cyrilzakka/clinical-trials huggingface dataset:
Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare insulin degludec and insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high concentration were explorative formulations, not similar to the proposed commercial formulation.


Eligibility Criteria:
Inclusion Criteria:

* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
* Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trialproduct, as judged by the Investigator
* A subject who is known to have hepatitis or who is carrier of the Hepatitis B surface antibodies, or has a positive result to the test for HIV antigen (HBsAg) or Hepatitis C antibodies
* A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.

This is a multi-center study. Neither the study subjects nor the physicians will know what treatment an individual subject is receiving. Subjects will be randomly assigned (like flipping a coin) to one of five treatment groups. The treatment groups include four different dosing groups of active study drug and one group of subjects who will receive placebo. A 12 week follow up period occurs after the 12 weeks of dosing. The study endpoint is a reduction in Hepatitis C viral load.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be adults,
* have a positive Hepatitis C antibody test,
* and be genotype 1, with a minimum of 100,000 IU of Hepatitis C virus by nucleic acid testing, be non-cirrhotic with a Metavir score of F0-3 (or equivalent) on liver biopsy, and have failed previous therapy with Interferon or Peg Interferon monotherapy, Interferon plus ribavirin, or Peg Interferon and ribavirin.

Exclusion Criteria:

* Diabetics are excluded.
Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC

The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With EGFR - TKI Resistance of EGFR Mutations

from the first cycle of treatment (day one) to two month after the last cycle

Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent
2. ≥18 years
3. According to RECIST 1.1 standard, at least one measurable lesions
4. Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation
5. Palliative treatment has received two medicine first-line platinum-based chemotherapy and EGFR - TKI second-line treatment and objective clinical benefit (CR, PR or SD is more than 6 months), RESIST standard curative effect evaluation for progress
6. PS=0,1,2
7. No serious blood, heart, lung, liver and kidney dysfunction, and immune deficiency
8. Hb≥9g/dL；WBC≥3\*109/L，ANC≥1.5\*109/L，PLT≥75\*109/L
9. Men or women of childbearing age in the experiment are willing to take contraceptive measures
10. Estimated survival period for 3 months or more

Exclusion Criteria:

1. The palliative chemotherapy ever use docetaxel and pemetrexed
2. small cell lung cancer non small cell hybrid
3. Women during pregnancy or lactation
4. In the past the anti-tumor treatment of any outstanding ease of \> CTCAE 2 levels of toxicity
5. Ccr\<30 ml/min (calculated by Cockcroft-Gault formula)
6. hepatic insufficiency： Tbil\> 1.5×ULN ALT and AST \> 2.5×ULN (Patients with liver metastasis\>5×ULN) Alkaline phosphatase\>2.5 ×ULN(Patients with liver metastasis\>5×ULN)
7. Severe symptomatic heart disease
8. Symptomatic brain metastases
9. In the last 5 years have been or are suffering from other histological types of malignant tumor
10. There are serious or uncontrolled systemic diseases
11. During the study period planned radiotherapy on target lesion
12. During the study period, plans to use other antineoplastic therapy
13. Clinical study on treatment of 30 days beginning period prior to participate in any study drug
Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes

This study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients.

This study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients. All the recurited patients were treated with metformin 1500-2000mg daily for 3 months. Stool specimens and blood samples were collected at the beginning and 3 months later.

Eligibility Criteria:
Inclusion Criteria:

newly diagnosis type 2 diabetes ,HbA1c \>7 %

Exclusion Criteria:

history of cardiovascular disease, hypertension, severe renal dysfunction defined as glomerular filtration rate \< 45 mL/min/1.73 m2; severe illness or diabetic ketoacidosis within 30 days, inability to tolerate ≥500 mg metformin twice per day and pregnancy.
Effects of Soft Tissue Mobilization at Different Muscle Lengths

The purpose of this study will be to compare the effects of instrument assisted soft tissue mobilization at different muscle lengths on pain pressure thresholds and measures of flexibility.

Instrument assisted soft tissue mobilization is a widely used manual therapy technique, which aims at reducing pain and improving range of motion. Evidence regarding acute responses to instrument assisted soft tissue mobilization at different muscle lengths is lacking. Therefore, the purpose of our study was to conduct a cross-over trial and compare the acute effects of instrument assisted soft tissue mobilization at short and long muscle lengths of the calf muscles on pain pressure thresholds and measures of flexibility.

Eligibility Criteria:
Inclusion Criteria:

* without previous lower limb injuries in the last year
* healthy individuals
* students

Exclusion Criteria:

* Patients with acute lower limb disorders e.g. open wounds, hematoma, trauma
* General hypermobility: Beighton score \>4.
Topical Silver Nanoparticles for Microbial Activity

Silver nanoparticles are one of most nanoparticles use nowadays in the research area because it has specific physical and chemical properties, in medical fields silver nanoparticles can involve in diagnostic and treatment processes. Silver nanoparticles have antibacterial, antiviral, antifungal, antiangiogenic, antioxidant, cosmetics, antitumor, anti-inflammatory, the drug carrier, imaging, water treatment, and biosensing effects. Silver nanoparticles prepared with reducing agent tri-sodium citrate then incorporated in a topical cream to obtain a significant inhibition of the bacterial strains, inhibition of growth of bacterial strains in the face or other parts in the bodies.

1. Preparation of vanishing cream Vanishing cream is an emulsion base which is oil in water, the oil phase gives the cream shine and pearl look because of stearic acid in the oil. To form an emulsion, the alkali will react with stearic acid to form stearate soap. Then mix sodium hydroxide (NaOH) with potassium hydroxide (KOH) to give cream hard and soft properties.
2. Preparation of cream containing silver nanoparticles Silver nanoparticles will be produced by using the reduction reaction method. The reaction involves heating silver nitrate at a high temperature with adding a reducing agent, the particles will produce as silver nanoparticles in liquid form.
3. Characterization of the Vanishing cream containing drug:

   3.1. Drug content: The amount of drug in cream will be determined by taking 100 mg of the cream formulation and dissolve it in 10 mL of methanol after that it will be filtrated. In addition, it will be analyzed the content of drug spectrophotometrically using (UV-VIS) at specific λmax.

   3.2. Irritation to skin: In this test, the cream formulation will be applied to four healthy volunteers which they should not have any sensitivity to the drug. They will inform about the nature of the formulation and obtain a written approval from them about the irritation effect of the formulated cream.
4. Anti-microbial studies:

The antifungal action for formula will be studied using different 6 groups volunteers The inhibition microbial activity for all formulae were compared with known standard antimicrobial drugs.

Eligibility Criteria:
Inclusion Criteria:

* It is important to follow up and collect data, preferably for six months for the local and systemic activity of silver nanoparticles, to establish whether the infection recurrent or not.

Exclusion Criteria:

* Larger numbers of participants having a different kind of skin infection are needed to test efficiency drug in order to produce more reliable data.
Genetic Variants and Perioperative Morbidity and Mortality

Prospective association study to analyse perioperative patients' outcome. Outcome comprises intraoperative and postoperative complications e.g. cardio-vascular events, allergic reactions, Possible variables which might have on influence: patient- and surgery-related data, patients' genetic background etc.

Background Anesthesia and surgery are related to unwanted adverse events, side effects and postoperative discomfort. Whereas severe complications like cardiovascular events are rare, postoperative side effects like nausea and vomiting, pain, long-lasting pain and pain related interference of daily activities are frequent. The question arises which patient is at specific risk for this sequelae. Pre-exiting predisposing factors (e.g. patients' genetic background), surgery and anesthesia related variables (drugs, techniques administered for anesthesia and analgesia) as well as psychological and social factors might influence the outcome.

In this prospective association study these variables will be investigated in a well-described patient cohort presenting for elective surgery.

Objective

The aim of this study is to associate perioperative and postoperative complications and side effects as well as long-term outcome after surgery to patient- and surgery-related variables, including genetic variants.

Methods

Prospective association study performed in two independent patient cohorts.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Written informed consent
* Scheduled surgery

Exclusion Criteria

* No informed consent
* Cognitive impairment
Arthroereisis With Corrective Osteotomy Versus Arthroereisis Alone in Management of Symptomatic Flexible Pes Planovalgus in Adolescents

Arthroereisis ,corrective osteotomies, flexible pes planovalgus, adolescents


Eligibility Criteria:
Inclusion Criteria:

* cases complaining of flexible pes planovalgus non responsive for conservative treatment and cases with generalized ligamentous laxity

Exclusion Criteria:

* neurological disorders and rigid peaplanovalgus
Prospective Trial of Induction Immunotherapy in Locally Advanced or Oligometastatic NSCLC Without a Primary Curative Option

In a certified lung- cancer center, patients with NSCLC and a potentially curative stage (including patients with oligometastatic disease) are prospectively enrolled if curative treatment (either definitive radio-chemotherapy or resection) cannot be performed due to large tumor size or for functional reasons. For these patients, the multidisciplinary tumor board (MDB) recommends immuno-(chemo)therapy and re-evaluation. Response is assessed radiologically including PET-CT if indicated. After review of the MDB, patients receive either definitive curative treatment or palliative treatment.

In a certified lung- cancer center, patients with NSCLC and a potentially curative stage (including patients with oligometastatic disease) are prospectively enrolled if curative treatment (either definitive radio-chemotherapy or resection) cannot be performed due to large tumor size or for functional reasons (e. g. too large radiation field or functionally inoperable for the required resection). For these patients, the multidisciplinary tumor board (MDB) recommends immuno-(chemo)therapy and re-evaluation. Response is assessed radiologically including PET-CT if indicated. After review of the MDB, patients receive either definitive curative treatment or palliative treatment.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed NSCLC
* histologically or cytologically proven
* stage III - IVA (oligometastatic) by complete staging
* ECOG 0-2
* life expectancy 3 months
* ability to provide written informed consent

Exclusion Criteria:

* primary resectability
* primary definitive chemoradiotherapy feasible
Effect of Neomycin on the Pharmacokinetics of Regorafenib

To investigate the effect of neomycin on the pharmacokinetics (PK) of regorafenib in healthy male subjects


Eligibility Criteria:
Inclusion:

* Healthy male subjects
* Age: 18 to 45 years (inclusive) at the first screening examination/visit
* Body mass index (BMI): above/equal 18 and below 30 kg / m²
* Confirmation of the subject's health insurance coverage prior to the first screening examination/visit
* Subjects enrolled in this study must use adequate barrier birth control measures prior to, during the course of the study, and 3 months after the last administration of regorafenib. An adequate contraception includes the use of condoms or a vasectomy. In addition, adequate birth control measures for the subject's partner is required, such as a hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices, bilateral tubal ligation, or hysterectomy.

Exclusion:

* Known or suspected hypersensitivity to regorafenib and/or neomycin
* Any illness or medical condition that is unstable or could jeopardize the safety of the subject and his compliance in the study
* Clinically significant illness within 30 days prior to Day 1, Period 1.
* Regular use of medicines at the time of screening, including herbal supplements and high dose vitamins
* Smoking; however, former smokers who have stopped smoking at least 3 months before the first study drug administration may be included
* Clinically relevant findings in the electrocardiogram (ECG)
* Clinically relevant findings in the complete physical examination
* Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2) at screening.
* Positive urine drug screening
Development of a Risk Prediction Screening Tool for Opioid-Prescription Injury (STOP Injury) in Older Adults Initiated on Opioids From the Emergency Department

The long-term goal of this project is to promote responsible opioid prescribing, immediately improving patient safety and ultimately decreasing healthcare costs by reducing older adult morbidity and mortality due to opioid-related injury. The objective of this pilot project is to gather data to inform the development of the STOP Injury tool and evaluate additional predictive factors and important outcomes relevant to prescription opioids.

The experience from this project will lay the groundwork on prospective validation of STOP Injury in a large appropriately powered study. Aim 1 will provide data that will help narrow inclusion of candidate variables in the STOP Injury tool to include those that are most feasible to collect and most predictive. Aim 2 will help inform the possible inclusion of genetic factors into a predictive model. Finally, Aim 3 will help identify quality of life outcomes that should be considered when assessing opioid medication adverse events.

Aim 1. Evaluate the association between prescription opioid adverse events in older adults and candidate risk prediction variables proposed for STOP Injury prediction score The study team will conduct a pilot prospective observational study of 200 patients 50 years or older who are initiated on opioids from the emergency department (ED). The investigators will analyze the association between candidate risk factors and opioid adverse events (falls and OD).

Aim 2. Evaluate the association between prescription opioid adverse events and genetic factors.

In the cohort from Aim 1, the study team will test subjects for 12 genetic single nucleotide polymorphisms related to opioid metabolism, transport, and effect.

Aim 3. Measure the impact of opioid medications on quality of life measures in older adults The investigators will implement a series of quality of life measures on a subset of patients as a pilot study to determine which measures capture the impact prescription opioids have on older adults' quality of life

Eligibility Criteria:
Inclusion Criteria:

* Presenting to UF JAX ED with pain or a pain-related complaint (i.e., fracture, burn, etc.)
* Patient has not used opioids 15 days or more within the last 30 days
* Patient does not have opioid medications at home
* Discharge to home with an opioid prescription

Exclusion Criteria:

* Bed-bound or uses wheelchair
* Living in skilled nursing facility or assisted living facility
* Non-English speaking
* Unable to provide consent
* Incarcerated
* Lack of reliable telephone access
* Use of opioids on most days for \>3 months
Changes in Quality of Life Following Surgical Treatment of Benign Non-toxic Goiter

The aim is to investigate the influence of surgical treatment on benign non-toxic goiter on the disease specific quality of life evaluated 6 months after thyroid surgery.

All investigations follow already scheduled treatments.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hemi- or total thyroidectomy for benign non-toxic goiter with pressure symptoms
* The patients must be able to understand, read and write Danish

Exclusion Criteria:

* Previous surgery to the neck
* Diabetes or any neuromuscular disorders
* Present or previous head and neck malignancy, including malignancy found in the surgical thyroid specimen or suspicion hereof
Evaluate the Impact of Afatinib on Quality of Life and Symptom Burden of Greek Subjects With Advanced NSCLC in Routine Patient Care Settings

This non-interventional study will include a representative sample of patients with locally advanced or metastatic NSCLC harboring Epidermal Growth Factor Receptor (EGFR)-mutations in Greece. Eligible NSCLC patients, for whom the physician has decided to initiate treatment with the study medication (afatinib, GIOTRIF®) will be treated according to the local prescribing information and standard medical practice in terms of visit frequency and types of assessments performed.

The study will investigate the impact of GIOTRIF (Afatinib) on patients' disease-related symptom burden and Health-Related Quality of Life (HRQoL) in a real world clinical setting in Greece.The Average Symptom Burden Index (ASBI) score of the Lung Cancer Symptom Scale (LCSS) in eligible patients, after 6 months of therapy, will be analyzed.

The overall study duration period is expected to be 60 months, including a 48-month enrollment period and a minimum 12-month follow-up period.

Study Design:

Eligibility Criteria:
Inclusion criteria:

* Adult outpatients (18 years and older) of either gender;
* Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) NSCLC of any histological type with activating EGFR mutation(s) according to local laboratory EGFR testing;
* EGFR- tyrosine kinase inhibitor (TKI) naive patients;
* Patients for whom the decision to prescribe therapy with afatinib (GIOTRIF®) according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study; the assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of afatinib is clearly separated from the physicians decision to include the patient in the current study;
* Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;

Exclusion criteria:

* Patients who have initiated treatment with Afatinib more than 7 days prior to their enrolment into the study;
* Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
* Receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with afatinib
Enhanced Reality for Hemiparetic Arm in the Stroke Patients

The researchers found that enhanced reality developed for the first time in the word by us had a synergistic or additive effect on brain plasticity in patients without central nervous system injury. The aim of this study is to determine the validity and feasibility of enhanced reality in hemiparetic arm in the stroke patients with central nervous system injury.

Pre-interventional evaluation; within 1 day of initiation of the intervention; 10 days after initiation of the intervention; 30 days after termination of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Arm motor Fugl-Mayer scale; wrist/hand subscales ≥ 2-20
* 9-hole pegboard ; ≥ 25% of contra-lateral hand

Exclusion Criteria:

* Alexander apraxia scale ≤2
* NIH stroke scale question Ia-c ≥1
* Nottingham sensory scale; \<75% of contra-lateral hand
* Ashworth scale ≥3
* NIH stroke scale question IX ≥2
* Beck depression inventory ≥21
* Significant upper extremity disease causing hand or below elbow dysfunction
* Visual disturbance
* Refusal of participation