cyrilzakka/clinical-trials huggingface dataset:
Study of Application of Transcutaneous Trigeminal Nerve Stimulation and Sound Fusion Stimulation on Tinnitus

This study aims to evaluate the efficacy of applying transcutaneous trigeminal nerve stimulation (NUEYNE-T30, NUEYNE-T100) and sound fusion stimulation on tinnitus.

Duration of study period (per participant): Screening period (-7\~0 days), Intervention period (30 days) Patient needs to visit site at least 3 times (Screening, V1, V2). V1 can be done with screening visit. Tele-visit should be done on day 15.

Eligibility Criteria:
Inclusion Criteria:

* adults suffering from tinnitus
* Participants must be 19 to 70 years of age, at the time of screening
* Patient who suffers from tinnitus symptom more than 3 months and scores more than 18(criteria of mild) in Tinnitus Handicap Inventory (THI) examination
* Patients with a hearing threshold of 70dB or less when calculated using the quadrant method in the pure tone audiometry
* A person who has no physical or mental restrictions in participating in clinical trial
* Those who voluntarily agreed to participate in clinical trials
* A person who has no pregnancy plan and has agreed to the contraceptive plan for infertile women during the intervention period of clinical trial

Exclusion Criteria:

* A person who does not meet the inclusion criteria
* A person who has difficulty communicating and conducting examinations.
* The disease of the outer or middle ear or central nervous system.
* Subjects who have difficulty conducting clinical trials due to intellectual or cognitive impairment
* Pregnant or lactating women
* A person who cannot understand or read ICF (illiterate or foreigner)
* A person who received tinnitus treatment (blood circulation enhancer, tranquilizer, tinnitus masker, biofeedback etc.) within 2 weeks of baseline or plans to receive it.
* A person who is difficult to participate in a clinical trial according to the researcher's judgment. (e.g., heart-related problems, seizure, epilepsy. Patients transplanted metal or electronic device in head \& neck. Patient suffering from unknown pain. Patients who are warned not to use out clinical trial device or is prohibited from using it.)
Digestive Tolerance of Maltitol and FOS

Digestive symptoms following consumption of low digestibe carbohydrates are generally assessed product by product but several ingredients can be used simultaneously. The study aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 and 30
* normal and regular stool frequency: at least 3 stools per week and no more than 3 per days
* subjects not sufferinf from a metabolic, functional or inflammatory disease affecting intestinal transit and nutrients absorption
* subjects not sufferinf from IBS according to Rome III criteria
* subjects not using mdeiction which could affect nutrients absoprtion

Exclusion Criteria:

-
Medication Reviews in Elderly in Primary Care

The study is a follow-up of a randomized controlled study performed in 2011-2012 with medication reviews in elderly patients in Sweden. Additional data about mortality and hospital admissions have been collected.

Background Drug-related problems among the elderly population are common and increasing. Multi-professional medication reviews (MR) have arisen as a method to optimize drug therapy for frail elderly patients. Research has not yet been able to show conclusive evidence of the effect of MRs on mortality or hospital admissions. Aim The aim of this study was to assess the impact of MRs' on hospital admissions and mortality after six and 12 months in a frail population of 369 patients in primary care in a randomized controlled study. Methods Patients were blindly randomized to an intervention group (receiving MRs) and a control group (receiving usual care). Descriptive data on mortality and hospital admissions at six and 12 months were collected. Survival analysis was performed for time to death and time to the first hospital admission within 12 months.

Eligibility Criteria:
Inclusion Criteria:

* age\>75 years, living in nursing homes or community-dwelling with municipality-provided care, with multi-dose drug dispensing

Exclusion Criteria:

* lack of multi-dose drug dispensing, living at home with no municipality-provided care, \<75 years old
Comparison Of Efficacy Of Hydrocortisone And Methyl Prednisolone In Acute Severe Asthma

COMPARISON OF EFFICACY OF HYDROCORTISONE AND METHYLPREDNISOLONE IN ACUTE SEVERE ASTHMA

In this study Investigator will compare the efficacy of hydrocortisone and methyl prednisolone in acute severe asthma that will lead to final result and beneficial effects that will help in early resoloution of symptoms and help in preventing recurrence

investigator will compare the efficacy of hydrocortisone v/s methylprednisolone in management of patients presented with acute severe asthma in emergency.

A local study was conducted in 2009, after that there is a big research gap exists at national level although international literature is available on the same but it can not be generalized to our population due to socio, geographic and economic differences so there is dire need to conduct this study this gives a strong rationale to implement in our settings

Eligibility Criteria:
Inclusion Criteria:

* Either Gender (18 to 50 years old)
* Patient presenting to emergency department with acute severe asthma

Exclusion Criteria:

* Patients with critical illness or pregnant females. .Patient treated other than hydrocortisone and methylprednisolone. .Patients not willing to participate in study.
* Life threatening asthma
* Near fatal asthm
Natalizumab Subcutaneous Immunogenicity and Safety Study

The primary objective of this study is to evaluate the immunogenicity of natalizumab (BG00002) 300 mg subcutaneous (SC) administered to participants with relapsing multiple sclerosis (RMS). The secondary objectives of the study are to evaluate the safety of natalizumab SC injections and to evaluate the efficacy of natalizumab SC injections on relapses and on new magnetic resonance imaging (MRI) lesions.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have documented diagnosis of RMS at screening.
* Must fall within the therapeutic indications stated in the locally approved label for natalizumab.
* Must have an EDSS score from 0 to 6.5, inclusive.

Key Exclusion Criteria:

* Any prior use of natalizumab.
* Positive for anti-natalizumab antibodies at screening.
* Treatment with immunomodulatory injections (including IFN-β and glatiramer acetate) within 2 weeks prior to Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Vitamin D as a Key Player in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a systemic, chronic and inflammatory disease of joints linked to autoimmunity. Vitamin D was found to modulate cell growth, function of immune cells and anti-inflammatory action. The aim of this study was to investigate serum vitamin D level and some cytokines and to identify the correlation between vitamin D and these cytokines in RA.

Methods: Totally 60 RA patients without vitamin D supplement were involved in this study. The serum level of vitamin D, interleukin-6 (IL-6), IL-10, IL-35, tumor necrosis factor α (TNF-α) and C-reactive protein (CRP) were measure in all patients by enzyme-linked immunosorbent assay (ELISA) then they will divided into 2 groups, group I receive vit. D supplementation and group II will receive placebo and follow up for 3 months.

Rheumatoid arthritis (RA) is a systemic, chronic and inflammatory disease of joints linked to autoimmunity. Vitamin D was found to modulate cell growth, function of immune cells and anti-inflammatory action. The aim of this study was to investigate serum vitamin D level and some cytokines and to identify the correlation between vitamin D and these cytokines in RA.

Methods: Totally 60 RA patients without vitamin D supplement were involved in this study. The serum level of vitamin D, interleukin-6 (IL-6), IL-10, IL-35, tumor necrosis factor α (TNF-α) and C-reactive protein (CRP) were measure in all patients by enzyme-linked immunosorbent assay (ELISA) then they will divided into 2 groups, group I receive vit. D supplementation and group II will receive placebo and follow up for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* RA patients

Exclusion Criteria:

* Patients with inflammatory bowel disease patients with any other autoimmune diseases
Multimorbidity and Sarcopenia Feasibility Study in Chronic Kidney Disease

The aim of this research study is to look at the body composition (such as muscle and fat) in people with chronic kidney disease (CKD) and comparing it with body composition is people without CKD. The investigators currently understand loss of muscle function and mass (sarcopenia) affect the general health of people as they age, but this process seems to be more common, accelerated, and occurs earlier in people with CKD. There is limited evidence in this area, and we believe that if we understand when and how sarcopenia affects people with CKD, investigators can guide future trials and treatments to help treat sarcopenia, and in turn improve quality of life and health outcomes in people with CKD.

In this study, the investigators will follow up people with CKD in two visits a year apart. In both visits, the investigators will measure the participants body composition and estimated kidney function using 2 different testing methods - Cystatin C eGFR and Creatinine eGFR. Using both the results in a formula, the creatinine muscle index can be calculated. If this index correlated with sarcopenia, it will be helpful tool in the care of people with CKD as will be a easy to use screening tool for sarcopenia in this population.

Eligibility Criteria:
Inclusion Criteria:

Subjects capable of giving informed consent

≥18 years of age Chronic kidney disease stages 3-5 looked after in secondary care nephrology Healthy volunteers with normal kidney function (Control)

Exclusion Criteria:

* Pregnancy
* Subjects with known neuromuscular diseases, e.g. myopathy, muscular dystrophy, muscular atrophy
* Renal transplant recipients
* Patients with pacemakers
Improving Muslim Women's Uptake of Cancer Screening (IMCAN)

The goal of this non-randomised trial is to test how a workshop that includes religiously-tailored messages can help increase the uptake of breast, colorectal and cervical cancer screening among Muslim women in North East England and Scotland.

The results of this trial will inform the development of a full-scale randomised-controlled trial.

Participants in this study will be asked to take part in a two-hour workshop, deliver either online or in-person.

Low rates of cancer screening among Muslim women puts them at higher risk of death from screening since they do not detect cancer early. This study will work to increase the uptake of cancer screening among Muslim women using two-hour workshops delivered in the community.

The workshops were developed with the help of 10 Muslim women in Scotland. The workshops include four parts:

* A discussion on the barriers and facilitators to breast, cervical and colorectal cancer screening
* A health information session given by a female health provider on cancer screening
* Videos of Muslim women talking about their experiences with cancer screening
* A session given by a female religious scholar to discuss Islamic perspectives on cancer screening.

Another eighteen Muslim women then took part in the workshops; they gave positive feedback on the content of the workshops and how the sessions were delivered.

In the feasibility trial, the workshops will be delivered to 200 Muslim women to find out whether a full-scale randomised-controlled trial can take place. This study will be carried out with the help of 10 Muslim women who will give advice on the content of the workshops and plan for implementation; they will also help with the delivery of the workshops.

It is expected that this study will lead to changes in knowledge and screening uptake among participants.

Eligibility Criteria:
Inclusion Criteria:

* Women from any ethnicity identifying as Muslim
* Muslim Women aged 25-74 years
* Muslim women living in North East England or Scotland
* Muslim women who are not up-to-date with all cancer screening they are eligible for; women who are up-to-date with one type of screening but not others would be eligible (for example, women might be up-to-date with breast cancer screening but not cervical or bowel cancer screening)

Exclusion Criteria:

* Women who do not identify as Muslim
* Women aged less than 25 years or older than 74 years
* Women who are up-to-date with all the screening they are eligible for
* Women who had either breast, cervical or bowel cancer before as their knowledge of the disease and treatment would differ from other women who do not have any prior experience with the disease
* Women who have had BReast CAncer gene testing and underwent mastectomy and/or hysterectomy
Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients

The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2 diabetes. After screening, all patients received gliclazide MR 30mg and instruction regarding diet and physical exercise for 12 weeks. After 4 weeks treated with gliclazide MR 30mg, the patients was randomized to additional GP tea or placebo tea, 3 g twice daily during 8 weeks. Oral glucose tolerance tests were performed at baseline, after 4 and 12 weeks. Blood tests were taken with the purpose to monitor lipids, kidney and liver function.

In Vietnam, herbal extracts have been used as a long-standing tradition to treat diabetic patients, but effects of these extracts have not been studied adequately. Based on previous results in experimental animal, the investigators have selected the plant Gynostemma pentapyllum (GP), which grows in the mountain region of Northern Vietnam. GP extract had a hypoglycemic effect on mice and rat. In addition, GP has been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker fatty rats.The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2 diabetes.In addition to monitoring effects plasma glucose regulation, the investigators also studied possible effects on plasma lipids, kidney and liver function as well as body weight and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, drug-naive patients with type 2 diabetes
* Fasting plasma glucose (FPG)9.0-14.0 mmol/L
* HbA1C 9-13%

Exclusion Criteria:

* Type 1 diabetes
* Liver failure
* Kidney failure
CliniMACS® CD34+ Reagent System for Expanded Access Use

CliniMACs is an investigational device used to select and enrich stem cells. The device will select the stem cells with CD34+ protein. The participant will be infused with the CD34+ selected cells in the hopes that it will help the participant engraft. Engraftment is when transplanted stem cells resume production of healthy blood cells.

* After the screening procedures confirm that the participant is eligible to participate in the research study: If the participant takes part in this research study, the participant (and their donor) will have the following tests and procedures:
* Donor Graft Collection: The participant's cell donor will undergo stem cell collection. The cells collected will be sent to the laboratory for processing.
* Donor Graft Processing: In the laboratory the CliniMACS device will be used to separate the CD34+ stem cells from the other types of cells in the graft. After completing the necessary safety tests, the CD34+ selected donor graft will be ready for administration.
* Donor Graft Infusion: The CD34+ selected donor graft will be infused through an intravenous (I.V.) catheter. The day of this infusion is called Day 0.
* Follow-Up Visits: Approximately 3, 6 and 12 months after the donor graft infusion, the participant will return to clinic for follow-up visits. At each of the visits, the participant will have a physical exam and asked questions about your general health. The participant will also have routine blood tests performed (approximately 1 tablespoon of blood).
* At times more cells are collected from a donation than are needed to do the transplantation. If your physician determines that it is preferable to administer a dose of cells that is less than the complete collection, the extra cells may be frozen and stored in our freezers for the participant's future use. If the cell counts do not improve, the participant will be given the remaining cells through an intravenous (I.V.) catheter.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years
* Diagnosis is graft exhaustion.
* Ability to understand and willingness to sign a written informed consent document
* Matched related or unrelated donor must consent to provide an allograft.

Exclusion Criteria:

* Symptomatic or uncontrolled cardiac failure or coronary artery disease.
* Karnofsky performance status \< 60%.
Effect of Adding Renin-Angiotensin System Inhibitors to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Ellitus

Type 2 diabetes mellitus (T2DM) is a progressive metabolic disorder in which a substantial number of patients cannot attain treatment target despite antidiabetic drugs. The renin-angiotensin system (RAS) has recently been implicated in the development of insulin resistance and impaired glucose metabolism. This study investigates the effect of adding RAS inhibitors to standard antidiabetic therapy in patients with T2DM. The primary outcome measure is the change in serum glycosylated hemoglobin A1c after 24 weeks of treatment. Secondary outcomes measures include changes in plasma lipid profile and blood pressure after treatment.


Eligibility Criteria:
Inclusion Criteria:

* adults over 21 years of age
* clinically diagnosed type 2 diabetes mellitus
* recipients of metformin monotherapy
* compliance with prescriptions and dietary intervention

Exclusion Criteria:

* recipients of any second-line antidiabetic drug in addition to metformin
* recipients of any antihypertensive medication before study enrollment
* hemoglobin disorders
* chronic kidney disease
* thyroid dysfunction
Hydrus Microstent for Refractory Open-Angle Glaucoma

The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.

Participants will attend a screening visit, a baseline visit, a surgery visit, and 8 post-operative visits (Day 1, Day 7, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12), for a total individual duration of approximately 14 months.

Eligibility Criteria:
Inclusion Criteria:

* Open-angle glaucoma with optic nerve pathology;
* Best Corrected Visual Acuity of 20/80 or better in study eye;
* Refractory glaucoma;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Secondary glaucoma other than pseudoexfoliative and pigmentary glaucoma;
* Acute angle closure, chronic angle closure, or congenial, malignant, or developmental glaucoma;
* Pre-perimetric glaucoma;
* Ocular hypertension
* Shallow or flat anterior chamber;
* Other protocol-specified exclusion criteria may apply.
Working Memory Training for Children With Dyslexia

The main aim of this interventional study is to investigate whether the effects of computerized working memory training improves reading abilities for children, i.e. ages 9 - 16 years, diagnosed with dyslexia.

Dyslexia is a specific learning difficulty which mainly affects the development of literacy and language related skills. It is characterized by difficulties with phonological processing, rapid naming, working memory, processing speed and the automatic development of skills that may not match up to an individual's other cognitive abilities. Phonological processing deficit is well established as one of the main causes of dyslexia. Working memory (WM) is today considered to be a cognitive system that strongly relates to a person's ability to think and learn. Over the last decade an increasing body of evidence indicates that WM deficits may cause particular problems for individuals with dyslexia. This is consistent with many of the every day problems reported by dyslexics and those around them. WM deficits are frequent in children with reading deficits. A major question is whether the WM impairment is secondary to phonological core deficit affecting the phonological loop only, or caused by an additional deficit involving central executive. Exploratory findings from fMRI studies indicates that impaired WM processes in dyslexia have a unique neuronal signature which may be associated with central executive processes. However there are conflicting findings and further studies are needed.

The children in the study, all diagnosed with dyslexia, will be divided into two subgroups (16/16 children). They are randomly allocated to either the adaptive training group or the treatment as usual control group after the baseline assessment. Both groups will meet for baseline testing and re-testing 4 weeks after completed training. Those that serve as non-trained controls will be offered to participate in training after completion of the study.

The intervention in this study aim to increase WM of children with dyslexia. We hypothesise that intensive computerized working memory training will improve reading fluency, speed and comprehension for children with dyslexia.

Eligibility Criteria:
Inclusion Criteria:

* Dyslexia

Exclusion Criteria:

* Mental retardation (IQ below 70)