cyrilzakka/clinical-trials huggingface dataset:
The Comparison of Effectivity Therapy by HILT and TRT in Muscle Hypertonus

Comparing the effect of high-intensity laser therapy (HILT) and targeted radiofrequency therapy (TRT) on muscle tone in the cervical and thoracic regions. The research aims to determine the effectiveness of the effect of novel physical therapy on the change of muscle tone in the cervical and thoracic region. This is an intervention experiment applied to a group of 60 probands.

Approximately 60 probands, aged 18-60 years, with no gender preference, will be recruited from patients of an unnamed healthcare facility based on their voluntary participation while receiving a current indication for physiotherapy with a diagnosis of CB syndrome.

Subjects will be randomized into three groups. The first probands (n'20) will have HILT applied bilaterally to the mm. scalene, m.levator scapulae and m.trapezius pars descendens. The second group (n'20) will have TRT applied bilaterally to mm. scalene, m.levator scapulae and m.trapezius pars descendens. No physical therapy or physiotherapy will be used for the third group (n'20) for the duration of the study. Subjects will be examined and treated three times a week for a total of 6 times. The effect of each type of therapy will be demonstrated palpationally and subjectively using an analogue pain scale and an algometer. The obtained results will be further statistically processed.

Eligibility Criteria:
Inclusion Criteria:

* the presence of hypertonus in the mm.scalene, m.levator scapulae and m.trapezius pars descendens bilaterally
* tension demonstrated by palpation and subjective assessment of the patient on an analogue pain scale

Exclusion Criteria:

* Individuals with acute or infectious disease
* probands psychiatric diagnoses
* patients with cancers
* problems with skin integrity disorders
* other contraindications to the use of HILT and TRT
EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal.

The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy.

The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.


Eligibility Criteria:
Inclusion Criteria:

indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent

Exclusion Criteria:

* pregnancy
* age\<18 years
* known colonic strictures
* chronic inflammatory bowel disease
* active inflammation
* s/p colonic resection
Omics4Aging: Stratification of Frailty Population

The overall objective of the study is to stratify a frailty population based on nutrients profiling (amino acids, vitamins, minerals, fatty acids) and metabolic profiling (low molecular weight metabolites in urine and plasma) at baseline.

This exploratory study will investigate ways to better characterize the frailty phenotype by a combination of i) geriatric assessment (here only: frailty criteria according to Fried), ii) clinical surrogate markers (including those of inflammation), iii) body composition, iv) nutritional profiling, v) metabolite profiling using a metabolomics approaches.

Eligibility Criteria:
Inclusion Criteria:

Unless otherwise specified, subjects who fulfill all of the following will be included:

1. Caucasian
2. Male or female between the ages of 65 and 79 years old
3. Three or more Fried Frailty Criteria (as diagnosed by investigator)
4. Informed consent obtained

Exclusion Criteria:

Any of the following criteria would render a subject ineligible for inclusion:

1. Dementia (previously diagnosed by general practitioner)
2. Hb1c (glycate Haemoglobin) \>7.5% (\>58 mmol/mol).
3. End stage disease (1 year after last chemotherapy treatment for cancer)
4. Drug abuse (alcohol - assessed by investigator)
5. Medications: no antibiotic treatment (for at least 4 weeks), immune suppressants, and or chronic use of corticosteroids
6. Currently participating or having participated in another clinical or nutritional intervention trial during the last 3 month
7. Chronic active inflammatory disease (e.g. rheumatoid arthritis, vasculitis, lupus erythematosus and Crohn's disease)
8. Chronic Active hepatitis
9. Kidney failure in Dialysis treatment
10. Any other condition that in the judgment of the lead investigator would not allow the subject to complete the study protocol
A Study on Ca Blocker Versus AII Antagonists in Hypertension With Type 2 Diabetes

The antihypertensive effect of the increased dose of angiotensin II receptor blocker (AII antagonist) is compared with that of the additional combined use of amlodipine in hypertensive patients with Type 2 diabetes mellitus, who have been treated with AII antagonist, the antihypertensive effect of which has been inadequate.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus.
* Patients who have been treated by the single use of AII antagonist at usual for at least 8 weeks or patients who have been treated by the combined use of AII antagonist at usual doses and calcium channel blocker or a antihypertensive drug other than ACE inhibitors for at least 8 weeks.
* Patients who show a systolic blood pressure (blood pressure) \> 135 mm Hg or a diastolic blood pressure \> 85 mm Hg, which is measured (in a sitting position) on an outpatient basis at the time of start of the observation period, and show the mean (blood pressure level measured at home after getting up before the start of study) of systolic blood pressure \> 130 mm Hg or diastolic blood pressure \> 80 mm Hg measured at home after getting up for last 5 days during the last 2-week observation period.
* Patients whose consent is obtained at age 20 years or over.
* Patients whose consent is obtained from themselves in written form. With regard to 2) and 3), however, the case, in which the mean of the systolic blood pressure levels measured at home after getting up for last 5 days during the first 1-week observation period is \> 180 mm Hg or the mean diastolic blood pressure level is \> 110 mm Hg, is included in the present study.

Exclusion Criteria:

* Patients with secondary hypertension.
* Patients who show a systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 110 mm Hg on the measurement (in a sitting position) on an outpatient basis at the time of start of the observation period.
* Patients with severe hepatic dysfunction.
* Patients with severe renal dysfunction.
* Patients with a past history of hypersensitiveness to study drugs.
* Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant during the study period.
* Patients who have participated in the trial within 3 months before the start of the observation period or who attend the trial simultaneously with the present study.
* Other patients judged as being inappropriate for the subjects of the study by investigators.
The Impact of Magnesium on Exercise Tolerance, Quality of Life and Clinical Outcomes in Chronic Heart Failure Patients

Magnesium supplementation could improve cardiac performance. Patients with chronic heart failure (CHF) are magnesium deficient and we hypothesized that 1 year supplementation of oral magnesium comparted to placebo will improve exercise duration time and quality of life.

Magnesium supplementation improves myocardial metabolism, inhibits calcium accumulation and myocardial cell death; it improves vascular tone, peripheral vascular resistance, afterload and cardiac output, reduces cardiac arrhythmias and improves lipid metabolism. Magnesium also reduces vulnerability to oxygen-derived free radicals, improves human endothelial function and inhibits platelet function. Patients with chronic heart failure (CHF) are magnesium deficient. The activation of the renin-angiotensin-aldosterone system and the use of diuretics are associated with depletion of potassium and magnesium in CHF. Magnesium deficiency stimulates aldosterone production and secretion, while magnesium infusion decreases aldosterone production production by inhibiting cellular calcium influx. Adamopoulos et al recently found that CHF in patients \[mainly New York Heart Association (NYHA) II-II\] with low serum magnesium ≤ 2 mEq/L was associated with increased cardiovascular mortality (but had no association with cardiovascular hospitalization) compared to those with serum magnesium \> 2 mEq/L in a long-term follow-up of 36 months, suggesting that most of these deaths were likely sudden (arrhythmic) in nature.

Furthermore, Stepura and Martynow demonstrated that oral magnesium orotate used as adjuvant therapy in severe NYHA IV CHF patients increased 1-year survival rate and improved clinical symptoms and patient's quality of life compared to placebo. The investigators hypothesized that 1-year supplementation of oral magnesium compared to placebo to CHF patients will improve exercise duration time and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* CHF patients NYHA II-IV \> 3 months
* Diuretic therapy \> 3 months
* Signed informed consent

Exclusion Criteria:

* chronic renal failure (serum creatinine \> 3 mg/dL)
* AMI/ACS\< 3 months from randomization
* Cardiac or other organ transplantation
* Uncontrolled hypo/hyperthyroidism
* Chronic diarrhea
* Life expectancy \< 1 year
* Known psychiatric disease which inhibits patient's enrollment to the study
* Inability to come for follow-up visits
* Any planned operation/invasive procedures in the near 6 months
* Uncontrolled cardiac arrhythmias
* Inability to perform 6 minute walk testing
* Any participation in another interventional clinical trial \< 1 month from randomization
* Any malignancy with life expectancy \< 1 year Any AV Block\> 2 degree without a pacemaker
Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia

Background: Dexmedetomidine (Dex) is a highly selective 2-adrenergic receptor agonist with significant analgesia affection. This study is planned to explore the brain regions and functional neuronal network involved in promoting analgesia of Dexmedetomidine. Methods: Select 28 patients with the proposed intraoperative MR-guided radiofrequency ablation of epilepsy. The subjects were randomized into the Dexmedetomidine group (Dex group) (n=14) and the Placebo group (PO group) (n=14). DEX group: continuous intravenously administered 1.5 µg kg-1 h-1 dexmedetomidine 15min before anesthesia induction, continuous infusion for 15min after anesthesia induction, and then Intraoperative functional magnetic resonance imaging scanning was started. PO group: the equivalent administered speed 0.9% sodium chloride was continuously pumped for 15min before anesthesia induction, then induce and intraoperative fMRI scanning started after continuous 30min infusion. The intraoperative fMIR scan results were compared and analyzed to find the unique analgesic brain regions of DEX, and the differences of the functional neuronal network of analgesia effect between the two groups.

Background: Dexmedetomidine (DEX) is a highly selective 2-adrenergic receptor agonist with significant analgesia affection. This study is planned to explore the brain regions and functional neuronal network involved in promoting analgesia of Dexmedetomidine. Methods: Select 12 patients with the proposed intraoperative MR-guided radiofrequency ablation of epilepsy. The subjects were randomized into the Dexmedetomidine group (DEX group) (n=14) and the Placebo group (PO group) (n=14). DEX group: continuous intravenously administered 1.5 µg kg-1 h-1 dexmedetomidine 15min before anesthesia induction, continuous infusion for 15min after anesthesia induction, and then Intraoperative functional magnetic resonance imaging scanning was started. OPI group: the equivalent administered speed 0.9% sodium chloride was continuously pumped for 15min before anesthesia induction, then induce and intraoperative fMRI scanning started after continuous 30min infusion. The intraoperative fMIR scan results were compared and analyzed to find the unique analgesic brain regions of DEX, and the differences of the functional neuronal network of analgesia effect between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of epilepsy and eligible for radiofrequency ablation
2. 20-50 years old;
3. American Society of Anesthesiologists rated (ASA) I-II
4. body mass index (BMI)18.5\~27.9 kg·m2.

Exclusion Criteria:

1. pre-existing neuropsychiatric disorders;
2. emergency surgery;
3. coma;
4. depression;
5. cognitive impairment;
6. implanted with metal devices.
Intraocular Pressure and Tolerability Study of Preservative-free Prostaglandins (Bimatoprost and Latanoprost) on Glaucoma and Ocular Hypertension: European, Multicentric, Investigator-led, Single Masked Study

Bimatoprost 0.03% preservative free monodose eye drops solution (BUDPF) is a new product composed of a synthetic prostamide, bimatoprost 0.3% in a preservative free formulation. This new product is used as a once-daily topical ocular therapy for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma, or ocular hypertension, and that are sensitive to preservatives. The individual active component of BUDPF, bimatoprost is an established therapeutic agent with well documented IOP efficacy (1). Prostamides, such as bimatoprost, are believed to lower IOP mainly by increasing uveoscleral outflow. The comparator, Preservative Free Latanoprost 0.005% Unit Dose (LUDPF, eg. Monoprost®), was recently launched in a number of countries in Europe and contains latanoprost in a new preservative free formulation.

It is clinically important to compare these newly entered preservative free products with respect to tolerability and efficacy. A better tolerability combined with maximum efficacy will reduce the burden of daily glaucoma therapy and provide a clear therapeutic benefit to the glaucoma patient by providing enhanced compliance and real-world IOP-lowering efficacy.

The hypothesis of the study is that monodose bimatoprost is more effective than monodose latanoprost by at least 1 mmHg.

(AIBILI applied for an unrestricted grant from Allergan to perform this study)


Eligibility Criteria:
Inclusion Criteria includes:

* Ocular hypertension, pseudoexfoliation glaucoma (XFG) or primary open-angle glaucoma (POAG) patients that have been on a preserved prostaglandin monotherapy for at least 6 weeks. At prescreening and screening visit the IOP is less than or equal to 21 mm Hg in both eyes.

Exclusion Criteria includes:

* Any ocular condition that are of safety concern, visual field defects with an MD value above -12dB, a closed/barely open anterior chamber angles or history of acute angle closure on either eye, ocular surgery within the past three months on either eye; glaucoma surgery within the past 6 months on either eye, ocular inflammation/infection occurring within three months prior to pretrial visit on either eye, pigmentary glaucoma or neovascular glaucoma on either eye, topical ocular medication that can interfere with study medication on either eye and known hypersensitivity to any component of the trial drug solutions and participation in any other clinical trial, involving an investigational drug within one month prior to pretrial visit
Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria

This is a phase II a, double-blind, randomized, parallel-design, four-week study to investigate the efficacy, safety and tolerability of two different doses of SPP635 in type II diabetic patients with mild to moderate hypertension and albuminuria.

The total study duration for patients completing the entire study will be approximately 7 weeks including a 2 weeks Screening Phase, 1 week Wash-out Phase, 4 week Treatment Phase and 1 week Follow-up Phase.

All treatments other than certain antihypertensive drugs (which are to be washed-out) with an effect on BP and all antidiabetic treatments must be kept at stable dose during the whole study.

A maximum of 50 patients in total is planned to be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* men or women, 18 to 75 years
* hypertension
* diabetes mellitus type II
* albuminuria

Exclusion Criteria:

* donation of blood in the past month
* significant illness
* history of malignancy
* Heart failure, stroke, myocardial infarction, transient ischaemic attack, or hypertensive encephalopathy within the past 6 months
* Current or past history of clinically significant electrocardiogram (ECG) abnormalities such as permanent 2nd degree atrioventricular (AV) block or higher, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) or cerebrovascular accident in the last three months
Acute Effects of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Forced Expiratory Flow Volume in One Second (FEV1) and Blood β-Endorphin Level in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The objective of this study is to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions, dyspnoeic symptoms and its association with beta endorphin level in subjects with COPD.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis with COPD

Exclusion Criteria:

* allergic to gel
* unable to perform spirometry
* unable to communicate
Predictive Clinical Diagnosis of Rheumatoid Arthritis Flares Using Non-Invasive Infra-red Thermal Imaging and an AI/ML Algorithm

The hypothesis for this clinical research project is that the severity of RA may be detected and predicted using an optimized ML/AI algorithm that uses infrared thermal images of inflamed joints and standard clinical RA-related markers (i.e., ESR and CRP) by computing DAS-28 ESR scores in real-time. The infrared thermal images coupled with clinical laboratory markers and the ML/AI algorithm are expected to assist a practicing clinician in the RA diagnosis and the prediction of the occurrence of flares in RA patients. Physicians who use this technology, would need minimum training and will be able to accurately and reliably diagnose RA using a cheaper method which does not involve incident radiation emitted by other imaging modalities such a X-RAY, musculoskeletal (MSK) ultrasound, or a magnetic resonance imaging (MRI). The aim would be to have the Infrared thermal imaging devices at remote VA clinics that do not have a rheumatology specialist where veterans can go for their inflammatory arthritis flare and get this image by the local VA RN. These clinical results can then be assessed by and discussed with a Rheumatologist via telehealth visits.

Objective #1: To assess the clinical feasibility of implementing a novel, physician assisting, diagnostic approach for RA when compared to conventional RA examination and diagnostic procedures.

This prospective, non-interventional study will assess clinically assess and diagnose the severity of RA in sero-positive RA patients experiencing active flares by using conventional examination and diagnostic methods, and compared those with a physician-assisting, diagnostic approach that involves the use of an infrared thermal imaging device, which detects heat waves to be correlated between RA patients and control subjects (i.e., those who do not have RA or who are in remission). Standard clinical laboratory values will be documented from the EHR system as well and will include ESR (sedimentation rate) and CRP (c-reactive protein).

Objective #2: To develop and optimize a ML/Artificial intelligence(AI) algorithm that would process and analyze thermal images and assist in the predictive diagnosis of RA using the DAS-28 ESR score for those thermal images of the inflamed joints of patients.

This study will predict the probability of an actual flare occurrence and its severity in RA patients by using an optimized, physician assisting ML/AI algorithm that processes and analyzes thermal images from sero-positive RA patients in pain and experiencing flares and that calculates the DAS-28 scoring system in real-time

Eligibility Criteria:
Inclusion Criteria:

* rheumatoid arthritis

Exclusion Criteria:

* non complaince
Empowering Patients On Choices for Renal Replacement Therapy (Aim 1)

The EPOCH-RRT study seeks to fill knowledge gaps by gaining more understanding of chronic kidney disease (CKD) patients' priorities; assessing the comparative benefits of hemodialysis (HD) versus peritoneal dialysis (PD), with respect to these priorities; and providing tailored information to assist patients with identifying the best dialysis modality fit for their own unique circumstances and perspectives.

The outcomes most relevant to patients ("patient-centered") extend beyond those traditionally assessed in clinical research, with the relative importance varying across patient groups. A tailored decision aid based on these findings can improve patient decision-making processes regarding choice of dialysis modality.

Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT)study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. The inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis.

Aim One of EPOCH-RRT identifies outcomes that are most important to different groups of advanced CKD and dialysis patients through qualitative methods applied for conducting in-depth interviews.

Eligibility Criteria:
Inclusion Criteria:

* Individuals 18 years of age or older.
* Individuals with advanced chronic kidney disease or on dialysis (in-center, hemodialysis, or peritoneal dialysis) for at least three months.

Exclusion Criteria:

* Individuals under 18 years of age.
* Individuals unable to provide informed consent.
* Individuals who do not have chronic kidney disease.
Expanded Access to Everolimus, for an Individual Patient With Uterine Sarcoma (CTMS#18-0020)

Single patient treatment with everolimus.


Eligibility Criteria: