cyrilzakka/clinical-trials huggingface dataset:
Laser Activation in Reducing Pain During and After Root Canal Treatment for Painful Lower Molar Teeth.

Effectiveness of lasers in reducing pain during and after root canal treatment for mandibular molar teeth affected with acute irreversible pulpitis.

AIM : To assess the intraoperative and postoperative pain incidence for single visit root canal treatment for mandibular molar teeth with acute irreversible pulpitis following laser activation.

MATERIALS AND METHODS: The study will account the patients who are referred to the Department of Endodontics,both male and female patients,with pain due to acute irreversible pulpitis from carious mandibular first and second molar teeth requiring root canal treatment. Subjects of age 13 to 70 years who met the inclusion criteria and responded positively to cold test will be included in the study.

Single visit root canal treatment with 2.5 mL of 2% lignocaine containing 1:80,000 adrenaline for an inferior alveolar block injection will be administered for each individual. After achieving anesthesia, patients who exhibit pain following access opening will be subjected to diode laser application on the pulp canal orifices. With regard to intraoperative pain, pre laser and post laser intraoperative pain incidence will be recorded. Once when the intraoperative pain incidence is reduced, patients will be reassessed for the need of additional anesthesia. If fully anesthetised, root canal procedure will be completed. Preoperative, intraoperative( before and laser application) pulse rate will also be measured. The levels of preoperative and post-operative pain at 24 hrs and 48 hrs for each patient will be recorded using a 10-point visual analog scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Patients with painful mandibular molar teeth due to caries with no history of medication intake before 7 days prior to root canal treatment
* Patients who respond exaggerated pain with or without lingering response on cold test

Exclusion Criteria:

* Patients who do not have pain upon access opening following local anesthesia administration
* Teeth with poor periodontal or restorative prognosis,
* Patients with serious systemic ailments or conditions hindering single visit root canal treatment
* patients not willing to participate in the post operative recall evaluation
* Teeth with anatomic variations and
* Allergic patients are excluded
Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease

The aim of this study was to evaluate the impact in safety and efficacy of a new formulation of prolonged-released Pirfenidone in the progression of renal damage in patients with Chronic kidney Disease (CKD).


Eligibility Criteria:
Inclusion Criteria:

1. Patients between 10 and 40 years old with CKD
2. Diagnosis of CKD stage 1 to 4 according with KDIGO definition and classification
3. No glucocorticoids, cyclophasphamide, mycophenolate, or other immunosuppressive drugs for at least two months before starting PFD administration
4. Sign of consent forms

Exclusion Criteria:

1. Known intolerance to PFD
2. CKD stage V according with KDOQI classification
3. Post-transplant patients
4. History of peptic ulcer within six months
5. History of cerebrovascular disease within six months
6. Evidence of hepatic disease
7. Pregnancy or breast feeding
8. Malignancy
Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy

Open-heart surgery causes injury of the heart muscle. Although this is usually mild, temporary and reversible, if it is severe it can endanger life and require additional high cost care. During surgery, techniques are used to protect the heart from injury, but these remain imperfect. Patients with a thickened wall of the heart (left ventricular hypertrophy) may be at greater risk. This study assesses the effect of facilitating sugar metabolism (a more efficient fuel) by the heart muscle using the drug Perhexiline given before the operation.

This treatment has a sound experimental basis for improving outcome. If this improvement is confirmed surgical results could be improved. The investigators will be studying heart function, heart muscle energy stores and chemicals which quantify the amount of heart muscle injury. The investigators' hypothesis is that Perhexiline will improve the protection of the heart by decreasing damage that may occur during heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* First-time
* Aortic valve surgery for aortic stenosis +/- coronary artery bypass

Exclusion Criteria:

* Diabetes Mellitus
* Renal impairment with Creatinine greater than or equal to 200micromol/L
* Atrial fibrillation
* Amiodarone therapy, recent (in last month) or current
* Hepatic impairment, significant preoperative
* Peripheral neuropathy
* Pregnancy or breast-feeding
* Emergency surgery or required on clinical grounds within 5 days of referral
Laser and High Intensity Tesla Magnetic Stimulation (HITS) for Stress Urinary Incontinence (SUI)

To investigate the efficacy of combined laser and HITS treatment for female stress urinary incontinence (SUI)

This study is a single-centre, two-arm randomized control trial study conducted according to Helsinki Declaration. Women with symptoms of stress urinary incontinence (SUI) (stress or mixed with stress incontinence as the predominant symptom) will be enrolled.

The efficacy and safety of combined treatment with non-ablative intravaginal Er:YAG laser procedure and high intensity Tesla magnetic stimulation will be compared to the treatment of non-ablative intravaginal Er:YAG laser alone.

Eligibility Criteria:
Inclusion Criteria:

1. Adult female, 18 years of age or older
2. Clinical diagnosis of stress or mixed urinary incontinence, with stress incontinence as the predominant symptom (SUI or MUI)

Exclusion Criteria:

1. Very severe urinary incontinence (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) ICIQ-UI )score at baseline \>18 or Pad test \> 50 gr)
2. Pregnancy
3. BMI\>35
4. Acute urinary tract infections (UTIs)
5. History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during screening physical exam (e.g., perineal body)
6. Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
7. Prolapse grade 2 or higher
8. History of radiotherapy for cervical or uterine cancer
9. Medical condition that may interfere with participants' compliance to the protocol
10. Medical condition for which the HITS and laser therapy are contraindicated
11. Previous laser or HITS treatment for SUI
A Web-based Calculator Predicts Heterogeneous Frailty Trajectories

To explore the predictive factors of frailty trajectories and develop a web-based nomogram among gastric cancer survivors.

The aims of this study are to explore the predictive factors of frailty trajectories in gastric cancer patients more comprehensively based on the health ecology theory and to construct a clinically convenient web-based prediction calculator, so as to screen high-risk frailty elderly gastric cancer patients at an early stage in clinical practice, and thus to implement early interventions to improve the prognosis.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with gastric cancer by endoscopy or pathology;
* age ≥60 years old;
* radical gastrectomy was proposed;
* be able to communicate simply in writing and verbally.

Exclusion Criteria:

* combined with other sites of malignant tumors;
* combined with severe heart, liver, lung, and renal insufficiency;
* recent using hormones, immunosuppressants;
* with physical disabilities.
Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients

The purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer.

The randomization is between 50 Gy/25 fractions, 2.0 Gy per fraction, 5 fractions weekly, and 40 Gy/15 fractions, 2.67 Gy per fraction, 5 fractions weekly. The primary endpoint is late radiation morbidity; secondly, we want to investigate the frequency of local recurrences, and try to establish a genetic risk profile for development of late radiation morbidity.

The hypothesis is that women operated with breast conserving strategy for early breast cancer can be offered moderately hypofractionated radiotherapy without developing more late radiation morbidity compared to standard fractionated radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* operated with breast conserving strategy for:

  1. invasive breast cancer, pT1-2, pN0-1mi, M0 OR
  2. carcinoma in situ of the breast

Exclusion Criteria:

* previous radiation of the breast/thorax
* breast implants
* pregnant/lactating
* comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years
The Effects of a Dietary Supplement on Exercise Performance in Healthy Older Adults"

Human exercise capacity decreases with aging. One explanation may be that blood vessels stiffen with age and release less of a compound called nitric oxide (NO). This compound normally relaxes blood vessels and increases blood flow to muscles, but damaging compounds called free radicals can interfere with this process. Antioxidants may help prevent free radicals from inactivating nitric oxide. The purpose of this study was to investigate the effects of an antioxidant supplement that supports NO production on exercise performance in elderly male cyclists.

Since the discovery of the vascular smooth muscle relaxant properties of nitric oxide (NO) over 25 years ago, studies have implicated this molecule in modulating such processes as atherosclerosis, impotence, angina, platelet function, and blood pressure, among others. Through vascular smooth muscle relaxation in both coronary and skeletal muscle arteries, as well as via independent mechanisms, nitric oxide has also been implicated in improvement of exercise capacity. In addition, NO may be involved in the immune system, assist in memory function and sleep regulation, and act as a cellular signaling messenger. Youthful, healthy and athletic individuals generally have a healthier NO system, compared to sedentary, unhealthy and aging individuals. NiteworksTM is a dietary supplement that includes L-arginine, an amino acid that acts as a nitric oxide donor and has been shown to increase levels of this molecule in the body. NiteworksTM has been formulated as a composite mixture along with other supplements, including antioxidants, that may act synergistically with L-arginine in enhancing exercise capacity.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age 50-75 years, inclusive
* Ability to perform pulmonary function and exercise tests
* Willingness to take supplement powder for 3 weeks
* Ethical: Subject must sign the Institutional Review Board-approved written informed consent prior to he initiation of any study specific procedures or randomization. A subject will be excluded for any condition that might compromise the ability to give truly informed consent for participation in the study.

Exclusion Criteria:

* Existing pulmonary or cardiovascular disease
* Previous cardiac surgery
* Not able to tolerate breathing through mouthpiece for up to 20 minutes
* Musculoskeletal disease that would limit exercise
Effect of Physiotherapy and Rehabilitation Program on Physical Activity Level in the Elderly Inpatient

In inpatient older adults, decrement in their mobility and loss in their physical activity are seen in time line between their hospitalization and discharge. The aim of our study was to investigate the effect of physiotherapy and rehabilitation program on physical activity, functional skills and quality of life in elderly inpatient. A total of 124 patients who were randomized as study and control group followed by Hacettepe University Faculty of Medicine Department of Internal Medicine, Division of Geriatric Medicine were included to the study. Thirty minutes physiotherapy and rehabilitation program was applied to the patients in the study group according to their functional levels. Geriatric patients in the control group did exercises by themselves. Demographic data, cognitive functions, muscle strength, presence of comorbidity, functional mobility, physical activity, daily living activities, fear of fall, quality of life and depression status were assessed of all cases. Activities of daily living and depression status was questioned again three months later. This study evaluated the efficacy and cost effectiveness of increasing physical activity in older people during inpatient rehabilitation. These results could assist in the development of evidenced-based rehabilitation programs for this population.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Mini Mental State Examination score greater than 24;
* Stayed in the hospital at least 48 hours.

Exclusion Criteria :

* Angiina pectoris, acute myocarditis, myocardial infarction story in the last 3 months,
* Pulmonary embolism and deep vein thrombosis within the last 3 months,
* Active infection,
* Malignancy and terminal disease status,
* Fracture story in the lower and upper extremities in the last three months
* Severe hearing and visual loss.
Impact of Black Pepper on Energy Expenditure and Substrate Utilization

As obesity rates worldwide continue to increase, there is a focus on identifying active food ingredients which increase metabolic rate which can be used as a dietary supplement in the treatment of overweight and obesity. Promising animal and cell studies have suggested a role for black pepper and an active component of black pepper, piperine, in energy expenditure. However, the effects of black pepper have not been determined in humans. The investigators hypothesis if that consumption of 1.5g black pepper (0.5g in each of three meals over one day) will result in an elevation in 24-h resting energy expenditure when contrasted to a control day (no black pepper, same diet intake).


Eligibility Criteria:
Inclusion Criteria:

* Woman
* Postmenopausal
* Aged 50-65 years
* BMI 25-35kg/m2
* Not taking blood pressure or anti-inflammatory medications or any other medications that may impact the results
* Thyroid hormone profile within the normal reference range
* No medical condition which may impact the results (e.g. diabetes)
* Accustomed to eating regular meals including breakfast

Exclusion Criteria:

* Smoker
* Heavy exerciser (defined as \>150 minutes/week for more than 3 months)
* Abuses alcohol or drugs
* Vegetarian
12 Lead ECG Database

The purpose of this investigation is to collect a database of simultaneous electrocardiogram (ECG) recordings from the SANSA device and a reference 12-lead ECG recording device.

The purpose of this database is to aid development and evaluation of algorithms to detect cardiac arrhythmias and other parameters from the electrocardiogram. Example analyses that may utilize this database are ECG vector transformations and ECG waveform timing analyses.

The study is for scientific purposes and does not intend to diagnose, cure, mitigate, treat, or prevent any disease and does not involve any medical procedures.


Eligibility Criteria:
Inclusion Criteria:

* are 18 years of age or older.
* are able to read, understand, and sign informed consent documentation.
* are willing to undergo simultaneous recordings with the Sansa and 12-lead ECG device.

Exclusion Criteria:

* exhibit deformities of the chest (e.g., pronounced scarring, pectus carinatum) that would interfere with sensor placement
* have broken or injured skin that would interfere with sensor placement
* are known to experience adverse reactions to medical-grade adhesive
* are pregnant
Opting In vs Opting Out

The purpose of this study is to compare methods for consenting (opting in vs opting out) on influenza vaccine uptake rate in pregnant women. This study is designed to learn about the impact of influenza vaccination in pregnant women. This study will help gather knowledge about influenza vaccine side effects (if given) and whether the vaccine reduces the number of respiratory infection in mothers and their infants.

Pregnant women who present for routine prenatal care when influenza vaccine is available would be eligible. Enrolled women would be randomized to either the Opting in (obtaining written consent to administer the vaccine) or Opting out (signing only to refuse the vaccine) study group (Part 1). Vaccine uptake rate and reason for refusal will be captured for enrollees. At the end of this clinic visit, enrollees will be asked if they are interested in participating in Part 2 and 3 of the study. If yes, consent will be obtained. Part 2 of the study, a random sample of 50 women will be called 2 days after enrollment to determine 1) vaccine side effects 2) recall of information provided in consent and 3) to confirm next followup visit with Obstetrician. During Part 3, at 6 weeks post EDD (estimated due date), data about episodes of respiratory illness in the mothers and their infants occuring between the time when influenza vaccine was offered (Part 1) and 6 weeks post-EDD will be abstracted using a standard form. Data will be collected retrospectively by research nurses.

Eligibility Criteria:
Inclusion Criteria:

* pregnant female age \>17 years
* presenting for routine PNC at UT Houston or UT Galveston
* pregnant during influenza season
* pregnant when influenza vaccine available

Exclusion Criteria:

* influenza vaccine contraindication
A Study of the ADME of [14C]RIST4721 in Healthy Male Subjects

A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of \[14C\]RIST4721 Following a Single Oral Dose to Healthy Male Subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Must provide written informed consent
* Body mass index (BMI) 18.0 to 30.0 kg/m2 as measured at screening
* Weight ≥50 kg and ≤100 kg inclusive at screening
* Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)

Exclusion Criteria:

* Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
* Evidence of current SARS-CoV-2 infection
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
Strata EXPress™: A Study Using StrataEXP™ to Identify RNA-Expression Biomarkers in Advanced Cancer Patients

The primary goal of this study is to identify patients with RNA expression profiles consistent with eligibility requirements for therapeutic clinical trials across solid tumors. Left-over tumor tissue will be collected from eligible participants for RNA expression analysis using next-generation sequencing.

The primary goal of this study is to identify patients with RNA expression profiles consistent with eligibility requirements for therapeutic clinical trials across solid tumors. Left-over tumor tissue will be collected from eligible participants for RNA expression analysis using next-generation sequencing.

A parallel study, StrataPATH™ (STR-004-001), has been developed to support therapeutic hypotheses. Participants may be consented and screened for enrollment separately into StrataPATH with an eligible matching biomarker/drug treatment cohort upon positive identification of a relevant expression signature. Treatment effectiveness of antibody drug conjugates and other targeted therapies will be evaluated in these molecularly defined cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. Must be ≥18 years of age,
2. Participant must have pathologically confirmed advanced, metastatic, or recurrent solid tumor,
3. Measurable disease,
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2,
5. Participant must meet at least 1 of the following:

   1. Is/has not adequately responded to standard therapy, or
   2. For whom no life-extending standard therapy exists, or
   3. Who decline standard therapy, or
   4. In the opinion of the investigator, is not a candidate for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy
6. Adequate cardiac, bone marrow, organ function \& laboratory parameters as determined by the treating physician for potential participation in a clinical trial,
7. Leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for StrataEXP testing

Exclusion Criteria:

1. Females who are pregnant or nursing,
2. History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 4 months of enrollment,
3. Any other clinically significant medical condition that, in the opinion of the treating physician, makes participation in a clinical trial undesirable, including but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness.
Efficacy of Whole-body Electromyostimulation (WB-EMS) Training in Participants With Pre-diabetes

The goal of this pilot study is to assess the efficacy of the intervention (WB-EMS Training) in a sedentary group of adults with pre-diabetes and to estimate the potential effect sizes.

The main goals and questions it aims to answer are:

* Efficacy WB-EMS training in sedentary adults with pre-diabetes,
* Has WB-EMS training positive effects on HbA1c and other biomarkers?

Researchers will compare the intervention group with two control groups to see if WB-EMS training has effects on pre-diabetes.

The study is planned as a randomized controlled pilot study. The intervention phase duration is set to 16 weeks. Prior to the study start, all subjects will be screened for their eligibility according to defined inclusion and exclusion criteria.

Sixty eligible sedentary individuals with pre-diabetes between the ages of 40 and 65 years will be randomised to one intervention group (n=20) and two control groups (n=20 each).

The main exercise intervention will be conducted via WB-EMS using a medical device approved system (miha bodytec®, Type II, Gersthofen, Germany). Participants in the intervention and one control group will receive an activity tracker (vivosmart 5, Garmin) to measure daily steps during the 16-week intervention phase. All study groups will further receive an evidence-based lifestyle education programme (6 x 20 minutes for 3 months), which provides education, information, and advice to prevent disease progression and improve quality of life and mobility.

During the baseline visit and after 16 weeks endpoint measurements incl. blood biomarkers, cardiometabolic and body composition parameters will be assessed. The intervention group will additionally attend a follow-up visit after 32 weeks and the parameters will be assessed again.

Eligibility Criteria:
Inclusion Criteria:

* community-dwelling sedentary (\<20 min physical activity on \<3 days/week) men and women aged 40-65 years without Diabetes Type 2
* elevated HbA1c levels (5.7%-6.4%),
* not functionally impaired (Short Physical Performance Battery (SPPB) ≥10)
* signed informed consent
* consent to use the WB-EMS and activity tracker

Exclusion Criteria:

* high-grade arrhythmia/VHF/SM carriers, heart failure \>NYHA2, nephropathy (GFR\<60),
* cognitive impairment
* Diabetes Type 2