitors of cyp3a4, including cyclosporine,

systemic itraconazole or ketoconazole, erythromycin or clarithromycin,

nefazodone, verapamil and protease inhibitors

* Consumption of greater than 250 ml of grapefruit juice/day
* Taking oral corticosteroids unless used as replacement therapy for pituitary/adrenal disease and on a stable regimen for at least 6 weeks prior to visit 1
* Treatment with psyllium, other fiber-based laxatives, and/or OTC therapies

known to affect serum lipid levels, phytosterol margarines, unless treated with

a stable regimen for at least 6 weeks prior to visit 1 and patient agrees to remain on constant regimen for the duration of the study

* Women who are pregnant or lactating
Comparing the Location of the Motor Cortex in Children Using Two Methods

Hypothesis: In typically developing children (TDC), use of conventional EEG landmarks to determine the brain area that controls hand function will not differ from TMS-guided determination of individual motor hotspots. In children with hemiparesis, however, those two locations will diverge. The prediction is that TMS will best guide Transcranial Direct Current Stimulation (tDCS) interventions

Congenital hemiparesis, mainly due to stroke, affects approximately 25% of children with cerebral palsy. Noninvasive brain stimulation has emerged to influence improvements in hand function specifically in children with congenital hemiparesis due to stroke.

The use of one type of noninvasive brain stimulation, Transcranial Direct Current Stimulation (tDCS), in conjunction with rehabilitation training intervention for a child with hemiparesis proposes a synergistic approach to improving hand function. Application of electrodes over certain targeted areas are placed with the intent to stimulate and influence neuronal activity.

Our preliminary evidence suggests that in children with hemiparesis due to stroke, the area for placement is variable as noted by electroencephalogram (EEG) and Transcranial Magnetic Stimulation (TMS) measurement methods, influencing the site location of optimal stimulation for tDCS.

Due to this variation, the optimal site of stimulation warrants investigation for the optimal placement of tDCS.

Eligibility Criteria:
Inclusion Criteria:

Typically Developing Children:

* Ages 8-17

Children with congenital hemiparesis due to hemispheric stroke:

* Ages 8-17
* Equal of greater than 10 degrees of active motion at the metacarpophalangeal joint
* No evidence of seizure activity within the last 2 years.

Exclusion Criteria:

Typically Developing Children:

* neurologic disorders
* indwelling metal
* pregnancy
* history of seizures

Children with hemiparesis:

* Metabolic disorders
* Neoplasm
* Epilepsy
* Disorders of cellular migration and proliferation
* Expressive aphasia
* Pregnancy
* Indwelling metal
* Botulinum toxin or phenol intramuscular block within the one-month preceding TMS application.
Incidence of Acute Lung Injury in Children

Acute lung injury in children is a syndrome of rapid onset of acute respiratory failure and require admission into intensive care units (ICU) for advanced life support. There are almost no information on epidemiology of acute lung injury. Published studies do not have information for an entire year and none of them have evaluated the degree of oxygenation failure under standard ventilator settings. The investigators will perform a 1-year prospective audit of all patients admitted with acute lung injury in a network of pediatric ICUs in Spain.

We will evaluate oxygenation under standard ventilator settings (FiO2 0.5 and 1 on PEEP 5 or 10 cmH2O) in pediatric acute respiratory distress syndrome.

Outcome measures will include: overall ICU mortality, number of patients meeting ARDS criteria at 24 hours, and stratification of patients depending on PaO2/FiO2 ratio at 24 h of meeting acute respiratory distress syndrome criteria.

Eligibility Criteria:
Inclusion Criteria:

* Acute onset of respiratory failure
* Age 1 month to 18 years old
* Bilateral pulmonary infiltrates on Chest X-ray
* Absence of left ventricular failure, PaO2/FiO2\>300 mmHg

Exclusion Criteria:

* None
Muscle Dysfunction in Patients With Haematological Diseases

PURPOSE: To evaluate the prevalence and prognostic value of sarcopenia in patients diagnosed with hematological cancer diseases.

Some patients diagnosed with malignant hematological diseases are faced with poor prognosis and thus must undergo a demanding course of treatment associated with severe deconditioning potentially leading to worse prognostic outcomes. It is currently not well-described, to what extend patients body composition at the point of diagnoses should be part of standard clinical evaluation in order to optimize therapy-efficacy. Recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long-term prognosis.

Eligibility Criteria:
Inclusion Criteria:

• Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment at the Department of Haematology, Rigshospitalet.

Exclusion Criteria:

* Age: \<18
* Pregnancy
* Physical or mental disabilities precluding test of muscle function
* Inability to read and understand Danish.
Role of the Dentist in the Control of the Alcoholic Habit in Patients with Potentially Malignant Oral Lesions

Introduction: Alcohol is the most consumed psychoactive substance, its consumption is very prevalent and there is a low perception of the risk it poses in our society. Alcohol is a risk factor and a causal factor for multiple pathologies, including cancer and potentially malignant oral lesions (LOPM). The dentist can play a relevant role in the evaluation of consumption, as well as provide brief interventions (BI) to assist them in the cessation of the habit.

Objectives: The main objective is to evaluate the efficacy of the intervention, carried out by dentists, to stop or reduce alcohol consumption in a patient with LOPM.

Material and methods: clinical trial, randomized, with balanced randomization, single-blind (for the evaluator of the results) with 1 experimental arm and a control group, carried out in a single-center manner. Group 1 incident brief intervention and Group 2 no incident intervention (only usual clinical information). 200 patients from the Unit of Oral Medicine, Oral Surgery and Implantology of the University of Santiago de Compostela will participate in this study, they will make an initial visit, one month, three months, six months and one year. In these visits, evaluations related to alcohol consumption, the evolution of injuries, quality of life and satisfaction with the BI were carried out.

Predictable results: If IB contributes to the cessation or reduction of alcohol consumption, and improves the clinical evolution of LOPM, it could be implemented immediately in our Oral Medicine unit and could lay the foundations for its implementation in different public centers and private.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a clinical and histopathological diagnosis of oral lichen planus (OPL) and/or oral leukoplakia (LO) (in all its clinical forms) as chronic LOPMs according to the WHO 2017 classification.
2. Patients over 40 years old
3. Patients in follow-up, with chronic injuries, without medical and/or surgical treatment for at least 1 month
4. Patients with frequent daily alcohol consumption \> 1 Standard Beverage Unit (more than two glasses of wine/beer per day or one glass of liquor/distilled drink per day)

Exclusion Criteria:

1. Participants who do not sign the informed consent.
2. Patients with a score above 20 in the AUDIT.
3. Patients undergoing treatment for problems with alcohol and other drugs.
4. Patients with systemic pathology associated with alcohol consumption
5. Pregnant patients.
6. Patients undergoing active pharmacological treatment for OPL.
7. Patients who have undergone surgical resection and/or CO2 laser treatment for LO in the last month.
8. Patients with a history of malignant oral lesions.
The Danish Comorbidity in Liver Transplant Recipients Study

Background:

Liver transplantation is the only curative treatment for patients with end-stage liver disease. Short-term survival has improved due to improved surgical techniques and greater efficacy of immunosuppressive drugs. At present, the 10-year survival after liver transplantation is 60%, but long-term survival has not improved to the same extent the short-term survival. In addition to liver- and transplant-related causes, comorbidities such as cardiovascular, pulmonary, renal, and metabolic diseases have emerged as leading causes of morbidity and mortality in liver transplant recipients.

The objective of this study is to assess the burden of comorbidities and identify both liver- and transplant-related risk factors as well as traditional risk factors that contribute to the pathogenesis of comorbidity in liver transplant recipients.

Methods/design:

The DACOLT study is an observational, longitudinal study. The investigators aim to include all adult liver transplant recipients in Denmark. Participants will be matched by sex and age to controls from the Copenhagen General Population Study (CGPS) and the Copenhagen City Heart Study (CCHS). Physical and biological measures including blood pressure, ancle-brachial index, spirometry, exhaled nitric oxide, electrocardiogram, transthoracic echocardiography, computed tomography (CT) angiography of the heart, unenhanced CT of chest and abdomen and blood samples will be collected using uniform protocols in participants in CGPS, CCHS and DACOLT. Blood samples will be collected and stored in a research biobank. Follow-up examinations at regular intervals up to 10 years of follow-up are planned.

Discussion:

There is no international consensus standard for optimal clinical care or monitoring of liver transplant recipients. The study will determine prevalence, incidence and risk factors for comorbidity in liver transplant recipients and may be used to provide evidence for guidelines on screening and long-term treatment and thereby contribute to improvement of the long-term survival.


Eligibility Criteria:
Inclusion Criteria:

* Liver transplanted
* age between 20 and 100 years
* be able to understand the study information in either Danish or English and to be able to provide an informed consent

Exclusion Criteria:

* none
Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

Comparison of open and laparoscopic pyloromyotomy


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of infantile hypertrophic pyloric stenosis

Exclusion Criteria:

* Presence of co-existing congenital or chromosomal abnormality
* The need to perform any additional procedure at the time of pylotomyotomy
* Failure to receive informed consent